# Final Formulary November إصدار معتمد

Benha Children Hospital
Pharmacy department
Drug information center
Hospital Drug formulary

2024
WHO AWaRe Antibiotic classification included
Supervised by: head of pharmacy department/

Dr. Abeer Nagib Al shafeey
Prepared by: clinical pharmacist/

Amira Mahmoud Hamdy
Revised by Clinical pharmacists/

Eman Mohammed Abdulaziz
Eman Mostafa Badr
Amira Mahmoud Hamdy
References
1– Pamphlet of available product

2– Lawrence A. Trissel's database on injectable drug accessed via lexicomp
3– Lexicomp pediatric and neonatal /multinational drug information data bases
4– Micromedex Neofax accessed via mobile App
5– BNFC British national formulary for Children 2022-2023
6– Inhaled pharmacotherapy for neonate, Turkish archives of pediatric 2022
7– AHFS: American hospital formulary service
8 – eMC: electronic medicines compendium accessed at medecines.org.uk
9 – BC Cancer Chemotherapy Preparation and Stability version 2.00 issued 13 April 2023
10 – C&W online formulary accessed via www.pedmed.org
11 – Medscape drug information databases accessed via mobile app
12 – ASPEN recommendations on enteral/parenteral nutrition 2020
13 – Manley, B.J., Kamlin, C.O.F., Donath, S. et al. Intratracheal budesonide mixed with surfactant
to increase survival free of bronchopulmonary dysplasia in extremely preterm infants: study
protocol for the international, multicenter, randomized PLUSS trial. Trials 24, 320 (2023)
14 – Kothe TB, Sadiq FH, Burleyson N, Williams HL, Anderson C, Hillman NH. Surfactant and
budesonide for respiratory distress syndrome: an observational study. Pediatr Res. 2020
Apr;87(5):940-945.
15 – Dewi T. Depositario-Cabacar,Jurriaan M. Peters, Amanda W. Pong,Julie Roth,
Alexander Rotenberg, James J. Riviello Jr, and Masanori Takeoka 2010, High-dose intravenous
levetiracetam for acute seizure exacerbation in children with intractable epilepsy, Epilepsia,
51(7):1319–1322
16 – Micromedex pediatric accessed via mobile app
17 – Nelson's pediatric antimicrobial 2021
18 – Children's and Women's Hospital (C&W) Online Formulary! accessed online
19 – Stanford pediatric critical care
20 – Leaute-Labreze C, Dumas de la Roque E, Hubiche T et al. Propranolol for severe hemangiomas
of infancy. New Engl. J. Med. 2008; 358: 2649–51.
21 – Shenoi RP, Timm N; Committee on Drugs; Committee on Pediatric Emergency Medicine.
Drugs Used to Treat Pediatric Emergencies. Pediatrics. 2020;145(1):e20193450
22 – Pugh RN, Murray-Lyon IM, Dawson JL, et al. Transection of the esophagus for bleeding
esophageal varices. Br J Surg. 1973, 60:646.
23 – Child CG, Turcotte JG. The Liver and Portal Hypertension. Philadelphia, WB Saunders Co.
1964.
24 – Trey C, Burns DG, Saunders SJ. Treatment of hepatic coma by exchange blood
transfusion. NEJM. 1966, 274:473
25 – Traub SL and Kichen L, "Estimating Ideal Body Mass in Children," Am J Hosp Pharm, 1983,
40(1):107-10
26 – Schwartz GJ, Work DF. Measurement and estimation of GFR in children and adolescents. Clin
J Am Soc Nephrol. 2009;4:1832–43
27 – Staples A, LeBlond R, Watkins S, et al. Validation of the revised Schwartz estimating equation
in a predominantly non-CKD population. Pediatr Nephrol. 2010 Nov;25(11):2321-6
28 – Dodds Ashley ES, Zaas AK, Fang AF, Damle B, Perfect JR. Comparative pharmacokinetics of
voriconazole administered orally as either crushed or whole tablets. Antimicrob Agents
Chemother. 2007 Mar;51(3):877-80
29 – Garcia-Lloret M, McGhee S, Chatila TA. Immunoglobulin replacement therapy in children.
Immunol Allergy Clin North Am. 2008 Nov;28(4):833-49, ix
30 – LTHT Paediatric ICU Administration Guide/Intravenous Atracurium
1
Abbreviations in this formulary
+ve Positive GBS Group B Streptococcus
↑ Increase /increased GERD Gastroesophageal Reflux Disease
↓ Decrease/decreased GFR Glomerular Filtration Rate
ABG Arterial Blood Gases GGT Gamma-Glutamyl Transferase
ACE Angiotensin converting enzyme GINA Global Initiative For Asthma Guidelines
AGEP Acute Generalized Exanthematous Pustulosis GIT Gastrointestinal Tract
ALL Acute Lymphocytic Leukemia G-ve Gram Negative
ALP Alkaline Phosphatase GVHD Graft-Versus-Host Disease
ALT Alanine Aminotransferase Hct Hematocrit
AMI Acute Myocardial Infarction hr Hour
ANC Absolute Neutrophil Count HR Heart rate
ARDS Acute Respiratory Distress Syndrome HSCT Human Stem Cell Transplant
ARF Acute Renal Failure HSV Herpes Simplex Virus
AST Aspartate Aminotransferase HUS Hemolytic-Uremic Syndrome
BJI Bone & Joint Infection IAI Intra-Abdominal Infection
BP Blood Pressure IBW Ideal Body Weight
BSA Body Surface Area IEM Inborn error of metabolism
BUN Blood Urea Nitrogen IgA Immunoglobulin A
CAPD Continuous ambulatory peritoneal dialysis IHD Intermittent Hemodialysis
CD Clostridioides Difficile IM Intramuscular
CDAD Clostridioides Difficile-Associated Diarrhea INR International Normalized Ration
CF Cystic Fibrosis IO Intraosseous
CIDP Chronic Inflammatory Demyelinating IOP Intraocular Pressure
CLD Polyneuropathy
Chronic Lung Disease ISMP Institute For Safe Medication Practice
CLL Chronic Lymphocytic Leukemia IT Intrathecal
Cm Centimeter ITP Immune Thrombocytopenia
CML Chronic Mylocytic Leukemia IV Intravenous
CMV Cytomegalovirus LDH Lactate Dehydrogenase
CNS Central Nervous System LMWH Low Molecular Weight Heparin
CoN Coagulase Negative LRT Lower Respiratory Tract
Conc Concentration MAOI Monoamine Oxidase Inhibitors
COPD Chronic Obstructive Pulmonary Disease max Maximum
CrCl Creatinine Clearance MDR Multidrug Resistant
CRP C-Reactive Protein MDS Myelodysplastic Syndrome
CRRT Continuous Renal Replacement Therapy Mg Magnesium
CSF Cerebrospinal Fluid Mg so4
Magnesium Sulfate
D5W Dextrose 5% min Minute
DIC Disseminated Intravascular Coagulation MPE Maculopapular Eruption
DRESSDrug Reaction With Eosinophilia & Systemic NAEPPNational Asthma Education And
Symptoms Prevention Program
DVT Deep Vein Thrombophlebitis NEC Necrotizing Enterocolitis
EEG Electroencephalogram NS Normal Saline 0.9%
ELBW Extremely Low Birth Weight Neonate OTC Over The Counter
ESRD End Stage Renal Disease PHACE Posterior fossa anomalies, Hemangioma,
FN Febrile Neutropenia Arterial anomalies, Cardiac anomalies,
G+ve Gram Positive and Eye anomalies
GA Gestational Age PCR Polymerase Chain Reaction
GAS Group A Streptococcus PD Peritoneal Dialysis
2
PE Pulmonary Embolism Sr Serum
PFL Protect from light Sr Cr Serum Creatinine
PIRRT Prolonged intermittent renal replacement therapy SSI Skin & Skin Structure Infection
PMA Postmenstrual Age SVT Supraventricular Tachycardia
PNA Post Natal Age = Age SWFI Sterile Water For Injection
PP polypropylene syringe TDM Therapeutic Drug Monitoring
PPIs Proton Pump Inhibitor Temp. Temperature
PRCA Pure Red Cell Aplasia TEN Toxic Epidermal Necrolysis
PT Prothrombin Time THC Tetrahydrocannabinol
PTT Partial Thromboplastin Time TLS Trimethoprim
PVC Polyvinyl chloride TMP Trimethoprim
RD Respiratory Distress UAC Umbilical Artery Catheter
RT Room Temperature ULN Upper Normal Level
RTI Respiratory Tract Infection UOP Urine Output
RPLS Reversible posterior leukoencephalopathy UTI Urinary Tract Infection
syndrome VLBW Very Low Birth Weight Neonate
SIADH Syndrome of inappropriate antidiuretic VT Ventricular Tachycardia
hhhorhormone
SCARs Severe cutaneous adverse reactions Yr Year
SJS Stevens-Johnson Syndrome
SLE Systemic Lupus Erythematosis
3
Child Pugh score for hepatic impairment (Cirrhosis) in children22, 23, 24
Encephalopathy
None: (1 point)
Grade 1: (2 points) Altered mood/confusion
Grade 2: (2 points)Inappropriate behavior, impending stupor, somnolence
Grade 3: (3 points)Markedly confused, stuporous but arousable
Grade 4: (3 points)Comatose/unresponsive
Ascites
Absent (1 point)
Slight (2 points)
Moderate (3 points)
Bilirubin
<2 mg/dL (1 point)
2 – 3 mg/dL (2 points)
> 3 mg/dL (3 points)
Albumin
>3.5 g/dL (1 point)
2.8 – 3.5 g/dL (2 points)
< 2.8 g/dL (3 points)
Prothrombin time prolongation
Less than 4 sec above control/INR <1.7 (1 point)
4 - 6 sec above control/INR 1.7-2.3 (2 points)
> 6 sec above control/INR >2.3 (3 points)
Score Interpretation
5 – 6 points Child class A
7 – 9 points Child class B
10 – 15 points Child class C
In cases of Primary Biliary Cirrhosis, Bilirubin point values are sometimes considered differently:
o 1 – 4 mg/dL -->1 point
o 4 – 10 mg/dL -->2 points
o >10 mg/dL -->3 points
Ideal body weight for pediatric 25

IBW = [(height2) x 1.65] ÷ 1000
 IBW = ideal body weight in kg
 Height measured in cm
This formula is intended for patients younger than 18 years old and with a height ≤60 inches (152 cm).
Schwartz Equations for calculating kidney function in low-birth-weight infants and patients up to age 21 years26
eGFR = k x (height in cm) ÷ serum Cr (ml/min/1.73 m2)
 k = 0.33 in preterm infants
 k = 0.45 in term infants to 1 year of age
 k = 0.55 in children to 13 years of age
 k = 0.70 in adolescent males (females remain at 0.55 after age 13 years)
Bedside Schwartz Equation (Modified Schwartz Equation) for age: 1–18 yr27
GFR = [0.413 × L] ÷ Sr Cr (ml/min/1.73 m2)
4
Equivalent anti-inflammatory doses of corticosteroids
Prednisolone 1 mg Betamethasone 150 micrograms
Deflazacort 1.2 mg
Dexamethasone 150 micrograms
Hydrocortisone 4 mg
Methylprednisolone 800 micrograms
Triamcinolone 800 micrograms
Adapted from BNFC 2022-2023
Body surface area in pediatric

Body-weight Surface area Body-weight Surface area Body-weight Surface area
(kg) (m2) (kg) (m2) (kg) (m2)
1 0.10 25 0.92 58 1.6
1.5 0.13 26 0.95 59 1.7
2 0.16 27 0.97 60 1.7
2.5 0.19 28 1.0 61 1.7
3 0.21 29 1.0 62 1.7
3.5 0.24 30 1.1 63 1.7
4 0.26 31 1.1 64 1.7
4.5 0.28 31 1.1 65 1.8
5 0.30 33 1.1 66 1.8
5.5 0.32 34 1.1 67 1.8
6 0.34 35 1.2 68 1.8
6.5 0.36 36 1.2 69 1.8
7 0.38 37 1.2 70 1.9
7.5 0.40 38 1.2 71 1.9
8 0.42 39 1.3 72 1.9
8.5 0.44 40 1.3 73 1.9
9 0.46 41 1.3 74 1.9
9.5 0.47 42 1.3 75 1.9
10 0.49 43 1.3 76 2.0
11 0.53 44 1.4 77 2.0
12 0.56 45 1.4 78 2.0
13 0.59 46 1.4 79 2.0
14 0.62 47 1.4 80 2.0
15 0.65 48 1.4 81 2.0
16 0.68 49 1.5 82 2.1
17 0.71 50 1.5 83 2.1
18 0.74 51 1.5 84 2.1
19 0.77 52 1.5 85 2.1
20 0.79 53 1.5 86 2.1
21 0.82 54 1.6 87 2.1
22 0.85 55 1.6 88 2.2
23 0.87 56 1.6 89 2.2
24 0.90 57 1.6 90 2.2
Adapted from the BNFC 2022-2023
5
Formulary AWaRe classification
Access group antibiotics
This group includes antibiotics that have activity against a wide range of commonly encountered susceptible
pathogens while also showing lower resistance potential than antibiotics in the other groups. Access group
antibiotics are recommended as essential first or second choice empiric treatment options for infectious
syndromes reviewed by the EML Expert Committee
Antibiotic Class ATC code Category
Amikacin Aminoglycosides J01GB06 Access
Amoxicillin Penicillins J01CA04 Access
Amoxicillin/clavulanic-acid Beta-lactam/beta-lactamase-inhibitor J01CR02 Access
Ampicillin Penicillins J01CA01 Access
Ampicillin/sulbactam Beta-lactam/beta-lactamase-inhibitor J01CR01 Access
Clindamycin Lincosamides J01FF01 Access
Flucloxacillin Penicillins J01CF05 Access
Gentamicin Aminoglycosides J01GB03 Access
Metronidazole_IV Imidazoles J01XD01 Access
Metronidazole_oral Imidazoles P01AB01 Access
Sulfamethoxazole/trimethoprim Sulfonamide-trimethoprim-combinations J01EE01 Access
Watch group antibiotics
This group includes antibiotic classes that have higher resistance potential and includes most of the highest
priority agents among the Critically Important Antimicrobials for Human Medicine and/or antibiotics that are at
relatively high risk of selection of bacterial resistance. Selected Watch group antibiotics are recommended as
essential first or second choice empiric treatment options for a limited number of specific infectious syndromes
Azithromycin Macrolides J01FA10 Watch
Cefepime Fourth-generation-cephalosporin J01DE01 Watch
Cefixime Third-generation-cephalosporin J01DD08 Watch
Cefotaxime Third-generation-cephalosporin J01DD01 Watch
Ceftazidime Third-generation-cephalosporin J01DD02 Watch
Ceftriaxone Third-generation-cephalosporin J01DD04 Watch
Ciprofloxacin Fluoroquinolones J01MA02 Watch
Clarithromycin Macrolides J01FA09 Watch
Imipenem/cilastatin Carbapenems J01DH51 Watch
Levofloxacin Fluoroquinolones J01MA12 Watch
Meropenem Carbapenems J01DH02 Watch
Piperacillin/tazobactam ß-lactam/beta-lactamase-inhibitor_anti-pseudomonal J01CR05 Watch
Teicoplanin Glycopeptides J01XA02 Watch
Vancomycin_IV Glycopeptides J01XA01 Watch
Vancomycin_oral Glycopeptides A07AA09 Watch
Reserve group antibiotics
This group includes antibiotics that should be reserved "last resort” for treatment of confirmed or suspected
infections due to multi-drug-resistant organisms. These antibiotics use should be tailored to highly specific patients
and settings, when all alternatives have failed or are not suitable. These medicines could be protected and
prioritized as key targets of national and international stewardship programs involving monitoring and utilization
reporting, to preserve their effectiveness
Colistin_IV Polymyxins J01XB01 Reserve
Colistin_oral Polymyxins A07AA10 Reserve
Linezolid Oxazolidinones J01XX08 Reserve
Adapted from WHO excel sheet 2021 for WHO AWaRe classification list of Antibiotics 2021.
6
Antibiotics /Aminopenicillin
Ampicillin sodium injection
Trade name Ampicillin
Active drug Ampicillin sodium
Dosage form Vial 500 mg for IV ,IM
Mechanism of action Bactericidal agent inhibits cell wall synthesis of many G+ve, G-ve & anaerobic bacteria
Indications Upper & lower RTI, Gynecologic infection, SSI, GIT infection, UTI, Meningitis
Dose Neonate 425 - 50 mg/kg/dose slow IV push or IM , Intervals according to table below
PMA Age Intervals
(weeks) (days) (hours)
≤29 0 – 28 12
>28 8
30-36 0 – 14 12
>14 8
37-44 0–7 12
>7 8
≥45 All 6
Septicemia, Bacteremia, GBS empiric- targeted (Early, late) & Meningitis (Non- GBS)
GA PNA Dosing &
(weeks) (days) Intervals
≤34 ≤7 50 mg/kg/12 hr Duration : 48-72 hr after evidenced
8-28 75 mg/kg/12 hr or clinical resolution & at least 10
>34 0-28 50 mg/kg/8 hr days for GAS
Meningitis with GBS empiric- targeted
PNA(days) Dosing & interval
≤7 100 mg/kg/8 hr Duration: 14 days for uncomplicated infection,
>7 75 mg/kg/6 hr longer durations for complicated infection
Infant, child & Adolescent 3: IV, IM:
50 – 200 mg/Kg/day divided/ 6 hr. Usual max.: 2g /dose. (8 g /day)
Severe3: Up to 400 mg /kg/day divided/6 hr Usual max.: 3g /dose.(12 g /day)
Endocarditis(child, adolescent IV):200 – 300 mg/Kg/day divided/ 4 – 6 hr (max. 12 g/day)
Duration : at least 4 weeks in combination regimen
Meningitis: (age≥ 1 month IV):300 – 400 mg/Kg/day divided/ 4 – 6 hr (max. 12 g/day)
Surgical prophylaxis: 50 mg/ kg within 60 min prior to procedure, may repeat in 2 hr in
lengthy procedure or excessive blood loss (max.: 2g /dose)
Dose adjustment Renal impairment : Infant, Child & Adolescent3
based on doses of 100 - 200 mg/kg/day divided/ 6 hr IM, IV:
GFR 30 – 50 mL/min1.73 m2: 35 – 50 mg/kg/ 6 hr
GFR 10 – 29 mL/min/1.73 m2: 35 – 50 mg/kg/ 8 - 12 hr
GFR <10 mL/min/1.73 m2: 35 – 50 mg/kg/12 hr
IHD: 35 – 50 mg/kg/dose / 12 hr
PD: 35 – 50 mg/kg/dose / 12 hr
CRRT: 35 – 50 mg/kg/dose/ 6 hr
Hepatic Impairment: Pediatric: no adjustment
Preparation IV: 500 mg + 5 ml SWFI 2
IM: 500 mg + 1.8 ml SWFI 2 (conc 125 – 250 mg /ml accepted) 3. Incompatible with D10W
Administration IV: Doses ≤ 500 mg direct IV over 3-5 min2,3
Doses > 500 mg over 10-15 min3 (Rapid administration may cause seizures)
Stability Store at 25 ◦c protected from light
Use reconstituted solutions within 1 hr 2,3
7
Adverse reactions3 1 – 10 %
CNS: Brain disease (penicillin-induced), glossalgia, seizure, sore mouth
Dermatologic: Erythema multiforme, exfoliative dermatitis, skin rash, urticaria
GIT: Diarrhea, nausea, oral candidiasis, pseudomembranous colitis, stomatitis, vomiting
Hematologic: Agranulocytosis, anemia, eosinophilia, hemolytic anemia, ITP, leukopenia
Hepatic: ↑Sr AST
Hypersensitivity: Anaphylaxis
Immunologic: Serum sickness-like reaction
Renal: Interstitial nephritis (rare)
Respiratory: Stridor
Other: Fever
<1%, postmarketing, and/or case reports: Dysgeusia
Contraindications3 Hypersensitivity to ampicillin, any component of the formulation, or other penicillins
infections caused by penicillinase-producing organisms
Antibiotics /Aminopenicillin+ß-lactamase inhibitor

Ampicillin /Sulbactam Injection
Trade name Unictam /Novactam /Sulbin 750 mg
Active drug Ampicillin Sodium 500 mg + Sulbactam sodium 250 mg
Dosage form Vial 750 mg for IV,IM
Mechanism of action Bactericidal agent inhibits cell wall synthesis of many G+ve, G-ve & anaerobic bacteria
Indications Skin and soft tissue, IAI, gynecological, endocarditis, meningitis, BJI & surgical prophylaxis.
Dose Neonate
Age ≤7 days: 150 mg/kg/ day divided /12 hr IV/IM 1
Age > 7 days: 150 mg/kg/day divided /6 – 8 hr IV/IM 1
Higher dosing may be necessary for severe/resistant Acinetobacter infections 3
Other references suggest
Preterm neonate : 150 mg/kg/day divided /12 hr IV 3
Term neonate 150 mg/kg/day divided / 8 hr IV 3
infants & children: 150 mg /kg/day divided /6 – 8 hr 1 up to 300 mg /kg /day divided /6 hr3
Severe infections: 200 – 400 mg ampicillin/kg/day divided/6 hr 3
Endocarditis, Meningitis: Daily dose may be divided /4 – 6 hr (max. 3g Unictam/dose)
Max. dose: 2 g Ampicillin/dose= 3 g Unictam (4g Sulbactam , 8 g Ampicillin/day)
Surgical prophylaxis3: IV: 75 mg Unictam/kg within 60 min. prior to procedure
may repeat in 2 hr if prolonged procedure & excessive blood loss
Max. dose: 2 g ampicillin/dose = 3 g Unictam /dose
Dose adjustment Altered Kidney Function3
Child & Adolescent: IV:
CrCl ≥30 mL/min/1.73 m2: No adjustment.
CrCl 15 – 29 mL/min/1.73 m2: dose/ 12 hr
CrCl 5 – 14 mL/min/1.73 m2: dose/ 24 hr
Hepatic Impairment There are no dosage adjustments provided
Preparation1 IV: 750 mg + SWFI 1.6 ml
IM: 750 mg + SWFI 1.6 ml Or 0.5 % Lidocaine (375mg/ml)
Administration 1,3 IV slow injection over: 10-15 min
1
Stability Use immediately after preparation or within 1 hr of preparation
Store intact vial at 25◦ C protected from light
Adverse reactions 3 >10%: Local: Pain at injection site (IM, IV)
1% - 10%:
CVS: Phlebitis , thrombophlebitis
Dermatologic: Skin rash
GIT: Diarrhea
<1%:
CVS: Chest pain, edema, substernal pain
8
Dermatologic: Erythema of skin, facial swelling, pruritus
GIT: Abdominal distention, flatulence, glossitis, nausea, vomiting
Genitourinary: Dysuria, urinary retention
Hematologic: Lymphocytosis (atypical), mucous membrane bleeding
Infection: Candidiasis
CNS: Chills, fatigue, headache, malaise
Respiratory: Constriction of the pharynx, epistaxis
Frequency not defined:
Endocrine & metabolic: ↓Sr albumin & total protein, ↑LDH
Genitourinary: Casts in urine (hyaline), blood in urine
Hematologic: Basophilia, ↓HCT, ↓hemoglobin, ↓neutrophils, ↓RBCs, eosinophilia,
leukopenia, lymphocytopenia, monocytosis, thrombocythemia, thrombocytopenia
Hepatic: ↑ALT, ALP & AST in serum
Renal: ↑BUN & Sr Cr
Postmarketing:
Dermatologic: AGEP, erythema multiforme, exfoliative SJS, TEN , urticaria
GIT: Abdominal pain, cholestasis, CDAD, dyspepsia, gastritis, hairy tongue, melena
Hematologic: Agranulocytosis, hemolytic anemia, ITP , positive direct Coombs test
Hepatic: Cholestatic hepatitis, cholestatic jaundice, hepatitis, hyperbilirubinemia
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
Local: Injection site reaction
CNS: Dizziness, seizure
Renal: Interstitial nephritis
Respiratory: Dyspnea
Contraindications3 Hypersensitivity (eg, anaphylaxis or SJS) to ampicillin, Sulbactam, or to other beta-lactam
antibacterials, or any component of the formulations
History of cholestatic jaundice or hepatic dysfunction associated with therapy
Antibiotics /Aminopenicillin + antistaphylococcal penicillin

Amoxicillin / Flucloxacillin injection
Trade name Flumox, Flucamox
Active drug Amoxicillin sodium 250 mg + flucloxacillin Sodium 250 mg
Dosage form Vial 500 mg for IV,IM
Mechanism of action Bacterial Cell wall inhibitor
Indications Infection by Susceptible G -, G + organism including penicillinase producing staph.
1
Dose Neonate1 IV:
Age < 7 days: 50 mg /kg/12hr
7 – 21 days: 50 mg /kg/8 hr
22 – 28 days 50 mg /kg/6 hr
1 month – 18 Year1 : 25 – 50 mg/kg/6hr
IM: 25 – 50mg/kg/6hr. Doses may be doubled in severe infection IM, IV
Preparation IV : 500mg + (5 – 10) ml SWFI 1
IM: 500mg +2 ml
Administration IV: direct injection over 3-4 min
Stability Use immediately, Discard after use
Store intact vial at 25 ◦ C , protected from light
5
Adverse reactions Mild transient: diarrhea, Indigestion, skin rash
Infection, Headache , confusion, dizziness, depression, seizures, Increased liver enzymes
↑ PT, Bleeding time, thrombocytopenia, granulocytopenia, leukopenia /with eosinophilia
Contraindications Hypersensitivity to penicillins, neonate with hyper bilirubinuria
9
Antibiotics /Aminopenicillin + ß-lactamase inhibitor
Amoxicillin/clavulanate Injection
Trade name Magnabiotic
Active drug Amoxicillin sodium 500 mg + clavulanic acid 100 mg
Dosage form Vial 600 mg for IV
Mechanism of Bacterial Cell wall inhibitor of susceptible G + ve organisms in addition to beta-lactamase
action producing M. catarrhalis, H. influenzae, N. gonorrhoeae, and S. aureus (excluding MRSA)
Indications Infections caused by susceptible organisms involving the lower respiratory tract, otitis media,
sinusitis, skin and skin structure, and urinary tract
Dose Neonates & age < 3 months (wt < 4 kg) : 30 mg (amox/clav)/kg /12 hr 1,3
3 months (wt ≥4 kg) – 12 year: 30mg /kg /8 hr , Max 1.2 g/dose 3,5
Severe infections: 30 mg /kg /6 hr 1
Age > 12 years & Adult: 1.2 g /dose /8 hr 1
Serious infection: 1.2 g/ dose/6 hr 1
Dose adjustment3 Infants, Child & Adolescent weighing <40 kg: IV (doses based on both components)
CrCl >30 mL/min: No dosage adjustment necessary.
CrCl 10 - 30 mL/min: 30 mg /kg/ 12 hr.
CrCl <10 mL/minute: 30 mg /kg/dose/ 24 hr.
IHD: 30 mg /kg/dose/ 24 hr. Give a dose of 15 mg /kg at the end of each dialysis.
Infants, Child & Adolescent weighing ≥40 kg: IV (doses based on both components)
CrCl >30 mL/min: No dosage adjustment necessary.
CrCl 10 – 30 mL/min: 1.2 g followed by 600 mg / 12 hr.
CrCl <10 mL/min: 1.2 g followed by 600 mg /dose/ 24 hr.
Hemodialysis: 1.2 g followed by 600 mg /dose/ 24 hr. Give a dose of 600mg after each dialysis
Hepatic Impairment: use with caution. Contraindicated in drug induced liver dysfunction.
Preparation1 IV direct: 600mg + 10 ml SWFI
Infusion: dilute at conc (10 – 20 mg/amoxicillin) in NS
Administration Age < 3 months: IV over 30 min
Infant ≥ 3 month: IV Over 3 – 5 min
Stability1 Use immediately , Discard any unused solutions
Store intact vial at 30◦ C, protect from light
Adverse reactions >10%:
GIT: Diarrhea
1% - 10%:
Dermatologic: Candidal diaper rash, diaper rash, skin rash, urticaria
GIT: Nausea, vomiting
Genitourinary: Vaginitis
Infection: Candidiasis, vaginal mycosis
<1%:
GIT: Abdominal distress, flatulence
Hematologic: Thrombocythemia
CNS: Headache
Post marketing:
CVS: Hypersensitivity angiitis
Dermatologic: AGEP, bullous dermatitis (linear IgA), erythema multiforme, exfoliative
dermatitis, fixed drug eruption, pruritus, SJS, TEN
GIT: CDAD, CD colitis, dyspepsia, enterocolitis, gastritis, glossitis, hemorrhagic colitis,
melanoglossia, mucocutaneous candidiasis, staining of tooth, stomatitis
Genitourinary: Crystalluria, hematuria
Hematologic: Agranulocytosis, anemia, eosinophilia, hemolytic anemia, leukopenia, ITP,
thrombocytopenia.
Hepatic: Cholestatic hepatitis, hepatocellular hepatitis.
Hypersensitivity: Anaphylaxis, angioedema, serum sickness-like reaction.
10
Immunologic: DRESS.
CNS: Agitation, anxiety, behavioral changes, confusion, dizziness, hyperactive behavior
(reversible), insomnia, myoclonus.
Contraindications Hypersensitivity to amoxicillin, clavulanic acid or other beta-lactam antibacterial
History of cholestatic jaundice or hepatic dysfunction with therapy
Suspected or confirmed mononucleosis.
Antibiotics /Aminopenicillin + ß-lactamase inhibitor

Amoxicillin / clavulanate Oral
Trade name Emoxclave 457mg/ Clavimox/Augram
Augram 642 mg
Active drug Amoxicillin sodium 400mg + clavulanic acid 57 mg (7 : 1 formulation)
Amoxicillin sodium 600 mg + clavulanic acid 42 mg(14 : 1 formulation)
Dosage form Oral suspension 7:1 formulation (amoxicillin 7 : clavulanic 1)
Oral suspension 14:1 formulation (amoxicillin 14 : clavulanic 1)
Mechanism of Bacterial Cell wall inhibitor of susceptible G + ve organisms in addition to beta-lactamase
action producing M. catarrhalis, H. influenzae, N. gonorrhoeae, and S. aureus (excluding MRSA)
Indications Infections caused by susceptible organisms involving the lower respiratory tract, otitis media,
sinusitis, skin and skin structure, and urinary tract
Dose 3 Neonate: 30 mg amoxicillin/kg/day divided/12 hr (recommended 4:1 formulation:156
mg/5ml)
Infants, Child & Adolescent
(7:1 formulation): 25 – 45 mg amoxicillin/kg/day divided/ 12 hr
Standard dosing in otitis media age ≥ 3 months: 40 – 45 amoxicillin/day divided / 8 – 12 hr
Up to 60 mg /kg/day divided /8 hr in age ≥ 6 months and body weight wt ≤ 35 kg
Max. daily dose: 1,750 mg/day.
14:1 formulation: for High dose regimens intended in severe infection
80 – 90 mg amoxicillin/kg/day in divided /12 hr (max 4,000 mg/day) (preferred in otitis media)
Dose adjustment 3 Renal impairment
Mild – moderate infection
Dosing based on 20 – 40 mg amoxicillin/kg/day divided/ 8 hr
or 25 – 45 mg amoxicillin/kg/day divided/12 hr
(not applied to high doses 80 – 90 mg/kg/day)
GFR >30 mL/min/1.73 m2: No adjustment required.
GFR 10 - 29 mL/min/1.73 m2: 8 – 20 mg amoxicillin/kg/12 hr.
GFR <10 mL/min/1.73 m2: 8 – 20 mg amoxicillin/kg/dose/24 hr.
Hemodialysis: 8 – 20 mg amoxicillin/kg/dose/ 24 hr, give after dialysis.
PD: 8 – 20 mg amoxicillin/kg/dose/ 24 hr.
Dosing based on 80 – 90 mg amoxicillin/kg/day divided /12 hr: (642 mg /5ml)
CrCl >30 mL/min/1.73 m2: No adjustment.
CrCl 10 – 29 mL/min/1.73 m2: 20 mg amoxicillin/kg/12hr
CrCl <10 mL/min/1.73 m2: 20 mg amoxicillin/kg/24 hr
IHD: 20 mg amoxicillin/kg/24 hr, give after dialysis
PD: 20 mg amoxicillin/kg/24 hr
Hepatic Impairment Pediatric: no dosage adjustments
Preparation 1 Oral: Reconstitute powder for suspension with water to the mark, Shake until suspended
Shake well before each use
Administration1 May be taken on an empty stomach ,Take with meals to decrease GI upset
May mix with milk, formula, or juice.
Stability 1 After reconstitution: 7 days at 2 – 8 ◦ c ( 457mg, 642 mg)
Before use: store below 30° c, away from sunlight
Adverse reactions Refer to IV monograph.
11
Contraindications Hypersensitivity to amoxicillin, clavulanic acid or other beta-lactam antibacterial agents
History of cholestatic jaundice or hepatic dysfunction with therapy
Suspected or confirmed mononucleosis.
Antibiotic/ Extended spectrum penicillin + ß-lactamase inhibitor

Piperacillin /Tazobactam Injection
Trade name Tazocin 4.5 g
Active drug Piperacillin sodium 4 g + Tazobactam 500 mg
Dosage form Vial 4.5 g for IV
Mechanism of action Cell wall inhibitor of most G+ve, G-ve including pseudomonas and anaerobic bacteria
Indications Severe & complicated infection: appendicitis, peritonitis, HAP, severe CAP by P. aeroginosa or
due to aspiration, pelvic, SSI: cellulitis, cutaneous abscesses & ischemic/diabetic foot.
Dose Neonate 4 100 mg/ kg/interval (piperacillin based). Interval according to chart
PMA Age Interval
(weeks) (days) (hr)
≤ 29 0 – 28 12
˃28 8
30 – 36 0 – 14 12
˃ 14 8
37 – 44 0 – 7 12
˃7 8
≥ 45 all 8
All doses and maximum doses based on piperacillin component ONLY
Age<2 months3 IV: 240 – 300mg /kg/day divided/6 – 8 hr (80 mg /kg /4 hr based on PK study)
Max.: 16 g /day (4 g/dose) 5 (Endocarditis max: 18 g /day)3
Age ≥2 months – 18 yr 3 IV: 240 - 300 mg /kg/day divided/ 6 – 8 hr
Max.: 16 g /day 3 (4 g/dose) 5 (Endocarditis max : 18 g /day)3
Doses outside the general range
Extended infusion: Child & Adolescent: 100 mg /kg/6 - 8 hr dose infused over 4 hr
Doses in cystic fibrosis: up to 450 mg /kg/day divided / 4 - 6 hr or up to 600 mg
piperacillin/kg/day divided / 4 hr (max. 18-24 g /day)
Endocarditis max dose: 18 g piperacillin/day
IAI complicated (infant, child & adolescent) 200-300 mg/kg /day divided/6 – 8 hr, max. 12
g/day
HAP in age >9 months & wt≤40 kg: 100mg /kg/6hr max. 4 g/dose
Wt >40 kg: 4 g/6hr (max 16 g/day)
Alternate dosing5 (based on piperacillin component only)
Age 1month – 11years: 80 mg/ kg/6 – 8 hr max. 4 g/6hr (In FN: 80 mg/kg/6hr)
12 -17 years: 4g /dose/6 – 8 hr according to severity
Surgical prophylaxis3
given within 60 min. prior to procedure, may repeat in 2 hr if prolonged procedure or in
excessive blood loss
Age 2-9 months IV: 80 mg /kg /dose
Age > 9 months Child & Adolescent weighing ≤40 kg: 100 mg /kg/dose, Max dose: 3g/dose
Adolescents >40 kg body weight: 3g piperacillin /dose
Dose adjustment3 Renal dysfunction
Infant, Children & Adolescent:
eGFR ≥ 40 mL/min/1.73 m2: No adjustment required
eGFR < 40 ml/min/1.73 m2 : based on pharmacokinetic parameters, limited pediatric studies,
adult studies, and expert opinion
based on piperacillin component (Max. 4 g /dose)
12
Extended infusion
Traditional intermittent infusion over 30 min
over 3 – 4 hr
Based on 200 – 300 300 – 400 mg/kg/day
300 – 400 mg/kg/day
mg/kg/day divided /8 – 6 hr divided/ 8 – 6 hr
eGFR Divided /8 hr Divided /6 hr Divided /8 hr Divided /6 hr Usual 100 mg/kg
ml/min/1.73 m2 Usual 67 – 100 Usual 50 – 75 Usual 100 – 133 Usual 75 – 100 /dose/6 – 8 hr
mg /kg /8hr mg/kg/6 hr mg /kg/8hr mg/kg/6 hr
45 – 70 35 – 50 70 – 90 50 – 70 70 mg/kg /8 hr
20 – < 40 mg/kg /8 hr mg/kg/6 hr mg/kg /8 hr mg/kg /6 hr
45 – 70 35 – 50 70 – 90 50 – 70 70 mg/kg /12 hr
<20
mg/kg /12 hr mg/kg /8hr mg/kg/12 hr mg/kg/8 hr
IHD: (removes 30 – 40% of dose): 50 – 100 mg/kg/12 hr on dialysis days after dialysis
PD: (removes 21% of Tazobactam & 6% of piperacillin): 50 – 100 mg /kg/12 hr
CRRT: children, adolescent
Intermittent infusion 100 mg /kg/ 8 hr
Continuous infusion: IV: 200 mg /kg/dose infused over 24 hr
Hepatic Impairment: Pediatric: No dosing adjustment required
Preparation1 4.5 g +20 ml NS, SWFI or D5W, then dilute in NS, D5W (Conc.20 – 80 mg/ml )
Use common dilution 1+3 ml NS, D5W (Conc. 50mg/ml For all ages)
Administration1,3 IV infusion: over 30 min at least
Extended infusion: over 4 hr
Separate time of administration from aminoglycoside
Stability1 Reconstituted vial : 48 hr at 2 – 8 ◦ c 2,3
Intact vial 25° C, protect from light
Adverse reactions3 >10%: GIT: Diarrhea
1% - 10%: CVS: Flushing, hypotension, phlebitis, thrombophlebitis
Dermatologic: Pruritus, skin rash
Endocrine & metabolic: Hypoglycemia
GIT: Abdominal pain, CD colitis, constipation, dyspepsia, nausea, vomiting
Hematologic: Purpuric disease
Local: Injection-site reaction
CNS: Headache, insomnia, rigors
Neuromuscular & skeletal: Arthralgia, myalgia
Respiratory: Epistaxis
Other: Fever
Endocrine & metabolic: ↓Sr albumin & total protein, ↑GGT, altered Na+, k+, Ca+2 & glucose
Hematologic: ↓Hct, ↓Hb, eosinophilia, +ve direct Coombs test, ↑PT, PTT & bleeding time.
Hepatic: ↑ALT, ALP, AST & bilirubin in serum
Renal: ↑BUN & Sr Cr & renal failure syndrome
Postmarketing:
Dermatologic: AGEP, linear IgA dermatosis, erythema multiforme, exfoliative dermatitis, SJS, TEN
GIT: CDAD, melanoglossia
Hematologic: Agranulocytosis, ITP, hemolytic anemia, neutropenia, pancytopenia,
thrombocytopenia
Hepatic: Hepatic insufficiency, hepatitis, jaundice
Hypersensitivity: Anaphylactic shock, DRESS , nonimmune anaphylaxis
Immunologic: Serum sickness-like reaction
CNS: Delirium, encephalopathy, intracranial hemorrhage (periprocedural), tonic-clonic seizure
Renal: Acute kidney injury, interstitial nephritis, nephrotoxicity
Respiratory: Eosinophilic pneumonitis
Other: Drug fever
Contraindication 3 Hypersensitivity to penicillins, beta-lactamase inhibitors, or any component of the formulation
13
rd
3 generation Cephalosporin Antibiotics
Ceftriaxone Injection
Trade name Cefaxone/ Epicephin/Rameceftrax
Active drug Ceftriaxone 500 mg
Dosage form Vial for IV, may be used IM (proper diluent)
Mechanism of action 3rd generation cephalosporin inhibits cell wall synthesis of G-ve & some G+ve bacteria
Indications Sepsis, meningitis, the lower RTI, acute bacterial otitis media, SSI, BJI, intra-abdominal and UTI
Dose Neonate 4
General: 50 mg/kg/24 hr IV4, IM. 3,4
Meningitis: loading dose: 100 mg/kg IV, then 80 mg/kg 24 hr IV.
Gonococcal disseminated Infections & Scalp Abscesses:
25 – 50 mg/kg/24 hr interval IV/IM for 7 days (if meningitis documented 10 – 14 days)
Gonococcal Infection neonate of untreated mother / Ophthalmia neonatorum: 25 – 50 mg
/kg (max 250 mg) IV/IM as a single dose
Infant, Child & Adolescent3
Usual dosing IM, IV: 50 – 75 mg/kg/24 hr (max. 1g/dose)
Severe infection IV : Up to 100 mg/kg/24 hr or divided 12 hr (max. 2g/single dose/12 – 24 hr)
Acute bacterial rhinosinusitis in hospitalized patient IV: 25 mg/kg/12hr (max. 2g/dose)
SSI: IM, IV: 50 – 75 mg/kg/day divided /12 – 24 hr (max. 2g/day)
Surgical prophylaxis IV: 50 – 75 mg/kg/dose 60 min prior to procedure, (max. 2g/dose)
Alternate dosing for IM,IV in child with body weight ≥ 50 kg 5
Child 9 – 17 yr : 1–2 g once daily, up to 4 g/24 hr (recommended to be divided /12 hr)
In severe infection & febrile neutropenia5: 4 g/24 hr (recommended to be divided /12 hr)
Dose adjustment3 Altered Kidney Function: No dosage adjustment is generally necessary
Dialysis: not dialyzable no supplemental dose is necessary after IHD or PD
Hepatic Impairment: No adjustment is generally necessary
Concurrent renal & hepatic: ↓max. daily dose (adults max. dose ≤2g/day is suggested)
Preparation IV: 500 mg + 4.8 ml SWFI 1 (with NS, D5W, D10W is accepted)3 to conc 100 mg/ml
dilute to infusion (use with caution in direct IV)
IV infusion dilute in NS, D5W, D10W to 10 – 40 mg/ml 4 (1+9 ml or 1 +1.5 ml)
IM: reconstitute with 1.8 ml 1% Lidocaine to conc. of 250 mg/mL
May use SWFI, BWFI, NS, D5W, Lidocaine 1 % to 250 – 350 mg /ml for IM
Administration IV: at Conc. 10 – 40 mg/ml Infusion over 60 min for neonates & 15 – 30 min for older age
Neonate Avoid administration of Ca+2 containing products within 48 hr of last ceftriaxone dose
IV doses˃2 g should be divided /12 hr
Direct IV: not recommended (adverse events) however, use reported over 5 min in pediatrics
Do not mix with calcium-containing solutions in the same IV line
1,3,5
IM: doses ≥ 1 g should be divided between different IM injection sites
When IM Doses ˃2g switch to IV route 5
Stability2 Reconstituted sol. 24 hr at 2 – 8◦ c1 ( with NS, D5W 10 days refrigerated)3
Intact vials stored at 30 ◦ C protected from light
Adverse reactions3 >10%
Dermatologic: Skin tightness
Local: Induration/ warm sensation at injection site (higher with IM)
1% - 10%:
CVS: Flushing.
Dermatologic: Diaphoresis, pruritus, skin rash.
GIT: CD colitis, diarrhea, dysgeusia, nausea, vomiting.
Genitourinary: Casts in urine, vaginitis.
Hematologic: Anemia, eosinophilia, hemolytic anemia, leukopenia, lymphocytopenia,
neutropenia, ↑PT, thrombocythemia, thrombocytopenia.
Hepatic: ↑ ALT, ↑ ALP, ↑ AST, ↑ Sr bilirubin.
Infection: Candidiasis.
Local: Injection site phlebitis, pain/ tenderness at injection site.
14
CNS: Chills, dizziness, headache.
Renal: ↑ BUN, ↑ Sr Cr.
<1%:
CVS: Palpitations
Endocrine & metabolic: Glycosuria
GIT: Abdominal pain, cholelithiasis, dyspepsia, flatulence, gallbladder sludge, pancreatitis
Genitourinary: Hematuria
Hematologic: Agranulocytosis, basophilia, ↓ PT , granulocytopenia, lymphocytosis,
monocytosis
Hepatic: Jaundice
Hypersensitivity: Anaphylaxis, serum sickness
CNS: Seizure
Renal: Nephrolithiasis
Respiratory: Bronchospasm, epistaxis, hypersensitivity pneumonitis
Postmarketing
Dermatologic: AGEP, allergic dermatitis, erythema multiforme, SJS, TEN, urticaria
GIT: CDAD, glossitis, stomatitis
Genitourinary: Hypercalciuria, oliguria, ureteral obstruction, urolithiasis
Hepatic: Hepatitis
Hypersensitivity: Anaphylactic shock
Immunologic: DRESS
CNS: Encephalopathy, kernicterus, neurotoxicity (myoclonus & nonconvulsive status
epilepticus)
Renal: Acute kidney injury (post-renal)
Contraindications Hypersensitivity to ceftriaxone, any component of the formulation, or other cephalosporins
Do not use in hyperbilirubinemic neonates
Concomitant use with IV calcium-containing solutions/products in neonates (≤28 days)
rd
Cefotaxime Injection
Trade name Rametax / cefause
Active drug Cefotaxime Sodium 500 mg
Dosage form Vial for IV, IM
Mechanism of action 3rd generation cephalosporin inhibits cell wall synthesis of G-ve / little G+ve bacteria
Indications Meningitis, lower RTI, acute bacterial otitis media, SSI, BJI, intra-abdominal and UTI
Dose Neonate 4 IV dosing (unless stated)
Indication Qualifiers and dosage
Sepsis Age  7 days 50 mg/kg/12 hr
Age ≥ 7 days : GA32 weeks 50 mg/kg/8 hr
GA≥32 weeks 50 mg/kg/6 hr
Meningitis 0 – 7 days 100 – 150 mg/kg/day divided/ 8 – 12hr
Consider smaller doses & longer intervals for VLBW ( 2 kg)
≥ 8 days: 150 – 200 mg/kg/day divided/ 8 – 6 hr
LRT, IAI, SSI ,BJ infections Age:  7 days 50 mg/kg/12 hr
IV/IM Age: 8 – 28 days & ≤ 2 kg : 50 mg/kg/8 – 12 hr
Age: 8 – 28 days & ˃2 kg: 50 mg/kg/8 hr
Gonococcal, disseminated 25 mg/kg/12 hr X 7 days
infection IV/IM In meningitis X 10 – 14 days
Alternate dosing IV, IM neonate 5
<7 days: 25 mg/kg/12 hr, in Severe infection, up to 50 mg/kg/12 hr
7 – 20 days: 25 mg/kg/8 hr, in Severe infection up to 50 mg/kg/8 hr
21 – 28 days: 25 mg/kg/6 – 8 hr, in Severe infection up to 50 mg/kg/6–8 hr
15
Infant & child & Adolescent 3
General : IV,IM: 150 – 180 mg/kg/day divided /6 – 8 hr (max: 8 g/day)
IV 150 – 200 mg/kg/day divided /6 – 8 hr, max 8 g /day, (2g /dose )
Acute bacterial rhinosinusitis in hospitalized patient IV child & adolescent
100 – 200 mg/kg/day divided /6 hr (max. 2g/dose)
Endocarditis IV: child & adolescent IV 200 mg/kg/day divided/6hr (max 12 g/day)
Meningitis: 225 – 300 mg/kg/day divided / 6 – 8 hr, Max. : 2g/dose, (however
300 mg/kg/day divided /4 – 6 hr [with max 12 g/day] was used)
Surgical prophylaxis: Child & Adolescents: IV: 50 mg/kg within 60 min prior to surgery, may
repeat in 3 hr if prolonged surgery or excessive blood loss, max.1g /dose (obese 2g/dose)
Alternate dosing IV, IM 5
Infant8/Child: 50 mg/kg/8 – 12 hr, in Severe infection up to 50 mg/kg/6 hr (max 12 g / day)
Alternate dosing for Age > 12 year8
General : 1 g /12 hr IV, IM (typical infection by sensitive bacteria)
Infection by bacteria with high to medium sensitivity: 2 g /12 hr IV, IM
Severe, critically ill patient : 2 – 3 g /6 – 8 hr (up to 12 g /day)
Daily doses ≤ 6 g are to be divided at least/ 12 hr
Daily doses > 6 g are to be divided/6 – 8 hr
Dose adjustment Renal impairment 3: Age ≥ 1months: based on doses of 100 - 200 mg/kg/day divided / 8 hr.
GFR 30 – 50 mL/min/1.73 m2: 35 – 70 mg/kg / 8 – 12 hr
GFR 10 – 29 mL/min/1.73 m2: 35 – 70 mg/kg / 12 hr
GFR <10 mL/min/1.73 m2: 35 to 70 mg/kg/24 hr
IHD, PD: 35 – 70 mg/kg/24 hr
CRRT: 35 – 70 mg/kg/12 hr
Hepatic Impairment: no dosage adjustment
Preparation IV: 500 mg + 10ml SWFI = 50 mg/ml 2 (may reconstitute to max conc. 200 mg/ml for IV push)
Solution color light yellow to amber color
IV infusion Dilute with, NS, D5W, D10W, LR to conc. 10 – 40 mg/ml, up to 60 mg/ml 3
IM 500 mg + 1.8 ml SWFI ≈ 240 mg/ml (may reconstitute to conc. 230 – 330)3
Administration Direct IV : over 3 – 5 min 3 (Rapid IV over˂ 1 min associated with arrhythmia)
IV Infusion over 15 - 30 min 3
IM: doses ≥ 2 g should be divided between different IM injection sites 2,3
Stability Store Intact vial at 25 ◦ and protect from light
Reconstituted sol. Is stable 24 hr at 2 – 8 °c
Diluted sol. Is stable 24 hr at room temp and at 2 – 8 °c (Discard for microbiological instability)
Adverse reactions 1 - 10%:
Dermatologic: Pruritus, skin rash.
GIT: Colitis, diarrhea, nausea, vomiting.
Hematologic: Eosinophilia.
Local: Induration/pain/tenderness at injection site (IM), inflammation at injection site (IV)
Other: Fever.
<1%, postmarketing and/or case reports:
AGEP, erythema multiforme, urticaria, SJS, TEN
ARF, ↑Sr Cr, ↑BUN, interstitial nephritis
Bone marrow failure, Agranulocytosis, granulocytopenia, hemolytic anemia, leukopenia,
neutropenia, pancytopenia, thrombocytopenia
Anaphylaxis
Brain disease, dizziness, headache
Candidiasis, vaginitis
Cardiac arrhythmia (after rapid IV injection via central catheter)
Cholestasis, ↑ALP, ↑ ALT, ↑AST, ↑Sr bilirubin, hepatitis, jaundice
CDAD, pseudomembranous colitis,
Metabolic:↑GGT, ↑LDH
injection site phlebitis, local irritation, Positive direct Coombs test
Contraindications Hypersensitivity to Cefotaxime, any component of the formulation, or other cephalosporins
16
rd
Ceftazidime Injection
Trade name Kefadim/ maximodim
Active drug Ceftazidime
Dosage form Vial 500 mg for IV, IM
Mechanism of action 3rd generation cephalosporin inhibits cell wall synthesis of G-ve /Some G+ve bacteria
Indications Pseudomonas Infection: RTI, UTI, gynecologic, SSI, IAI, osteomyelitis, sepsis, meningitis,
peritonitis and endocarditis.
Dose Neonate 4 IV/IM : 30 mg/ kg/interval acc. to chart
PMA(weeks) Age (days) Interval (hr)
≤ 29 0 – 28 12
˃ 28 8
30 – 36 0 – 14 12
˃ 14 8
37 – 44 0–7 12
˃7 8
≥ 45 all 8
Meningitis IV 0 – 7 days : 100 – 150 mg/kg/day divided/8 – 12 hr
≥ 8 days: 150 mg/kg/day divided/ 8 hr
Alternate dosing in severe infection and meningitis5
Age <days: 50 mg/kg/24 hr.
7 – 20 days: 50 mg/kg / 12 hr.
21 – 28 days: 50 mg/kg / 8 hr.
>1 month & child (IV/IM)3
Non-Pseudomonal infections: 90 – 150 mg/kg/day divided / 8 hr (max: 6 g/day)
Severe Pseudomonal infections: 200 – 300 mg/kg/day divided/ 8 hr (max:12 g/day)
May use 90 – 150 mg/kg/day divided/ 8 hr (max: 6 g/day) in mild - moderate infection
Cystic fibrosis lung infection Traditional IV intermittent infusion: 200 – 400 mg/kg/day divided
/6 – 8 hr (max.12 g/day), doses of 150 mg/kg/day in divided/8 hr have also been reported
Endocarditis (Child & Older): 100 – 150 mg/kg/day divided/8 hr, max: 4g/day in combination
Meningitis: 150–200 mg/kg/day divided /6 –8 hr (max: 6g/day) used in combination
Continuous infusion in febrile neutropenia3 Age ≥ 6 months
Loading: IV 60 – 100 mg/kg, max.2g /Loading followed by 100 – 200 mg/kg/day as Continuous
infusion over 24 hr (max. 6 /day)
Dose adjustment Renal impairment infant child, adolescent based on a usual dose of 25 – 50 mg/kg/ 8 hr
GFR 30 – 50 mL/min/1.73 m2: 50 mg/kg/ 12 hr.
GFR 10 – 29 mL/min/1.73 m2: 50 mg/kg / 24 hr.
GFR <10 mL/min/1.73 m2: 50 mg/kg/48 hr.
IHD: Dialyzable (50% - 100%): 50 mg/kg/48 hr after dialysis on dialysis days.
PD: 50 mg/kg/48 hr.
CRRT: 50 mg/kg/12 hr
Hepatic Impairment: No adjustment required.
Preparation IV : 500 mg + 5 ml SWFI ≈ 90 mg/ml 1 (displacement value = 0.55 ml /500 mg)2
Bubble of carbon dioxide should be expelled prior to injection
IM: 500 mg + 1.5 ml SWFI = 280 mg/ml, (may use, BWFI, 0.5 – 1% Lidocaine)
IV infusion: dilute in NS, D5W, D10W to 10 – 50mg/ml (In fluid restriction: 125 mg/ ml SWFI)
Continuous IV infusion
Prepare/24 hr at conc ≤ 30 mg/ml at room temp =15 – 22 ° C (Insulation, ice packs)
Prepare/12 hr at conc ≤ 52 mg/ml at room temp ≤ 22 ° C (Insulation, ice packs)
Administration IV push over 3 – 5 min at max. conc. of 100 – 200 mg/ml 4 is accepted
17
IV infusion over 30 min 3,4
Continuous IV infusion: give Loading dose : over 60 min3
Stability Store Intact vial at 30 ◦ C protected from light
IV reconstitution 24 hr refrigerated 1
Adverse reactions 1% - 10%:
Endocrine & metabolic: ↑LDH, ↑GGT
GIT: Diarrhea
Hematologic: Eosinophilia, +ve direct Coombs test (without hemolysis), thrombocythemia
Hepatic: ↑ALT, ↑ AST, ↑ ALP
Hypersensitivity: Hypersensitivity reactions
Local: Inflammation at injection site, injection site phlebitis
Other: Fever
Frequency not defined:CNS: Seizure
Hematologic: Agranulocytosis, leukopenia, lymphocytosis, neutropenia, thrombocytopenia
Renal: ↑ BUN, ↑ Sr Cr
<1%, postmarketing/case reports: Abdominal pain, anaphylaxis (severe), angioedema,
candidiasis, CDAD, dizziness, erythema multiforme, headache, hemolytic anemia, jaundice ↑
bilirubin, nausea, injection site pain, paresthesia, renal insufficiency, SJS, TEN, urticaria,
vaginitis, vomiting
Contraindications Hypersensitivity to ceftazidime, other cephalosporins, penicillins, other beta-lactam
antibiotics, or any component of the formulation
rd
3 generation oral cephalosporin
Cefixime oral
Trade name Ximacef/ cefixime
Active drug Cefixime
Dosage form Oral suspension 100 mg / 5 ml
Mechanism of action 3rd generation cephalosporin inhibits cell wall synthesis of susceptible bacteria
Indications UTI, otitis media, acute exacerbations of chronic bronchitis, pharyngitis & tonsillitis
Dose Infant, Child & Adolescents 3
Oral: 8 mg/kg/day once daily or divided/ 12 hr. Max daily dose: 400 mg/day
Typhoid fever (Salmonella typhi): 15 – 20 mg/kg/day divided / 12 hr for 7 – 14 days
Dose adjustment 3 Renal Impairment 6 months – 18 yr:
Mild – moderate impairment: No adjustment recommended
Severe: (GFR ≤ 20 mL/min/1.73 m2)5: Reduce dose by 50% (max 200 mg/ml)
Anuric: Reduce dose by 50%
Hepatic Impairment: There are no dosage adjustments provided
Preparation1 Reconstitute powder for suspension with water to the mark, Shake until suspended
Administration May be taken on an empty stomach. Take with meals to decrease GI upset
Shake well before each use.
Stability1 After reconstitution : 14 days at 2 – 8 ◦ C
Intact bottles: store at 30 °c in dry place
Adverse reactions 3 >10%: GIT: Diarrhea
2% - 10%: GIT: Abdominal pain, nausea, dyspepsia, flatulence, loose stools
<2%: ARF, anaphylactoid reaction, anaphylaxis, angioedema, candidiasis, dizziness, drug
fever, eosinophilia, erythema multiforme, facial edema, headache, hepatitis, ↑BUN ,Sr Cr,
↑bilirubin/Transaminases, jaundice, leukopenia, neutropenia, thrombocytopenia ↑PT,
pruritus, pseudomembranous colitis, seizure, serum sickness-like reaction, skin rash,
SJS,TEN, urticaria, vaginitis, vomiting
Contraindications Hypersensitivity to cefixime, any component of the formulation, or other B-lactams.
18
th
Cefepime Injection
Trade name Wincef
Active drug Cefepime 500 mg
Dosage form Vial for IV, IM
Mechanism of action 4th generation cephalosporin inhibits cell wall synthesis of G+ve, G-ve bacteria (Pseudomonas)
Indications Pneumonia, uncomplicated SSI, UTI, FN, complicated IAI in combination, endocarditis, and
meningitis.
Dose Neonate4
IV Dosing for Term & preterm neonate
Age ≤ 28 days: 30 mg/kg/ 12 hr
Meningitis & severe infections : 50 mg/kg/12 hr
Infants, Children, and Adolescents3
General dosing, susceptible infection: Traditional intermittent-infusion
Non-Pseudomonal infections: IM, IV: 50 mg/kg/dose /8 – 12 hr (max. 2g/dose)
Every – 12hr dosing may be suboptimal for infection in which bacterial (MICs) ≥1 mg/L
Used in some mild IAI,SSI, UTI infections
Pseudomonal infections (suspected or proven): IM,IV: 50 mg/kg/dose/ 8 hr (max: 2g/dose)
Extended infusion over 3 – 4 hr max. 2 g/dose (In bacterial infection with MIC 4 – 8 mg/L)
Doses outside the above range
Cystic fibrosis extended infusion method
with resistant pseudomonas (MIC ≥16 mg/L): 50 mg /kg /6 hr IV
Durations for treatment
Endocarditis: 6 weeks with other antibiotics
Febrile neutropenia (FN) low risk: 72 hr duration in culture negative & afebrile for 24 hr
FN high risk: culture negative at 48 hr + afebrile for 24 hr + bone marrow recovery
IAI : 4 – 7 days
Meningitis:10 – 14 days minimum, 14 days after CSF – ve culture, or at least for 21 days
Pneumonia, SSI, UTI: 10 days
Dosing for Child with body-weight ≥ 40 kg 5
Mild – moderate: 0.5 – 1 g /12 hr
Severe infection: 2 g /12 – 8 hr
Dose adjustment3 Renal impairment: Infant, child, & adolescent (IV,IM) based on adult data & experts opinion
Cr Cl
Usual Vs. Recommended dosing
mg/min/1.73/ m2
>60 mL 50 mg/kg/12 hr 50 mg/kg/12 hr 50 mg/kg/8 hr
No adjustment Max. 1g/dose Max.:2g/dose Max. 2g/dose
50 mg/kg/24 hr 50 mg/kg/24 hr 50 mg/kg/12 hr
30 – 60
Max. 1g /dose Max. 2g/dose Max. 2g/dose
25 mg/kg/24 hr 25 – 50 mg/kg/24 hr 50 mg/kg/24 hr
11 – 29
Max. 0.5g/dose Max. 1g /dose Max.2g/dose
25 mg/kg/24 hr 25 – 50 mg/kg/24 hr 25 – 50 mg/kg/24 hr
<11
Max. 0.25g/dose Max. 0.5g/dose Max. 1g /dose
For IHD,PD, CRRT: Review detailed reference
Hepatic impairment: no adjustment
Preparation IV: Reconstitute 500 mg + 5 mL SWFI solution1 conc ≈ 90 mg/ml (may be yellow-brown)
IV infusion: dilute in D5W, NS, D10W to final conc. ≤ 40 mg/mL.
IM: Reconstitute 500 mg + 1.5 ml SWFI,NS, D5W, 0.5 -1 % Lidocaine (230mg/ml)spectracef
Administration IV infusion over 30 min3
IV injection over 3 – 5 min 5
Extended infusion: over 3 – 4 hr
Stability 1 Intact vial at room temp 30 ◦C, Protect from light
Reconstituted : 24 hr refrigerated at 2 – 8 ◦ c
19
Adverse reactions ˃10% :
Hematologic: Positive direct Coombs test (without hemolysis)
1% to 10%:
CVS: Localized phlebitis
Endocrine & metabolic: Hypophosphatemia
GIT: Diarrhea, nausea, vomiting.
Hematologic: Abnormal PTT, change in PT, eosinophilia
Hepatic: ↑ ALT, ↑ AST
Hypersensitivity: Hypersensitivity reaction (with a history of penicillin allergy)
CNS: Headache.
Other: Fever.
<1%:
Dermatologic: Erythema of skin, urticaria
Endocrine & metabolic: Hypercalcemia, hyperkalemia, hyperphosphatemia, hypocalcemia
GIT: CD colitis, oral candidiasis
Hematologic: Anemia
Hepatic: ↑ALP, ↑ Sr bilirubin
Local: Local inflammation, local pain
Postmarketing:
Dermatologic: AGEP, SJS
GIT: CDAD
Hematologic: Agranulocytosis, leukopenia, neutropenia, thrombocytopenia
Hypersensitivity: Anaphylaxis, angioedema
Immunologic: DRESS
CNS: Aphasia, coma, confusion, encephalopathy, hallucination, myoclonus, neurotoxicity, seizure,
status epilepticus (nonconvulsive), stupor
Renal: Acute interstitial nephritis,
Contraindications Hypersensitivity to Cefepime, other cephalosporins, other β-lactams or any formulation component
20
Carbapenem Antibiotics
Meropenem Injection
Trade name Mirage / merostarkill/Meropenem Eva /sunny merop 1 g
Active drug Meropenem
Dosage form Vial 1g for IV
Mechanism of action Bactericidal: Inhibits bacterial cell wall synthesis of G +ve, G-ve (pseudomonas) &anaerobes
Indications Treatment of complicated appendicitis, peritonitis, bacterial meningitis, complicated SSI
lower RTI, acute pulmonary exacerbations in cystic fibrosis, UTI, febrile neutropenia & sepsis
Dose Neonate 4
Dosing – interval chart based on GA,PNA & site of infection (IV)
GA (Week) Age (Days) Dose - Non CNS Dose (meningitis) Interval (hr)
< 32 ˂ 14 20 mg/kg 40 mg/kg 12
≥ 14 20 mg/kg 40 mg/kg 8
≥ 32 ˂ 14 20 mg/kg 40 mg/kg 8
≥ 14 30 mg/kg 40 mg/kg 8
Alternate dosing5
< 7 days: 20 – 40 mg/kg / 12 hr. Acc. to severity
7 – 28 days: 20 – 40 mg/kg /8 hr. Acc. to severity
Infants, Children, and Adolescents: 3 IV
General: 20 mg/kg/ 8 hr (max. 1g/dose)-(febrile neutropenia, severe SSI, IAI)
Severe infections (meningitis, cystic fibrosis) 40 mg/kg/ 8 hr (max. 2g/dose)
Extended infusion over 3 – 4 hr for resistant organism may be effective
In CNS infection: for 10 – 14 days minimum, 14 days after CSF culture –ve or at least 21 days
Doses outside the above range:
IAI in infant ˂ 3 months with GA ≥ 32 weeks :30 mg/kg/8hr
SSI in Age > 3 months : 10 mg /kg /8 hr (max 0.5 g/dose)
Or Age > 1 months 20 mg /kg /8 hr, (max 1g/dose) in severe ,necrotizing infection
Alternate dosing5
1 month–11 yr (wt< 50 kg):
10 – 20 mg/kg/8 hr, up to 40 mg/kg/8hr in severe infection & Cystic Fibrosis
12 – 17 yr or (age < 11 yr & wt ≥ 50 kg):
0.5 – 1 g/8 hr, up to 2 g/8 hr in severe infection &Cystic Fibrosis
Dose adjustment 3,5 Renal impairment: Age ≥ 1 month IV (based on PK data/studies, adult data & expert opinion)
GFR (mg/min/1.73/ m2) Regimen: 20 mg/kg/8 hr Regimen: 40mg/kg/8 hr
>50 mL No adjustment No adjustment
20 mg/kg/12 hr 40 mg/kg/12 hr
26 – 50
Max. 1g /dose Max. 2g/dose
10 mg/kg/12 hr 20mg/kg/12 hr
10 – 25
Max. 0.5g/dose Max. 1g /dose
10 mg/kg/24 hr 20mg/kg/24 hr
<10
Max. 0.5g/dose Max. 1 g/dose
For IHD,PD, CRRT: Review detailed reference
Preparation1,3 Reconstitution: 1 g + 20 ml SWFI = 50 mg/mL 1,3
IV infusion: dilute with NS (preferred), D5W to conc.1 – 20 mg/mL(1 ml x 2.5 ml = 20 mg/ml)
Extended infusion: 10 mg/ml in NS (12 hr stability at room temp.= 1ml x5 ml)3
Administration3 Neonate & infant <3 months: Intermittent IV infusion: of diluted sol. over 30 min
age ≥3 months
IV push: reconstituted sol. over 3 – 5 min (for doses 20 mg/kg/dose, max : 1 g / IV push)
IV Infusion use diluted sol. (40 mg/kg doses , must use infusion method)
Age< 3 months: Over 30 min.
Age≥3 months: Over 15 – 30 min.
21
Extended IV infusion: recommended for infection with resistant organism.
Neonates: over 4 hr. Children & Adolescents: over 3 - 4 hr
Stability Intact vials: Store at room temperature 30°C, protect from light
Reconstituted sol. :Discard after use , (only if necessary use within 12 hr1 )
Diluted solution: 10 mg/ml in NS (12 hr stability at room temp.= 1ml x5 ml)2,3
CVS: AMI, bradycardia, cardiac failure, chest pain, HTN/hypotension, peripheral edema/ vascular
disease, PE, shock syncope, tachycardia
Dermatologic: Dermal ulcer, diaphoresis, pruritus, skin rash (diaper area moniliasis), urticaria
Endocrine & metabolic: Hypervolemia, hypoglycemia.
GIT: Abdominal pain, anorexia, constipation, diarrhea, dyspepsia, enlargement of abdomen,
flatulence, GIT disease, glossitis, intestinal obstruction, nausea, oral candidiasis, vomiting
Genitourinary: Dysuria, pelvic pain, urinary incontinence, vulvovaginal candidiasis.
Hematologic: Anemia, hypochromic anemia.
Hepatic: Cholestatic jaundice, hepatic failure, jaundice.
Infection: Sepsis
Local: Inflammation at injection site
CNS: Agitation, anxiety, chills, confusion, delirium, depression, dizziness, drowsiness,
hallucination, headache, insomnia, nervousness, pain, paresthesia, seizure.
Neuromuscular & skeletal: Asthenia, back pain.
Renal: Renal failure syndrome.
Respiratory: Apnea, asthma, cough, dyspnea, hypoxia, pharyngitis, pleural effusion, pneumonia,
pulmonary edema, respiratory system disorder.
Other: Accidental injury, fever.
<1%: CVS: Local thrombophlebitis, localized phlebitis
Endocrine & metabolic: Edema at insertion site
GIT: GIT hemorrhage, melena
Hematologic: Hemoperitoneum
Local: Injection site reaction, pain at injection site
Frequency not defined: Endocrine & metabolic: Hypokalemia, ↑LDH
Hematologic: ↓PTT, ↓ PT , eosinophilia, quantitative disorders of platelets
Postmarketing: Dermatologic: AGEP, erythema multiforme, SJS, TEN
GIT: CDAD
Hematologic: Agranulocytosis, hemolytic anemia, leukopenia, neutropenia, +ve direct/ indirect
Coombs test, thrombocytopenia
Immunologic: DRESS
Contraindications Hypersensitivity to Meropenem, other Carbapenems , or any component of the formulation
Patients who have experienced anaphylactic reactions to beta-lactams
Carbapenem Antibiotics
Imipenem / Cilastatin Injection
Trade name Tienam
Active drug Imipenem / Cilastatin
Mechanism of action Bactericidal agent Inhibits bacterial cell wall synthesis of G +ve, G-ve including pseudomonas.
Spp. and anaerobes
Indications Treatment of peritonitis, SSI lower RTI, UTI, febrile neutropenia, BJI, endocarditis, IAI & sepsis
Dose Neonate Usual dose IV 4
Wt ≤ 2 kg
age ≤ 7 days : 20 mg/kg 12 hr
age ˃7 days: 25 mg/kg/12 hr
OR alternate method 3
22
Age ≤ 7 days : 25 mg/kg/12 hr
Age >7 days 25 mg/kg/8 hr
Alternate dosing BY IV infusion (non CNS infection)5
Age: < 7 days: 20 mg/kg / 12 hr.
Age 7 – 20 days: 20 mg/kg / 8 hr.
Age 21 – 60 days: 20 mg/kg / 6 hr
infants, Children, and Adolescents3 IV
15 – 25 mg/kg/ 6 hr (max. 4 g/day)
Not approved for CNS infections (↑ risk of Seizure)
Dose adjustment Renal impairment 4
No adjustment in renal impairment for wt ˂ 30 kg 4, use is not recommended however,
A proposed regimen: based on doses of 15 – 25 mg/kg/ 6 hr 3
GFR 30 – 50 mL/min/1.73 m2: 7 – 13 mg/kg/8 hr
GFR 10 – 29 mL/min/1.73 m2: 7.5 – 12.5 mg/kg/12 hr
GFR <10 mL/min/1.73 m2: 7.5 – 12.5 mg/kg/24 hr
IHD: Moderately dialyzable (20% – 50%): 7.5 – 12.5 mg/kg/24 hr (on dialysis days after IHD)
PD: 7.5 – 12.5 mg/kg/ 24 hr
CRRT: 7 – 13 mg/kg/ 8 hr
Hepatic impairment: no dose adjustment provided for pediatric or adult
Preparation Vial + 100 ml as a final volume, NS preferred, may use D5W, D10W if needed
Method: 10 ml from a 100 ml NS bottle added to the powder then withdrawn and reinjected
into the NS bottle again
A second 10 ml from the previous NS bottle are added to the empty vial for wash of
remaining then the 10 ml transferred again to the NS bottle
Administration3 IV infusion3,4,5(prolong IV infusion rate If nausea and/or vomiting occur during infusion)
doses ≤500 mg over 20 – 30 min
>500 mg over 40 - 60 min.
Stability1 Store intact vials at 30 °C
Reconstituted solution is stable for 24 hr refrigerated at 2-8 °C. Do not freeze.
Adverse reactions ˃10%
Hematologic: ↓hematocrit, ↓hemoglobin, eosinophilia, thrombocythemia
Hepatic: Increased Sr. AST & ALT
1% to 10%: CVS: Phlebitis, tachycardia
CNS: Seizure
GIT: Diarrhea, nausea, oral candidiasis, vomiting, gastroenteritis
Genitourinary: Proteinuria, urine discoloration, oliguria
Hematologic: Neutropenia, ↓platelet count, increased hematocrit
Hepatic: ↑ ALP, ↑ Sr bilirubin, ↓Sr. bilirubin
Local: Irritation at injection site
Renal: ↑ Sr Cr
<1%, postmarketing and/or case reports:
Abdominal pain, CDAD, dysgeusia, glossitis, heartburn, pseudomembranous colitis, sore throat
hemorrhagic colitis, tongue changes, tongue discoloration, dental discoloration
ARF, casts in urine, hematuria, ↑ BUN, leukocyturia, ↑urinary urobilinogen, polyuria, positive
direct Coombs' test, pruritus vulvae Agitation, brain disease, confusion, dyskinesia dizziness,
drowsiness, hallucination, headache vertigo, hearing loss, weakness psychiatric disturbances,
myoclonus, paresthesia, tinnitus, tremor. Agranulocytosis, basophilia, bone marrow depression,
altered PT, hemolytic anemia, leukopenia ↑monocytes, leukocytosis, lymphocytosis,
pancytopenia neutropenia, thrombocytopenia. Hypersensitivity, anaphylaxis, angioedema, drug
fever, back pain (thoracic/spinal), polyarthralgia. Bilirubinuria, hepatic failure, hepatitis
induration (including fulminant onset), jaundice. Candidiasis, pseudomonas infection. Dyspnea,
chest discomfort, hyperventilation, cyanosis, flushing. Hypotension, palpitations, ↓Sr. sodium,
hyperchloremia, hyperhidrosis ↑Sr. potassium, ↑LDH. Erythema, injection site pain, erythema
multiforme, skin changes (texture), pruritus, SJS, TEN, urticaria, fever
Contraindications Hypersensitivity to Imipenem /cilastatin , other Carbapenems or any formulation component
Patients who have experienced anaphylactic reactions to beta-lactams
23
Aminoglycoside antibiotics
Amikacin Injection
Trade name Amikin/Epikacin
Active drug Amikacin
Dosage form Vial 100 mg/2 ml
Mechanism of action Antibiotic Inhibits protein synthesis in susceptible G – ve bacteria
Indications Serious infections of bone, respiratory tract, bloodstream infections due to susceptible g-ve
bacteria and in combination for CNS endocarditis, IAI, and mycobacterial infection.
Dose Neonate IV 4
PMA (weeks) Age (days) Dose (mg/kg) Interval (hr)
≤29** 0–7 14 48
8 – 28 12 36
≥ 29 12 24
30 - 34 0–7 12 36
≥8 12 24
≥ 35 All 12 24
Duration: 10 days for bacteremia of unknown focus
Alternate dosing 17
GA (weeks) Age (days) Dose mg/kg Interval (hr)
<30 ≤14 15 48
>14 15 24
30 – 34 ≤ 10 15 24 – 36
11 – 60 15 24
≥ 35 ≤7 15 24
8 – 60 17.5 – 18 24
Alternate dosing for neonatal sepsis 5
Start a Loading dose 10 mg/kg, then 7.5 mg/kg / 12 hr, IV injection over 3 – 5 min
OR start with 15 mg/kg/24 hr regardless of age
Infant, child & adolescent3
In obese pediatrics use adjusted weight (IBW + 0.4 [TBW – IBW]) to calculate initial dosage
Or use adjusted body weight for obese pediatrics = 0.7 x TBW
Extended-interval IV, IM: 15 – 30 mg/kg/24 hr. high Doses for critical illness, malignancy,
cystic fibrosis, or burn injury, or for bacterial isolates with (MIC) ≥4 mg/L)
Conventional dosing: IV, IM: 15 – 22.5 mg/kg/day divided /8 – 12 hr (endocarditis)
CNS infections IV 20 – 30 mg/kg/day divided/8 hr
Intraventricular/intrathecal (preservative – free): 5 – 50 mg/day
Cystic fibrosis IV,IM: 10 mg/kg/8hr or 30 – 35 mg/kg /day/24 hr
Up to 40 mg /kg /day in MIC≥ 8 mg/L
Suggested maximum doses5
1.5 g/dose/day in extended dosing regimen in UTI
500 mg /8 hr for conventional every 8 hr regimen
Dose adjustment Neonate4
Co-administration with ibuprofen: Prolong the dosing interval by 10 hr
Hypothermia/Asphyxia:
Asphyxia: Prolong the interval by 10 hr
perinatal asphyxia with hypothermia Proposed regimen
body wt 1.2 – 2.8 kg: 15 mg/kg/48 hr
˃ 2.8 kg: 15 mg/kg/42 hr for the first 2 consecutive doses during hypothermia
Renal Impairment: prolong intervals or reduce dose acc.to sr. conc.
Infants, Children, and Adolescents: IM, IV based on doses of 5 – 7.5 mg/kg/ 8 hr
GFR > 50 mL/min/1.73 m2: No adjustment required.
GFR 30 – 50 mL/min/1.73 m2: dose / 12 – 18 hr
24
GFR 10 – 29 mL/min/1.73 m2: dose / 18 – 24 hr.
GFR < 10 mL/min/1.73 m2: dose / 48 – 72 hr.
IHD: 5 mg/kg/dose, redose based on Sr. concentrations.
PD: 5 mg/kg/dose, redose based on Sr. concentrations.
CRRT: 7.5 mg/kg/12 hr, monitor Sr. concentrations.
Hepatic Impairment: no dosage adjustments
Preparation3 IM: undiluted
IV intermittent infusion: Dilute in NS, D5W to 0.25 – 5 mg/mL, Up to 10 mg/mL reported
1 + 9 ml = 5 mg/ml
Intrathecal/Intraventricular use Preservative-free Amikacin & preservative free NS
Dilute just prior to use, conc.: 1 mg/mL (1+49 ml) and 30 mg/mL (1 + 0.65 ml) are used.
Administration3 IV infusion over 1 -3 hr for neonate, 1 – 5 min slow injection reported
Pediatrics : 30 – 60 min infusion , 20 min infusion and 1 – 5 min slow injection reported
Separate infusion from penicillin compounds
Intrathecal/Intraventricular instillation of small volumes (<3 mL) over 1 – 2 min
Stability3 Store intact vials 30°C
Unused portion in vial may be kept if necessary 24 hr at room temp. (microbiologically)
Adverse reactions Frequency not defined:
CNS: Neurotoxicity (including muscle twitching, numbness, seizure, tingling of skin)
Otic: Auditory ototoxicity, vestibular ototoxicity
Renal: Nephrotoxicity
Respiratory: Respiratory paralysis
Postmarketing: CVS: Hypotension
Endocrine & metabolic: Albuminuria, hypomagnesemia
GIT: CDAD, nausea, vomiting
Genitourinary: Azotemia, hematuria, oliguria, toxic nephrosis
Hematologic: Anemia, eosinophilia, leukocyturia
Hypersensitivity: DRESS
CNS: Drug fever, headache, paresthesia, tremor
Neuromuscular & skeletal: Arthralgia, state of neuromuscular blockade
Renal: Acute kidney injury, casts in urine, ↑ Sr Cr
Contraindications Hypersensitivity to Amikacin, other aminoglycosides, or any component of the formulation
Aminoglycoside antibiotics
Gentamicin Injection
Trade name Epigent
Active drug Gentamicin
Dosage form Ampoule 20 mg/2 ml
Mechanism of action Antibiotic Inhibits protein synthesis in susceptible G –ve bacteria
Indications Serious infections, bone, respiratory tract, bloodstream infections due to susceptible gram-
negative bacteria and in combination for CNS endocarditis, IAI, and mycobacterial infection.
Dose Neonate IV 4 Dosing according to the chart
PMA(weeks) Age (days) Dose (mg/kg) Intervals (hours)
≤29** 0–7 5 48
8 – 28 4 36
≥ 29 4 24
30 - 34 0–7 4.5 36
≥8 4 24
≥ 35 All 4 24
**or significant asphyxia, PDA, Or treatment with Indomethacin
Discontinue antibiotics by 36 – 48 hr when blood cultures are sterile, unless a site specific
infection has been identified, for preterm and full term neonates
25
Gestational – age based Alternate dosing 17
GA (weeks) Age (days) Dose (mg/kg) Intervals(hr)
<30 ≤ 14 5 48
>14 5 36
30 – 34 ≤ 10 5 36
11 – 60 5 24
≥ 35 ≤7 4 24
8 – 60 5 24
Age – based Alternate dosing in sepsis IV 5
<7 days: 5 mg/kg/36 hr
7 – 28 days: 5 mg/kg /24 hr
CNS infection3 Intraventricular/intrathecal (use a preservative-free preparation)
1 mg/day (higher mortality rate in the Intraventricular use of a higher dose 2.5 mg/day)
In obese pediatrics use adjusted weight (IBW + 0.4 [TBW – IBW]) to calculate initial dosage
Or use adjusted body weight for obese pediatrics = 0.7 x TBW
Conventional dosing: IV, IM: 2 – 2.5 mg/kg/8 hr (endocarditis)
Endocarditis, treatment: Child & Adolescent IV
Synergy (G+ve bacteria): 3 – 6 mg/kg/day divided /8 hr
Treatment (G-ve bacteria): 7.5 mg/kg/day divided /8 hr
CNS infections IV: 2.5 mg/kg/8 hr
Intraventricular/intrathecal (preservative-free)
Infants & Children: 1– 2 mg/day3. (May increase if necessary up to 5 mg/day)5
Adolescents: 4 – 8 mg/day (based on adult recommendation data)
Extended-interval IV: 5 – 7.5 mg/kg/24 hr in normal renal function
Age-directed dosing ≥3 months – <2 years: 9.5 mg/kg/24 hr.
2 – < 8 years: 8.5 mg/kg/24 hr
≥8 years & Adolescents: IV: 7 mg/kg/24 hr.
Pulmonary infection in CF, IV: 10 – 12 mg/kg/24 hr Preferred, max.12 – 20 mg/kg/dose
Or IM, IV : 3.3 mg/kg/8 hr
IAI, complicated: IV: 3 – 7.5 mg/kg/day divided/ 8 - 24 h
Urinary tract infection (UTI):
Conventional IV:
2.5 mg/kg/ 8 hr until improvement, switch to appropriate oral antibiotics as soon as possible
Duration: patients < 2 yr or with pyelonephritis: 7 – 14 days
˃ 2 yr with uncomplicated cystitis: 3 – 7 days
Extended-interval IV: <5 yr: IV: 7.5 mg/kg/ 24 hr.
5 – 10 yr: IV: 6 mg/kg/ 24 hr.
11 – 12 yr: IV: 4.5 mg/kg/24 hr
Switch to oral appropriate therapy once afebrile for 24 hr.
IM: uncomplicated cystitis (resistant g –ve): 5 mg/kg as a single dose (data clinical trials)
Surgical prophylaxis: Infant, child & adolescent: IV: 2.5 mg/kg within 60 min prior to surgery
Dose adjustment Neonate 4
**Significant asphyxia, hypothermia, PDA, Or treatment with Indomethacin follow age based
adjustment for ≤ 29 weeks PMA with patient age
Hypothermia,
GA: 36 – 40 Weeks: 5 mg /kg /36 hr
GA: 42 weeks: 5 mg /kg/24 (in hypothermia 6 hr after birth)
Renal Impairment: prolong intervals or reduce dose acc.to sr. conc.
Infants, Children, and Adolescents3: IM, IV based on doses of 2.5 mg/kg/ 8 hr
GFR 30 – 50 mL/min/1.73 m2: dose /12 – 18 hr
GFR 10 – 29 mL/min/1.73 m2: dose /18 – 24 hr.
GFR <10 mL/min/1.73 m2: dose /48 – 72 hr.
26
IHD: 2 mg/kg/dose, redose based on Sr. concentrations.
PD: 2 mg/kg/dose, redose based on Sr. concentrations.
CRRT: 2 - 2.5 mg/kg/12 - 24 hr, monitor Sr. concentrations.
Preparation IV Use Conc. 1 – 10 mg/ml in NS3, D5W,D10W 3,4
IV local Standard dilution 1 mg/mL used (=1+9 ml)
Intrathecal/Intraventricular: Must use preservative-free gentamicin & preservative-free NS
to a final conc. of 1 – 5 mg/mL (1+9 ml to 1+1 ml)
Administration3 IV infusion 30 – 120 min
Slow injection over 3 – 5 min reported even in neonates on ≤ 4 mg/kg/dose
Separate infusion from penicillin compounds
Intrathecal/Intraventricular instillation of small volumes (<3 mL) over 1 – 2 min
IM: undiluted
Stability3 Store intact ampoules at 15 – 30°C
Any unused portion is discarded
Adverse reactions Frequency not defined.
CVS: Edema, HTN, hypotension, phlebitis, thrombophlebitis
CNS: Abnormal gait, ataxia, brain disease, confusion, depression, dizziness, drowsiness,
headache, lethargy, myasthenia, numbness, paresthesia, peripheral neuropathy,
pseudomotor cerebri, seizure, vertigo
Dermatologic: Alopecia, erythema, pruritus, skin rash, urticaria
Endocrine & metabolic: Hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia,
weight loss
GIT: Anorexia, CDAD, ↓appetite, enterocolitis, nausea, sialorrhea, stomatitis, vomiting
Genitourinary: Casts in urine (hyaline, granular), Fanconi-like syndrome (high dose,
prolonged course), oliguria, proteinuria
Hematologic: Agranulocytosis, anemia, eosinophilia, granulocytopenia, leukopenia, purpura,
reticulocytopenia, reticulocytosis, splenomegaly, thrombocytopenia
Hepatic: Hepatomegaly, ↑liver enzymes
Hypersensitivity: Anaphylaxis, anaphylactoid reaction, hypersensitivity reaction
Local: pain at injection site
Neuromuscular & skeletal: Arthralgia, muscle cramps, muscle fatigue (myasthenia gravis-like
syndrome), muscle twitching, tremor, weakness
Ophthalmic: Visual disturbance
Otic: Auditory impairment, hearing loss (with sustained ↑ Sr conc, early toxicity usually
affects high-pitched sound), tinnitus
Renal: ↓Cr Cl, ↓urine specific gravity, ↑ BUN, ↑ Sr Cr, polyuria, renal failure (high trough
Sr. conc.), renal tubular necrosis
Respiratory: Dyspnea, laryngeal edema, pulmonary fibrosis, RD
Other: Fever
Contraindications Hypersensitivity to gentamicin, other aminoglycosides, or any component of the formulation
27
Glycopeptide antibiotics
Vancomycin Injection
Trade name Vancobact / Vancocin
Active drug Vancomycin
Dosage form Vial 500 mg for IV Use (used Oral in CD colitis)
Mechanism of action Bactericidal agentinhibits cell wall synthesis of most G +ve bacteria
Indications IV: Infections by confirmed/suspected MRSA or beta-lactam resistant CoN Staph. & for
susceptible infections in penicillins/cephalosporins allergy. Oral: Treatment of CD infection
Dose Neonate4
Initial Dose: 10 – 15 mg/kg/ interval IV up to 20 mg/kg in serious MRSA infection
PMA (weeks) Age (days) Interval (hr)
≤ 29 0 – 14 18
˃ 14 12
30 – 36 0 – 14 12
˃ 14 8
37 – 44 0–7 12
˃7 8
≥ 45 all 6
IT, Intraventricular(preservative free): 3 – 20 mg/day (5 mg/dose is reported sufficient)
Surgical prophylaxis of Endocarditis: 15 mg/kg/dose 60 min prior to procedure
Alternate dosing5:IV
PMA <29 Week: 15 mg/kg/24 hr
29 – 34 weeks: 15 mg/kg/12 hr
≥35 weeks: 15 mg/kg/8 hr
Infant, Child & Adolescent 3
IV : 40 – 60 mg/kg/day divided/ 6 – 8 hr Max 2 g/day
Alternate general dosing 12 – 17 yr: 15 – 20 mg/kg/ 12 hr5
Endocarditis age 1 month – 11 years: 10 – 15 mg/ kg/ 6 hr 5
Endocarditis 12 – 17 yr IV: 15 – 20 mg/kg/ 8 – 12hr (loading: 25 – 30 mg /kg, max. 2 g, in
critically ill patient, then start usual regimen after loading)
CNS infection: IV: 15 mg/kg/6 hr
Intraventricular/Intrathecal (preservative-free): 5 – 20 mg/day acc. To ventricular size
Pre-dose trough conc should be ≤ 10 mg/L
If CSF not draining free prolong interval to /2 – 3 days
Serious MRSA infection3 including Skin & skin structure infection with MRSA
3months – 11 yr: 60 – 80 mg/kg/day divided /6 hr (max: 3.6 g/day)
≥ 12 yr: 60 – 70 mg/kg/day divided /6 - 8 hr (max: 3.6 g /day)
Complicated Skin & skin structure infection IV:
Necrotizing Non – MRSA (1 month – 18 yr) : 10 – 13 mg/kg /8hr
Cystic fibrosis : BY INHALATION OF NEBULISED SOLUTION5
Child: 4 mg/kg /6 or 12 hr (max. 250 mg /dose) for 5 days
Surgical prophylaxis IV3: 15 mg/kg/dose within 120 min prior to procedure
CD, Oral: 10 mg/kg/6 hr, max. 125 mg/dose, up to 500 mg/dose in severe infection for 10
days )3, in recurrent infection review detailed reference for pulsed -tapered regimen
OR 40 mg/kg/day divided 6 – 8 hr (7 – 10 days, max 2 g/day)
In CD with ileus (review rectal dosing regimen)3
Continuous infusion dosing regimen: (Limited data) Infants, Children & Adolescents:
IV: Loading dose: 10 – 15 mg/kg/dose over 1 – 2 hr, then
Maintenance of 40 – 60 mg/kg/day infusion over 24 hr, adjust dose to target Sr conc.
Doses: 30 – 110 mg/kg/day reported, in cancer or critically ill, may require higher doses
Transitioning from intermittent to continuous infusion may require no loading dose, total
daily dose needs reduction based on conc achieved during intermittent IV & patient factors
28
Dose adjustment3 Renal function-based dose in PNA ≤ 60 days, (for a target trough conc. of 5 – 10 mg/L)
Loading : All patients 20 mg/kg once & Maintenance dose: acc. to the table
GA (Weeks) Sr Cr (mg/dl) Dose (mg/kg) Interval (hr)
≤28 < 0.5 15 12
0.5 – 0.7 20 24
0.8 – 1 15 24
1.1 – 1.4 10 24
>1.4 15 48
>28 < 0.7 15 12
0.7 – 0.9 20 24
1 – 1.2 15 24
1.3 – 1.6 10 24
> 1.6 15 48
Renal impairment
Oral: no dosage adjustment
IV: Infant, Child & Adolescent: based on IV doses of 10 mg/kg/ 6 hr or 15 mg/kg/ 8 hr.
GFR 30 – 50 mL/min/1.73 m2: 10 mg/kg/12 hr.
GFR 10 – 29 mL/min/1.73 m2: 10 mg/kg/18 – 24 hr.
GFR <10 mL/min/1.73 m2, IHD & PD: 10 mg/kg/dose, adjust interval based on Sr level.
CRRT: 10 mg/kg/ 12 – 24 hr, monitor Sr level.
Hepatic Impairment: Oral, IV no dosage adjustment.
Preparation3 IV: Vial 500 mg + 10 ml SWFI (= 50 mg/ml , colorless to bronze )
Must be diluted before IV infusion with D5W or NS to at least 5 mg/ml (1 x 10ml)
10 mg /ml may be used in fluid restriction (1 ml x 5 ml dilution) Red man syndrome risk
Compatible with D10W at 5 mg / ml
IT/Intraventricular: dilute to 1 – 10 mg/ml (1+ 49 ml to 1 +4 ml) with preservative free NS
Oral: dose withdrawn from reconstituted sol. + 30 ml water in nasogastric tube or oral
Administration3 IV infusion over1 – 2 hr (no more than 10 mg/min) Red man syndrome
May be irritant, Avoid extravasation
IN red man syndrome may increase dilution & prolong rate to 90 – 120 min, administration
of antihistaminic just before infusion may minimize or prevent reaction
IT, Intraventricular: give over 1 – 2 min
Oral: shake before use, may add to flavored syrup but in nasogastric route use water only
Stability Store intact vial at 30 ◦ C 1
Reconstituted: (500 mg /10 ml) SWFI: 24 hr at 2 – 8 ◦ c 2, extended stability reported
(Vancobact 4 days at 2 – 8 ◦ c)1
Adverse reactions3 Frequency not defined: CVS: Chest pain, flushing, hypotension, shock, vacuities
Dermatologic: Bullous dermatitis, erythema, exfoliative dermatitis, pruritus, SJS
Hematologic: Agranulocytosis, eosinophilia, leukopenia, thrombocytopenia
Hypersensitivity: Hypersensitivity reaction
Local: Injection site phlebitis, irritation & pain
CNS: Chills, dizziness, malaise, vertigo
Neuromuscular & skeletal: Myalgia
Otic: Hearing loss, tinnitus
Renal: ↑BUN & Sr Cr, interstitial nephritis , renal tubular necrosis
Respiratory: Dyspnea, wheezing
Other: Fever
Postmarketing: CVS: Hypersensitivity angiitis
Dermatologic: AGEP, linear IgA bullous dermatosis, erythema multiforme, MPE, TEN
GIT: CDAD & CD colitis, peritonitis
Hematologic: Henoch-Schonlein purpura, ITP, neutropenia (reversible), pancytopenia.
Hypersensitivity: Anaphylaxis, fixed drug eruption, Vancomycin infusion reaction
Immunologic: DRESS
Renal: Acute kidney injury
Contraindications3 Hypersensitivity to Vancomycin or any component of the formulation
29
Glycopeptide antibiotics
Teicoplanin Injection
Trade name Targocid
Active drug Teicoplanin
Dosage form Vial 200 mg/3 ml for IV, IM , Oral in CD colitis
Mechanism of action Bactericidal activity against aerobic/anaerobic G +ve bacteria including MDR staphylococci.
Indications Serious infections by G+ve bacteria including endocarditis, complicated SSI , pneumonia,
complicated UTI & BJI
Dose neonate and infant ˂2 months 3,5
Loading IV: 16 mg /kg once
Maintenance IV: 8mg/kg/24 hr, start 24 hr after loading
2 month – 12 yr 1,5
Loading: 10 mg/kg/12 hr for 3 doses (by IV injection or infusion)
Maintenance: 6 – 10 mg/kg/day, start 24 hr after loading (IV)
>12 yr 5
Loading: 6 mg /kg/12 hr for 3 doses (IV injection or infusion)
Maintenance; 6 mg/kg/day, start 24 hr after loading(IV,IM)
Endocarditis (streptococcus, staphylococcus):
Loading: 12 mg /kg/12 hr for 3 – 5 doses (IV injection or infusion)
Maintenance: 12 mg/kg/day, startb24 hr after loading (IV)
CD infection Oral: 100 – 200 mg /12 hr
Dose adjustment Renal impairment 5
Day1 – 4 : give full doses
Day5 : according to renal function
GFR (ml/min) Adjustment
30 – 80 Full dose /48 hr
˂30 Full dose /72 hr
Hepatic impairment : no adjustment necessary.
Preparation1,5 Vial 200 mg +3 ml solvent, add solvent on wall sides, Roll gently, don’t shake to avoid foam
IV infusion : dilute reconstituted solution in D5W or NS (1 ml + 4 ml diluent)
Oral: topical action in GIT for CD colitis only: use reconstituted sol
Administration IV injection administer reconstituted solution over 3 – 5 min 2
IV infusion: give over 30 min 2,5
Stability1 Store vials at Max. 30 ◦ C
200 mg/3ml stable for 24 hr at 2 – 8 ◦ C1
Adverse reactions 5 Common / very common
Fever, Pain, skin reactions
Uncommon:
Hypersensitivity: bronchospasm, hypersensitivity
CNS: dizziness, headache.
Auditory: hearing impairment, ototoxicity
Hematologic: eosinophilia, thrombocytopenia, leucopenia.
GIT: nausea, vomiting, Diarrhea
Rare / very rare:
red man syndrome
Frequency not known:
CNS: Chills
Hematologic: Agranulocytosis, angioedema, thrombophlebitis, neutropenia
Infection: overgrowth of nonsusceptible organisms
Renal: renal impairment.
CNS: seizure.
Dermatologic: SCARs.
Contraindications 1 Hypersensitivity to Teicoplanin or any component in the formulation
30
Fluroquinolone antibiotics
Ciprofloxacin Injection
Trade name Ciprocin
Active drug Ciprofloxacin
Dosage form Vial 200 mg/20 ml (must be diluted for IV)
Mechanism of action Bactericidal agent inhibits the enzymes topoisomerase II & IV required for bacterial DNA
replication, transcription, repair, and recombination
Indications Complicated UTI and pyelonephritis, Cystitis, chronic bacterial prostatitis, lower RTI , acute
exacerbation of chronic bronchitis, SSI , BJI, and acute sinusitis, complicated IAI, infectious
diarrhea, HAP, febrile neutropenia, surgical prophylaxis, endocarditis
Dose Neonatal 4
Sepsis with MDRO IV: 5 – 10 mg/kg/12 hr 4
Alternate regimen3
PMA <34 weeks: IV: 7.5 – 10 mg/kg/12 hr
PMA ≥34 weeks: IV: 10 – 15 mg/kg/12 hr
In older neonate with CNS Infection: A higher daily doses up 50 – 60 mg/kg/day 3
Infant, Child & Adolescent 3
IV: 10 mg/kg/ 8 – 12 hr (max. dose: 400 mg/dose)3,5
Endocarditis (culture negative),IAI, IV: 10 – 15 mg/kg/12 hr in (max: 400 mg/dose)
CNS infection IV: 10 mg/kg/8 hr or 15 mg/kg/12 hr
CAP with H. influenza (age 3 > months IV): 15 mg/kg/12hr, max 400 mg/dose for 5 – 10 days
Complicated UTI, IV: 6 – 10 mg /kg /8 hr (max 400 mg /dose)
Duration Age <2 yr : 7 – 14 days
children & adolescent: 6 – 10 days
Surgical prophylaxis 3: Child & Adolescent: IV: 10 mg/kg within 120 min. prior to surgery
Max. dose: 400 mg/dose
Dose adjustment Renal impairment: Infant, Child & adolescent3 (expert opinions)
GFR ≥30 mL/min/1.73 m2: No adjustment
GFR 10 – 29 mL/min/1.73 m2: 10 – 15 mg/kg/ 18 hr
IHD/PD (after dialysis on dialysis days): Minimally dialyzable (<10%): 10 – 15 mg/kg/ 24 hr
CRRT: 10 – 15 mg/kg/12 hr
Hepatic Impairment no adjustments, use with caution in severe impairment.
Preparation Dilute to Conc. 0.5 – 2 mg/mL4
Vial 200 mg + 80 mg NS(or D5W, D10W, LR) 1,2 ( 200 mg /100 ml) = 2 mg /ml
Administration IV infusion over 60 min 3,4
Rapid injection causes venous irritation, burning, pain, erythema & swelling
Stability Store intact vial at 30 ◦C , protect from light 1
200 mg/100 ml NS: chemically stable for 30 days at 2 – 8 °c & up to 31°C protect from light 2
Adverse reactions >10% : Neuromuscular & skeletal signs and symptoms
1% - 10%
GIT: Abdominal pain, diarrhea, dyspepsia, nausea, vomiting
Genitourinary: Vulvovaginal candidiasis
Local: Injection site reactions
CNS: Dizziness, drowsiness, headache, insomnia, nervousness, restlessness
Respiratory: Asthma
Other: Fever
<1%: CVS: AMI, angina pectoris, bradycardia, flushing, HTN, hypotension, syncope, tachycardia,
thrombophlebitis, vasculitis, vasodilation
Dermatologic: Diaphoresis, erythema multiforme/ nodosum, exfoliative dermatitis, MPE,
pruritus, skin photosensitivity, SJS, TEN, urticaria, bullous dermatitis
Endocrine & metabolic: Albuminuria, gynecomastia, hyperglycemia, hypoglycemia, ↑thirst
31
GIT: Abdominal distress, anorexia, CD colitis, constipation, dysgeusia, flatulence, GIT
hemorrhage, intestinal obstruction/ perforation, buccal ulcer, pancreatitis
Genitourinary: Casts/crystals in urine, dysmenorrhea, hematuria, hemorrhagic cystitis, urinary
frequency, vaginitis
Hematologic: Agranulocytosis, petechia, ↑PT, purpuric disease
Hepatic: Cholestatic jaundice, hepatic necrosis
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema
CNS: abnormal gait, anosmia, ataxia, burning sensation, confusion, depression, hallucination,
hypertonia, malaise, manic reaction, migraine, myasthenia, nightmares, pain, paranoid ideation,
paresthesia, phobia, seizure, status epilepticus, suicidal ideation/tendency , taste disorder,
unresponsive to stimuli, vertigo
Neuromuscular & skeletal: Arthralgia, asthenia, joint stiffness, tremor
Ophthalmic: Blurred vision, chromatopsia, ↓visual acuity, diplopia, nystagmus, photopsia
Renal: Acute kidney injury, interstitial nephritis, nephrolithiasis
Respiratory: Bronchospasm, dyspnea, hemoptysis, laryngeal edema
Postmarketing:
CVS: Aortic aneurysm/dissection, prolonged QT interval, torsades de pointes
Dermatologic: AGEP
GIT: Ageusia, CDAD
Hematologic: Anemia, eosinophilia, hemolytic anemia, leukopenia, lymphocytosis,
methemoglobinemia, monocytosis, pancytopenia, thrombocythemia, thrombocytopenia.
Hepatic: Hepatic failure, hepatotoxicity
Hypersensitivity: Fixed drug eruption, non-immune anaphylaxis
Immunologic: DRESS, Serum Sickness-like reaction
CNS: Agitation, anxiety, delirium, disturbed attention, myasthenia gravis exacerbation, Guillain-
Barré syndrome, hyperesthesia, hypoesthesia, ↑ICP, memory impairment, myoclonus,
peripheral neuropathy, polyneuropathy, twitching
Neuromuscular & skeletal: Myalgia, rupture of tendon, tendinopathy
Ophthalmic: Retinal detachment
Respiratory: Pneumonitis
Contraindications Hypersensitivity to ciprofloxacin, any component in formulation or other quinolones &
concurrent administration of tizanidine
Respiratory Fluroquinolone antibiotic

Levofloxacin Injection /Oral Tablet
Trade name Levaquin, Levofloxacin Eva, Levofloxacin Arabcomed
Active drug Levofloxacin
Dosage form Vial 500 mg/100 ml for IV
Mechanism of action Bactericidal agent inhibits the enzymes topoisomerase II & IV required for bacterial DNA
replication, transcription, repair and recombination
Indications Acute bacterial sinusitis, HAP,CAP, bacterial exacerbation of chronic bronchitis, chronic bacterial
prostatitis SSI (uncomplicated/complicated), UTI (uncomplicated/complicated), bacteremia,
pulmonary infection in CF, tuberculosis with MDRO & exit-site /tunnel infection
3
Dose 6 months – <5 years: Oral, IV: 8 – 10 mg/kg/12 hr. (max 250 mg/12 hr)
≥5 years: Oral, IV: 10 mg/kg/24 hr (max. dose: 750 mg/day.)
Pneumonia in age ≥ 5 – 16 yr IV, Oral: 8 – 10 mg/kg/24 hr
Rhinosinusitis, acute bacterial: in Type I penicillin allergy or initial therapy failure or MDRO
Child/Adolescent
Oral, IV: 10 – 20 mg/kg/day divided/12 – 24 hr for 10 – 14 days, max.500 mg/day.
Surgical prophylaxis
Child & Adolescent: IV: 10 mg/kg / dose 120 min prior to surgery max. 500 mg/dose
Dose adjustment3 Renal impairment
Based on: 5 – 10 mg/kg/12 hr in age ≤ 5 yr & 5 – 10 mg/kg/24 hr in ages > 5 years.
GFR ≥30 mL/min/1.73 m2: No adjustment necessary
32
GFR 10 – 29 mL/min/1.73 m2: 5 – 10 mg/kg/dose/24 hr
IHD or PD: 5 – 10 mg/kg/48 hr (not dialyzable), supplemental doses are not required
Preparation IV: Ready to use
Extemporaneously prepared Suspension 50 mg /ml in syrup is attained by crushing tablets &
completing the volume with a special syrup to conc 50 mg/ml suspension (review reference)3
Administration3 IV infusion over 60 – 90 min, rapid IV infusion may cause hypotension (750 mg over 90 min)
Don't administer in same IV line with solution of multivalent cations (magnesium, calcium).
Maintain adequate hydration to prevent crystalluria
Oral Tablets: use without regard to meals, separate from times of antacids (2 hours)
Missed dose: take as soon as possible when time remaining for next scheduled dose ≥8 hr
Stability1 Store intact vial at 30 ◦ C, protect from light
Single use vial: Discard after use. Some products may be stable for 3 hr at 30 ◦C Arabcomed product
Oral tablet store at max. at 30 ◦ C
Adverse reactions 1% - 10%: CVS: Chest pain, edema
GIT: Abdominal pain, constipation, diarrhea, dyspepsia, nausea, vomiting.
Genitourinary: Vaginitis.
Infection: Candidiasis.
Local: Injection site reaction.
CNS: Dizziness, headache, insomnia.
Respiratory: Dyspnea.
<1%: CVS: Palpitations, phlebitis, syncope, ventricular arrhythmia/tachycardia
Dermatologic: Urticaria
Endocrine & metabolic: Hyperglycemia, hyperkalemia, hypoglycemia
GIT: Anorexia, CD colitis, esophagitis, gastritis, gastroenteritis, pancreatitis, stomatitis
Genitourinary: Genital candidiasis
Hematologic: Anemia, granulocytopenia, thrombocytopenia
CNS: Abnormal dreams/nightmares, altered gait, agitation, anxiety, confusion, depression,
drowsiness, hallucination, hypertonia, paresthesia, seizure, vertigo
Neuromusculoskeletal: hyperkinetic muscle activity, myalgia, skeletal/joint pain, tremor
Postmarketing: CVS: Aortic aneurysm, aortic dissection, hypersensitivity angiitis, hypotension,
prolonged QT, tachycardia, torsades de pointes, vasodilation
Dermatologic: AGEP, erythema multiforme, hyperpigmentation, phototoxicity, photosensitivity,
SJS, TEN
GIT: Ageusia, CDAD, dysgeusia
Genitourinary: Casts in urine, crystalluria
Hematologic: Agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia, ↑INR,
leukopenia, pancytopenia, ↑PT, thrombotic thrombocytopenic purpura
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, fixed drug eruption, nonimmune
anaphylaxis, serum sickness
Immunologic: DRESS
CNS: Abnormal EEG, anosmia, delirium, altered attention/smelling/voice, encephalopathy, ↑ICP
myasthenia gravis exacerbation, Guillain-Barre syndrome, nervousness, peripheral neuropathy,
altered memory, paranoia, psychosis, restlessness, suicidal thoughts, toxic psychosis
Neuromuscular/skeletal: Muscular paralysis, rhabdomyolysis, tendon rupture, tendinopathy
Ophthalmic: Blurred vision, ↓visual acuity, diplopia, scotoma, uveitis
Otic: Hypoacusis, tinnitus
Respiratory: Bronchospasm, hypersensitivity pneumonitis
Other: Fever, multi-organ failure
Contraindications Hypersensitivity to levofloxacin, any component of the formulation, or other quinolones
33
Oxazolidinones Antibiotics
Linezolid Injection
Trade name Linezolid / Linzomentin /Linzobact/Foxazoldin
Dosage form Vial 200 mg / 100 ml for IV
Mechanism of Inhibits protein synthesis, bacteriostatic against enterococci & staphylococci and bactericidal
action against most streptococci.
Indications CAP, HAP, VAP, uncomplicated and complicated SSI, and VRE , bloodstream, osteoarticular,
meningitis, tuberculosis, peritonitis in patients with peritoneal dialysis catheters.
Dose Neonate Oral , IV
Preterm Age ≤7 days: 10 mg/ kg/ 12 hr 4.
Term (& preterm Age >7 days): 10 mg/ kg/ 8 hr 4, 5.
Other reference suggest GA ≥34 weeks: 10 mg/kg/ 8hr.(all ages)3
Infant & Child <12 yr 3: Oral, IV: 10 mg/kg/ 8 hr, (max. dose: 600 mg/dose).
Uncomplicated SSI in oral age 5 – 11 yr : 10 mg /kg /12 hr for 5 days
Child ≥12 yr & Adolescent3: Oral, IV: 600 mg / 12 hr.
In blood stream infection: 10 mg/kg/12 hr with max 600mg/dose may be used
Dose adjustment3 Renal Impairment: Infants, Children, and Adolescents IV, Oral
No adjustment recommended, ↑risk of thrombocytopenia, utilize TDM and monitor closely
IHD, PD: Administer after dialysis session and Monitor
Hepatic Impairment: Pediatric , Mild - moderate : No adjustment
Severe: risk of thrombocytopenia in cirrhosis, use with caution and monitor closely
Preparation IV: Ready to use – with time yellow color of drug may intensify but potency not affected
Oral: not Available
Administration3 Oral suspension: no regard to food (gently invert bottle 3 – 5 times before use, don’t shake)
IV: infusion over 30 - 120 min.
Flush line before and after infusion with D5W, NS, Or LR
Stability1 Store intact vial at 30 ◦ C, protect from light
Use immediately, discard any unused portion
GIT: Diarrhea.
Hematologic: ↓WBC.
1% - 10%:
Endocrine & metabolic: ↑amylase ,↑LDH
GIT: Abdominal pain, dysgeusia , ↑Sr lipase, loose stools, nausea, vomiting, oral candidiasis,
tongue discoloration
Genitourinary: Vulvovaginal candidiasis
Hematologic: Anemia, neutropenia, eosinophilia, thrombocytopenia
Hepatic: Abnormal hepatic function tests, ↑ALT, ALP, AST & Sr bilirubin.
Infection: Fungal infection
CNS: Dizziness, headache, vertigo.
Renal: ↑ BUN , Sr Cr
Postmarketing: CVS: Hypersensitivity angiitis
Dermatologic: Bullous skin disease, SJS, TEN
Endocrine & metabolic: Hypoglycemia, hyponatremia, lactic acidosis.
GIT: CDAD, staining of tooth.
Hematologic: Leukopenia, pancytopenia, sideroblastic anemia.
Hypersensitivity: Anaphylaxis, angioedema.
CNS: Peripheral neuropathy, seizure, serotonin syndrome.
Ophthalmic: Blurred vision, optic neuropathy, vision loss.
Contraindications Hypersensitivity to linezolid or any component of the formulation
Concurrent use or within 2 weeks of MAO inhibitors
Uncontrolled hypertension, thyrotoxicosis
34
Polymyxin Antibiotic
Colistin injection
Trade name Colixin
Active drug Colistin
Dosage form Vial 1 million unit for IV
Mechanism of Colistin is the metabolite of colistimethate acts as a cationic detergent damages the bacterial
action cytoplasmic membrane causing leaking of intracellular substances and cell death
Indications Infections due to sensitive strains of certain gram-negative bacilli (particularly Pseudomonas
aeruginosa) which are resistant to other antibacterials
Dose Colistin base activity CBA 1 mg = colistimethate sodium (CMS) 30,000 units
Neonates
2.5 – 5 mg/kg/day divided/6 – 12 hr IV3,4
Or 75,000 – 150,000 Unit /Kg/day divided/ 6 – 12 hr IV 4
Intraventricular/Intrathecal CNS infection (VP-shunt infection, ventriculitis, meningitis),
multidrug resistant: Preterm & term neonates3
Intraventricular/Intrathecal: 4,800 – 7,200 unit (0.16 – 0.24 mg CBA)/kg/24 – 48 hr
Max. reported: 60,000 – 126,000 unit (2 - 4.2 mg CBA)/dose, duration: 6 – 2 8 days
Inhalation in VAP (limited data) nebulization3
120,000 Unit/kg/12 hr (4mg CBA/kg/12 hr) for up to 14 days
Age > 1 months 3
General IV: 75,000 – 150,000 unit/ Kg/day divided/ 6 – 12 hr 3,5
Systemic infection due to MDR gram negative bacilli infection IM, IV
Loading 75,000 – 150,000 unit /kg once max (9,000,000 units/dose) followed by
150,000 unit /kg/day divided/8 – 12 hr (max 5,400,000 unit /dose)
(Up to 300,000 units /kg/day divided, reported from pharmacokinetic studies)
Cystic fibrosis, pulmonary infection (Age ≥5 years )
IV: 90,000 – 150,000 unit/kg/day divided/8 hr (max.3 million unit/dose) for 10 – 21 days
Doses >150,000 unit/day (up to 240,000 unit/kg/day) used but associated with severe toxicity
By inhalation: may start at 990,000 unit /12hr, Usual range :2,250,000 – 4,500,000 unit /12hr
Doses ≤1,980,000 unit /8 hr has been reported
Inhalation in Pulmonary infection in MDR gram negative bacilli
Infant :120,000 unit/kg /12hr (max. 2,250,000/dose)
Child: 2,250,000 – 4,500,000 unit /12hr (reported range: 900,000 - 4,500,000/12hr)
CNS infection by Intraventricular/IT
Infant, children: 30,000 – 126,000 units once daily
(as high as 300,000 units reported after titration in treatment of MDR Acinetobacter)
In adolescent: range 60,000 – 249,000 unit/day divided/12 – 24 hr for 10 – 24 days
Dose adjustment4 Renal impairment: no data available for pediatric patients with renal impairment
the following dose adjustments are based on adults recommendations in renal impairment 4
Cr Cl 50 – 79 mL/min: 75,000 – 114,000 unit/kg/day divided/12 hr
Cr Cl 30 – 49 mL/min: 75,000 units/kg divided/12 – 24 hr
Cr Cl 10 – 29 mL/min: 45,000 units/kg /36 hr
hepatic Impairment: no dosage adjustments provided
Preparation Reconstitution: Vial 1 million units +10 ml SWFI or NS (roll gently) →100,000/ml 8
Dilution: 1ml + 4 ml NS 8or D5W1, May use (1ml + 1.5 ml) 5
Compatibility data with D10W NOT available2
Inhalation warnings!!
Dose in 3 ml of NS (4ml total), Use immediately after preparation to avoid lung toxicity
Intraventricular/Intrathecal: Dose + (1 – 2 ml) NS (preservative free)
35
Administration3 Intermittent IV infusion: Administer over 20 – 60 min, over 30 min in neonates
IV push Over 3 – 5 min
Intraventricular/Intrathecal: use freshly prepared sol, discard any unused portion
Inhalation: Administer via nebulizer immediately after preparation of solution to avoid
potentially life – threatening lung toxicity
Consider using bronchodilator(salbutamol)15 min before inhalation dose to avoid
bronchospasm
Stability1 Store intact at 25 °C, protect from light
Reconstituted Sol. 24 hr refrigerated8
Diluted solution 1 + 4ml should be used immediately
Inhalation: used immediately after preparation (toxic if stored)3
Intraventricular/Intrathecal: discard immediately after use3
Genitourinary: Nephrotoxicity, Acute renal failure
1% - 10%:
CNS: Neurotoxicity (with high-dose IV use in cystic fibrosis)
CNS: Dizziness, oral/ peripheral paresthesia, seizures, slurred speech, vertigo
Dermatologic: Pruritus, skin rash, urticaria
GIT: CDAD, gastric distress
Genitourinary: ↓urine output
Renal: ↓Cr Cl, ↑BUN, ↑ Sr Cr
Respiratory: Apnea, respiratory distress
Other: Fever
Contraindication Hypersensitivity to colistimethate, colistin, or any component of the formulation
36
Lincosamide Antibiotics
Clindamycin Injection
Trade name Dalacin
Active drug Clindamycin
Dosage form Ampoule 600 mg/4 ml for IV, IM
Mechanism of action Antibiotic inhibits protein synthesis, bacteriostatic or bactericidal depending on drug
concentration, infection site, and organism
Indications RTI, SSI, female pelvis/genital tract, sepsis & IAI by susceptible bacteria, BJI, toxoplasmosis
malaria, Pneumocystis j. pneumonia, prophylaxis for surgery &endocarditis and peritonitis.
Dose Neonate
IV dosing : 15 – 20 mg/kg/day divided / 6 – 8 hr3,4
PMA based dosing PO/IV 3,4 :
PMA (Weeks) Dosage
≤ 32 5 mg /kg/ 8hr
˃32 – 40 7 mg /kg/ 8hr
>40 9 mg /kg/ 8hr
Infant, Child, & Adolescent 3
IM, IV: 20 – 40 mg/kg/day divided / 6 – 8 hr
Max. daily dose: 2,700 mg/day
Surgical prophylaxis:
Child & Adolescent IV: 10 mg/kg 30 – 60 min prior to procedure, may repeat in 6 hr in
prolonged procedure or excessive blood loss (max. dose: 900 mg/dose)
Dose adjustment Renal: no dosage adjustment necessary
Hepatic Impairment: No adjustment required. Use caution with severe hepatic impairment.
Preparation IV: 1 ml (150 mg) + 9 ml D5W, NS, D10W yields conc. 15 mg/ml for infusion
IM: undiluted, max. 600mg / injection
Administration IV infusion over 10 – 60 min, MAX: 30 mg/min. 3,4 (hypotension, cardiopulmonary arrest)
conc. not to exceed 18 mg/mL (some references suggest conc. is 6 mg/mL for neonate) 4
Stability Intact ampoule: at max. 30° c2
Diluted: Use immediately after preparation
Dermatologic: Urticaria, vesiculobullous dermatitis
GIT: Abdominal pain, nausea, vomiting
Postmarketing:
CVS: Hypotension (following rapid IV administration), thrombophlebitis (IV)
Dermatological: AGEP, erythema multiforme, exfoliative dermatitis, maculopapular rash, SJS,
Sweet syndrome, TEN
GIT: CDAD & colitis, diarrhea, dysgeusia, esophageal ulcer, esophagitis.
Hematologic: Agranulocytosis, transient eosinophilia /neutropenia, pancytopenia,
thrombocytopenia
Hepatic: Cholestatic hepatitis
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, DRESS, hypersensitivity
angiitis
Local: Abscess, induration, irritation & pain at injection site (IM)
Neuromuscular & skeletal: Inflammatory polyarthritis
Contraindications Hypersensitivity to clindamycin, lincomycin, or any component of the formulation.
37
Antibiotic /antiprotozoal/nitroimidazole
Metronidazole Injection /Oral
Trade name Flazole vial/Cidogel vial / Amrizole oral
Active drug Metronidazole
Dosage form Vial 500 mg /100 ml for IV infusion, oral suspension 125 mg/ 5ml
Mechanism of action Antimicrobial agent inhibits protein synthesis in susceptible anaerobic organisms
Indications Infection by susceptible anaerobes as SSI, BJI, lower RTI, IAI, peritonitis, endocarditis & H.
pylori, surgical prophylaxis, protozoal infections as amoebiasis & trichomoniasis.
Dose Neonate4 Loading IV/PO: 15 mg/kg
Maintenance: Oral or IV Infusion 1Begin one dosing interval after initial dose acc. to chart
PMA (week) Maintenance IV/PO (mg/kg) Interval (hr)
24 – 25* 7.5 24 4,5
26 – 27* 10 24
28 – 33 7.5 12
34 – 40 7.5 8 (GA ≥34 weeks: /8 hr5)
>40 7.5 6 (or 10 mg/kg/8 hr3)
* alternative maintenance Dose 7.5 mg/kg/12 hr3
Surgical prophylaxis IV 3,4 30 – 60 min before procedure
˂ 1.2 kg: 7.5 mg/kg/dose
≥ 1.2 kg: 15 mg/kg/dose
Infant ,child & Adolescent3
Oral: 15 – 50 mg/kg/day/8 hr ( max. dose: 2,25 g/day) 3
IV: 22.5 – 40 mg/kg/day divided /6 – 8 hr (max. daily dose :4 g/day)
Reference suggests IV max. dose: 500 mg/8hr in age 2 months – 17yr for anerobic infection5
Dosage outside above range:
Amebiasis
Oral, IV: 35 – 50 mg/kg/day divided/8 hr for 7 – 10 days, max dose: 750 mg
Alternate Oral5 (for 5 days in intestinal infection & for 5 –10 days if extra-intestinal)
Age 1 – 2 yr: 200 mg/8 hr
Age 3 – 6 yr: 200 mg/6 hr
Age 7 – 9 yr: 400 mg /8 hr
Age 10 –17 yr: 800 mg/8 hr
Appendicitis, perforated (once – daily dose)
Child & adolescent IV: 30 mg/kg/dose once daily + Ceftriaxone. Max: 1,500 mg/day
Helicobacter pylori eradication Child & Adolescent Oral
In combination regimen, usual duration of therapy is 14 days.
Weight-directed dosing: 10 – 15 mg/kg/12 hr, (max dose: 500 mg/dose)
Fixed dosing: wt 15 – < 25 kg : 250 mg / 12 hr
25 – < 35 kg : 500 mg in morning & 250 in evening (oral suspension: 375 mg /12 hr)
≥ 35 kg : 500 mg / 12 hr
Pelvic inflammatory disease: Adolescents Oral, IV
500 mg/12 hr for 14 days in combination regimen
Peritonitis (peritoneal dialysis) Infants, Children and Adolescents
Prophylaxis GIT, genitourinary IV: 10 mg/kg once before procedure + cefazolin, max 1g/dose
Treatment Oral: 10 mg/kg/8 hr, max: 1,200 mg/day
Giardiasis oral : 5 mg /kg/8 hr for 5 – 7 days (max 250 mg/dose)
Tetanus IV, Oral: 10 mg /kg/8hr for 7 – 10 days (max 500 mg /dose)
Surgical prophylaxis 3
Child – 18 yr IV: 15 mg/kg/dose (max: 500 mg /dose) 30 – 60 min before procedures
Colorectal surgery Child up to – 18 yr
Oral: 15 mg /kg /3 – 4 hr for 3 doses starting after mechanical bowl preparation in the
afternoon and evening before procedure (max. 1g/dose) + proper IV antibiotic prophylaxis
Dose adjustment3 Renal impairment: adjustment may not be necessary however, experts recommend
adjusting the dose based on doses of 15 – 30 mg/kg/day divided /6 – 8 hr.
38
GFR <10 mL/min/1.73 m2: 4mg/kg/6 hr
IHD or PD: 4mg/kg/6 hr
CRRT: no Adjustment
Hepatic impairment: Severe (Child-Pugh C) IV, oral immediate release: ↓dose by 50% 3,4
In hepatic encephalopathy reduce to one-third of the daily dose (may be given once daily)5
Preparation IV: Ready to use1
Avoid contact of drug solution with equipment containing aluminum.
Administration3 Oral: May administer with food to minimize GI upset.
IV: Administer undiluted (5 mg/mL) by slow intermittent infusion over 30 – 60 min.
Stability1 IV, oral : Store intact container at 30° C and protect from light
Discard unused IV solutions immediately after use.
GIT: Nausea
CNS: Headache
1% - 10%:
Dermatologic: Genital pruritus
GIT: Abdominal pain, diarrhea, xerostomia
Genitourinary: Dysmenorrhea, UTI urine abnormality
Infection: Bacterial infection, candidiasis
CNS: Dizziness, metallic taste
Respiratory: Flu-like symptoms, pharyngitis, rhinitis, sinusitis, upper RTI
CVS: Chest pain, facial/peripheral edema, flattened T-wave on ECG, flushing, palpitations,
syncope, tachycardia
Dermatologic: Erythematous rash, hyperhidrosis, pruritus, urticaria
Endocrine & metabolic: ↓libido
GIT: Abdominal cramps, anorexia, constipation, ↓appetite, dysgeusia, epigastric discomfort,
glossitis, hairy tongue, proctitis, stomatitis, vomiting
Genitourinary: Cystitis, dark urine (rare), dyspareunia, dysuria, urinary incontinence, urine
discoloration, vaginal dryness, vulvovaginal candidiasis
Hematologic: Agranulocytosis, eosinophilia
Immunologic: DRESS
Local: Inflammation/reaction at injection site.
CNS: Chills, depression, drowsiness, epilepsy, hypoesthesia, insomnia, irritability, malaise,
numbness, psychosis
Neuromuscular & skeletal: Arthralgia, asthenia, muscle spasm, myalgia
Ophthalmic: Abnormal eye movements (saccadic), nystagmus disorder
Renal: Polyuria
Respiratory: Dyspnea, nasal congestion
Other: Fever
Postmarketing:
CVS: Prolonged QT interval on ECG
Dermatologic: SJS,TEN
GIT: Pancreatitis (rare)
Hematologic: Leukopenia, neutropenia (reversible) thrombocytopenia (reversible, rare)
Hepatic: Acute hepatic failure, hepatotoxicity
Immunologic: Serum sickness-like reaction (joint pains)
CNS: Aseptic meningitis, ataxia, confusion, disulfiram-like reaction(with alcohol), dysarthria,
encephalopathy, mania, neurocerebellar toxicity, paresthesia, peripheral neuropathy,
seizure, vertigo
Ophthalmic: Optic neuropathy
Contraindications Hypersensitivity to metronidazole, nitroimidazoles, or any component of the formulation
Active neurological disorders, history of blood dyscrasia, hypothyroidism, hypoadrenalism.
39
Oral Sulfa derivative Antibiotics
Sulfamethoxazole / trimethoprim oral
Trade name Cotrimoxazole
Active drug Sulfamethoxazole (SMX) 200 mg + trimethoprim (TMP) 40 mg/ 5 ml
Dosage form Suspension for oral use
Mechanism of action Bacteriostatic Antibiotic interferes with bacterial folic acid synthesis and growth
Indications UTI, otitis media, acute exacerbations of chronic bronchitis, pharyngitis & tonsillitis,
Pneumocystis jirovecii pneumonia, meningitis, peritonitis, SSI, treatment or prophylaxis of
toxoplasmosis.
Dose3 2 months – 18 yr3
Oral: 8 – 12 mg TMP/kg/day divided/12 hr, Max. dose: 160 mg TMP/dose
UTI Oral: 6 – 12 mg TMP/kg/day in divided/ 12 hr, Max. dose: 160 mg TMP/dose
UTI Prophylaxis: 2 – 3 mg TMP/kg once daily
Osteoarticular infection: step down after IV: 6 – 20 mg TMP/kg /day divided/6 – 12 hr
Prophylaxis (pneumocystis pneumonia)
In Immunocompromised (hematologic malignancies or primary immunodeficiencies)
Infants, Children, and Adolescents
Oral: 5 mg TMP/kg/day or:
150 mg TMP/m2/day divided/12 hr for 2 – 3 days /week on alternating or consecutive days
or as a single daily dose given 7 days per week or 3 times weekly on consecutive days
Max. dose: 160 mg TMP/dose
Duration of prophylaxis varies based on underlying condition
Pneumocystis pneumonia Treatment
Infant, child oral: 15 – 20 mg TPM/day divided/6 – 8 hr (for 21 days)
Adolescent (mild, moderate, severe) oral: 15 – 20mg TPM/day divided/6 – 8hr (for 21 days)
Adolescent (mild – moderate) oral: 320 mg TMP/dose /8 hr (for 21 days)
Dose adjustment3
Renal impairment: according to table 3

Cr Cal Based on 5 – 12 mg TMP /kg Based on 15 – 20 mg TMP 80 – 160 mg TMP/day or
2
ml/min/1.73m /day divided / 24 – 12 hr /kg/day divided / 6 – 8 hr 160 mg 3 times /week
>30 No adjustment No adjustment No adjustment
15 – 30 Caution / monitoring. Caution / monitoring. Caution /monitoring.
0.5 dose/day 0.5 dose/day 80 mg TMP/interval
divided/12 – 24 hr divided/8 – 12 hr
<15 not recommended not recommended 80 mg TMP 3 times a week.
0.25 – 0.5 dose/day 0.25 –0.5 dose/day
divided/12 – 24 hr divided/12 – 24 hr
IHD: Dialyzable (~44% of TMP and ~57% of SMX removed)
Children & Adolescents: Oral, IV: 3 - 5 mg TMP/kg/ 24 hr on dialysis days, after dialysis
If dose given before dialysis : give additional 2.5 mg TMP /kg /dose after dialysis
Pneumocystis pneumonia: Oral, IV: 5 mg TMP/kg/12 hr on dialysis days after dialysis
If prior to dialysis give additional 2.5 mg TMP/kg dose after IHD sessions
Peritoneal dialysis: Oral, IV: Follow dose adjustment for CrCl <15 mL/min/1.73 m2
CRRT: No adjustment likely necessary
Hepatic Impairment: no adjustment, BUT contraindicated in marked hepatic damage.
Preparation Readily prepared suspension
Shake suspension well before each use.
40
Administration3 Administer without regard to meals.
Maintain adequate fluid intake during use
Stability1 Suspension: Store at 30 ◦ C, protect from light
CVS: Circulatory shock, hypersensitivity myocarditis, polyarteritis nodosa,
thrombophlebitis
Dermatologic: AGEP, erythema multiforme, exfoliative dermatitis, skin photosensitivity,
rash, SJS, Sweet’s syndrome TEN, urticaria
Endocrine: Hyperkalemia, hyponatremia
GIT: Abdominal pain, anorexia, diarrhea, glossitis, nausea, pancreatitis, stomatitis,
vomiting
Genitourinary: Crystalluria, diuresis, toxic nephrosis (with anuria and oliguria)
Hematologic: Agranulocytosis, aplastic anemia, eosinophilia, hemolysis (with G6PD
deficiency), hemolytic anemia, Henoch-Schönlein purpura, hypoprothrombinemia,
leukopenia, megaloblastic anemia, methemoglobinemia, neutropenia, thrombocytopenia
Hepatic: Cholestatic jaundice, hepatotoxicity (hepatitis, cholestasis, & hepatic necrosis)
↑Sr ALT, AST & Bilirubin
Hypersensitivity: Angioedema, serum sickness
Immunologic: DRESS
CNS: Apathy, aseptic meningitis, ataxia, chills, depression, fatigue, hallucination, vertigo
headache, insomnia, kernicterus (neonates), nervousness, peripheral neuritis, seizure,
Neuromuscular & skeletal: Arthralgia, asthenia, myalgia, rhabdomyolysis, SLP
Ophthalmic: Conjunctival injection, injected sclera, uveitis
Otic: Tinnitus
Renal: Interstitial nephritis, renal insufficiency
Respiratory: Acute respiratory failure, cough, dyspnea, eosinophilic pneumonitis (acute),
interstitial pulmonary disease, pulmonary infiltrates, pulmonary injury (acute and
delayed)
Other: Fever
Postmarketing:
CVS: Prolonged QT interval on ECG, torsades de pointes
Endocrine & metabolic: Hypoglycemia, metabolic acidosis
GIT: CD colitis, dysgeusia
Hematologic: Thrombotic thrombocytopenic purpura
Hypersensitivity: Anaphylaxis, fixed drug eruption
Respiratory: ARDS
Contraindications 3 Hypersensitivity to any sulfa drug, trimethoprim, or any component of the formulation
History of drug induced-ITP with sulfonamides or trimethoprim
Megaloblastic anemia due to folate deficiency
Infants <2 months
Marked hepatic damage or severe renal disease (if patient not monitored)
41
Macrolide antibiotic
Azithromycin Oral
Trade name Zithrokan/ azalide
Active drug Azithromycin
Dosage form Powder for oral suspension 200 mg /5 ml
Mechanism of Macrolide antibiotic Inhibits RNA-dependent protein synthesis of Susceptible bacterial
action including atypicals
Indications Treatment of acute otitis media , CAP, pharyngitis/tonsillitis, acute bacterial sinusitis or
acute exacerbations of chronic bronchitis, uncomplicated SSI, urethritis & cervicitis,
pertussis, typhoid fever, endocarditis prophylaxis in penicillin allergy
Dose Neonate 4
Oral: 10 mg/kg once daily for 5 days3 (pertussis treatment and prophylaxis)
Chlamydia infection : 20 mg/kg/day for 3 days orally
Infant, Child, & Adolescent3 Oral:
Day 1: 10 – 12 mg/kg/dose (usual max.: 500 mg/dose)
Day 2 – 5 : 5 – 6 mg/kg once daily (usual max. : 250 mg/dose)
3 – days regimen: 10 mg/kg/24 hr for 3 days5
Wt ≥46 kg: Oral: 500 mg /dose/day for 3 days 1,5
Pertussis : Oral:
1 – 5 months: 10 mg/kg/24 hr for 5 days
≥ 6 months : 10 mg/kg once on day 1 (maximum dose: 500 mg/dose)
Then: 5 mg/kg once daily on days 2 – 5 (maximum dose: 250 mg/dose).
Acute otitis media: Age ≥ 6 months
Single dose: 30 mg/kg/ once (max 1500 mg /dose), repeat dose if vomiting occurs within
30 min of dose administration
3 – days regimen: 10 mg/kg once daily for 3 days, max 500 mg /dose
Recurrent or persistent: 20 mg/kg/day for 3 days in age below 6 yr
5 – days regimen:
Day 1: 10 mg/kg/dose(usual max.: 500 mg/dose)
Day 2 – 5: 5 mg/kg once daily (usual max. : 250 mg/dose)
GAS pharyngitis/tonsillitis
12 mg/kg/day for 5 days (max 500 mg/day)3,5
Or 20 mg/kg/day for 3 days ( max 1 g/dose)
Typhoid fever: (Child & Adolescent)
Oral: 10 mg/kg/dose (max: 500 mg/dose) once daily for 7 days
Or 20 mg/kg/dose (max 1g/dose) once daily for 5 – 7 days
Cystic fibrosis, chronic lung maintenance Oral 3
Patients with non-tuberculous mycobacterial infection shouldn't receive azithromycin
Age ≥6 month – 18 yr
10 mg/kg/dose 3 times weekly, max: 500 mg/dose
Or Fixed dosing for Age 6 – 18 yr
18 – <36 kg: Oral: 250 mg 3 times weekly
≥36 kg: Oral: 500 mg 3 times weekly
Dose adjustment3 Renal Impairment: no adjustment
Hepatic Impairment: no adjustment but use with caution (discontinue immediately if
hepatitis signs or symptoms appear)
Preparation1 Powder + 8 ml water or up to the mark and shake until suspended (the prepared
suspension conc. Is 200 mg/5 ml)
Administration1,3 Dose taken without regard to meals (suspension of immediate release)
Not administered with antacids that contain aluminum or magnesium.
Tablets, capsules Taken on an empty stomach (at least 1 hr before or 2 hr after meal)
42
Stability1 Prepared suspension: 5 days at max 30 °C, protect from light
Intact bottle: store at 30 °C, protect from light
Adverse reactions3 >10%
GIT: Diarrhea, nausea.
1% - 10%:
CVS: Chest pain, facial edema, palpitations.
Dermatologic: Diaphoresis, eczema, fungal dermatitis, pruritus, skin photosensitivity, skin
rash, urticarial, vesiculobullous dermatitis.
Endocrine & metabolic: ↑LDH
GIT: Abdominal pain, anorexia, constipation/diarrhea, dysgeusia, dyspepsia, enteritis
flatulence, gastritis, melena, oral candidiasis, stomatitis, vomiting
Hypersensitivity: Angioedema
Infection: Fungal infection, Genital candidiasis
CNS: Agitation, dizziness, drowsiness, fatigue, headache, insomnia, malaise, nervousness,
pain, vertigo.
Neuromuscular & skeletal: Hyperkinetic muscle activity, ↑creatine phosphokinase
Respiratory: Bronchospasm, cough, pleural effusion.
Other: Fever.
Postmarketing:
CVS: Prolonged QT interval on ECG, syncope, torsades de pointes, ventricular tachycardia
Dermatologic: AGEP, erythema multiforme, SJS, TEN
GIT: Ageusia, CDAD, CD colitis, pancreatitis, pyloric stenosis (infantile hypertrophic), tongue
discoloration
Hematologic: Thrombocytopenia
Hepatic: Cholestatic hepatitis, hepatic failure, hepatic necrosis, hepatocellular hepatitis
Immunologic: DRESS.
CNS: Aggressive behavior, altered sense of smell, anosmia anxiety, exacerbation of
myasthenia gravis, hyperactive behavior, paresthesia, seizure
Neuromuscular & skeletal: Arthralgia, asthenia
Otic: Deafness, hearing loss, tinnitus
Renal: Acute kidney injury, interstitial nephritis
Contraindications 3 Hypersensitivity to azithromycin, erythromycin, other macrolide (eg, azalide or ketolide)
antibiotics, or any component of the formulation, history of cholestatic jaundice/hepatic
dysfunction associated with prior azithromycin use
43
Systemic Antivirals
Acyclovir IV
Trade name Acyclovir
Active drug Acyclovir
Dosage form Vial for IV 500 mg
Mechanism of action Anti-viral agent that inhibit viral DNA synthesis and viral replication.
Indications HSV infections: encephalitis, genital, mucocutaneous, Herpes zoster and varicella zoster
Dose Neonates 4
HSV IV
PMA <30 week 20 mg/kg /12 – 8 hr4
PMA ≥ 30 week: 20 mg/kg/8 hr
(for 14 days for localized disease & at least 21 days for disseminated & CNS infection and
continue till CSF PCR negative for CNS disease )
Varicella
10 – 15 mg /kg/8 hr for 5 – 10 days 3,4
Infant, child & adolescent 3
Dosing based on IBW in obese patient.
IV doses >15 mg/kg/dose or 500 mg/m2 associated with ↑ nephrotoxicity risk
HSV treatment and suppressive therapy
Treatment (disseminated, CNS, or skin, eye, or mouth disease)
1 – 3 months: IV: 20 mg/kg/8hr (duration: 14 days For mucocutaneous & 21 days for CNS or
disseminated infection)
HSV encephalitis, treatment
3 months – <12 yr IV: 10 – 15 mg/kg/8 hr for 14 – 21 day, 20mg/kg not routinely recommended
≥12 years: IV: 10 mg/kg/8 hr for 14 – 21 days
HSV infection in Immunocompromised (disseminated & progressive), treatment
1 month – 18 yr: IV: 10 mg/kg/8 hr for 7 – 14 days
HSV genital infection
First infection,& severe: IV
≥12 yr: 5 – 10 mg/kg/8 hr for 2 – 7days, followed by oral therapy to complete at least 10
days of therapy
For First mild infection, Recurrent infection & chronic Suppression, HSV orolabial disease
Oral acyclovir used( refer to detailed reference on oral dosing of acyclovir)
HSV Mucocutaneous infection
Immuncompetent: IV: 1 month – 18 yr IV: 5 mg/kg/8 hr
Immunocompromised Treatment IV:
1 month – 12 yr IV: 10 mg/kg/8 hr for 7 - 14 days
>12 yr IV: 5 – 10 mg/kg/8 hr, change to oral after lesions begin to regress
HSV prophylaxis
Immunocompromised prophylaxis, seropositive non-HSCT , IV
1 month – 18 yr IV: 5 mg/kg/8 hr during period of risk
Herpes zoster treatment 3
Immuncompetent, Hospitalized patient IV:
<2 years: 10 mg/kg/ 8 hr for 7 – 10 days
≥2 years – 18 yr: 500 mg/m2/8hr for 7 – 10 day (experts suggest 10 mg/kg/8 hr)
Immunocompromised IV
1 month – 18 yr : 10 mg/kg/ 8hr for 7 – 10 days
Varicella zoster treatment
Immuncompetent, Hospitalized (IV)
1 month – 18 yr: 10 mg/kg/8hr or (500 mg/m2)/8hr for 7 – 14 days (15 – 20 mg/kg/dose in
severe disseminated or CNS infection was suggested)
Immunocompromised (IV)
<2 years: 10 mg/kg/8 hr
44
≥2 yr – 18 yr: 500 mg/m2/8 hr (experts recommend 10 mg/kg/8 hr)
Duration depends upon clinical response, typically 7 – 14 days.
Dose adjustment Altered kidney function
Term neonates 3,4 IV:
CrCl >50 mL/min/1.73 m2: No adjustments necessary.
CrCl 25 – 50 mL/min/1.73 m2 or Sr Cr 0.8 – 1.1mg/dL: usual dose/12 hr.
CrCl 10 – < 25 mL/min/1.73 m2 or Sr Cr >1.1 – 1.5 mg/dL: usual dose/24 hr.
CrCl <10 m or Sr Cr >1.5 mg/dL: or UOP ˂ 1ml/kg/hr : 50% of the usual dose/24 hr
Infant, Child & Adolescent3 IV: (Monitor closely for neurotoxicity)
CrCl >50 mL/min/1.73 m2: No adjustments necessary.
CrCl 25 – 50 mL/min/1.73 m2: recommended dose/ 12 hr.
CrCl 10 – <25 mL/min/1.73 m2: recommended dose/ 24 hr.
CrCl <10 mL/min/1.73 m2: 50% of the recommended dose/ 24 hr
IHD: Dialyzable (60% per 6 hr dialysis session): 5 mg/kg/24 hr after dialysis on dialysis days
PD: 5 mg/kg/24 hr, no supplemental dose needed
Hepatic Impairment: Pediatric no dosage adjustments, Use caution with severe impairment
Preparation1,2 Use preservative free diluents only to avoid drug precipitation
Reconstitution: 500 mg + 20 ml Preservative free SWFI, NS
Dilution to ≤ 7mg/ml (1 x 3.5 ml to avoid phlebitis) is necessary (up to 10 mg/ml in fluid
restriction but with increased risk of phlebitis)3
1x 5ml (D5W,NS, LR = 5mg/ml Is recommended by the manufacturer 1
Compatibility data with D10W IS NOT AVAILABLE
Administration IV ONLY, Diluted solution given as IV infusion over at least 60 min. Don’t use direct IV push
Rapid infusion associated with nephrotoxicity, Crystalluria, and acute tubular damage
Stability Intact Vial: store at 25 ◦ C
Reconstituted : 12 hr at room temp 1 don’t refrigerate, Diluted sol. to be discarded after use
Hematologic: ↓hemoglobin , ↓ANC
CNS: Malaise (oral)
1% - 10%:
GIT: Diarrhea, nausea, vomiting
Hematologic: Thrombocytopenia (more in neonates)
Hepatic: ↑ Sr bilirubin, ↑Sr transaminases
Local: Inflammation at injection site , injection site phlebitis
CNS: Headache
Renal: ↑ BUN & Sr Cr
<1%: Hematologic: Anemia, leukocytosis, neutropenia, neutrophilia, thrombocythemia
Frequency not defined: Anorexia
Postmarketing: CVS : Hypersensitivity angiitis, hypotension, peripheral edema
Dermatologic: AGEP, alopecia , bullous rash, contact dermatitis (topical), erythema
multiforme, skin photosensitivity (topical) , SJS ,TEN
Hematologic: DIC , hemolysis, HUS, leukopenia, lymphadenopathy, thrombotic
thrombocytopenic purpura
Hepatic: Hepatitis, hyperbilirubinemia, jaundice
Hypersensitivity: Anaphylaxis, angioedema, fixed drug eruption
CNS: Aggressive behavior, agitation, aphasia, ataxia, coma, confusion, delirium, dizziness,
drowsiness, dysarthria, encephalopathy, fatigue, hallucination, impaired consciousness,
myoclonus, obtundation, pain, paresthesia, psychosis, seizure
Neuromuscular & skeletal: Myalgia, tremor
Renal: Acute renal injury, interstitial nephritis, obstructive nephropathy, tubular necrosis
Other: Fever
Contraindications Hypersensitivity to acyclovir, valacyclovir, or any component of the formulation
45
Systemic Antifungals
Amphotericin B injection
Trade name Photericin
Active drug Amphotericin B
Dosage form Vial 50 mg for IV infusion
Mechanism of action Polyene antifungal Binds to ergosterol altering cell membrane permeability in susceptible
fungi and causing leakage of cell components with subsequent cell death
Indications Invasive fungal infections by susceptible Candida spp, Aspergillus spp. and Cryptococcus spp
Dose Neonate
IV: 1 mg/kg/dose once daily 3,4
Or 1.5 mg/kg every other day 4
Duration: 2 weeks after clinical resolution of symptoms clearance from blood stream
CNS: duration until all signs , symptoms, CSF, radiologic abnormalities have resolved
Severe progressive infection may use higher dose 1.5 mg/kg/day3,4, for short-term.
Once therapy established, can be given every-other-day at 1 – 1.5 mg/kg/dose
Intrathecal, Intraventricular 3, or intracisternal (based on experience older patients)
0.01 – 1 mg/day or every other day or twice weekly
Infant, Child, & Adolescent 3 IV
Initial: 0.25 – 0.5 mg/kg/24 hr, ↑gradually by 0.25 mg/kg/day till desired dose is reached
(max: 1.5 mg/kg/day )
Critically ill patients: (↑ by ≥ 0.5 mg/kg/day or even start at desired targeted dose)
Maintenance: 0.25 –1 mg/kg/24 hr (up to 1.5 mg/kg/day for short term in rapidly
progressive disease)
after therapy establishment 1 – 1.5 mg/kg every other day may be used in some cases
If therapy interrupted for > 7 days start by lowest dose in increase gradually
Intrathecal/intraventricular/ intracisternal 0.01 – 1mg/day, every other day or twice/week
Dose adjustment3 Renal Impairment: Infants, Children & Adolescents:
If renal dysfunction is due to the drug ↓ daily dose by 50% or give full dose /other day.
Preexisting renal impairment: (from adult recommendations)
Only use when benefits outweigh risks. Lipid-based amphotericin forms are preferred.
limit dose & duration of treatment (as clinically appropriate), extend infusion time, avoid
concomitant nephrotoxic drugs, maintain hydration and necessary Na maintenance
Need for adjustment is unlikely by expert opinion3
IHD, CRRT Poorly dialyzed no supplemental dose or dosage adjustment
Preparation Use preservative free SWFI & D5W 1,2,3
Reconstitution: Vial 50 mg + 10 ml SWFI = 5 mg/ml concentrated solution
Dilution For IV: Must dilute the reconstituted solution 1ml + 49 ml D5W ONLY (to render PH
suitable for Amphotericin B stability, however, D10W, D20W may be used)
1ml + 49 ml preparation contains 0.1 mg/ml = max conc. for peripheral infusion2,3
In fluid restriction3: use 1 +19 ml D5W, D10W dilution in central line.
For Intraventricular/ Intrathecal: dilute the dose in 0.5 – 2ml preservative free D5W3
Administration IV infusion over 2 – 6 hr according to dose and patient tolerance
Rapid infusion may result in hypotension, hypokalemia, arrhythmias, and shock.
Do not flush IV or mix with saline solution (precipitation)
To avoid febrile reactions, administration of acetaminophen or diphenhydramine4 or
hydrocortisone3 or ibuprofen 30 – 60 min before infusion, may be considered or starting at
lowest dose and increase gradually 4
Intrathecal :dilute the dose in 0.5 – 2 ml preservative free D5W3
In neonate: extremely preterm or ELBW < 1.25 Kg: to decrease nephrotoxicity risk maintain
Na+ intake > 4 mEq /kg /day
Bolus NS infusion immediately before & after the dose may ↓drug-induced nephrotoxicity
Stability Intact Vial: Store in refrigerator at 2 – 8 ◦C ,protect from light
46
Reconstituted sol. 50 mg +10 ml SWFI Chemically stable for 7 days at 2 – 8 ◦C 3,4
Several published reports found little or no difference in amphotericin B concentrations
whether exposed to light or protected from light, at least over periods of 8 – 24 hr.
Exposure of amphotericin B aqueous dispersions to light over longer periods of time or at
higher light intensity has resulted in unacceptable amphotericin B loss 2
Solution compatibility D5W, D10 W, D20W
Adverse reactions ˃ 10 %
CVS: Hypotension
Endocrine & metabolic: Hypokalemia, hypomagnesemia, weight loss
GIT: Anorexia, diarrhea, dyspepsia, epigastric pain, nausea, stomach cramps, vomiting
Genitourinary: Azotemia
Hematologic: Normocytic anemia (normochromic)
Local: Pain at injection site (with or without phlebitis or thrombophlebitis)
CNS: Chills, headache, malaise, pain
Neuromuscular & skeletal: Arthralgia, myalgia
Renal: Ca++ nephrolithiasis, ↓urine specific gravity, renal insufficiency, renal tubular acidosis
Respiratory: Tachypnea
Other: Fever
1-10 % CVS flushing , hypotension
CNS arachnoiditis, delirium, neuralgia & parathesia with IT
Genitourinary urine retention
Hematologic: leukocytosis
Postmarketing: CVS: Cardiac arrhythmia, flushing, HF, HTN, shock, ventricular fibrillation
Dermatologic: Maculopapular rash, pruritus, skin rash
Endocrine & metabolic: Hyperkalemia, hypocalcemia, hypomagnesemia
GIT: Hemorrhagic gastroenteritis, melena
Genitourinary: Anuria, oliguria
Hematologic: Agranulocytosis, disorder of hemostatic components of blood, eosinophilia,
leukocytosis, leukopenia, thrombocytopenia
Hepatic: Acute hepatic failure, hepatitis, ↑ Sr ALT , ALP, AST ,Bilirubin & jaundice
Hypersensitivity: Hypersensitivity reactions, nonimmune anaphylaxis
CNS: Encephalopathy, leukoencephalopathy, peripheral neuropathy, seizure, vertigo
Ophthalmic: Diplopia, visual disturbance
Renal: Acute kidney injury, ↑ BUN & Sr Cr
Respiratory: Bronchospasm, dyspnea, hypersensitivity pneumonitis, pulmonary edema
Contraindications Hypersensitivity to amphotericin or any component of the formulation
Systemic Antifungals
Liposomal Amphotericin B injection
Trade name Ambisome
Active drug Liposomal Amphotericin B
Dosage form Vial for IV infusion 50 mg
Mechanism of action As conventional amphotericin B
Indications Empirical in FN, Aspergillus, Candida, Cryptococcus, conventional agent refractory infections,
in renal impairment, Histoplasmosis, blastomycosis, coccidioidomycosis, and Sporotrichosis.
Dose Neonate
IV: 2.5 – 7 mg/kg/dose /24 hr IV infusion. 3,4
Duration: 2 weeks after 1st negative blood culture & resolution of symptoms and signs
CNS infection: IV: 5 mg/kg/dose/24hr IV infusion3 (not recommended in neonates for poor
penetration to many infection site including CNS, conventional amphotericin recommended)
Infant, Child, & Adolescent 3 IV
Empiric: 3mg/kg/24 hr (empiric febrile neutropenia)
Susceptible systemic infection: 3 – 5 mg/kg/dose/24 hr IV infusion (high dose preferred in
CNS infection)
47
Considerations for treatment with liposomal amphotericin B
Blastomycosis Invasive CNS infection use for 4 – 6 weeks before switch to oral Itraconazole
Coccidioidomycosis, invasive: Non-HIV:
Disseminated infection, nonpulmonary: 2 – 5 mg/kg/24 hr ± azole antifungal
Pulmonary infection, diffuse: 2 – 5 mg/kg/24 hr for several weeks, followed oral azole for
total duration ≥12 months
Cryptococcosis, invasive: Disseminated (non-CNS or severe pulmonary disease)
Adolescents: Non-HIV: 3 – 4 mg/kg/24 hr, IV for at least 14 days
Leishmaniasis Visceral infection: Infants, Children, and Adolescents: IV:
Immunocompetent: 3 mg/kg/24 hr on days 1 – 5, and on days 14 and 21. Course May be
Repeated with patients who do not achieve parasitic clearance.
Immunocompromised: Initial 4 mg/kg/24 on days 1 – 5, and on days 10, 17, 24, 31, 38
Dose adjustment3 Renal Impairment: no dosage adjustments provided.
ESRD: (ESRD on IHD), administer after hemodialysis on dialysis days, (Poorly dialyzed).
Hepatic Impairment: no dosage adjustments provided (has not been studied).
Preparation Use preservative free SWFI in reconstitution 1.3
Reconstitution: Vial 50 mg + 12 ml SWFI = 4 mg/ml concentrated solution
Shake vigorously for at least 30 sec till translucent yellow suspension is formed
Don’t use NS in reconstitution & don’t mix with other drugs
Dilution For IV: use D5W ONLY dilute the reconstituted solution to conc 0.2 – 2 mg/ml
(1+1 ml – 1 + 19 ml)
In infant & small children: 0.2 – 0.5 mg /ml may be used to provide sufficient infusion vol.
May use D10W, D20W, D25W in dilution1.3
Administration1.3 IV infusion over 2 hr, reduced to 1 hr in patients who tolerate the treatment.
Flush line with D5W prior to infusion
If the patient experiences discomfort during infusion, duration of infusion may be increased
Discontinue if severe respiratory distress occurs.
To avoid infusion related reactions (non-anaphylactic) 3
administration of NSAID ± diphenhydramine OR acetaminophen + diphenhydramine OR
hydrocortisone 30 – 60 min before infusion may be considered, (use Pethidine in rigors)
Stability1.3 Intact Vial: Store at 25° C, protect from light
Reconstituted: single use only, discard after use (however, reconstituted sol, may be kept
for max 24 hr at 2 – 8 ◦C 1,3, or 7 days refrigerated if reconstituted under controlled and
validated aseptic technique1 in glass vial or PP syringe)
Solution compatibility D5W, D10 W, D20W, D25W (Start Infusion within 6 hr of preparation)
However, Under aseptic technique dilution in PVC bags at concentrations of1 :
0.2 mg /ml in D5W stable for 4 days refrigerated, 24 hr at 25° C
0.5, 2 mg/ml in D5W stable for 7 days refrigerated 48 hr at 25° C
2 mg/ml in D10W, D20W stable for 2 days refrigerated, 3 days at 25° C
Adverse reactions ˃ 10 %
CVS: Hypotension, Chest pain, edema, HTN, peripheral edema, tachycardia
Endocrine & metabolic: Hyperglycemia, hypervolemia, ↓ Ca++, Mg++, K+ & Na+
GIT: Abdominal pain, anorexia, constipation, diarrhea, nausea , vomiting
Hematologic: Anemia, leukopenia, thrombocytopenia
Hepatic: Hyperbilirubinemia, ↑ Sr ALT , ↑ Sr ALP, ↑ Sr AST
Hypersensitivity: Infusion-related reaction
Local: Localized phlebitis
CNS: Anxiety, asthenia, chills, confusion, headache, insomnia, pain, rigors
Neuromuscular & skeletal: Back pain
Renal: ↑ BUN, ↑ Sr Cr, nephrotoxicity
Respiratory: Cough, dyspnea, epistaxis, pleural effusion , rhinitis
1% - 10%: CVS: AF, bradycardia, arrhythmia, cardiomegaly, flushing, heart valve disease,
orthostatic hypotension, vascular disease, vasodilation.
Dermatologic: Alopecia, cellulitis, dermal ulcer, diaphoresis, maculopapular rash, skin
48
discoloration, urticaria, vesiculobullous dermatitis , xeroderma
Endocrine/metabolic: Acidosis, ↑ Sr Cl –, K+, Mg++ & Na+, respiratory alkalosis, ↑ Sr LDH, ↓ or ↑ Sr
phosphate, increased nonprotein nitrogen,
GIT: Aphthous stomatitis, dyspepsia, dysphagia, enlarged abdomen, eructation, hematemesis
flatulence, fecal incontinence, gingival/oral /GI hemorrhage, hemorrhoids, hiccups, ↑ Sr amylase,
intestinal obstruction, rectal disease, stomatitis, xerostomia
Genitourinary: Dysuria, toxic nephrosis, urinary incontinence, vaginal hemorrhage
Hematologic: Bruise, ↓ or ↑ PT, disorder of hemostatic components of blood, hemorrhage
hemophthalmos, hypoproteinemia, petechia, purpuric disease
Hepatic: Hepatic injury/sinusoidal obstruction syndrome, hepatomegaly
Hypersensitivity: Facial edema, hypersensitivity reaction, type IV hypersensitivity reaction
Local: Inflammation at injection site
CNS: thinking abnormality, agitation, coma, depression, dizziness, drowsiness, dysesthesia,
dystonia, hallucination, malaise, nervousness, paresthesia, seizure, tremor
Neuromuscular & skeletal: Arthralgia, myalgia, neck pain, ostealgia
Ophthalmic: Conjunctivitis, dry eye syndrome
Renal: Acute kidney injury, renal failure syndrome, renal function abnormality
Respiratory: Asthma, atelectasis, dry nose, flu-like symptoms, hemoptysis, hyperventilation,
hypoxia, pharyngitis, pneumonia, pulmonary edema, respiratory failure/insufficiency, sinusitis
Postmarketing: Dermatologic: Erythema of skin
Genitourinary: Hemorrhagic cystitis
Hematologic: Agranulocytosis
Hypersensitivity: Anaphylaxis, angioedema, DRESS
Neuromuscular & skeletal: Rhabdomyolysis
Respiratory: Bronchospasm, cyanosis, hypoventilation
Contraindications Hypersensitivity to amphotericin or any component of the formulation
Systemic Azole Antifungals
Fluconazole injection
Trade name Sunnyfungal/Naviluca
Active drug Fluconazole
Dosage form Vial 100 mg /50ml for IV infusion
Mechanism of action Azole Fugistatic agent inhibits fungal sterol synthesis and CYP450 enzyme system
Indications Treatment of candidiasis, systemic candidemia, pneumonia & cryptococcal meningitis, and
antifungal prophylaxis in allogeneic hematopoietic cell transplant recipients
Dose Neonate IV/oral
Loading 12 – 25 mg/kg on day 1
Maintenance 6 – 12 mg/kg/ interval according to chart
GA (week) Age (day) Interval (hr)
≤ 29 0 – 14 48
˃14 24
≥ 30 0–7 48
˃7 24
Duration: for 2 weeks after documented candidal clearance
Upper range of doses are considered for Severe infection or candida with MIC 4 – 8 mcg/L
Prophylaxis (1.5 kg & 1 kg body weight) 3,4
3 – 6 mg/kg IV, oral twice/week for 6 weeks in NICU with high incidence > 10% of Candida
infections (start within 48 – 72 hr of birth)3. (3 mg/kg is suitable for MIC < 2 mcg/L)
High risk patients requiring prophylaxis in NICU with low incidence for candida are
cephalosporins, Carbapenems & CVC
Treatment IV/oral
Loading 6 – 12 mg/kg on day 1 (in severe infection a loading 25 mg/kg/dose may be used)
Maintenance 3 – 12 mg/kg/24 hr (use higher dose in CNS and severe infections)
Higher ends of dose range may be necessary for severe invasive disease
49
Max. dose: 600 mg/dose in moderate infection & 800 mg/dose severe infection
Duration depend on site & severity of infection, usually for ≥14 days after documented
clearance (and CSF Clearance), resolution of symptoms, and neutropenia if present in
systemic infections
Candida infections, prophylaxis:
Oncology patients (high risk) = (AML, recurrent ALL, MDS, HSCT recipients)
IV, Oral: 6 – 12 mg/kg/24 hr (max. dose: 400 mg/dose)
Surgical prophylaxis (high-risk ) = (liver, pancreas, kidney, or pancreas-kidney transplant)
IV: 6 mg/kg/ dose 60 min before procedure (max. dose: 400 mg/dose)
Dose adjustment Altered kidney function
Neonate 4
Loading dose : Full recommended dose is used, then adjust maintenance as follows:
CrCl ≤ 50mL/min/1.73m2: reduce daily dose by 50%
Dialysis: 100% of dose after dialysis on dialysis days - & renally adjusted dose based on Cr Cl
on non- dialysis day
Candidiasis, prophylaxis (IV, Oral) 3
PNA ≥3 days: Sr cr ≥1.3 mg/dL: 6 mg/kg/dose once weekly
Sr cr is ≤1 mg/dL: 6 mg/kg/dose twice weekly
Infants, Children, and Adolescent3 (IV, Oral)
CrCl ≥50 mL/min/1.73 m2: usual indication-specific dose/24 hr.
CrCl <50 mL/ min/1.73 m2: usual indication-specific dose/48 hr (or 100% of indication-specific
dose/loading dose initially, followed by 50% of indication-specific dose/24 hr).
IHD: dialyzable
Dialysis days: indication-specific dose after each dialysis session OR
100% of dose on dialysis days and renally adjusted dose on non-dialysis days
Peritoneal dialysis: 50% of indication-specific dose/24 – 48 hr
Hepatic Impairment: no adjustment, use with caution.
Preparation IV: Ready to use
3
Administration Neonate: Loading doses (25 mg/kg) IV infusion over 2 hr
Doses 3 – 12 mg/kg infused over 1 – 2 hr including VLBW
Pediatric: Doses up to 8 – 10 mg/kg were infused over 2 hr
Max. rate 200 mg/hr
Stability Store intact vial at 30° C 1. Use immediately after preparation
Solution compatibility: D5W, D10W 4 (1+1ml). Manufacturer recommends against dilution
CNS: Headache
1% – 10%:
GIT: Abdominal pain, diarrhea, dysgeusia, dyspepsia, nausea vomiting
CNS: Dizziness
Frequency not defined: Hepatic: ↑ ALP
Postmarketing:
CVS: Prolonged QT interval on ECG, torsades de pointes
Dermatologic: AGEP, alopecia, diaphoresis, exfoliative dermatitis, SJS, Sweet’s syndrome, TEN.
Endocrine & metabolic: Hypercholesterolemia, hypertriglyceridemia, hypokalemia
GIT: Xerostomia
Hematologic: Agranulocytosis, leukopenia, neutropenia, thrombocytopenia
Hepatic: Cholestatic/cellular hepatitis hepatic failure, hepatitis(mixed), hepatotoxicity,↑ALT & AST
Hypersensitivity: Anaphylaxis angioedema, fixed drug eruption
Immunologic: DRESS
CNS: Drowsiness, fatigue, insomnia, malaise, paresthesia, seizure, vertigo
Neuromuscular & skeletal: Asthenia, myalgia, tremor
Other: Fever
Contraindications Hypersensitivity to fluconazole, other azoles or any component of the formulation
Coadministration with CYP3A4 substrates, which may lead to QTc prolongation
50
Systemic Azole Antifungals
Voriconazole IV / oral
Trade name Vfend / Conazoglobe
Active drug Voriconazole
Dosage form Vial 200 mg for IV, tablet 200 mg
Mechanism of action Azole agent inhibits fungal sterol synthesis &CYP450 enzyme system, inhibiting cell membrane
Indications Invasive aspergillosis, esophageal candidiasis, candidemia & disseminated Candida infections
3
Dose Neonate 3
doses: 12 – 24 mg /kg /day divided /8 – 12 hr Reported
Earlier data suggested: IV/Oral 4 – 8 mg/kg/day divided/12hr
1month – ˂ 2 yr
IV/PO initial 9 mg/kg/12 hr (after 3 – 5 days: adjust to achieve trough conc.)
Range: 12 – 71 mg/kg/day divided/12 hr, (Doses >40 mg/kg/day divided/8 hr)
2 –  12 yr treatment and (prophylaxis for high risk patient)
Oral: 9 mg/kg/12 hr max: 350 mg/dose
IV: 9 mg/kg/12 hr for 2 doses on day1, then 8 mg/kg/12 hr
12 – 14 yr (prophylaxis for high risk patient)
weight Oral dose IV dose
<50 kg 9 mg/kg/ 12 hr Loading: 9 mg/kg/ 12 hr for 2 doses
(max: 350 mg/dose) Maintenance: 4 – 8 mg/kg/ 12 hr.
≥50 kg 200 mg /12 hr. Loading: 6 mg/kg/12 hr for 2 doses
Maintenance:3 – 4 mg/kg/12 hr
in prophylaxis: 4 mg/kg /12 hr without loading dose
≥15 years:
IV: Loading: 6 mg/kg/12 hr for 2 doses
Maintenance dose of 3 – 4 mg/kg/ 12 hr
Oral <40 kg: 100 mg /12 hr
≥40 kg: 200 mg /12 hr
in prophylaxis : 4 mg/kg /12 hr
Dose adjustment3 Dosage adjustment for inadequate response:
Children ≥2 – <15 years weighing <50 kg:
IV: Increase by 1 mg/kg/dose increments.
Oral: Increase by 1 mg/kg/dose or 50 mg increments, max.: 350 mg/dose.
≥12 – <15 years weighing ≥50 kg & Adolescents ≥15 years regardless of weight):
IV: Increase by 1 mg/kg/dose increments.
Oral: <40 kg: Titrate in 50 mg/dose increments, minimum recommended dose: 100 mg/12 hr
max. recommended dose: 300 mg/dose.
≥40 kg: Increase to 300 mg / 12 hr.
Dosage adjustment for patients unable to tolerate treatment:
Children ≥2 years and Adolescents <15 years weighing <50 kg:
IV: Reduce dose by 1 mg/kg/dose increments.
Oral: Reduce dose by 1 mg/kg/dose increments or 50 mg increments.
Children 12 – <15 yr weighing ≥50 kg and Adolescents ≥15 yr:
IV: Reduce dose by 1 mg/kg/dose increments.
Oral: Reduce dose by 50 mg increments. Minimum dose in patients <40 kg: 100 mg/dose
Minimum dose in patients ≥40 kg: 200 mg/dose
Renal impairment
≥2 years & Adolescents (Oral)3,5 no pediatric – specific dosage adjustment necessary.
Dialysis: Poorly dialyzed, no supplemental dose or dosage adjustment necessary.
CRRT: monitor pharmacologic response, signs of adverse reactions & trough level
≥2 years & Adolescents (IV) 3,5
CrCl ≥50 mL/min: no dosage adjustment.
CrCl <50 mL/min: no pediatric-specific dosage adjustments provided
Use of oral Voriconazole is recommended in adult data. if IV therapy is used, closely monitor
51
Sr Cr and change to oral Voriconazole when possible
Hepatic Impairment
Mild – moderate: no pediatric data, adult data recommend dosage reduction:
Child-Pugh A – B: give standard loading dose, reduce maintenance dose by 50%
Child Pugh C: no adjustments provided used only if benefit outweighs risk, monitor.
Preparation1,2,3 IV: Vial 200 mg + 19 ml SWFI =200 mg/ 20 ml
Then Dilute 1+1 ml up to 1+19 ml NS, D5W,LR
Administration3 IV: Must be infused over 1 – 3hr, (max. rate 3mg/kg/hr). Don't mix with any drugs or TPN
Oral: Administer 1 hr before or 1 hr after a meal
Maintain adequate hydration during use.
Voriconazole crushed tablets are bioequivalent to whole tablet28
Stability1 Tablets & Intact vial at max. 30 ◦ C
Vial : 200 mg + 19 ml SWFI stable for 24 hr at 2 – 8 ◦ c 4
CVS: Hypertension
Endocrine & metabolic: Hyperkalemia, hypokalemia
GIT: Abdominal pain, diarrhea, nausea, vomiting
Hepatic: ↑ AST, ALP & AST
Renal: Renal insufficiency, ↑Sr Cr, acute kidney injury
Other: Fever
1% - 10%:
CVS: AMI, AF, AV nodal arrhythmia, bigeminy, bradycardia, bundle branch block, cardiomegaly,
cardiomyopathy, chest/substernal pain, complete AV block, DVT, edema, endocarditis, phlebitis
extrasystole, flushing, HF, hypotension, orthostatic hypotension, peripheral edema, prolonged QT
interval, PE, supraventricular extrasystole, SVT, syncope, tachycardia, thrombophlebitis, torsades
de pointes, vasodilation, ventricular fibrillation, ventricular tachycardia
Dermatologic: Allergic dermatitis, alopecia, cellulitis, cheilitis, contact dermatitis, diaphoresis,
ecchymoses, eczema, erythema multiforme, exfoliative dermatitis, fixed drug eruption,
furunculosis, maculopapular rash, malignant melanoma, pruritus, psoriasis, skin discoloration
/photosensitivity SJS, TEN, urticaria, xeroderma
Endocrine & metabolic: Adrenal insufficiency, albuminuria, ↓glucose tolerance, ↓ libido,
diabetes insipidus, ↑or↓ In Mg, Na, Ca, glucose & phosphate in serum, ↑LDH, uric acid &
cholesterol, hypo/hyperthyroidism, hypervolemia, hypoalbuminemia, pseudoporphyria
GIT: Abdominal distention, Ageusia, anorexia, cholecystitis, cholelithiasis, cholestasis, CD colitis,
constipation, duodenitis, dysgeusia, dyspepsia, dysphagia, esophageal ulcer, esophagitis,
flatulence, gastric ulcer, gastroenteritis, GIT hemorrhage, gingival hemorrhage/hyperplasia,
gingivitis, glossitis, hematemesis, intestinal perforation, melanosis, melena, oral
inflammation/mucosal ulcer, pancreatitis, parotid gland enlargement, perforated duodenal ulcer,
periodontitis peritonitis, proctitis, rectal hemorrhage, stomatitis, xerostomia.
Genitourinary: Anuria, blighted ovum, dysmenorrhea, dysuria, epididymitis, glycosuria,
hematuria, hemorrhagic cystitis, impotence, oliguria, pelvic pain, scrotal edema, uremia, urinary
incontinence/retention, UTI, uterine hemorrhage, vaginal hemorrhage.
Hematologic: Agranulocytosis, DIC, eosinophilia, leukopenia, lymphadenopathy, lymphangitis,
anemia (aplastic/hemolytic/megaloblastic/microcytic/macrocytic), pancytopenia, petechia,
↑bleeding time, purpuric disease, splenomegaly, squamous cell carcinoma, thrombocytopenia,
thrombotic thrombocytopenic purpura
Hepatic: Ascites, cholestatic jaundice, hepatic coma/failure, hepatitis, hepatomegaly, ↑GGT
Hypersensitivity: reaction, Angioedema, facial/tongue edema, nonimmune anaphylaxis
Immunologic: GVHD.
Infection: HSV, bacterial, fungal infection, sepsis.
Local: Inflammation, infection & pain at injection site
CNS: Abnormal dreams, akathisia, amnesia, anxiety, asthenia, ataxia, brain hemorrhage/edema/
ischemia, chills, coma, confusion, delirium, voice disorder, dementia, depression, drowsiness,
emotional liability, encephalitis, vertigo encephalopathy, tremor, extrapyramidal signs, Guillain-
Barre syndrome, hallucination, headache, hypertonia, hypoesthesia, hypothermia, insomnia, ↑ICP,
52
lethargy, myasthenia, neuralgia, neuropathy, pain, paresthesia, psychosis, suicidal ideation,
Neuromuscular/skeletal: Arthralgia, arthritis, back pain, discoid lupus, ↑creatine phosphokinase,
lower limb cramp, myalgia, myopathy, ostealgia, osteomalacia, osteonecrosis, osteoporosis.
Ophthalmic: Accommodation disturbance, blepharitis, chromatopsia, color blindness, oculogyric
crisis conjunctivitis, corneal opacity, diplopia, dry eye syndrome, eye pain, keratitis, photophobia
subconjunctival hemorrhage, keratoconjunctivitis, mydriasis, night blindness, nystagmus, optic
atrophy/neuritis, papilledema, retinal hemorrhage, retinitis, scleritis, uveitis, visual field defect
Otic: Deafness, hypoacusis, otalgia, otitis externa, tinnitus.
Renal: ↓Cr Cl, flank pain, hydronephrosis, ↑BUN, nephritis, renal tubular necrosis
Respiratory: ARDS, bronchospasm, cough, cyanosis, dyspnea flu-like symptoms, upper RTI, hypoxia
hemoptysis, nasal congestion, pharyngitis, pleural effusion, pneumonia, sinusitis, pulmonary
edema, respiratory failure, RTI, rhinitis, tachypnea,
Other: Granuloma, multi-organ failure
Postmarketing
Dermatologic: Changes in nails, cutaneous lupus erythematosus, phototoxicity
Hepatic: Hepatotoxicity
Hypersensitivity: DRESS
Nervous system: Peripheral neuropathy
Neuromuscular & skeletal: Myositis, periosteal disease, skeletal fluorosis
Ophthalmic: Episcleritis, ocular epitheliopathy (ocular surface dysplasia), vision color changes
Contraindications Hypersensitivity to Voriconazole or any component of the formulation
Coadministration with barbiturates (long acting), carbamazepine
Cross-sensitivity between imidazole antifungals cannot be ruled out with certainty.
Oral Antifungal
Nystatin oral
Trade name Nystatin
Active drug Nystatin
Dosage form Oral suspension 100,000 unit/ ml
Mechanism of action Polyene antifungal causes disruption of cell membrane of fungi
Indications Oral Candidiasis treatment & Invasive Candidiasis Prophylaxis
Dose neonate3
Preterm 1 mL (100,000 units) orally /6 hr for at least 48 hr after perioral symptoms disappear
Term neonate : 2 mL (200,000 units) orally /6 hr
Invasive Candidiasis, Prophylaxis (birth weight <1500 g)3.4 (or GA <33 Weeks) 3:
100,000 units/8 – 6 hr for 6 weeks (or until risk factor resolves ) 3 in NICUs with greater than
10% rate of invasive candidiasis
Infants: 2 mL (200,000 units) /6 hr Orally3,4
Child & Adolescent: 2 – 3 ml (400,000 - 600,000 units) /6hr
Alternate dosing for age > 1 months & children: 1 mL (100,000 units) orally /6 hr5
peritonitis, prophylaxis for high-risk situations3
Infant, Child & Adolescents: 10,000 units/kg/24 hr
Dose adjustment Renal/ hepatic impairment: no dosage adjustment
Preparation Readily prepared
Administration Administer half dose on each side of the mouth Avoid feeding for 5 – 10 min
shake well before each use
Stability Store bottles at max 30 ° C
Adverse reactions 1% - 10%: GIT: Diarrhea, nausea, stomach pain, vomiting
<1%, Postmarketing, Hypersensitivity reaction
Contraindications Hypersensitivity to Nystatin or any component of the formulation
53
Antimetabolite Chemotherapeutic agent
6-mercaptopurine
Trade name Mercaptopurine
Active drug 6-mercaptopurine
Dosage form Tablet 50 mg
Mechanism of action Purine antagonist inhibits DNA & RNA synthesis, acts as false metabolite incorporated into
DNA and RNA, eventually inhibiting their synthesis, specific for the S phase of the cell cycle
Indications Maintenance treatment of ALL in combination regimens, to treat inflammatory bowel
disease, autoimmune hepatitis &maintenance treatment in acute promyelocytic leukemia
Dose According to type, stage of cancer, and the specific protocol of treatment
Refer to protocol specific dosing
Dose adjustment3 According to patient specific outcomes
Renal impairment Proposed adjustments (Children and Adolescents)
CrCl ≥50 mL/min: No adjustment required.
CrCl <50 mL/min: Initiate at lowest recommended starting dose or increase the dosing
interval to every 36 – 48 hr to avoid accumulation in patients with renal impairment adjust
dose to maintain desirable ANC level and for adverse reactions
Hemodialysis: Administer / 48 hr
Continuous ambulatory peritoneal dialysis (CAPD): Administer /48 hr
CRRT: Administer every 48 hr.
Hepatic Impairment in Children and Adolescents:
Hepatic impairment at baseline: Initiate at lowest recommended starting dose & adjust to
maintain desirable ANC level and for adverse reactions.
Hepatotoxicity during treatment: Withhold therapy
Administration3 Administer at the same time(s) each day, preferably on an empty stomach, avoid
concomitant milk products if possible
Stability3 Store at 20 – 25 ° C, protect from light
3
GIT: Anorexia, diarrhea, nausea, vomiting.
Hematologic & oncologic: Bone marrow depression (dose-related: >20%, including anemia,
neutropenia, lymphocytopenia, and thrombocytopenia)
CNS: Malaise
1% to 10%:
Dermatologic: Hyperpigmentation, urticaria
Endocrine & metabolic: Hyperuricemia
GIT: Oral lesion, pancreatitis
Hepatic: Hyperbilirubinemia, increased Sr transaminases
Infection: Infection.
Frequency not defined: Dermatologic: Alopecia
GIT: Cholestasis, sprue-like symptoms, stomach pain, stomatitis, ulcerative bowel lesion
Genitourinary: Oligospermia, renal toxicity
Hematologic & oncologic: Granulocytopenia, leukopenia, metastases
Hepatic: Ascites, hepatic encephalopathy, hepatic fibrosis, hepatic injury, hepatic necrosis,
hepatomegaly, hepatotoxicity, intrahepatic cholestasis, jaundice, toxic hepatitis
Immunologic: Immunosuppression
CNS: Drug fever
Respiratory: Pulmonary fibrosis
Postmarketing:CVS: Portal hypertension
Dermatologic: Skin photosensitivity
Endocrine & metabolic: Hypoglycemia
Emetic Potential Pediatrics: ≤4.2 mg/kg/dose: Minimal (<10%) or Low (10% - 30%)
Contraindications3 Hypersensitivity to mercaptopurine or any component of the formulation, patients whose
disease showed prior resistance to mercaptopurine & immunizations with live vaccines
54
Antineoplastic Antibiotic
Bleomycin
Trade name Bleocel
Active drug Bleomycin 15 unit
Dosage form Vial for IV, IM, SubQ
Mechanism of action Inhibits DNA synthesis by binding to DNA leading to single- and double-strand breaks, also
inhibits (to a lesser degree) RNA and protein synthesis.
Indications Palliative treatment of squamous cell carcinoma, testicular carcinoma, Hodgkin lymphoma,
and non-Hodgkin lymphoma & therapy of germ cell tumors & pediatric Hodgkin lymphoma
Dose According to type and stage of cancer, and the specific protocol of treatment
3
Dose adjustment Review protocols for proposed adjustments first or consider following recommendations
Dosing adjustment for toxicity: (based on in adult data)
Pulmonary changes: Discontinue until determined not to be drug-related.
Pulmonary diffusion capacity for carbon monoxide (DLCO) <30–35% of baseline: Discontinue
Altered Kidney Function: from adult data as no pediatric info. provided
First regimen: CrCl estimated using the Cockcroft-Gault formula (interpret with caution as
the formula isn't applicable for children)
CrCl ≥ 50 mL/min: No dosage adjustment necessary.
CrCl 40 – 50 mL/ min: Reduce dose to 70% of normal dose.
Alternative dosing adjustment recommended: for CRRT: Reduce to 75% of normal dose.
Alternative regimen
CrCl 46 – 60 mL/min: Reduce dose to 70% of normal dose.
CrCl 31 – 45 mL/min: Reduce dose to 60% of normal dose.
CrCl <30 mL/ min: Consider use of alternative drug.
Alternative dosing
eGFR >50 mL/ min /1.73 m2: No dosage adjustment necessary.
eGFR 10 – 50 mL/ min /1.73 m2: Reduce dose to 75% of original dose.
eGFR <10 mL/ min /1.73 m2: Reduce dose to 50% of original dose.
Hemodialysis: Reduce dose to 50% of the original dose.
Dosing: Hepatic Impairment
No dosage adjustments provided in adult /pediatric data (has not been studied), however,
adjustment for hepatic impairment is not necessary
Preparation3 IV: Reconstitute 15-unit vial with 5 mL with NS for a conc. of 3 units/mL (3 mg/mL)1,3
Dilution for IV : dose + 50 ml NS9
Alternative 9
15-unit vial + 6 mL NS (conc. 2.5 units/mL stability 12 hr at 2 – 8 ◦ c) then dilute dose in 50
mL NS (stability 12 hr at 2 – 8 ◦ c)
IM or SubQ: Reconstitute 15-unit vial with 1 – 5 mL SWFI, BWFI, or NS to conc 3 – 15
units/mL for subcutaneous or IM injection.
Administration1,3 Administration: may be protocol specific, review protocol
IM, SubQ: Administer at a conc. of 3 – 15 units/mL. may cause pain at injection site
IV Push over at least 10 min
IV infusion: diluted sol given over at least 10 min
Slower administration may produce less severe pulmonary toxicity
May be irritant avoid extravasation
Stability2 Store intact vials at 2 – 8 °C protect from light.
Dilution for IV : dose + 50 ml NS stable 24 hr at RT (discard within 4 hr recommended)9
Stable for 24 hr in NS at room temperature° C and up to 28 days at room temperature or
refrigerated and protected from light.
55
Bleomycin in NS was stable for 10 days at 37 °C.
Don’t use D5W for 10 % loss of drug in 8 – 10 hr
No need to protect from light during infusions,
Bleomycin doesn’t undergo loss due to sorption with glass containers or PVC
Adverse reactions >10%
CVS: Phlebitis
CNS: Tumor pain
Dermatologic: Hyperpigmentation, atrophic striae, erythema, exfoliation of the skin (common
on palmar/plantar surfaces of the hands & feet), hyperkeratosis, localized vesiculation, skin
rash/sclerosis, alopecia and nail bed changes ( last two may be dose-related & reversible with
discontinuation)
Endocrine & metabolic: Weight loss
GIT: Stomatitis, mucositis, anorexia
Other: Febrile reaction (acute)
1% - 10%:
Dermatologic: Onycholysis, pruritus, thickening of skin
Hypersensitivity: Anaphylactoid reaction (including chills, confusion, fever, hypotension,
wheezing, onset may be immediate or delayed for several hours, includes idiosyncratic reaction
in 1% of lymphoma patients)
Neuromuscular & skeletal: Scleroderma (diffuse)
Respiratory: Tachypnea, rales, interstitial pneumonitis (acute or chronic), pulmonary fibrosis,
hypoxia
<1%, postmarketing, and/or case reports: Angioedema, bone marrow depression (rare),
cerebrovascular accident, cerebral arteritis, chest pain, coronary artery disease, hepatotoxicity,
hyperpigmentation (flagellate), ischemic heart disease, malaise, myocardial infarction, nausea,
nephrotoxicity, pericarditis, Raynaud’s phenomenon, scleroderma (scleroderma-like skin
changes), SJS, thrombotic thrombocytopenic purpura, TEN, vomiting
Oncology: Emetic Potential Pediatrics: Minimal (<10%).
Contraindications Hypersensitivity to bleomycin or any component of the formulation
Alkylating chemotherapy agent

Carboplatin
Trade name Carbotinol
Active drug Carboplatin
Dosage form Vial 150 mg/15 ml for IV
Mechanism of action Alkylating agent which covalently binds to DNA, interferes with the function of DNA by
producing interstrand DNA cross-links. Carboplatin is apparently not cell-cycle specific
Indications Treatment of CNS tumors (gliomas, neuroblastomas), retinoblastoma, sarcomas (Ewing
sarcoma, osteosarcoma), Wilms tumor, and as a conditioning regimen prior to HSCT
In pediatric patients, dosing may be based on either BSA (mg/m2), weight (mg/kg), or a
modified Calvert formula calculation (mg), use extra precaution to verify dosing parameters
and units of GFR/estimated CrCl during calculations, as errors can lead to significant
over/under dosing. Some protocols suggest weight or age cut-offs for weight-based (mg/kg)
dosing, refer to specific protocol. Carboplatin is associated with a high emetic potential in
pediatric patients
56
Dose (continue) 3
Modified Calvert Formulas3
Target AUC: Protocol specific dependent upon indication, value presented in terms of
mg/mL and min units (eg, mg/mL/min or mg/mL•min are frequently reported).
Note: Ensure appropriate GFR value*is used for calculation and resulting carboplatin dose
(mg or mg/m2) units.
Newell formula
Total dose (mg) = Target AUC x [uncorrected GFR (mL/min) + (0.36 x kg body wt)]
Mann/Pein formula
Total dose (mg) = Target AUC x [uncorrected GFR (mL/min) + (15 x BSA(m2))]
Marina/St. Jude formula
Dose (mg/m2) = Target AUC x [(0.93 x corrected GFR (mL/min/m2 )) + 15]
GFR definitions*:
Uncorrected GFR = Raw GFR = mL/min
Corrected GFR = Normalized GFR = mL/min/1.73 m2
converting GFR to a corrected GFR normalized to patient’s BSA (mL/min/m2) may be
done as follows:
Corrected GFR (mL/min/1.73 m2)/1.73 = GFR (mL/minute/m2)
Uncorrected GFR (mL/minute)/patient’s BSA = GFR (mL/minute/m2)
Dose adjustment3 Review protocols for proposed adjustments OR consider following recommendations
Dosing adjustment for toxicity: (based on adult data) pediatric patients are limited.
Post-treatment nadir: Platelets <50,000 cells/mm3 or ANC <500 cells/mm3: 75% of dose
Renal impairment Infant, Child & Adolescent: adjustments have been recommended
GFR >50 mL/min/1.73 m2: No dosage adjustment necessary
GFR ≤50 mL/min/1.73 m2: Use modified Calvert formula (see protocol for specific details)
incorporating patient's GFR
CRRT: Use modified Calvert formula (see protocol for specific details) incorporating GFR of
33 mL/min
Hemodialysis, peritoneal dialysis: Use modified Calvert formula (see protocol for specific
details) incorporating GFR <10 mL/min
Hepatic Impairment no dosage adjustments provided however, carboplatin undergoes
minimal hepatic metabolism, dosage adjustment may not be needed
Preparation 2,3 Carboplatin shouldn’t come in contact with aluminum needles or IV sets that contain
aluminum (reacts with carboplatin resulting in precipitation and loss of potency).
Preparation for IV: further dilute to conc. as low as 0.5 mg/mL (1ml x 20 ml) in NS or D5W,
in adults, doses are generally diluted in either 100 mL or 250 mL of NS or D5W.
Recommended conc : 0.5 – 10 mg/ml (1 x20 ml – undiluted)9
Administration3 Antiemetics needed before carboplatin for high emetogenic potential
Refer to protocol specific rated and sequence
IV: Administer over 15 – 60 min. Some protocols may require infusions up to 24 hr.
As a part of a combination regimen, review for sequence of administration is necessary
May be irritant avoid extravasation
Stability 2 Store intact vials at 150 mg at 25 ° C , and 450 mg at 2 - 8 ° C, Protect from light.1,2
Diluted solution: use within 8 hr recommended1,2
Carboplatin 10 mg/mL packaged in polypropylene plastic syringes underwent no
decomposition in 5 days refrigerated and 3% loss in 24 hours at body temperature of 37°C.
Stability detected by HPLC analysis for 8 days at room temp for 10-mg/mL in PP syringes
Dilution to conc. as low as 0.5 mg/mL is stable at room temp (25°C) for 8 hr in NS or D5W.
Additional chemical stability info.(not from microbiological view)
Dilution in D5W in PVC bags at room temp for 9 days
14 days at 37°C, 21 days refrigerated and at room temp & up to 28 days refrigerated
Dilution in NS
0.5 mg/mL in PVC bags at room temp for 24 hr (1x20 ml)
57
2 mg/mL in PVC bags at room temp for 24 hr(1x5 ml)
4 mg/mL) in PVC bags at room temp for 2 day ( 1x2.5 ml)
However, data about conversion of carboplatin (less than 0.1%) to the more toxic Cisplatin
occurred in chloride-containing infusion solutions as NS
Protection from light is NOT needed during administration of carboplatin.
Not found to undergo substantial sorption to polyvinyl chloride (PVC) or polypropylene (in
syringes or bags), or glass containers
Adverse reactions3 >10%:
Endocrine & metabolic: Decreased Sr calcium, magnesium, potassium & sodium
GIT: GI pain (17%), nausea (10% - 15%), nausea & vomiting (92%), vomiting (65% - 81%), severe
vomiting: (22%)
Hematologic & oncologic: Anemia (21% - 90%), leukopenia (15% - 85%), neutropenia (16% -
67%), thrombocytopenia (25% - 62%)
Hepatic: ↑ Sr ALP & AST
CNS: Asthenia, pain
Renal: ↓Cr Cl & BUN
1% - 10%:
Dermatologic: Alopecia
GIT: Constipation, diarrhea, dysgeusia, stomatitis
Hematologic & oncologic: Hemorrhage (including iatrogenic bleeding)
Hepatic: Increased Sr bilirubin
Infection: Infection
CNS: Neurotoxicity, peripheral neuropathy
Otic: Ototoxicity.
Renal: ↑ Sr Cr
Postmarketing:
CVS: Hypertension
Endocrine & metabolic: Dehydration
GIT: Anorexia
Hematologic & oncologic: Febrile neutropenia, HUS
Local: Injection site reaction (erythema, pain and/or swelling at the injection site)
CNS: Malaise
Ophthalmic: Papilledema (hemorrhagic)
Renal: Acute interstitial nephritis
Emetic Potential Pediatrics ≥175 mg/m2/dose: High (>90%).
Contraindications3 History of allergic reaction to carboplatin or other platinum-containing formulations, or any
component of the formulation
Severe bone marrow depression or significant bleeding.
Preexisting severe renal impairment.
Cisplatin
Trade name Cisplatin
Active drug Cisplatin
Dosage form Vial 10 mg/10ml and 50 mg/50 ml for IV
Mechanism of action Alkylating agent covalently binds to DNA producing interstrand DNA cross-links. May also
bind to proteins, cis-isomer is 14 times more cytotoxic than trans-isomer but cis-platinum is
less easily recognized by cell enzymes, therefore, not repaired.
Indications Treatment of CNS tumors, germ cell tumors, hepatoblastoma, medulloblastoma,
neuroblastoma, and osteosarcoma.
Dose3 According to type and stage of cancer, and the specific protocol of treatment
To prevent possible overdose, verify any cisplatin dose exceeding 100 mg/m2 per course
(eg, every 3 – 4 week cycle)
58
Pretreatment hydration is recommended.
3
Dose adjustment Review protocols for proposed adjustments or consider following recommendations
Repeat courses of Cisplatin for adults should not be given until Sr Cr is <1.5 mg/dL and/or
BUN is <25 mg/dL and use is contraindicated in preexisting renal impairment
The following adjustments have been recommended: Infants, Children, and Adolescents:
GFR >50 mL/min/1.73 m2: No dosage adjustment necessary.
GFR 10 – 50 mL/ min /1.73 m2: Administer 75% of dose.
GFR <10 mL/min/1.73 m2: Administer 50% of dose.
Hemodialysis: Partially hemodialyzable: Administer 50% of dose post-hemodialysis.
Peritoneal dialysis: Administer 50% of dose.
CRRT: Administer 75% of dose.
Hepatoblastoma: Infants, Children, and Adolescents:
GFR >60 mL/min/1.73 m2: No dosage adjustment necessary.
GFR <60 mL/ min /1.73 m2: Omit cisplatin dose until GFR is >60 mL/min/1.73 m2
Hepatic Impairment no adjustments provided however, Cisplatin undergoes nonenzymatic
metabolism and mainly renally eliminated therefore, dose adjustment isn't likely necessary
Preparation Cisplatin shouldn’t come in contact with aluminum needles or IV sets that contain
aluminum (reaction and precipitation and loss of potency).
9
Preparation for IV: further dilute dose in 100 – 500 ml NS .
Administration3 Administration details may be protocol specific, refer to treatment protocol however
IV: infusion over 30 – 240 min (adult data).
Some protocols may require infusions up to 24 hr.
As a part of a combination regimen, review for sequence of administration is necessarry
Stability1 Store intact vials at 25 ° C, Protect from light. Don’t refrigerate as it may precipitate in one
hour if refrigerated and redissolves very slowly at room temperature. Heating to enhance
redissolution is not recommended. Do not use if a precipitate remains.
Diluted: final sodium chloride conc. ≥0.2% 2
If diluted cisplatin is not used within 6 hr, protect the solution from light 2.
Dose diluted in 100 – 500 ml NS is stable for 24 hr at room temp.9
Not found to undergo sorption to PVC or PP (in syringes or bags), or glass containers
CNS: Neurotoxicity (peripheral neuropathy is dose and duration dependent)
GIT: Nausea and vomiting (76% - 100%)
Genitourinary: Nephrotoxicity (28% - 36%, ARF and chronic renal insufficiency)
Hematologic & oncologic: Anemia (≤40%), leukopenia (25 - 30%, nadir: Day 18 – 23, recovery:
By day 39, dose related), thrombocytopenia (25 - 30%, nadir: Day 18 – 23, recovery: By day 39,
dose related)
Hepatic: Increased liver enzymes
Otic: Ototoxicity (children 40% - 60% as tinnitus, high frequency hearing loss)
1% - 10%: Local: Local irritation
<1%, postmarketing, and/or case reports
Alopecia (mild), ageusia, anaphylaxis, autonomic neuropathy, bronchoconstriction, bradycardia,
cardiac arrhythmia/failure, cerebral arteritis, cerebrovascular accident, dehydration, diarrhea,
dysgeusia, extravasation, heart block, hemolytic anemia (acute), HUS, hiccups,
hypercholesterolemia, hyperuricemia, hypocalcemia, hypokalemia, hypomagnesemia,
hyponatremia, hypophosphatemia, hypotension, ↑ Sr amylase, ischemic heart disease,
leukoencephalopathy, Lhermitte's sign, mesenteric ischemia (acute), myocardial infarction,
neutropenic enterocolitis, optic neuritis, pancreatitis, papilledema, peripheral ischemia (acute),
phlebitis, reversible posterior leukoencephalopathy syndrome, seizure, SIADH, skin rash,
tachycardia, tetany, thrombosis (aortic), thrombotic thrombocytopenic purpura, vasospasm
(acute arterial), vision color changes, vision loss
Oncology: Emetic Potential Pediatrics: ≥12 mg/m2/dose: High (>90%)
Contraindications Severe hypersensitivity to cisplatin or any component of the formulation
59
Nitrogen mustard alkylating chemotherapy/immunesupressant
Cyclophosphamide
Trade name Cycram 200 mg and Endoxan 1 g
Active drug Cyclophosphamide
Dosage form Vial 200 mg (cycram) and vial 1 g (Endoxan)
Mechanism of action Cell cycle-phase nonspecific Prodrug metabolized to active metabolites that Cross-link DNA
strands decreasing DNA synthesis and has potent immunosuppressive activity.
Indications Oncologic uses: Treatment of Hodgkin, non-Hodgkin & Burkitt lymphoma, CLL, CML, ALL,
multiple myeloma, neuroblastoma, retinoblastoma, adenocarcinoma, Ewing sarcoma,
rhabdomyosarcoma, Wilms tumor, ovarian germ cell tumors, small cell lung cancer,
testicular cancer, pheochromocytoma, CNS tumors, and in HSCT conditioning regimens.
Nononcologic uses: Treatment of minimal change nephrotic syndrome, aplastic anemia,
lupus nephritis, uveitis, vasculitis (ANCA positive, eg, granulomatosis with polyangiitis [GPA]
Wegener granulomatosis) and Kawasaki Disease refractory to IVIG
Dose Oncologic According to type and stage of cancer, and the specific protocol of treatment
Non – oncologic uses:
Aplastic anemia, severe, refractory: Limited data
age ≥2 - 18years: High-dose therapy: IV: 45 – 50 mg/kg/day for 4 days, concurrent
prophylactic antimicrobial therapy should be considered
Kawasaki Disease, refractory to multiple therapies: limited data
Infants & Young Children IV: 2 mg/kg/24 hr (limited data: gradual tapering over 1.5 –7
months suggested). Dosing based on a retrospective study of patients with refractory
Kawasaki Disease that included two patients (ages 2.7 and 9 years)
Lupus nephritis, proliferative: Limited data available
Children and Adolescents:
Initial pulse therapy:
IV:6-month course: 500 – 1,000 mg/m2/dose once monthly
Alternative regimen Initial: 500 mg/m2, titrate as tolerated /4 weeks in 250 mg/m2
increments up to 750 or 1,000 mg/m2 / month, max. dose: 1,500 mg/month.
3-month course: 500 mg / 2 weeks for 3 months.
Maintenance: IV: 500 - 1,000 mg/m2 /3 months for a total of 1.5 – 3 years has been used
Vasculitis, ANCA-associated (eg, granulomatosis with polyangiitis [GPA], Wegener
granulomatosis): Limited data
IV: Initial: 15 mg/kg /2 weeks for 3 doses, then 15 mg/kg /3 weeks until remission or
azathioprine maintenance.
Dosing adjustment for toxicity: Infants, Children, and Adolescents:
Hematologic toxicity: dose reduction or treatment interruption acc. To patient.
Hemorrhagic cystitis: severe: Discontinue treatment.
Renal impairment no adjustments provided decreased renal excretion may occur, monitor
patients with severe impairment (CrCl 10 - 24 mL/min) for signs and symptoms of toxicity.
Infants, Children, and Adolescents: suggested by some clinicians experiences
CrCl ≥10 mL/min: No dosage adjustment required.
CrCl <10 mL/min: Administer 75% of normal dose.
Hemodialysis: (20% - 50 % dialyzable) administer 50% of normal dose after hemodialysis.
CAPD: Administer 75% of normal dose.
CRRT: Administer 100% of normal dose.
Lupus nephritis (KDIGO 2012) Children and Adolescents:
CrCl 25 – 50 mL/min: Administer 80% of normal dose.
CrCl 10 – <25 mL/min: Administer 70% of normal dose.
Hepatic Impairment
No dose adjustments provided, in severe hepatic impairment, conversion to an active
metabolite may be reduced potentially affecting efficacy. The half-life and clearance of
60
cyclophosphamide metabolites may be increased/decreased respectively.
Oncologic uses The following adjustments have been recommended for All patients:
Sr bilirubin 3.1 – 5 mg/dL or transaminases >3 times ULN: Administer 75% of dose.
Sr bilirubin >5 mg/mL: Avoid use
Preparation2 Reconstitution: inspect vial, do not use if melting is seen, melted drug is a clear or
yellowish viscous liquid found in droplets or a connected phase
IV push: Reconstitute with NS ONLY swirl gently swirl gently to mix
Vial 200 mg + 10 ml NS
Vial 1 g + 50 ml NS
Solutions reconstituted in SWFI should be further diluted immediately2
IV Infusion: Reconstitute with SWFI or NS to conc. 20 mg/ml (Vial 200 mg + 10 ml & Vial 1 g
+ 50 ml NS) swirl gently to mix.
Then further dilute in D5W to a minimum concentration of 2 mg/mL
Or dilute in NS at conc. of 0.24 – 20 mg/mL.
Administration3 IV push: administer reconstituted solution in NS without further dilution (20 mg/mL), rate
may vary based on protocols (refer to specific protocols)
IV infusion: over 15 – 60 min
Doses >1,800 mg/m2 infused over 1 – 6 hr by some centers and protocols. Infusion rate may
vary based on protocol (refer to specific protocol for infusion rate)
To minimize bladder toxicity, ↑fluid intake during and 1 - 2 days after cyclophosphamide
dose. In pediatric patients twice maintenance (3 L/m2/day).
High-dose regimens and some standard (low) cyclophosphamide doses should be
accompanied by vigorous hydration with mesna therapy (refer to specific protocols).
Stability2 Store intact vials of powder at ≤25°C.
Exposure to excessive temp. Causes drug melting (melted drug have a clear to yellow
viscous liquid which may appear as droplets), do not use vials with signs of melting.
Solutions reconstituted in SWFI less than 3% loss occurred in 4 weeks at 2 – 8°C
Reconstituted in NS is stable for 24 hr at room temp, and 6 days at 2 – 8°C 2,3
Solutions diluted for infusion
4 mg/ml in NS in PVC bags Stable for 4 weeks at 4 ◦C10 mg/ml in NS, D5W in PVC bags 10%
in 30 days at 4 ◦C protected from light2
9
Dose + 100 – 250 mL NS9 or D5W2,9 is stable for 36 hr at 2°C – 8°C & 24 hr at room temp°C
Protection from normal fluorescent light during infusion isn’t needed
Not found to undergo substantial sorption to PVC, polypropylene (in syringes) or glass.
Adverse reactions3 Postmarketing:
CVS: AMI, AF, atrial flutter, bradycardia, cardiac tamponade, cardiogenic shock,
cardiomyopathy, chest pain, edema, flushing, HF, hemorrhagic myocarditis, HTN, hypotension,
myocarditis, palpitations, pericardial effusion, pericarditis, peripheral ischemia, prolonged QT
interval, PE, SVT, tachycardia, vasculitis, venous thrombosis, ventricular arrhythmia/fibrillation,
Dermatologic: Alopecia, nails changes, dermatitis, erythema multiforme, hyperhidrosis, palmar-
plantar erythrodysesthesia, pruritus, skin blister/erythema /rash, SJS, TEN, urticaria
Endocrine &metabolic: Amenorrhea, ↓or↑ Sr glucose, fluid retention, hot flash, ↑Na+ ↑LDH,
malignant thyroid neoplasm, nephrogenic diabetes insipidus, water intoxication
GIT: Acute pancreatitis, Ageusia, cholestasis, constipation, dysgeusia, enteritis, GIT colitis/
hemorrhage, nausea, neutropenic typhlitis, oral mucosa ulcer, parotitis, stomatitis, vomiting
Genitourinary: Azospermia, bladder carcinoma, bladder disease (necrosis, contracture, or
atypical epithelial cells), cystitis (ulcerative), defective oogenesis, defective spermatogenesis,
hematuria, hemorrhagic cystitis, infertility, infrequent uterine bleeding, oligospermia, ovarian
failure, ovarian fibrosis, premature labor, pyelitis, testicular atrophy, toxic nephrosis, ureteral
disease (ureteritis)
Hematologic & oncologic: Anemia, bone marrow depression (including failure), ↑CRP, DIC, FN,
HUS , leukopenia, myelodysplastic syndrome, neutropenia, pulmonary hemorrhage, secondary
malignant neoplasm (including acute leukemia, malignant lymphoma, neoplasm of urinary tract
[pelvic, renal, and ureteric], myelatelia, sarcoma), thrombocytopenia, thrombotic
microangiopathy
Hepatic: Ascites, cholestatic hepatitis, hepatic encephalopathy, hepatic failure, hepatic
61
sinusoidal obstruction syndrome, hepatitis (including hepatic cytolysis), hepatomegaly,
increased liver enzymes, ↑ Sr bilirubin, jaundice
Hypersensitivity: Anaphylactic shock, anaphylaxis, facial swelling
Infection: CMV disease, infection (including reactivation of latent infection)
Local: Infusion- Injection site reaction (including erythema, inflammation, necrosis, pain,
phlebitis, swelling, and thrombosis)
CNS: Altered smelling, asthenia, chills, confusion, dizziness, dysesthesia, encephalopathy,
fatigue, headache, hypoesthesia, malaise, neuralgia, neurotoxicity, pain, paresthesia, peripheral
neuropathy, polyneuropathy, RPLS, seizure, tremor
Neuromuscular & skeletal: Arthralgia, muscle spasm, myalgia, myelopathy, rhabdomyolysis,
systemic sclerosis
Ophthalmic: Conjunctivitis, lacrimation, visual impairment
Otic: Auditory impairment, deafness, tinnitus
Renal: Hemorrhagic ureteritis, renal cell carcinoma, renal failure syndrome, renal insufficiency,
renal tubular disease
Respiratory: ARDS, bronchiolitis obliterans, bronchospasm, cough, dyspnea, flu-like signs,
hypersensitivity pneumonitis, hypoxia, interstitial disease, nasal congestion, nasal discomfort,
oropharyngeal pain, pleural effusion, pneumonia, pneumonitis (late onset >6 months),
pulmonary: edema/fibrosis/hypertension/veno-occlusive disease, RD, respiratory failure,
rhinorrhea
Emetic Potential in Pediatric IV: ≥1,200 mg/m2: High (>90%)
1,000 mg/m2: Moderate (30% - 90%)
500 mg/m2: Low (10% - 30%)
Contraindications3 Severe hypersensitivity to the drug, its metabolites, or any component of the formulation
Urinary outflow obstruction.
Severe myelosuppression, severe renal or hepatic impairment, active infection (especially
varicella zoster), severe immunosuppression.
Antimetabolite chemotherapy
Cytarabine conventional
Trade name Tabine, Alexan
Active drug Cytarabine
Dosage form Ampoule 100 mg/5 ml (Tabine)
Vial 1 g (Alexan)
Mechanism of action Pyrimidine analog incorporated into DNA, however, the primary action is inhibition of DNA
polymerase resulting in decreased DNA synthesis and repair. It is S phase cell cycle-specific
Indications IV: Remission induction in AML, treatment of ALL & CML (blast phase). Used in AML
consolidation phase, AML salvage treatment, and treatment of non-Hodgkin lymphomas
Intrathecal: Prophylaxis and treatment of meningeal leukemia
3
Dose adjustment Review protocols for adjustments, if not provided, consider following recommendations
Renal impairment: no adjustments provided however based on clinicians experience:
Infants, Children, and Adolescents:
Standard dosing range (100 – 200 mg/m2): No adjustment necessary
High-dose cytarabine (adult data available or refer to protocol if available)
High-dose cytarabine (1 – 3 g/m2)
CrCl 46 – 60 mL/min: Administer 60% of dose.
CrCl 31 – 45 mL/ min: Administer 50% of dose.
CrCl <30 mL/ min: Consider use of alternative drug
Alternative regimen (high-dose cytarabine ≥1 g/m2):
GFR ≥60 mL/ min /1.73 m2: No dosage adjustment necessary.
GFR 31 – 59 mL/ min /1.73 m2: Administer 50% of original dose.
GFR ≤30 mL/ min /1.73 m2: Use is not recommended.
62
Alternative regimen (high-dose cytarabine ≥2 g/m2):
Sr Cr 1.5 – 1.9 mg/dL or ↑ (from baseline) of 0.5 - 1.2 mg/dL: ↓dose to 1 g/m2/dose.
Sr Cr ≥2 mg/dL or ↑(from baseline)>1.2 mg/dL: ↓dose to 0.1 g/m2/day as continuous infusion
Cytarabine 3 g/m2/dose [studied in Burkitt or mantle cell lymphoma]:
Sr Cr ≥1.5 mg/dL: Reduce dose to 1 g/m2/dose.
Hemodialysis: In 4-hour dialysis sessions (with high flow polysulfone membrane) 6 hours
after cytarabine 1 g/m2 over 2 hours, 63% of the metabolite ARA-U was extracted from
plasma (based on a single adult case report)
Hepatic Impairment (adult data available or refer to protocol if available)
IV: Dose may need adjustment since cytarabine is partially metabolized in the liver.
All patients start as follows, may increase subsequent doses in the absence of toxicity
If Transaminases (any elevation): Administer 50% of dose
If Bilirubin >2 mg/dL: Administer 50% of dose.
Preparation3 bacteriostatic Solutions may be used for standard IV dose (100 – 200 mg/m2)
Never use bacteriostatic Solutions for intrathecal doses or high-dose IV
Tabine ampoule preservative free
IT: Dose + up to 6 ml preservative free NS, protect from light 9 volume range is 3 – 12mL3
Clearly mark intrathecal dose with a label identifying as "intrathecal" use only.
Intrathecal triple therapy (ITT): Cytarabine 30 – 50 mg
+hydrocortisone sodium succinate 15 – 25 mg
+ methotrexate 12 mg (compatible in a syringe)
other dose-specific combination:
Cytarabine 18 mg + hydrocortisone 12 mg + methotrexate 6 mg, to a final vol of 6 mL
Cytarabine 24 mg + hydrocortisone 16 mg + methotrexate 8 mg, to a final vol of 8 mL
Cytarabine 30 mg + hydrocortisone 20 mg + methotrexate 10 mg, to a final vol of 10 mL,
Cytarabine 36 mg + hydrocortisone 24 mg + methotrexate 12 mg, to a final vol of 12 ml,
have been reported compatible as well
IV: dose + 100 ml NS, D5W , SWFI (Conc. 0.1 – 3 7.5 mg/mL) protect from light 9
Or dose (standard – high) may be further diluted in 250 – 1,000 mL of NS or D5W 3
Alexan 1 g vial + SWFI preservative-free for high-dose preparations.
3
Administration Antiemetics may be recommended to prevent nausea and vomiting
IV Injection or infusion rates may depend mainly on protocol
continuous infusion over12 – 24 hr
IV infusion over 1 – 3 hr for High-dose cytarabine
IV Push over 15 – 30 min has been reported.
Stability2 Store ampoule at max 30 ° C , Vials 25 ° C, Protect from light2
IT: Dose Tabine only + up to 6 ml preservative free NS used within 4 hr 9
IV: dose + 100 ml NS, D5W , SWFI (Conc. 0.1 – 3 7.5 mg/mL) 9 stable for 48 hr at room temp,
and 72 hr at 2 – 8 ° C 9
Other chemical stability info. For IV Infusion Solutions of cytarabine: 2
0.5 mg/mL in D5W and NS (unspecified container) is stable for 8 days at room temp.
0.5 – 5 mg/mL in D5W ,NS (unspecified container) stable 14 days at room temp(˂10% loss)
1.25 – 25 mg/mL in D5W and NS to be stable for 28 days at room temp. & refrigerated.
Container specific data2
0.157 mg/mL D5W (unspecified Plastic bottles) stable 48 hr AT Room temp
exposed/protected from light and at 4 °C
0.2 mg/mL D5W in PVC stable for 48 hr at Room temp 22 - 23 °C & relative humidity 23 -
48% exposed to fluorescent light
0.5 mg/mL in D5W & NS in PVC stable for 24 hr at 5 °C
8 mg/ml in D5W & NS in glass or PVC stable for 7 days at Room temp. and 4 °C
37 mg/ml in D5W in glass or PVC stable for 7 days at Room temp. and 4 °C
40mg/mL in D5W in PVC stable for 48 hr Room temp 22 - 23 °C & relative humidity 23 -
48% exposed to fluorescent light
63
Not found to undergo substantial sorption to PVC, polypropylene (in syringes) or glass
CVS: Chest pain, thrombophlebitis
Dermatologic: Alopecia, dermal ulcer, ephelis, pruritus, urticaria
GIT: Abdominal pain, anorexia, diarrhea, esophageal ulcer, esophagitis, intestinal necrosis,
nausea, oral inflammation/mucosa ulcer, proctocolitis, rectal ulcer, sore throat, vomiting
Genitourinary: Urinary retention
Hematologic & oncologic: Anemia, bone marrow depression, hemorrhage, leukopenia,
megaloblastic anemia, reticulocytopenia, thrombocytopenia
Hepatic: Hepatic insufficiency, jaundice
Hypersensitivity: Allergic angioedema
Infection: Sepsis
Local: Cellulitis at injection site, inflammation at injection site, pain at injection site
CNS: Dizziness, headache, leukoencephalopathy(necrotizing), neuritis, paralysis, paraplegia
Ophthalmic: Blindness
Renal: Renal insufficiency
Respiratory: Dyspnea, pneumonia
Postmarketing (includes adverse reactions with intermediate or high dose cytarabine):
CVS: Acute myocarditis, pericarditis
Dermatologic: AGEP, maculopapular rash, skin rash, skin toxicity (including red ear syndrome
and palmar-plantar erythrodysesthesia)
Endocrine & metabolic: Hyperuricemia
GIT: ↑ Sr amylase, ↑Sr lipase, pancreatitis (including acute pancreatitis)
Hepatic: ↑liver enzymes
CNS: Aseptic meningitis, cerebellar syndrome (including ataxia, confusion, drowsiness,
dysarthria, dysmetria, encephalitis, impaired consciousness, nystagmus disorder), malaise,
neurotoxicity (including peripheral neuropathy), RPLS
Neuromuscular & skeletal: Myalgia, ostealgia, rhabdomyolysis
Ophthalmic: Conjunctivitis, corneal toxicity (epithelial keratopathy), keratoconjunctivitis, uveitis
(including anterior uveitis)
Respiratory: Pulmonary toxicity (including bronchiolitis obliterans organizing pneumonia,
hypoxemia, pulmonary edema, pulmonary infiltrates)
Other: Fever
Emetic Potential in Pediatrics: IV: ≥3,000 mg/m2/day: High (>90%).
75 mg/m2/dose: Moderate (30% - 90%).
Contraindications Hypersensitivity to cytarabine or any component of the formulation
Dacarbazine
Trade name Dacarbazine Medac
Active drug Dacarbazine
Dosage form Vial 200 mg powder for IV
Mechanism of action The active metabolite of dactinomycin causes alkylation of DNA that leads to DNA double
strand breaks and apoptosis. Dacarbazine is non-cell cycle specific
Indications Treatment of malignant melanoma, Hodgkin disease
Data from adult recommendation: (no pediatric specific data available)
Renal impairment no adjustments provided. However some regimens were recommended:
CrCl 46 – 60 mL/ min: Reduce dose to 80% of usual dose.
CrCl 31 – 45 mL/ min: Reduce dose to 75% of usual dose.
CrCl ≤30 mL/ min: Reduce dose to 70% of usual dose.
Alternative dosing adjustments:
CrCl ≥30 mL/min: No adjustment necessary.
64
CrCl <30 mL/ min: reduce dose to 70% of usual dose.
Hemodialysis: reduce dose to 70% of usual dose.
Hepatic Impairment no adjustments provided. May cause hepatotoxicity, monitor closely
Mild – moderate impairment: No adjustment necessary.
Severe impairment: Use is not recommended.
Preparation2 Reconstitute: Vial 20 mg + 9.7 mL SWFI (conc. of 10 mg/mL). Protect from light
Then further dilute in D5W or NS for infusion (with 150 or 250 mL D5W or NS, adult data)
Administration3 Antiemetics are recommended to prevent nausea and vomiting
IV infusion over 15 – 60 min rapid infusion may cause severe venous irritation
Infusion durations may be regimen Specific (review protocol).
Dacarbazine is an irritant, monitor infusion site for local reactions
Stability2 Store intact vial at 25 ° C, protect all solutions and vials from light
Reconstituted sol. stable for 24 hr at room temp (20°C) and 96 hr at 4°C, protect from light3
Color Change from the normal pale yellow–Ivory to pink or red is evidence of degradation.
Diluted sol. (in D5W or NS) in unspecified container, stable for up to 24 hr at 4°C & up to 8
hr at room temp, protect from light 3
9
Conc.: 0.19 – 3.0 mg/mL in NS, D5W stable for 24 hr at 2 – 8 ◦ C , protect from light
1.6 mg/ml in NS in PVC kept at 4◦ C protected from light for 30 days with 10 % loss
1.4 mg/mL in D5W in PVC kept at 2 – 6 ◦ C protected from all lights for 7 days with no loss
1.7 mg/mL in D5W in PVC kept at Room temp. exposed to light for 24 hr with 10% loss
3 mg/mL in D5W in PVC at Room temp 22 – 23 °C & relative humidity 23 - 48% exposed to
fluorescent light stable for 8 hr with 4% loss & 24 hr with 9 % loss & 48 hr with 15% loss
Complete Protection from light during infusion is needed
Not found to undergo substantial sorption to PVC, or glass
CNS: Infusion-site pain
Dermatologic: Alopecia
GIT: Nausea and vomiting (>90%), anorexia
Hematologic & oncologic: Bone marrow depression (onset: 5 – 7 days, nadir: 7 – 10 days,
recovery: 21 – 28 days), leukopenia, thrombocytopenia
<1%, postmarketing, and/or case reports: Anaphylaxis, anemia, diarrhea, dysgeusia,
eosinophilia, erythema, facial flushing, facial paresthesia, flu-like symptoms (fever, myalgia,
malaise), hepatic necrosis, ↑liver enzymes (transient), paresthesia, abnormal renal function
test, skin photosensitivity, skin rash, urticaria, venous obstruction (hepatic vein)
Emetogenic potential High (>90%)
Contraindications Hypersensitivity to Dacarbazine or any component of the formulation
Prior severe myelosuppression
Antineoplastic antibiotic
Dactinomycin
Trade name Cosmegen , Cosmedac
Active drug Dactinomycin
Dosage form Vial 500 mcg for IV
Mechanism of action Intercalating between guanine and cytosine base pairs in DNA inhibiting DNA and RNA
synthesis and protein synthesis
Indications Wilms tumor, childhood rhabdomyosarcoma, Ewing sarcoma, gestational trophoblastic
neoplasms, and metastatic nonseminomatous testicular tumors (age> 6 months) locally
recurrent or locoregional solid tumors, soft tissue sarcoma and Kaposi sarcoma
3
Renal impairment: no adjustments provided in adult or pediatric data however, based on
the amount of urinary excretion, dosage adjustments may not be necessary
Hepatic Impairment: no adjustments for pediatric (recommendations from adult data)
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Any transaminase increase: Reduce dose by 50% , may ↑dose by monitoring toxicities
2
Preparation Reconstitution: vial + 1.1 mL SWFI preservative-free (conc. 500 mcg/mL
Avoid diluents containing preservatives as it cause dactinomycin precipitation.
Dilution in D5W or NS in glass or PVC to a conc. of ≥10 mcg/mL (1ml x ≤ 50 mL dilution)
IV push: undiluted into the side-port of a free flowing IV infusion by over a few min
IV infusion over 10 – 15 min, consider a D5W or NS flush before and after a dactinomycin
Vesicant, avoid extravasation.
Stability 2 Store intact vial at max 30 ° C, Protect from light and humidity.
Reconstituted sol. discard unused portion
Diluted sol. In D5W or NS should be used within 4 hr
Not found to undergo substantial sorption to PVC, polypropylene (in syringes) or glass
CVS: Thrombophlebitis
CNS: Fatigue, malaise, peripheral neuropathy
Dermatologic: Acne vulgaris, alopecia, cheilitis, dermatitis, erythema multiforme, skin rash, SJS,
TEN
Endocrine & metabolic: Growth suppression, hypocalcemia
GIT: Abdominal pain, anorexia, aphthous stomatitis, constipation, diarrhea, dysphagia,
esophagitis, GIT ulcer, mucositis, nausea, proctitis, vomiting
Hematologic & oncologic: Anemia, bone marrow depression, DIC, FN, hemorrhage, leukopenia,
neutropenia (nadir: 14 – 21 days), pancytopenia, reticulocytopenia, second primary malignant
neoplasm (eg. leukemia), thrombocytopenia, tumor lysis syndrome
Hepatic: Abnormal hepatic function tests, ascites, hepatic failure, hepatic sinusoidal obstruction
syndrome, hepatitis, hepatomegaly, hepatotoxicity, severe hepatic disease (hepatopathy-
thrombocytopenia syndrome)
Infection: Infection, sepsis
Neuromuscular & skeletal: Myalgia
Ophthalmic: Optic neuropathy
Renal: Renal function abnormality, renal failure syndrome, renal insufficiency
Respiratory: Pneumonitis, pneumothorax
Other: Fever, radiation recall phenomenon
Emetic Potential Pediatrics: ≥1.35 mg/m2/dose: High (>90%)
0.01 mg/kg/dose: Moderate (30% - 90%)
Contraindications No contraindications listed
Anthracycline, topoisomerase II inhibitor chemotherapy
Doxorubicin conventional
Trade name Adricin 10 mg
Active drug Doxorubicin conventional
Dosage form Vial 10 mg/ 5ml solution for IV
Mechanism of action Direct binding to DNA (intercalation) and inhibition of DNA repair (topoisomerase II
inhibition) result in blockade of DNA and RNA synthesis and fragmentation of DNA
Indications metastatic cancers or disseminated neoplastic conditions ALL, AML, Hodgkin, non-Hodgkin
lymphoma, soft tissue and bone sarcomas, breast cancer, thyroid cancer, bronchiogenic
carcinoma (responsive small cell), gastric carcinoma, ovarian cancer, transitional cell
bladder carcinoma, neuroblastoma, and Wilms tumor, desmoplastic round cell tumor,
Ewing sarcoma, and hepatoblastoma.
Monitor cumulative Anthracycline dose (combined), the risk for cardiomyopathy increases
as the cumulative dose increases (>250 mg/m2 in pediatric patients <18 years and 550
mg/m2 in patients >18 years)
66
Renal impairment All patients: Mild, moderate, or severe impairment: no adjustments
provided (not studied) however, adjustments are likely not necessary given limited renal
excretion.
The following adjustments have also been recommended:
CrCl <50 mL/min: No dosage adjustment necessary.
Hemodialysis: Supplemental dose is not necessary.
Dosing: Hepatic Impairment
All patients, The manufacturers' labeling recommends the following adjustments:
Sr bilirubin 1.2 – 3 mg/dL: Administer 50% of dose.
Sr bilirubin 3.1 – 5 mg/dL: Administer 25% of dose.
Severe hepatic impairment (Child-Pugh class C or bilirubin >5 mg/dL): it is contraindicated
Alternative adjustments recommended based on experience in adults
Transaminases 2 – 3 times ULN: Administer 75% of dose.
Transaminases >3 times ULN: Administer 50% of dose.
Preparation2 Conventional doxorubicin & liposomal doxorubicin are different and NOT interchangeable
May further dilute doxorubicin solution in 50 to 1,000 mL D5W or NS for infusion
Refer to protocol specific rates
IV push over at least 3 - 10 min
IV infusion over at least 1 hr to reduce the potential for cardiotoxicity
Continuous IV infusion (via central venous line recommended)
Protect from light during administration
Vesicant, avoid extravasation.
Stability 2 Store intact vial at 2 – 8 °C. Must be Protected from light (PFL). Discard unused portion.
If Refrigeration result in formation of a gelled product, place vials at room temperature
before use for 2 – 4 hr to return the product to a slightly viscous, mobile solution.
Dilutions in D5W:
0.02 mg/mL(1x100ml) in PVC stable for 8 days at room temp & 4 °C, PFL, with ˂10 % loss
0.04 mg/mL(1x 50 ml) in PVC stable 7 days at 4 °C, PFL with loss 10 % in D5W & 6% in NS
0.1 mg/ml (1x 20 ml) in PP stable 28 days at Room temp 25 °C, PFL, with 5 % loss
0.1 mg/ml (1x 20 ml) in PVC stable 43 days at Room temp 25 °C & 4°C, PFL, with ˂10% loss
and ˂ 6 % loss in 8 days
Dilutions in NS
0.02 mg/mL(1x100ml) in PVC stable for 8 days at room temp & 4 °C, PFL, with ˂10 % loss
0.04 mg/mL(1x 50 ml) in PVC stable 7 days at 4 °C, PFL with loss 6% in NS
0.1 mg/ml (1x 20 ml) in PP stable 6 days at Room temp 25 °C, PFL, with 10 % loss
0.1 mg/ml (1x 20 ml) in PVC stable 43 days at Room temp 25 °C & 4°C, PFL, with ˂10% loss
1 mg /ml in PP syringe stable 124 days at 4 °C & room temp 23°C exposed to light
In several stability studies doxorubicin didn’t undergo substantial sorption to glass
containers, PVC containers or polypropylene (in syringes) however, sorption occurred in
PVC mostly at very low conc (0.016 mg/mL in 24 hr and 7-8 % loss at 0.1 mg/ml in 8 days)
Adverse reactions Frequency not defined
CVS: Acute cardiotoxicity: AV block, bradycardia, bundle branch block, ECG abnormality,
extrasystoles (atrial or ventricular), nonspecific ST or T wave changes on ECG, sinus tachycardia,
SVT, tachyarrhythmia, ventricular tachycardia
Delayed cardiotoxicity: Cardiac failure (manifestations include ascites, cardiomegaly, dyspnea,
edema, gallop rhythm, hepatomegaly, oliguria, pleural effusion, pulmonary edema,
tachycardia), decreased left ventricular ejection fraction, myocarditis, pericarditis
CNS: Malaise
Dermatologic: Alopecia, discoloration of sweat, pruritus, skin photosensitivity, skin rash,
urticaria
Endocrine & metabolic: Amenorrhea, dehydration, hyperuricemia
GIT: Abdominal pain, anorexia, diarrhea, discoloration of saliva, GIT ulcer, mucositis, nausea,
vomiting
Genitourinary: Urine discoloration, infertility (may be temporary)
67
Hematologic & oncologic: Leukopenia (≤75%, nadir: 10 to 14 days, recovery: by day 21),
neutropenia (≤75%, nadir: 10 - 14 days, recovery: by day 21), anemia, thrombocytopenia
Local: Post-injection flare
Neuromuscular & skeletal: Weakness
Ophthalmic: Discoloration of tears
Other: Necrosis (colon), radiation recall phenomenon
<1%, postmarketing, and/or case reports: AML (secondary), anaphylaxis, azoospermia, chills,
coma (when in combination with cisplatin or vincristine), conjunctivitis, dysgeusia, febrile
neutropenia, fever, gonadal disease (gonadal impairment, children), growth suppression
(prepubertal), hepatitis, hyperpigmentation (nail, oral mucosa, skin), hypersensitivity reaction
(systemic, including angioedema, dysphagia, and dyspnea, pruritus, urticaria), ↑Sr bilirubin,
↑Sr transaminases, infection, keratitis, lacrimation, myelodysplastic syndrome, oligospermia,
onycholysis, peripheral neurotoxicity (with intra-arterial doxorubicin), phlebosclerosis,
pneumonitis (radiation recall, children), seizure (when in combination with cisplatin or
vincristine), sepsis, shock, SJS, TEN, typhlitis (neutropenic)
Emetic Potential Pediatrics:
≥30 mg/m2/dose or when used in certain combinations: High (>90%)
25 mg/m2/dose: Moderate (30% to 90%)
10 mg/m2/dose: Minimal (<10%)
Contraindications Severe hypersensitivity (eg, anaphylaxis) to doxorubicin or component of formulation
recent myocardial infarction (within past 4 - 6 weeks), severe myocardial insufficiency,
severe persistent drug-induced myelosuppression, severe hepatic impairment (Child-Pugh
class C or bilirubin >5 mg/dL).
Hypersensitivity to other Anthracycline or anthracenediones, severe arrhythmias, history of
severe cardiac disease, previous treatment with maximum cumulative doses of doxorubicin,
daunorubicin, epirubicin, idarubicin, and/or other Anthracycline and anthracenediones.
Topoisomerase inhibitor antineoplastic
Etoposide
Trade name Etopul
Active drug Etoposide
Dosage form Ampoule 100 mg/5 ml for IV
Mechanism of action Topoisomerase II inhibitor and appears to cause DNA strand breaks, delay transit of cells
through the S phase and arrest cells in late S or early G2 phase, may inhibit mitochondrial
transport at the NADH dehydrogenase level or inhibit uptake of nucleosides into HeLa cells
Indications therapy of lymphoma, Hodgkin disease, ALL, AML, neuroblastoma, Wilms tumor, Ewing
sarcoma, retinoblastoma, CNS tumors, and in conditioning regimen before HSCT
Dosage adjustment for toxicity: (based on experience in adult
ANC <500/mm3 or platelets <50,000/mm3: Withhold treatment until recovery.
Hypotension: Interrupt infusion & administer IV fluids and supportive care then decrease
infusion rate upon reinitiation.
Infusion (hypersensitivity) reactions: Interrupt infusion (anaphylaxis medications should be
available).
Severe adverse reactions (nonhematologic): Reduce dose or discontinue treatment.
Altered Kidney Function
Infants, Children, and Adolescents: based on recommendations for adult patients.
CrCl >50 mL/min: No adjustment required.
CrCl 15 – 50 mL/ min: Administer 75% of dose.
CrCl <15 mL min: Data not available, consider further dose reductions.
Alternate adjustments
GFR >50 mL/ min /1.73 m2: No dosage adjustment necessary.
GFR <10 mL/ min/1.73 m2: Administer 50% of dose.
Hemodialysis/PD: Administer 50% of dose after dialysis on dialysis days
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CRRT: Administer 75% of dose and reduce for hyperbilirubinemia.
Dosing: Hepatic Impairment: Pediatric
Infants, Children, and Adolescents: based primarily on experience in adult patients
Bilirubin 1.5 – 3 mg/dL or AST >3 times ULN: Administer 50% of dose
Preparation2,3 For IV Infusion
Dilute in D5W or NS to a final conc. of 0.2 – 0.4 mg/mL (1 x100 – 1x 50 ml)
conc >0.4 mg/mL are very unstable
However more concentrated IV sol. (0.6 – 1 mg/mL) are used cautiously in some protocols.
Higher than recommended conc. of Etoposide can crack hard plastic and infusion lines
Inspect infusion sol. for particulate matter and plastic devices for cracks and leaks.
Etoposide injection contains polysorbate 80, may cause leaching of diethylhexyl phthalate
(DEHP), a plasticizer contained in PVC tools. Prepare in glass or polyolefin containers to
minimize patient exposure to DEHP.
Intraventricular (via Ommaya reservoir): dilute dose with preservative-free NS to a final
concentration of 0.1 mg/mL (1x 200 ml)
Oral Injection may be used for orally
Dilute Etoposide injection 1:1 with NS to a conc. 10 mg/mL.(stable in plastic oral syringes)
Prior to oral administration, further mix dose with orange juice, apple juice, or lemonade
(NOT grapefruit juice) at a final conc. ≤ 0.4 mg/mL
Administration Oral: In adults, doses ≤200 mg/day given as a single dose, divide doses >200 mg in 2 doses.
Food doesn’t significantly affect bioavailability of 100 mg Etoposide dose (oral capsule)
IV: IV infusion only over at least 60 min (rate ≤100 mg/m2/hr (or 3.3 mg/kg/hr) to minimize
hypotension risk). Don’t administer by rapid IV or by intrathecal or other routes of injection
by continuous IV infusion: refer to protocol specific rates
Use non-PVC (low sorbing) tubing will minimize patient exposure to DEHP.
Etoposide is irritant to tissue, avoid extravasation.
Due to risk for precipitation, a 0.22-micron inline filter may be used.
Intraventricular: doses injected over 2 min
Stability 2 Store at 25 ° C
Oral: diluted Etoposide 1:1 with NS to a conc. of 10 mg/mL. stable in plastic oral syringes for
22 days at room temp(RT)
IV dilutions
0.2 mg/mL in D5W & NS physically/chemically stable 192 hr at ambient RT and at 2 – 8 ° C.
Stability info in NS
0.2 mg/mL: 22 days at 24°C, 14 days at 4°C*
0.3 mg/mL: 2 days at 24°C, 7 days at 4°C
0.4 mg/mL: 1 day at 24°C, 2 days at 4°C
It's not recommended to store Etoposide preparation as precipitation is inevitable , and
leaching of DEHP in PVC is major at conc ≥ 0.4 mg/ml
Adverse reactions Events with higher doses used in stem cell transplantation: Alopecia, ethanol intoxication,
hepatitis, hypotension (infusion-related), metabolic acidosis, mucositis, nausea and vomiting
(severe), secondary malignancy, skin lesions (resembling SJS).
>10%:
Dermatologic: Alopecia (8% - 66%)
GIT: Nausea and vomiting (31 - 43%), anorexia (10 - 13%), diarrhea (1 – 13%)
Hematologic & oncologic:
Anemia (≤33%), Leukopenia (60 – 91%, grade4: 3 – 17%, nadir: 7 – 14 days, recovery by day 20),
thrombocytopenia (22–41%, grades 3/4: 1 –20%, nadir: 9 – 16 days, recovery by day 20)
1% to 10%:
CVS: Hypotension (due to rapid infusion)
CNS: Peripheral neuropathy
GIT: Stomatitis, abdominal pain.
Hypersensitivity: Anaphylactoid reaction (eg. bronchospasm, chills, dyspnea, fever ...etc.)
<1%, postmarketing, and/or case reports: Amenorrhea, apnea , back pain, constipation, cortical
blindness (transient), cough, cyanosis, diaphoresis, drowsiness, dysphagia, erythema,
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esophagitis, extravasation, facial swelling, fatigue, fever, hyperpigmentation, interstitial
pneumonitis, ischemic heart disease, laryngospasm, MPE, malaise, metabolic acidosis,
mucositis, myocardial infarction, optic neuritis, ovarian failure, pruritic erythematous rash,
pruritus, pulmonary fibrosis, radiation-recall phenomenon, seizure, skin rash, SJS, tongue
edema, TEN, toxic megacolon, urticaria, vasospasm, RPLS, weakness
Emetic Potential Pediatric
Oral: Moderate (30 – 90%)
IV: Low (10 – 30%)
Contraindications Hypersensitivity to Etoposide or any component of the formulation
Additional contraindications: Severe leukopenia or thrombocytopenia, severe hepatic
impairment, severe renal impairment
Antimetabolite chemotherapy (purine analogue)
Fludarabine
Trade name Fludara
Active drug Fludarabine
Mechanism of action inhibition of DNA polymerase and ribonucleotide reductase, inhibits DNA primase & ligase I
Indications Treatment of B-cell CLL, unresponsive to previous therapy with an alkylating agent-regimen,
in relapsed ALL or AML, conditioning regimens for allogeneic HSCT, non-Hodgkin
lymphomas (NHL), AML in refractory or poor risk patients
3
Dose adjustment Review protocol-specific adjustments, if not provided, consider following recommendations
Dosing adjustment for toxicity: adult Data recommendation: (no pediatric specific data)
Hematologic or nonhematologic toxicity (other than neurotoxicity): Consider treatment
delay or dosage reduction.
Hemolysis: Discontinue treatment.
Neurotoxicity: Consider treatment delay or discontinuation.
Renal impairment (Pediatric guidelines used by clinicians) Infants, Children, & Adolescents
GFR >50 mL/min/1.73 m2: No adjustment required
GFR <30 mL/ min /1.73 m2: Not recommended.
Hemodialysis: Administer 25% of dose
CAPD: Not recommended.
CRRT: Administer 80% of dose
Oral (adult data, oral capsule):
CrCl 30 – 70 mL/min: Reduce dose by up to 50%.
CrCl <30 mL/min: Use is contraindicated.
Hepatic Impairment: (adult data) no adjustments available in pediatric data however, adult
data suggest that dosage adjustment for hepatic impairment is not likely necessary
Preparation2,3 Reconstitution Vial + 2 mL SWFI (conc. of 25 mg/mL)
Dilution dose of reconstituted + 100 – 125 mL D5W or NS
Intermittent infusion Conc of 0.25 – 1 mg/mL have been used (1x 100 – 1x 25 ml)
Continuous IV infusion
Loading doses diluted in 20 mL D5W
Continuous infusions diluted in 240 mL D5W have been used in clinical trials.
Administration3 Review protocol – specific rates, IV infusion rates may vary by pediatric protocol.
Intermittent IV infusion: over 30 min, a shorter infusion has been used per protocol
Continuous IV infusion with loading dose
Loading dose: over 15 min
Continuous IV infusion: Administer at a constant rate of 10 mL/hour
Stability2 Store intact vial at 25 ° C, protected from light (PFL)
Reconstituted sol. 25 mg/mL in vials stable with ˂ 5% loss at RT & 2 – 8 ◦C for 15 days
Diluted In Solutions:
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0.2 mg/ml (1x 125 ml) in NS & D5W in PVC and glass containers stable with no loss for 24 hr
at RT 23 °C exposed to fluorescent light and at 4 °C PFL.
1 mg/ml (1x 25 ml) in NS & D5W (unspecified container) stable for 16 days at RT exposed to
fluorescent light with ˂10% loss.
9
Dilute to max 1 mg/ ml OR dose + 100 mL in NS, D5W is stable for 72 hr at 4 °C& 24 hr RT
CVS: Edema (8% – 19%)
CNS: Fatigue (10% – 38%)
neurological signs & symptoms (doses >96 mg/m2/day for 5 – 7 days: 36%
doses <125 mg/m2/cycle: <1%
characterized by cortical blindness, coma & paralysis, onset may be delayed for 3 - 4 weeks
Pain (20% – 22%), chills (11% – 19%), paresthesia (4% – 12%)
Dermatologic: Skin rash (15%), diaphoresis (1% – 13%)
GIT: Nausea & vomiting (31–36%), anorexia (7–34%), diarrhea (13 – 15%), GIT hemorrhage (3–13%)
Genitourinary: Urinary tract infection (2% - 15%)
Hematologic & oncologic: Anemia (60%), bone marrow depression (nadir: 10 – 14 days,
recovery: 5 – 7 weeks, dose-limiting toxicity)neutropenia (grade 4: 59%, nadir: ~13 days)
thrombocytopenia (55%, nadir: ~16 days),
Infection: Infection (33% – 44%)
Neuromuscular & skeletal: Asthenia (9% – 65%), myalgia (4% – 16%)
Ophthalmic: Visual disturbance (3% – 15%)
Respiratory: Cough (10 – 44%), pneumonia (16% – 22%), dyspnea (9 – 22%), upper RTI (2 – 16%)
Other: Fever (60% - 69%)
1% – 10%:
CVS: Angina pectoris, arrhythmia, cardiac failure, cerebrovascular accident, myocardial
infarction, SVT, DVT, phlebitis, aneurysm, transient ischemic attacks.
CNS: Malaise, headache, sleep disorder, cerebellar syndrome, depression, difficulty thinking.
Dermatologic: Alopecia, pruritus, seborrhea.
Endocrine & metabolic: Hyperglycemia, dehydration.
GIT: Stomatitis, cholelithiasis, esophagitis, constipation, mucositis, dysphagia.
Genitourinary: Dysuria, urinary hesitancy, hematuria, proteinuria.
Hematologic & oncologic: Hemorrhage, tumor lysis syndrome.
Hepatic: Abnormal hepatic function tests, hepatic failure.
Hypersensitivity: Anaphylaxis.
Neuromuscular & skeletal: Osteoporosis, arthralgia.
Otic: Hearing loss
Renal: Renal failure, renal function test abnormality.
Respiratory: Pharyngitis, hypersensitivity pneumonitis, hemoptysis, sinusitis, bronchitis,
epistaxis, hypoxia.
<1%, postmarketing, and/or case reports: Acquired blood coagulation disorder, [AML&
myelodysplastic syndrome (usually with prior or concurrent Use of other chemotherapy),
agitation, autoimmune hemolytic anemia, ITP, blindness, bone marrow aplasia (trilineage), bone
marrow depression (trilineage), cerebral hemorrhage, coma, confusion, Epstein-Barr-associated
lymphoproliferative disorder, erythema multiforme, Evans syndrome, flank pain, cystitis
(hemorrhagic), herpes zoster skin infection (reactivation), hyperkalemia,↓ Sr phosphate,
hyperuricemia, hypocalcemia, ↑ liver enzymes, interstitial pneumonitis, lactic/metabolic
acidosis, malignant neoplasm (new-onset/exacerbation), myelofibrosis, opportunistic infection,
optic neuritis/neuropathy, pancreatic disease, pancytopenia, pemphigus, pericardial effusion,
peripheral neuropathy, pneumonitis, progressive multifocal leukoencephalopathy (PML),
pulmonary fibrosis/hemorrhage, latent Epstein-Barr virus reactivation, RD, respiratory failure,
seizure, SJS, TEN, urate crystalluria, wrist-drop
Emetic Potential Pediatric
IV: Minimal (<10%).
Oral (not available in the US): Low (10% to 30%).
Contraindications Hypersensitivity to Fludarabine or any component of formulation, severe renal impairment
(CrCl <30 mL/min), decompensated hemolytic anemia, concurrent use with pentostatin
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Antimetabolite
Hydroxyurea oral
Trade name Hydrea/ Hydroxyurea medac
Active drug Hydroxyurea
Dosage form Hard Capsule 500 mg
Mechanism of action In sickle cell anemia, hydroxyurea increases red blood cell (RBC) hemoglobin F levels, RBC
water content, deformability of sickled cells, and alters adhesion of RBCs to endothelium.
Indications Antimetabolite intended for sickle cell anemia in this formulary
3
Dose Sickle cell anemia:
Infants ≥6 months, Children, and Adolescents: (children <2 years: limited data)
Round dose to nearest 50 to 100 mg (within 2 mg/kg /day limit)
Initial: Oral: 20 mg/kg/dose once daily, monitor blood count/ 2 weeks, may increase by 5
mg/kg/day/8 weeks or sooner if painful crisis occurs, max. dose: 35 mg/kg/day
continue therapy until mild myelosuppression (ANC 2,000 - 4,000/mm3) is achieved (as long
as myelosuppression acceptable)
An initial starting dose of 15 mg/kg/dose once daily has also been studied
A clinical response to treatment may take 3 - 6 months, a 6-month trial of the max.
tolerated dose is recommended prior to considering discontinuation due to treatment
failure, effectiveness of hydroxyurea depends upon daily dosing adherence
Acceptable hematologic ranges: Neutrophils ≥2,000/mm3 (younger patients with lower
baseline counts may safely tolerate ANC down to 1,250/mm3), platelets ≥80,000/mm3,
hemoglobin >5.3 g/dL, and reticulocytes ≥80,000/mm3 if hemoglobin is <9 g/dL.
Toxic hematologic ranges: Neutrophils <2,000/mm3 (younger patients with lower baseline
counts may safely tolerate ANC down to 1,250/mm3), platelets <80,000/mm3, hemoglobin
<4.5 g/dL, and reticulocytes <80,000/mm3 if hemoglobin is <9 g/dL.
Dose adjustment 3 Dosing adjustment for toxicity
Infants ≥6 months, Children, and Adolescents: Oral:
Hematologic: Sickle cell disease:
Toxic myelosuppression (neutrophils <2,000/mm3 [ANC minimum limit of 1,250/mm3 may
be acceptable in younger patients with lower baseline counts], platelets <80,000/mm3,
hemoglobin <4.5 g/dL, or reticulocyte <80,000/mm3 if hemoglobin <9 g/dL)
Hold therapy until counts recover (monitor weekly)
Decrease the dose by 2.5 – 5 mg/kg/day increment from the dose given prior to onset of
toxic myelosuppression
Titrate dose up or down/ 8 weeks by 5 mg/kg/day until the patient on dose causes no
hematologic toxicity for 24 weeks.
If hematologic toxicity develops again (i.e. twice), permanently discontinue therapy.
Non-hematologic: (based on adult patients with disease other than sickle cell disease)
Cutaneous vasculitic ulcerations: Discontinue.
Pancreatitis: Discontinue permanently.
Renal impairment: (use of 24-hr urine collection to calculate CrCl preferred)
Children ≥2 years and Adolescents:
CrCl ≥60 mL/min: No dosage adjustment (of initial dose) necessary.
CrCl <60 mL/min: Oral: Initial dose: 10 mg/kg/day, titrate to response/avoidance of toxicity
(refer to usual dosing).
ESRD: Oral: Initial dose: 10 mg/kg/day, on dialysis days, after hemodialysis sessions, titrate
to response/avoidance of toxicity (refer to usual dosing).
Hepatic Impairment: no adjustments provided, closely monitor for bone marrow toxicity.
Preparation3 If unable to swallow capsule a 200 mg/mL Oral Solution
A 100 mg/mL oral solution may be prepared with capsules.
Contents of 20 capsules (500 mg) + (~50 Ml sterile water = result in a 200 mg/mL conc.
Stir vigorously for several hr, then filter
Add 50 mL flavored syrup to filtered solution =resulting in (100 mL) of 100 mg/mL sol.
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Stable for 1 month at room temperature in amber plastic bottle
Hazardous agent , use NIOSH precaution for handling: protective gloves, and protecting
equipment, avoid exposure to powder in the capsules or crushed tablets
If accidental exposure occurs to the hands wash with soap and water
If accidental exposure occurs to the eyes wash with isotonic eye wash
If powder spilled wipe it up immediately with a damp disposable towel and discard in
closed container & clean spill areas with detergent sol. Then clear water
Administration3 Administer at the same time each day. Adequate hydration during treatment is necessary
Folic acid supplement may be recommended during therapy, may mask folic acid deficiency
Storage Store Capsules at max. 25 ° C
Oral sol. 100 mg/ml. Prepared from capsule Stable for 1 month at RT in amber plastic bottle
Dermatologic: Eczema, xeroderma
Hematologic: Macrocytosis (MCV >97), neutropenia
Infection: Bacterial infection , infection, serious infection
CNS: Headache
1% - 10 %:
CVS: Peripheral edema
Dermatologic: Alopecia, dermal ulcer, dermatological reaction, leg ulcer
Endocrine & metabolic: Vitamin D deficiency, weight gain
GIT: Acute mucocutaneous toxicity, constipation, diarrhea, nausea, upper abdominal pain
Genitourinary: Disorder of urinary system , urinary tract infection
Hematologic: Anemia, thrombocytopenia
Infection: Influenza, parvovirus B19 seroconversion, viral infection
CNS: Asthenia, dizziness, fatigue, severe CNS disease
Neuromuscular & skeletal: Arthralgia, back pain, limb pain
Renal: Renal disease.
Respiratory: Asthma, bronchitis, cough, dyspnea, nasopharyngitis, pulmonary disease
Other: Fever
Dermatologic: Skin depigmentation
Hematologic: Bone marrow depression (can be severe )hemorrhage, leukopenia
Postmarketing:
CVS: Edema, vasculitic skin ulceration (patients with myeloproliferative disorders)
Dermatologic: Actinic keratosis, atrophy of nail, basal cell carcinoma of skin, cutaneous lupus
erythematosus, dermatitis dermatomyositis-like skin changes, desquamation, dyschromia, facial
erythema, gangrene of skin/subcutaneous tissues (with myeloproliferative disorders) ,
hyperkeratosis, hyperpigmentation, maculopapular rash, nail discoloration
/hyperpigmentation/rash/atrophy, papule of skin, psoriasiform eruption (plaques)
Endocrine & metabolic: Amenorrhea, hypomagnesemia (severe), ↑ uric acid
GIT: Anorexia, cholestasis, gastric distress, GIT ulcer, mucous membrane lesion, oral mucosa
ulcer, stomatitis, vomiting
Genitourinary: Azospermia, dysuria, oligospermia
Hematologic: Hemolytic anemia, leukemia, malignant neoplasm, reticulocytopenia, skin
carcinoma, squamous cell carcinoma, tumor lysis syndrome
Hepatic: Hepatitis, ↑ liver enzymes
Hypersensitivity: Hypersensitivity angiitis
Local: Localized erythema of the extremities
CNS: Chills, disorientation, drowsiness, drug fever, hallucination, malaise, seizure
Neuromuscular & skeletal: Panniculitis, SLE (including lupus-like syndrome
Respiratory: Interstitial disease, pneumonitis, pulmonary alveolitis/fibrosis/infiltrates
Contraindications Hypersensitivity to hydroxyurea or any component of the formulation
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alkylating chemotherapy
Ifosfamide
Trade name Ifosfamide
Active drug Ifosfamide
Dosage form Vial 1 g for IV
Mechanism of action Alkylation and Cross-linking of strands of DNA ,binding other intracellular structures,
resulting in cell death & inhibits protein synthesis and DNA synthesis
Indications Used in the treatment of Hodgkin and non-Hodgkin lymphoma, Ewing sarcoma,
osteosarcoma, neuroblastoma, rhabdomyosarcoma, and soft tissue sarcomas
Renal impairment Infants, Children, and Adolescents: The recommended adjustments:
GFR ≥10 mL/min/1.73 m2: No dosage adjustment necessary
GFR <10 mL/min/1.73 m2: Administer 75% of dose
Hemodialysis: 1,000 mg/m2 followed by hemodialysis 6 - 8 hr later
CRRT: No dosage adjustment necessary
Hepatic Impairment
No pediatric specific recommendations, refer to protocol. Ifosfamide is extensively
metabolized in the liver to both active and inactive metabolites, use with caution.
Data from adult recommendation
Bilirubin >3 mg/dL: Administer 25% of dose.
Mild – moderate impairment: No dosage adjustment necessary.
Severe impairment: Use is not recommended.
Preparation2 Reconstitution: Vial + 20 ml SWFI or BWFI (conc. 50 mg/mL)
Dilution: to a final conc. of 0.6 – 20 mg/mL (1x 83 – 1x 2.5 ml) in D5W, NS, or LR
Review protocol specific rates
IV intermittent infusion over 1 – 6 hr
Continuous infusion over 24 hr
May be an irritant, avoid extravasation
Stability 2 Store intact vial at 25° C, avoid temperatures >30°C , protected from light (PFL)
Reconstituted sol.
physically/chemically stable for 7 days at RT & up to 6 weeks at 2 – 8° C (Trissel et al1994)
However manufacturers report stability for 24 hr at 2 – 8° C
o 0.6 – 20 mg/mL physically/chemically stable for 7 days at RT & up to 6 weeks at 2 – 8° C
in unspecified containers /Glass (Trissel et al1995)
o 0.6 – 20 mg/mL in D5W, NS, LR, and SWFI in PP syringes is physically/chemically stable
for 24 hr at RT
o 10 mg/ml in NS in PVC stable for 8 days at 4 °C PFL & RT25 °C exposed and PFL
o 20 mg/ml in NS in PVC stable for 8 days at 35 °C (no data on light protection)
o 30 mg/ml in NS stable at 25°Cwith 10% loss for
31 days in glass
32 days in PVC, 30 days at 4°C PFL
36 days in PP.
Not found to undergo substantial sorption to PP, PVC, or glass
Dermatologic: Alopecia (90%)
GIT: Nausea and vomiting (47%)
Genitourinary: Gross hematuria (11%, with mesna 5%), hematuria (44%, with mesna 21%)
Hematologic/oncologic: Bone marrow depression (anemia [38%], leukopenia [grade 4:44%]
granulocytopenia, lymphocytopenia, neutropenia, pancytopenia &thrombocytopenia [5%])
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CNS: CNS toxicity (≤15%, including neurotoxicity: abnormal EEG, aphasia, ataxia, cerebellar
syndrome, coma, cranial nerve disorder, encephalopathy, extrapyramidal reaction,
hallucination, impaired consciousness, motor dysfunction, muscle spasm, myoclonus, peripheral
neuropathy [<1%], psychotic reaction, seizure, tremor)
1% - 10%:
GIT: Anorexia
Hematologic & oncologic: Febrile neutropenia
Hepatic: Hepatotoxicity (including hepatorenal syndrome, ↑ GGT, ↑ lactate dehydrogenase, ↑
Sr ALT, ↑ Sr ALP, ↑ Sr AST, ↑ Sr bilirubin, jaundice)
Infection: Infection (10%, including bacterial infection, fungal infection, Pneumocystis infection,
parasitic infection [Strongyloides infection], pneumonia, reactivation of disease [latent
infections], sepsis, septic shock, and viral infection [herpes zoster infection])
Local: Localized phlebitis
<1%:
CVS: Cardiotoxicity (eg. abnormal ECG: {T waves, ST segment}, AF, atrial tachycardia,
cardiomyopathy, epicardial fibrosis, decreased QRS voltage, HF, hypotension, pericardial
effusion, pericarditis [fibrinous], pulmonary edema, supraventricular arrhythmia, SVT,
ventricular arrhythmia/ tachycardia)
Dermatologic: Dermatitis, papular rash
GIT: Diarrhea
CNS: Fatigue
Postmarketing:
CVS: AMI, angina pectoris, atrial flutter, atrial premature contractions, bradycardia, capillary
leak syndrome, cardiac insufficiency, cardiogenic shock, chest pain, congestive cardiomyopathy,
DVT, ECG abnormality (QRS complex abnormal), edema, flushing, HTN, inversion T wave on ECG,
left bundle branch block, left ventricular failure, myocarditis, palpitations, portal vein
thrombosis, PE, reduced ejection fraction, right bundle branch block, supraventricular
extrasystole, vasculitis, ventricular fibrillation, ventricular premature contractions
Dermatologic: Erythema of skin, hyperhidrosis, hyperpigmentation, macular eruption, nail
disease, palmar-plantar erythrodysesthesia, pruritus, skin abnormalities related to radiation
recall, skin necrosis, skin rash, SJS, TEN, urticaria
Endocrine & metabolic: Amenorrhea, ↓plasma estrogen, growth retardation, hyperglycemia,
hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, ↑ gonadal hormones,
malignant neoplasm of thyroid, menopause (premature), metabolic acidosis, nephrogenic
diabetes insipidus, polydipsia, rickets, SIADH
GIT: Abdominal pain, cholestasis, colitis, constipation, enterocolitis, fecal incontinence, GIT
hemorrhage, intestinal obstruction, mucous membrane ulceration, neutropenic typhlitis,
pancreatitis, sialorrhea, stomatitis.
Genitourinary: Azoospermia, ↑ post-void residual urine volume, infertility, inhibition of
spermatogenesis, oligospermia, ovarian disease, ovarian failure, ovulatory cycle (disorder),
sterility, urinary incontinence, urotoxicity (including hemorrhagic cystitis)
Hematologic & oncologic: Agranulocytosis, bone marrow aplasia (febrile), DIC, hemolytic
anemia, HUS, hemorrhage (including myocardial), leukemia (eg, AML, acute promyelocytic
leukemia, ALL), malignant lymphoma, methemoglobinemia, myelodysplastic syndrome, Non-
Hodgkin lymphoma, petechia, sarcoma, tumor lysis syndrome
Hepatic: Fulminant hepatitis, hepatic cytolysis, hepatic failure, hepatic sinusoidal obstruction
syndrome, viral hepatitis
Hypersensitivity: Anaphylaxis, angioedema, facial swelling, hypersensitivity reaction,
nonimmune anaphylaxis
Infection: Reactivation of HBV
Local: Erythema, inflammation, swelling, pruritus, pain &tenderness at injection site
CNS: Abnormal gait, amnesia, asterixis, bradyphrenia, catatonia, chills, delirium, delusion,
dysarthria, dysesthesia, Guillain-Barre syndrome, hypoesthesia, leukoencephalopathy
(progressive multifocal) malaise, mania, mental status changes, movement disorder, mutism,
neuralgia, pain, panic attack, paranoid ideation, paresthesia, polyneuropathy, reversible
posterior leukoencephalopathy syndrome, speech disturbance (echolalia), status epilepticus
(convulsive / nonconvulsive), talkativeness, vertigo
Neuromuscular & skeletal: Arthralgia, limb pain, muscle twitching, myalgia, osteomalacia,
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rhabdomyolysis
Ophthalmic: Conjunctivitis, eye irritation, visual impairment
Otic: Deafness, hypoacusis, tinnitus
Renal: Interstitial nephritis, nephrotoxicity (acute/chronic, Fanconi syndrome, parenchymal
necrosis, renal tubular acidosis disease/ necrosis), polyuria, renal cell carcinoma
Respiratory: ARDS, bronchospasm, cough, dyspnea, hypoxia, interstitial lung disease, interstitial
pneumonitis, pleural effusion, pneumonitis, pulmonary alveolitis (allergic), pulmonary fibrosis,
pulmonary hypertension, respiratory failure
Emetic Potential Pediatric: Moderate (30% - 90%).
Contraindications Known hypersensitivity to Ifosfamide or any formulation component, urinary outflow
obstruction
Additional: Severe leukopenia/thrombocytopenia, severe renal and/or hepatic impairment,
cystitis, active infection, advanced cerebral arteriosclerosis
Enzyme -antineoplastic
L – Asparaginase
Trade name L – Asparaginase
Active drug L – Asparaginase
Dosage form Vial 10,000 unit for IM
Mechanism of action In leukemic cells, it hydrolyzes L-asparagine to ammonia & L-aspartic acid causing depletion
of asparagine. Leukemia cells, in contrary of normal cells, can't synthesize asparagine
causing inhibition of protein synthesis & apoptosis. Asparaginase is G1 phase cycle-specific
Indications Treatment of ALL in combination with other chemotherapy & Lymphoblastic lymphoma
Asparaginase (E. coli) is very different than Asparaginase (Erwinia), Asparaginase (Erwinia
[Recombinant]) , and pegaspargase, NOT interchangeable
Dose adjustment Review protocols for proposed adjustments or consider following adult recommendation:
Adjustment for Toxicity (manufacturers)
Allergic reaction/hypersensitivity: Discontinue for severe reactions.
Neurotoxicity (posterior reversible encephalopathy syndrome, PRES): Interrupt therapy for
suspected PRES, control BP and closely monitor for seizure activity.
Pancreatitis: Discontinue permanently.
Thrombotic event: Discontinue for serious reactions.
alternative recommendations (Stock 2011):
Hyperammonemia-related fatigue: Continue therapy for grade 2 toxicity.
In grade 3 toxicity, ↓dose by 25%, resume full dose at toxicity ≤ grade 2 (make up for
missed doses).
In grade 4 toxicity, ↓dose by 50%, resume full dose when toxicity ≤ grade 2 (make up for
missed doses).
Hyperglycemia: Continue therapy for uncomplicated hyperglycemia.
Hyperglycemia requires insulin therapy, hold Asparaginase (and concomitant
corticosteroids) until blood glucose controlled, resume dosing at prior dose level.
Life-threatening hyperglycemia or toxicity requiring urgent intervention hold therapy
(and corticosteroids) until blood glucose is controlled with insulin, resume L – Aspa and
do not make up for missed doses.
Hypersensitivity reactions: continue dosing for urticaria without bronchospasm,
hypotension, edema, or need for parenteral intervention. If wheezing or other symptomatic
bronchospasm with or without urticaria, angioedema, hypotension, and/or life-threatening
hypersensitivity reactions occur, discontinue Asparaginase.
Hypertriglyceridemia:
If Sr triglyceride level <1,000 mg/dL, continue dosing & monitor closely for pancreatitis
If triglyceride level >1,000 mg/dL, hold Asparaginase & monitor, resume therapy at prior
dose level after triglyceride level returns to baseline.
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Pancreatitis:
Asymptomatic amylase or lipase >3 times ULN (chemical pancreatitis) or radiologic
abnormalities only: Continue Asparaginase and monitor levels closely.
Symptomatic amylase or lipase >3 times ULN: Hold Asparaginase until enzyme levels
stabilize or are declining.
Symptomatic pancreatitis or clinical pancreatitis (abdominal pain with amylase or lipase >3
times ULN for >3 days and/or pancreatic pseudocyst develop): Permanently discontinue.
Thrombosis and bleeding, CNS:
Thrombosis: Continue dosing for abnormal laboratory findings without a clinical correlate.
In grade 3 toxicity: discontinue therapy, if CNS signs/symptoms are fully resolved and
further doses required, may resume therapy at a lower dose and/or longer intervals.
In grade 4 toxicity: Discontinue therapy
Hemorrhage: Discontinue therapy
Do not withhold therapy for abnormal laboratory findings without a clinical correlate.
In grade 3 toxicity: discontinue therapy, if CNS signs/symptoms are fully resolved and
further doses required, may resume therapy at a lower dose and/or longer intervals.
In grade 4 toxicity: Discontinue therapy
Thrombosis and bleeding, non-CNS:
Do not withhold therapy for abnormal laboratory findings without clinical correlate.
Thrombosis: Continue dosing for abnormal laboratory findings without a clinical correlate.
In grade 3 or 4 toxicity: withhold therapy until acute toxicity and clinical signs resolve and
anticoagulant therapy is stable or completed.
Hemorrhage:
If grade 2 bleeding in conjunction with hypofibrinogenemia occurs, withhold therapy until
bleeding ≤ grade 1.
In grade 3 or 4 bleeding, withhold therapy until bleeding ≤ grade 1 and until acute toxicity
and clinical signs resolve and coagulant replacement therapy is stable or completed
Renal Impairment There are no dosage adjustments provided for adult or pediatric
Hepatic Impairment
Hepatic insufficiency: Use is contraindicated
hepatotoxicity during treatment(Stock 2011)
ALT/AST >3 – 5 times ULN: Continue therapy.
ALT/AST >5 – 20 times ULN: Delay next dose until transaminases <3 times ULN.
ALT/AST >20 times ULN: Discontinue therapy if ˃1 week for values to return <3 times ULN
Direct bilirubin <3 mg/dL: Continue therapy.
Direct bilirubin 3.1 – 5 mg/dL: hold therapy, resume at direct bilirubin <2 mg/dL, consider
using alternate Asparaginase product.
Direct bilirubin >5 mg/dL: Discontinue Asparaginase, do not substitute other Asparaginase
products, don’t make up for missed doses.
Preparation2 Volume & diluent are product–specific (review product details at every change of product)
For IM vial + 2 mL NS (conc of 5,000 units/mL)
However, some centers reconstitute + 1 mL NS for IM use (conc. 10,000 units/mL).
Shake well, but not too vigorously.
Administration Deep IM injection
Volumes >2 mL should be divided and administered in 2 separate sites.
Observe patients for 1 hour after administration, epinephrine, antihistaminics, and
hydrocortisone should be readily available for immediate hypersensitivity.
Stability Store intact vial at 2 – 8 ° C , protected from light (PFL)
Reconstituted sol. 7 days refrigerated however some manufacturers report 8 hr
refrigerated or 48 hr refrigerated, discard unused portion
CVS: Cerebrovascular accident (hemorrhagic/ thrombotic stroke), thrombosis
CNS: CNS disease (adults, includes delusion, disorientation, mild depression, Parkinsonian-like
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syndrome, personality disorder, seizure), cerebral hemorrhage, cerebrovascular hemorrhage
Endocrine & metabolic: Amenorrhea, decreased glucose tolerance, hyperammonemia (with
clinical signs of metabolic encephalopathy [eg, impaired consciousness with coma, confusion,
and stupor]), hypercholesterolemia, hyperglycemia, hypertriglyceridemia, hypoalbuminemia,
hypocholesterolemia, ↑ uric acid, weight loss
GIT: Abdominal pain (infrequent), acute pancreatitis (may be fatal), cholestatic injury, diarrhea
(infrequent), intestinal perforation (rare), nausea or vomiting(frequent, rarely severe, may be
secondary to ↑ BUN and ↑ uric acid)
Genitourinary: Azospermia
Hematologic: Antithrombin III deficiency, blood coagulation disorder (change in hemostatic
function), bone marrow depression, decreased clotting factors (factors VII, VIII, IX, and X),
↓plasminogen, hypofibrinogenemia, prolonged PTT /PT
Hepatic: Hepatic injury, hepatotoxicity (usually mild & regressive, but rarely fatal),
hyperbilirubinemia, ↑ Sr ALP, ↑ Sr ALT, ↑ Sr AST (mild), jaundice, liver steatosis
Hypersensitivity: Allergic reactions (includes anaphylactic shock, anaphylaxis, bronchospasm,
edema, hypotension, laryngeal edema, skin rash, urticaria, onset: within 1 hr of administration
and risk increasing with increasing number of exposures)
Immunologic: ↑ Sr globulins (beta and gamma)
Infection: Septicemia (during bone marrow depression)
Renal: ↑ blood urea nitrogen, renal failure
Respiratory: Respiratory distress (with retrosternal pressure)
Other: Fever
Contraindications Known hypersensitivity to Asparaginase (E. coli-derived) or any component of the
formulation, hepatic insufficiency, pancreatitis, pregnancy, breast-feeding, recent yellow
fever vaccination, concurrent administration with phenytoin
Antimetabolite chemotherapy
Methotrexate
Trade name Unitrexate
Active drug Methotrexate
Dosage form Vial 50 mg /2ml for IM & IV
Vial 500 mg /20ml for IV
Vial 5g / 50 ml for IV
Mechanism of action Folate antimetabolite binds & inhibits dihydrofolate reductase, inhibiting the formation of
reduced folates, and thymidylate synthase, thus interfering with DNA synthesis, repair &
cell replication. Cell cycle S phase – specific, effective on rapidly proliferative tissues.
The mechanism in the treatment of autoimmune disease is that it may have immune
modulator and anti-inflammatory activity.
Indications Oncologic indications: Treatment of ALL, osteosarcoma, breast cancer, head & neck cancer,
cutaneous T-Cell lymphoma, lung cancer (squamous cell and small cell) (oral, parenteral),
treatment of meningeal leukemia, CNS tumors (including nonleukemic meningeal cancers),
acute promyelocytic leukemia (maintenance), & soft tissue sarcoma.
Nononcologic indications: Treatment of active polyarticular juvenile idiopathic arthritis,
psoriasis (severe, recalcitrant, disabling) and severe active rheumatoid arthritis in patients
unresponsive or intolerant of first-line therapy and treatment/maintenance of remission in
Crohn's disease, dermatomyositis, uveitis, and scleroderma.
Dose Oncologic use:
According to type and stage of cancer, and the specific protocol of treatment
Doses ≥12 g/m2 (IV) are highly emetogenic, while 5 g/m2 (IV) is moderately emetogenic
Doses 100 - 500 mg/m2 may require folinate rescue & >500 mg/m2 require folinate rescue
Non – oncologic use3
Crohn's disease: Limited data available:
BSA-directed dosing: 15 mg/m2 once/week, max: 25 mg/dose.
Fixed dosing
20 – 29 kg: 10 mg once/week
30 – 39 kg: 15 mg once/week.
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40 – 49 kg: 20 mg once/week.
≥50 kg: 25 mg once/week.
Children & Adolescents: Oral, SUBQ in intolerant or unresponsive to purine analog(eg,
azathioprine, mercaptopurine), use in combination with folic acid supplement
Dermatomyositis: Limited data available:
IM, SUBQ (preferred): Initial: 15 – 20 mg/m2 or 1 mg/kg (whichever is less) once/week,
max. 40 mg/dose used with corticosteroids and with either folic or folinic acid supplement.
Oral (not preferred): Initial: 15 mg/m2 or 1 mg/kg (whichever is less) once/ week, max. 40
mg/dose, used in combination with corticosteroids.
Juvenile idiopathic arthritis (JIA), polyarticular:
o Therapy should be individualized based on disease severity and activity
o When initiating therapy, a try for 3 months is at least, if there is minimal or no response
after 6 – 8 weeks, changing therapy or adding additional therapy may be appropriate.
o Due to variable oral bioavailability and GI side effects, some experts suggest SubQ route
especially at doses >10 mg/m2
o When switching between dosage forms and routes, dosage adjustment may be needed.
BSA-directed dosing
Children and Adolescents: Oral, IM, SUBQ
Initial: 10 – 15 mg/m2 once/week, adjust gradually up to 20 – 30 mg/m2 once/week
Max. 25 mg/dose.
To ↓GI side effects & ↑bioavailability & efficacy, consider(IM, SUBQ) of doses >10 mg/m2
Weight-directed dosing
Children & Adolescents: Oral, SUBQ
Initial: 0.5 mg/kg once/week, max. initial: 15 mg/dose, if no response or worsening after 4
weeks, may ↑to SUBQ: 1 mg/kg, max. 25 mg/dose
Psoriasis, severe, recalcitrant to topical therapy: Limited data available
Usual: 0.2 - 0.4 mg/kg once/week, max. 25 mg/dose (reported duration 6 - 178 weeks)
Scleroderma localized Limited data available
Infants, Children & Adolescents: Oral, SUBQ (preferred)
1 mg/kg once/week, max. 25 mg/dose (± corticosteroids) (duration of therapy: 12 months)
Uveitis, recalcitrant: Limited data available:
BSA-directed dosing:
15 mg/m2 once/week (range: 10 - 25 mg/m2). SUBQ preferred for patients with GI
symptoms, poor bioavailability, or doses >15 mg/m2, a max. 25 mg/dose was reported.
Weight-directed dosing: SUBQ: 0.5 - 1 mg/kg once/week, max. 25 mg/dose
Dose adjustment3 Review protocols for proposed adjustments first or consider following recommendations
Dosing adjustment for toxicity: Infants, Children, and Adolescents:
Nonhematologic toxicity:
Diarrhea, stomatitis, or vomiting lead to dehydration: Discontinue until recovery.
Hematologic toxicity:
Psoriasis, arthritis (JIA): Significant blood count decrease: Discontinue immediately.
Oncologic uses:
Myelosuppression: Withhold, reduce dose, or discontinue as appropriate, provide
supportive care as needed.
Profound granulocytopenia and fever: Evaluate immediately consider broad-spectrum
parenteral antimicrobial coverage. Withhold, reduce dose, or discontinue as appropriate.
Renal impairment no adjustments provided, consider the following adjustments
Oncology uses: Refer to specific protocols for adjustments, the higher doses may require
aggressive adjustments than those recommended.
79
Nononcology doses/uses: The following have been recommended
CrCl >50 mL/min/1.73 m2: No adjustment necessary.
CrCl 10 – 50 mL/min/1.73 m2: Administer 50% of dose.
CrCl <10 mL/min/1.73 m2: Administer 30% of dose.
Hemodialysis: Administer 30% of dose.
Peritoneal dialysis (PD): Administer 30% of dose.
CRRT: Administer 50% of dose.
Hepatic Impairment:
No dosage adjustments provided, use with caution in impaired or preexisting hepatic
dysfunction. Oncology uses: Refer to specific protocols for adjustments, the higher doses
may require aggressive adjustments. The following adjustments recommended in adults
Bilirubin 3.1 – 5 mg/dL or transaminases >3 times ULN: Administer 75% of dose.
Bilirubin >5 mg/dL: Avoid use.
Preparation IM: Use sol. Ready in 50 mg/2ml vial
IV : dilute to 0.4–2 mg/mL NS, D5W (1x62.5 – 1x 12.5 ml) or dose + 50 – 500 ml NS, D5W
use within 24 h RT of initial puncture21 **(PFL)
High dose methotrexate: (1 – 12 g/m2 single dose ) + 1000 mL NS ( hypernatremia risk) 9
Administration Oral: Often preferred when low doses are being administered, administer on an empty
stomach (at least 1 hour before or 2 hours after food or drink except water).
Parenteral:
IM: Deep, at conc. ≤25 mg/mL.
IV refer to protocol - specific rates
IV push: slow at a conc. ≤25 mg/mL, a rate of ≤10 mg/min reported.
IV infusion or 24-hour continuous infusion according to protocol
2
Stability Store intact vial at 25° C , protected from light (PFL)
Reconstituted sol. Discard after use
Use diluted: 1x 62.5 – 1x 12.5 ml or dose + 50 – 500 ml NS, D5W within 24 hr at RT, PFL9
9 3
High dose preparations: use within 24 hr at RT, PFL or at 2 – 8 ° C
o 0.5 & 6 mg/mL in D5W in PVC stable for 48 hr at RT 22 - 23°C & relative humidity 23 -
48% exposed to fluorescent2
o 0.225 & 24 mg/ml in NS in PVC stable for 30 days at 4 °C protected from light.
o 1.25 & 12.5 mg/mL stable for 105 days at 2 – 8 °C followed by 7 days at 22 – 28 °C
o 0.4 & 5 mg/mL in D5W and in NS at ambient temperature and exposed to fluorescent
light and indirect daylight stability shown2:
In D5W: PVC: 1% loss in 17 days
Glass: 4% loss in 17 days
Polypropylene: 7% loss in 17 days
In NS, less than 5% loss occurred in 17 days in any of the container materials.
o Protection from sunlight is essential however exposure to normal fluorescent light2
during infusion for 24 hr may not be so influential on methotrexate conc. PFL generally
o Not found to undergo substantial sorption to PP, PVC, or glass container
Tablets: Store at 25°C. Protect from light.

Adverse reactions Adverse reactions vary by route, dosage, and indication.
>10%: CNS: Dizziness, fatigue, headache
GIT: Diarrhea, nausea, oral mucosal ulcer, vomiting
Hepatic: Hepatic cirrhosis (chronic therapy), hepatotoxicity (with dose 1, 2, or 5 g/m2, grades
≥3), ↑ liver enzymes (↑ Sr ALT: >1 – 2 × ULN)
Respiratory: Cough.
1% to 10%:
Dermatologic: Alopecia, burning sensation of skin (psoriasis), dermatitis (rheumatoid arthritis),
pruritus, skin photosensitivity, skin rash
Endocrine & metabolic: Weight loss
GIT: Anorexia, sore throat, stomach pain, stomatitis
80
Hematologic: Anemia, severe anemia [2 years after low-dose methotrexate, leukopenia (WBC
<3000/mm3), neutropenia, pancytopenia (rheumatoid arthritis), thrombocytopenia (rheumatoid
arthritis: platelet count <100,000/mm3)
Hepatic: Hepatic fibrosis (chronic therapy)
Infection: Chest infection.
Ophthalmic: Blurred vision.
Respiratory: Dyspnea, interstitial pneumonitis (rheumatoid arthritis)
Other: Fever.
Frequency not defined: CVS: Arterial thrombosis, chest pain, DVT, hypotension, pericarditis, PE,
thrombophlebitis, vasculitis
Dermatologic: Acne vulgaris, diaphoresis, dyschromia, ecchymoses, erythematous rash, necrosis
of skin psoriasis exacerbation (plaque erosion), exfoliative dermatitis, furunculosis, telangiectasia
Endocrine & metabolic: ↓Sr albumin, diabetes mellitus, gynecomastia, menstrual disease
GIT: Aphthous stomatitis, enteritis, GIT hemorrhage /ulcer, gingivitis, hematemesis, intestinal
perforation, melena, pancreatitis
Genitourinary: Azotemia, cystitis, defective oogenesis, defective spermatogenesis, dysuria,
hematuria, impotence, infertility, oligospermia, proteinuria, vaginal discharge
Hematologic & oncologic: Agranulocytosis, bone marrow depression (nadir: 7 - 10 days),
eosinophilia, hypogammaglobulinemia, lymphadenopathy, malignant lymphoma, non-Hodgkin
lymphoma (with low-dose oral methotrexate), tumor lysis syndrome
Hepatic: Hepatitis (acute)
Hypersensitivity: Nonimmune anaphylaxis
Infection: Cryptococcosis, CMV disease (including pneumonia), HSV infection, nocardiosis,
sepsis, vaccinia (disseminated, following smallpox immunization)
CNS: Abnormal cranial sensation (at low dosage), aphasia, cerebral thrombosis, chemical
arachnoiditis (intrathecal, acute), chills, cognitive dysfunction (at low dosage), drowsiness,
dysarthria, hemiparesis, malaise, mood changes (at low dosage), paresis, disturbed speech
Neuromuscular & skeletal: Arthralgia, myalgia, osteonecrosis (with radiotherapy), osteoporosis
Ophthalmic: Conjunctivitis, eye pain, retinal thrombosis, transient blindness
Otic: Tinnitus
Respiratory: COPD, epistaxis, pharyngitis, pneumonia, pulmonary alveolitis, pulmonary fibrosis,
respiratory failure, upper respiratory tract infection
Other: Nodule, tissue necrosis (with radiotherapy)
Postmarketing: CVS: Heart failure
Dermatologic: Dermal ulcer, erythema multiforme, palmar-plantar erythrodysesthesia, papular
rash, photodermatitis (reactivation), skin abnormalities related to radiation, skin carcinoma
(basal cell carcinoma, malignant melanoma, squamous cell carcinoma), SJS, TEN, urticaria .
Endocrine & metabolic: Decreased libido
GIT: Abdominal distress, mesenteric ischemia (acute)
Genitourinary: Crystalluria
Hematologic & oncologic: Aplastic anemia, febrile neutropenia, lymphoproliferative disorder
(eg, intestinal follicular lymphoma, large B-cell lymphoma &T-cell lymphoma)
Hepatic: Exacerbation of hepatitis B, hepatic failure
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity angiitis, severe reaction (include
hyperpigmentation, pustular rash, and severe stomatitis)
Infection: Herpes zoster infection, histoplasmosis, infection, septicemia
Local: Hypersensitivity at injection site (fixed drug eruption at injection site)
CNS: Cerebrovascular accident, encephalopathy, leukoencephalopathy (may be chronic), seizure,
severe neurotoxicity
Neuromuscular & skeletal: Bone fracture (stress), myelopathy (intrathecal, subacute)
Ophthalmic: Dry eye syndrome, eye irritation, optic neuropathy
Respiratory: Acute respiratory distress, Mycobacterium avium complex, pleuritic chest pain,
pneumonia due to Pneumocystis jirovecii, tuberculosis
Emetic Potential Pediatrics:
Intrathecal methotrexate: Moderate (30% - 90%).
IV: ≥12 g/m2/dose: High (>90%).
5 g/m2/dose: Moderate (30% - 90%).
38 - 83 mg/m2/dose: Low (10% - 30%).
81
Oral or SUBQ: ≤10 mg/m2/dose: Minimal (<10%).
Contraindications History of severe hypersensitivity to methotrexate or any component of the formulation
Patients with psoriasis, rheumatoid arthritis or polyarticular-course juvenile idiopathic
arthritis, chronic liver disease, immunodeficiency syndromes (overt or lab evidence),
preexisting blood dyscrasias (eg, bone marrow hypoplasia, significant anemia etc).
Severe renal impairment (including ESRD with or without dialysis), concomitant use with
nitrous oxide anesthesia.
topoisomerase II inhibitor chemotherapy
Mitoxantrone
Trade name Santrone
Active drug Mitoxantrone
Dosage form Vial 20 mg/ 10 ml for IV
Mechanism of action intercalates into DNA causing cross-links & strand breaks, binds to nucleic acids and inhibits
DNA & RNA synthesis by template disordering and steric obstruction, binds to DNA
topoisomerase II and may inhibit the incorporation of uridine into RNA and thymidine into
DNA, mitoxantrone is active throughout entire cell cycle (cell-cycle nonspecific).
Indications Acute nonlymphocytic leukemias (myelogenous, promyelocytic, monocytic, and erythroid),
relapsed ALL, pediatric acute AML, and pediatric acute promyelocytic leukemia (APL)
3
Dosing adjustment for toxicity: based on experience in adults
Oncology uses
Severe – life threatening nonhematologic toxicity: Withhold until toxicity resolves
Multiple sclerosis:
Neutrophils <1,500/mm3: Use is not recommended
Signs/symptoms of HF: Evaluate for cardiac signs/symptoms and monitor LVEF
LVEF <50% or baseline LVEF ˂the lower limit of normal (LLN): Use is not recommended
Renal Impairment no pediatric specific recommendations, based on experience in adults,
supplemental doses are not necessary with hemodialysis or peritoneal dialysis
Hepatic Impairment no pediatric specific recommendations. Based on experience in adults,
clearance is reduced in hepatic dysfunction, patients with severe hepatic dysfunction
(bilirubin >3.4 mg/dL) have an AUC of 3 times greater than patients with normal hepatic
function consider dose adjustments.
Preparation For IV only, Must be diluted dose + 50 mL of NS or D5W3,9
Conc. 0.2 – 0.6 mg/mL(1 x 10 – 1x 3.3 ml) NS, D5W 9
Administration3 IV bolus over 5 – 15 min. after dilution
IV intermittent infusion over 15 – 60 min, refer to protocol for infusion rates
Irritant with vesicant-like properties, avoid extravasation
Stability3 Store intact vials at 25 ° C
Opened vials may be stored at room temperature for 7 days or at 2 – 8 ° C for up to 14
days. (however data report stability for 42 days at room temperature of 23°C and at 4°C)2
Diluted in D5W or NS stable for 7 days at room temperature or at 2 – 8 ° C2
diluted dose + 50 mL of NS or D5W (or conc 0.2 – 0.6 mg /ml) stable 72 hr refrigerated 9
Discarding unused diluted solution is recommended
Protection from light during infusion isn’t needed
CVS: Edema (10% – 30%), cardiac disease/arrhythmia (3% – 18%), ECG changes (≤11%)
CNS: Pain (8% – 41%), fatigue (≤39%), headache (6% – 13%)
Dermatologic: Alopecia (20% – 61%), nail bed changes (≤11%)
Endocrine &metabolic: Menstrual disease (26 – 61%), amenorrhea (28 – 53%), hyperglycemia
(10% – 31%), weight gain/loss (≤17%), ↑ GGT (3% –15%)
GIT: Nausea (26 – 76%), vomiting (6 –72%), diarrhea (14 – 47%), mucositis (10–29%, onset: ≤1
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week), stomatitis (8 – 29%, onset: ≤1 week), anorexia (22 – 25%), constipation (10 – 16%), GIT
hemorrhage (2 – 16%), abdominal pain (9 – 15%), dyspepsia (5 – 14%)
Genitourinary: UTI (7 – 32%), hematuria (≤11%), urine abnormality (5 – 11%)
Hematologic & oncologic: Neutropenia (79 – 100%, onset: ≤3 weeks, grade 4: 23 – 54%),
leukopenia (9 –100%), lymphocytopenia (72 – 95%), anemia/↓hemoglobin (≤75%),
thrombocytopenia (33 – 39%, grades 3/4: 3 – 4%), bruise, febrile neutropenia & petechia (≤11%)
Hepatic: ↑ Sr ALP (≤37%), ↑ Sr transaminases (5% – 20%)
Infection: Infection (4% – 60%), sepsis (≤34%), fungal infection (9% – 15%)
Neuromuscular & skeletal: Weakness (≤24%)
Renal: ↑ BUN (≤22%), ↑ Sr Cr (≤13%)
Respiratory: Upper RTI (7% –53%), pharyngitis (≤19%), dyspnea (6% – 18%), cough (5% –13%)
Other: Fever (6% – 78%)
1% – 10%: CVS: Cardiac failure/ ischemia ,↓left ventricular ejection fraction, HTN
CNS: Chills, anxiety, depression, seizure
Dermatologic: Diaphoresis, skin infection
Endocrine & metabolic: Hypocalcemia, hypokalemia, hyponatremia, hypermenorrhea
GIT: Aphthous stomatitis
Genitourinary: Impotence, proteinuria, sterility
Hematologic & oncologic: Granulocytopenia, hemorrhage, acute leukemia
Hepatic: Jaundice
Infection: Fungal infection (cutaneous)
Neuromuscular & skeletal: Back pain , arthralgia, myalgia
Ophthalmic: Conjunctivitis, blurred vision
Renal: Renal failure
Respiratory: Rhinitis, pneumonia, sinusitis
<1%, postmarketing, and/or case reports: Anaphylactoid reaction, anaphylaxis, chest pain,
dehydration, hypersensitivity reaction, interstitial pneumonitis (in combination regimens),
hyperuricemia, hypotension, ocular discoloration (blue discoloration of sclera), phlebitis (at
infusion site), skin rash, tachycardia, urine discoloration (blue-green), urticaria
Emetic Potential Pediatric: ≤33 mg/m2/dose: Low (10% - 30%)
Contraindications Hypersensitivity to mitoxantrone or any component of the formulation
hypersensitivity to anthracyclines, prior substantial Anthracycline exposure (if abnormal
cardiac function before mitoxantrone therapy), presence of severe myelosuppression due
to prior chemo- and/or radiotherapy, severe hepatic impairment, intrathecal administration
Vinca alkaloid chemotherapy
Vinblastine
Trade name vinblastine
Active drug Vinblastine
Dosage form Vial 1 mg /ml ( 10 ml)
Mechanism of action Binds to tubulin & inhibits microtubule formation, therefore, arresting the cell at
metaphase by disrupting formation of mitotic spindle, it is specific for the M and S phases.
It may interfere with nucleic acid/protein synthesis by blocking glutamic acid utilization
Indications Hodgkin lymphoma, lymphocytic lymphoma, histiocytic lymphoma, testicular cancers,
Langerhans cell histiocytosis (histiocytosis X, Letterer-Siwe disease), choriocarcinoma,
mycosis fungoides, and Kaposi sarcoma
Renal impairment no dosage adjustment necessary.
Hepatic Impairment: All patients: manufacturers recommends the following adjustment:
Sr bilirubin >3 mg/dL: Administer 50% of dose.
The following adjustments have also been recommended
Sr bilirubin 1.5 to 3 mg/dL or transaminases 2 to 3 times ULN: Administer 50% of dose.
Sr bilirubin >3 times ULN: Avoid use.
Preparation To prevent inadvertent intrathecal administration (absolutely fatal):
Dose+25 – 50mL NS, LR or D5W in PVC bottle, dilution in volumes ≥100 mL not recommended
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Administration Infusion over few minutes (1 minute)
Vesicant, Avoid extravasation
Stability3 Store intact vials at 2 – 8° C, protected from light (PFL)
diluted in NS, D5W, or LR (20 mcg/mL conc,) stable for up to 21 days (PFL)
50 mcg/mL ( 1 x 20 ml) in NS stable 21 days with 5% loss at RT, PFL, and 21 days with 3%
loss at 2 – 8° C, PFL 2
CVS: Angina pectoris, cerebrovascular accident, ECG abnormality, HTN (common), ischemic
heart disease, limb ischemia, myocardial infarction, Raynaud's phenomenon
CNS: ↓deep tendon reflex, depression, dizziness, headache, malaise, metallic taste,
neurotoxicity (duration: >24 hr), paresthesia, peripheral neuritis, seizure, pain , vertigo
Dermatologic: Alopecia (common), dermatitis, skin blister/ rash, skin photosensitivity (rare)
Endocrine & metabolic: Hyperuricemia, SIADH
GIT: pain, anorexia, constipation (common), diarrhea, enterocolitis, GIT/rectal hemorrhage,
intestinal obstruction, nausea, paralytic ileus, stomatitis, toxic megacolon, vomiting
Genitourinary: Azoospermia, urinary retention
Hematologic & oncologic: Anemia, bone marrow depression (common), granulocytopenia/
leukopenia (common, nadir: 5 - 10 days, recovery: 7 - 14 days, dose-dependent), HUS,
thrombocytopenia (recovery within a few days), thrombotic thrombocytopenic purpura
Local: Local irritation
Neuromuscular & skeletal: Jaw pain, myalgia, ostealgia, weakness
Ophthalmic: Nystagmus
Otic: Auditory disturbance, deafness, vestibular disturbance
Respiratory: Bronchospasm, dyspnea, pharyngitis
Other: Radiation recall phenomenon
Emetic Potential Pediatrics and Adults: Minimal (<10%)
Contraindications Significant granulocytopenia (unless as a result of disease treated), bacterial infection
Hypersensitivity to vinblastine,(caution as cross sensitivity can't be ruled out)
Vinca alkaloid chemotherapy
Vincristine
Trade name Vinracine
Active drug Vincristine
Dosage form Vial 1mg/ml
Mechanism of action Binds to tubulin and inhibits microtubule formation, therefore, arresting the cell at
metaphase by disrupting formation of mitotic spindle, it is specific for the M and S phases.
It may interfere with nucleic acid/protein synthesis by blocking glutamic acid utilization
Indications Treatment of ALL, Hodgkin lymphoma, neuroblastoma, non-Hodgkin lymphomas, Wilms
tumor, and rhabdomyosarcoma, treatment of CNS tumors, CLL, Ewing sarcoma, gestational
trophoblastic tumors (high-risk), multiple myeloma, retinoblastoma & small cell lung cancer
Max dose 2 mg/dose/week
For infant & child <10 kg, dose is typically reduced (eg, 30% reduction), refer to protocols
Dosing adjustment for toxicity: Refer to specific protocols for detail for guidance.
Renal impairment no pediatric specific recommendations, consult individual protocols,
based on experience in adult patients, dosing adjustment may not be necessary.
Hepatic Impairment All patients
Sr bilirubin >3 mg/dL: Administer 50% of normal dose.
Alternate: adjustments have also been recommended:
Sr bilirubin 1.5 - 3 mg/dL or transaminases 2 - 3*ULN or ALP increased: Give 50% of dose.
Alternate adjustment Sr bilirubin 1.5 - 3 mg/dL: Administer 50% of dose.
Sr bilirubin >3 mg/dL: Avoid use.
Preparation To prevent inadvertent intrathecal administration (absolutely fatal):
Dose + 25 – 50 mL NS in PVC bottle
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final conc. 0.0015 – 0.08 mg/mL (1 x 25 ml = 0.04 mg/ml) in PVC bottle
0.01 – 0.1 mg/mL NS, D5W, 50 mL, 24 hr at 2 – 8° C and RT PFL9,
Administration3 Short IV infusion over 5 – 15 min
Vesicant, Avoid extravasation
Stability3 Store intact vials at 2 – 8° C, protected from light (PFL)1
1x25 ml (0.04 mg/ml) stable for 24hr at 25°C PFL & 7 days at 4°C followed by 2 days at 23°C2
diluted in NS, D5W, or LR (20 mcg/mL conc,) stable for up to 21 days (PFL)
Adverse reactions <1%: Endocrine & metabolic: SIADH
CVS: HTN, hypotension
Dermatologic: Alopecia (common)
Endocrine & metabolic: Dehydration, hyperuricemia, weight loss
GIT: Abdominal cramps, anorexia, constipation (may involve upper colon fecal impaction),
diarrhea, intestinal necrosis/perforation, nausea, oral mucosa ulcer, paralytic ileus, vomiting
Genitourinary: Bladder dysfunction (atony), dysuria
Hematologic & oncologic: Leukopenia
CNS: Abnormal gait/sensory symptoms, cranial nerve disorder (including extraocular movement
impairment, laryngeal muscle impairment, paresis, vocal cord paralysis, decreased deep tendon
reflex, headache, neuritic pain, paresthesia, sensorimotor neuropathy (dysfunction)
Neuromuscular & skeletal: Amyotrophy, foot-drop (including slap gait)
Renal: Polyuria
Other: Fever
Postmarketing:
Endocrine & metabolic: Uric acid nephropathy (acute)
GIT: Sore throat
Hematologic & oncologic: Anemia, thrombocytopenia
CNS: Ataxia, paralysis, parotid pain, seizure
Neuromuscular & skeletal: Back pain, jaw pain, limb pain, myalgia, ostealgia
Ophthalmic: Blepharoptosis, cortical blindness (transient), optic atrophy (with blindness)
Respiratory: ARDS
Emetic Potential Pediatrics: ≤1.5 mg/m2/dose: Minimal (<10%)
Contraindications Patients with the demyelinating form of Charcot-Marie-Tooth syndrome.
Documentation of allergenic cross-reactivity for drugs in this class is limited. However,
because of similarities in chemical structure and/or pharmacologic actions, the possibility of
cross-sensitivity cannot be ruled out with certainty.
Detoxifying agent – folic acid derivative
Calcium Folinate/ Leucovorin
Trade name Folinoglobin
Active drug Calcium Folinate
Dosage form Vial 10 mg /10 ml for IV
Mechanism of action Reduced form of folic acid, supplies the necessary cofactor blocked by methotrexate.
Folinate actively competes with methotrexate for transport sites, displacing it from
intracellular binding sites &restores active folate stores required for DNA/RNA synthesis.
Indications Rescue agent after high-dose methotrexate to diminish its toxicity and counteract effects of
impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists
treatment of megaloblastic anemias due to folic acid deficiency (if oral therapy isn't feasible)
Dose3 Oncologic use: refer to protocol specific dosing
Dose depend on protocol settings, specifically the methotrexate dosing and Sr level
Parenteral is preferred over oral when: single oral doses >25 mg (absorption is storable) &
in patients with GI toxicity, nausea, vomiting
Methotrexate (MTX) rescue, high-dose: refer to protocol
Methotrexate overexposure (high dose): review protocol first for dosing if available
Do not administer folinate intrathecal
Methotrexate overdose (inadvertent): oncologic use: refer to protocol-specific nomograms
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Oral, IM, IV: 10 mg/m2/ 6 hr until the MTX level is <0.01 micromolar, begin as soon as
possible after overdose.
increase folinate dose to 100 mg/m2 IV/ 3 hr until the MTX level is <0.01 micromolar when:
1- If Sr Cr is increased ˃50% above baseline 24 hr after MTX administration
2- 24-hour MTX level is >5 micromolar
3- 48-hour MTX level is >0.9 micromolar,
Dose adjustment Review cancer protocols for proposed adjustments
Renal/Hepatic Impairment no adjustments provided for pediatric or adult patients
Preparation For IV Dilute to 0.05 – 10 mg/mL NS, D5W, Ringer’s, Lactated ringer (LR) & D10W 9
Local Standard dilution: vial 100 mg + 90 ml NS (1mg/ml)
Administration3 Review protocol for rate of administration
IV push, or IV infusion over 15 – 120 min
Due to calcium content, IV administration rate must be ˂ 160 mg/min
Not intended for intrathecal use.
Folinate should not be administered concurrently with MTX.
It is commonly initiated 24 hr after the start of MTX. Toxicity to normal tissues may be
irreversible if folinate is not initiated by ~40 hr after the start of MTX
Stability 2 Store intact vial or ampoules at 2 – 8 ° C, protect from light1. Discard unused portion
1mg/ml in NS & D5W in PVC is stable 4 days (PFL) at 4 ° C and at 23 ° C 2
Conc. 0.05 – 10 mg/mL in NS, D5W, LR, Ringer stable 24 hr at RT, & 8 hr in D10W at RT9
Protection from light during infusion isn’t needed, but required for storage.
CNS: Fatigue, lethargy, malaise, (all ≤13%)
Dermatologic: Alopecia (42% - 43%), dermatitis (21- 25%)
GIT: Stomatitis (75- 84%, grades ≥3: 27- 29%), nausea, diarrhea, vomiting (44 – 46%), anorexia
1% - 10%:
GIT: Constipation
GIT: GIT toxicity
Postmarketing: Anaphylactic shock, anaphylaxis, hypersensitivity reaction, nonimmune
anaphylaxis, seizure, syncope, urticaria
Contraindications Pernicious anemia and other megaloblastic anemias secondary to vitamin B12-deficiency
Hypersensitivity to folinate or any component of formulation, intrathecal administration
Detoxifying agent – Antidote
Mesna
Trade name Uromes
Active drug Mesna
Mechanism of action oxidized to dimesna in blood then reduced by kidney to mesna, supply a free thiol group
that binds & inactivates acrolein urotoxic metabolite of Ifosfamide & cyclophosphamide
Indications protectant against cyclophosphamide and Ifosfamide-induced hemorrhagic cystitis
Dose adjustment Review protocols for proposed adjustments first if provided
Altered Kidney Function/Hepatic Impairment
There are no dosage adjustments provided for adults or pediatrics (has not been studied)
Preparation Prepare in syringe (because air can be expelled)
For IV: dilute in D5W, NS, or LR to a final conc ≤20 mg/ml3 (1x 5 ml)
Parenteral Sol. Can be given orally mixed in syrup, juice (grape, apple, tomato, orange),
carbonate beverages, or milk (including chocolate) (most palatable in chilled grape juice)
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Dilute injection to 20 mg/mL or 50 mg/mL with orange or grape syrup then before
administration may be dilute to a final conc of 1, 10, or 50 mg/mL with Carbonated
beverages, apple juice, orange juice, or milk
Administration 3 Review protocol specific rate
IV bolus or short IV infusion over 15 – 30 min,
Continuous IV infusion/Protocol (maintain for 12 – 24 hr after completion of Ifosfamide)
A shorter duration (8 hr) has been reported in some protocols
Oral: vomiting within 2 hr after oral mesna, repeat the dose or use IV mesna
Stability2 Store intact ampoules at 25 – 30 ° C, discard unused portion (oxidized)
Diluted in D5W, NS, or LR should be used within 24 hr at room temperature
20 mg/mL in D5W only lost 5% in 48 hr at room temperature.
Mesna + Ifosfamide (1:1) in NS at a conc up to 20 mg/mL are stable for 14 days in PVC
Mesna (0.5 – 3.2 mg/mL) + cyclophosphamide (1.8 - 10.8 mg/mL) in D5W stable for 48 hr at
2 – 8 ° C or 6 hr at RT
Mesna injection prepared for oral administration is stable for at least 9 days undiluted in
PP and stored at 5°C, 24°C, 35°C, for 7 days when diluted 1:2 or 1:5 with syrups and stored
at 24°C in capped tubes, or for 24 hr at 5°C when diluted to 1:2, 1:10, and 1:100 in orange
or apple juice, milk, or carbonated beverages.
Mesna is not light sensitive however; Protect any drug from direct sunlight during storage.
Adverse reactions3 Mesna alone
frequency not defined
CVS: Flushing
CNS: Dizziness, drowsiness, headache, hyperesthesia, rigors
GIT: Anorexia, constipation, diarrhea, dysgeusia (with oral administration), flatulence, nausea,
unpleasant taste (with oral administration), vomiting
Neuromuscular & skeletal: Arthralgia, back pain
Ophthalmic: Conjunctivitis
Respiratory: Cough, flu-like symptoms, pharyngitis, rhinitis
Other: Fever
<1%, postmarketing and/or case reports (mesna alone or in combination): Anaphylaxis,
erythema at injection site, hypersensitivity reaction, hypertension, hypotension, ↑ serum
transaminases, ↑ ST segment on ECG, limb pain, malaise, myalgia, pain at injection site,
tachycardia, tachypnea, thrombocytopenia
Contraindications3 Known hypersensitivity to mesna or any component of the formulation.
Detoxifying agent – granulocyte colony stimulating factor
Filgrastim
Trade name Zarzio
Active drug Filgrastim
Dosage form Prefilled syringe for subQ injection /IV infusion 30 million unit/0.5 ml
Mechanism of action Stimulate the production, maturation activation, migration & cytotoxicity of neutrophils
Indications Chemotherapy-induced neutropenia (Specific to this formulary)
Dose the specific protocol dosing may be reviewed
1 mcg = 100,000 units (30 million unit = 300 mcg)
Chemotherapy-induced neutropenia (myelosuppressive chemotherapy recipients with
non-myeloid malignancies):
IV , SubQ: 5 mcg/kg/24 hr, start at ≥24 hr after chemotherapy
Duration of therapy: for up to 14 days or until ANC reaches 10,000/mm3
Others suggest a lower target ANC of 5,000/mm3,review treatment-specific protocol
For subsequent chemotherapy cycles, dose may be increased by 5 mcg/kg based upon
patient's previous response to therapy along with duration and severity of neutropenia.
87
Dose adjustment Review protocols for proposed adjustments first, if not provided, consider following
recommendations
Data from adult recommendation: (no pediatric specific data available)
Altered Kidney Function
Baseline impairment at initiation (adult /pediatric)
Filgrastim and filgrastim biosimilars: No dosage adjustment necessary
Renal toxicity during therapy (adult /pediatric)
Glomerulonephritis due to filgrastim products: dose reduction or therapy interruption
Hepatic Impairment
Filgrastim and filgrastim biosimilars: No dosage adjustment necessary
Preparation Allow product to reach room temperature prior to use, after removal from refrigerator wait
a minimum of 30 minutes and maximum of 24 hours, discard after out of the refrigerator
at> 25 ° C for >24 hr
Syringes are not recommended for direct administration of doses <0.3 mL, dose cannot be
accurately measured.
Administration SubQ: Administer into the outer upper arm, abdomen (except within 2 inches of navel),
front middle thigh, or the upper outer buttocks area. Rotate injection site, do not inject into
areas that are tender, red, bruised, hardened, or scarred, or sites with stretch marks.
Do not administer earlier than 24 hr after or in the 24 hr prior to cytotoxic chemotherapy.
Stability Store intact syringes at 2 – 8 ° C ,protect from light
Discard if frozen more than once.
Discard any prefilled syringe left at room temperature for ˃4 days or at >25°C for ˃24 hr.
Solutions diluted for infusion in D5W may be stored at room temperature for up to 24 hr
(infusion must be completed within 24 hours of preparation).
CVS: Chest pain
GIT: Nausea (43%)
Hematologic & oncologic: Thrombocytopenia
Hepatic: ↑ Sr ALT
CNS: Dizziness, fatigue (20%), pain
Neuromuscular & skeletal: Back pain (15%), ostealgia (3% - 30%)
Respiratory: Cough, dyspnea
Other: Fever (8% - 48%)
1% - 10%: CVS: Hypertension.
Dermatologic: Alopecia, erythema of skin, maculopapular rash
Endocrine & metabolic: ↑ LDH
GIT: Diarrhea
Genitourinary: Urinary tract infection.
Hematologic & oncologic: Anemia, leukocytosis, splenomegaly.
Hypersensitivity: Hypersensitivity reaction (including severe hypersensitivity reactions)
Immunologic: Antibody development (no evidence of neutralizing response)
Infection: Sepsis.
CNS: Headache, hypoesthesia, insomnia.
Neuromuscular & skeletal: Arthralgia, limb pain, muscle spasm, musculoskeletal pain.
Respiratory: Bronchitis, epistaxis, upper respiratory tract infection
Postmarketing: CVS: Capillary leak syndrome, hypersensitivity angiitis, vasculitis (aortitis)
Dermatologic: Sweet syndrome
Hematologic & oncologic: Sickle cell crisis, splenic rupture
Neuromuscular & skeletal: Asthenia, ↓bone mineral density, myalgia, osteoporosis
Renal: Glomerulonephritis
Respiratory: ARDS, hemoptysis, pulmonary alveolar hemorrhage, pulmonary infiltrates
Contraindications Serious allergic reactions to human granulocyte colony-stimulating factors, or any
component of the formulation or Known hypersensitivity to E. coli-derived products.
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H1 -Antihistaminic
Chlorpheniramine injection
Trade name Pirafen
Active drug Chlorpheniramine maleate
Dosage form Ampoule 5 mg/1 ml for IV, IM
Mechanism of action Competes with histamine for H1-receptor on effector cells in blood vessels & respiratory tract
Indications Symptomatic relief of allergic symptoms caused by histamine release.
Dose Infant, children & adolescent 1,8
Allergic symptoms – allergic rhinitis – urticarial - pruritus (IM, IV)
1 month – <1 year: 0.25 mg/kg/dose. (Max 2.5 mg/dose and 4 doses /day) 5
1 – <6 years: 2.5 – 5 mg/dose or 0.2 mg/kg/ dose.
6 – 12 years: 5 - 10 mg/dose or 0.2 mg/kg/dose.
>12 years: 10 – 20 mg/dose or 0.2 mg/kg/dose.
Max. 4 doses/day 5
Dose adjustment3 Renal Impairment no dosage adjustments described (adult/pediatric)
Hepatic Impairment: no dosage adjustments described however, Chlorpheniramine is
metabolized by the liver, therefore, a dose adjustment may be necessary
Preparation3 IV: dilute with NS to a conc. 1 mg/mL (1+4 mL NS)2 for infants/young children
Administration IV: Inject slowly over at least 1 min5 to avoid hypotension and CNS stimulation
IM: undiluted in large muscle mass
Stability Store intact ampoules at 30°c
Discard after use
CNS: Drowsiness (slight to moderate)
Respiratory: Thickening of bronchial secretions
1% - 10%:
CNS: Dizziness, excitability, fatigue, headache, nervousness
Endocrine & metabolic: Weight gain
GIT: Abdominal pain, diarrhea, ↑ appetite, nausea, xerostomia
Genitourinary: Urinary retention
Neuromuscular & skeletal: Arthralgia, weakness
Ophthalmic: Diplopia
Renal: Polyuria
Respiratory: Pharyngitis
Contraindications Use in Neonate (due to significant antimuscarinic activity)5
Glucocorticoid
Dexamethasone injection/oral
Trade name Dexamethasone ampoule, Methabiogen tablet 8 mg, Dexazone tablet 0.5 mg
Active drug Dexamethasone
Dosage form Tablet 8 mg, Tablet 0.5 mg. And Ampoule 8 mg/2 ml for IV, IM
Mechanism of Long-acting corticosteroid suppresses neutrophil migration, ↓production of inflammatory
action mediators, ↓capillary permeability. It induces apoptosis in multiple myeloma cells.
Mechanism of antiemetic activity is unknown
Indications Anti-inflammatory or immunosuppressant in many diseases, including allergic, hematologic,
dermatologic, neoplastic, rheumatic, autoimmune, CNS, renal, & respiratory conditions
Dose Neonate 4
DART trial protocol IV, ORAL (using IV SOL.):
0.075 mg/kg/12 hr for 3 days
and 0.01 mg/kg/12 hr for 2 days
89
Airway edema, extubation3
IV: 0.25 mg/kg/dose given ~4 hr prior to extubation, then/8 hr for 3 doses total.
Range: 0.25 – 0.5 mg/kg/dose for 1 – 3 doses, max: 1.5 mg/kg/day
(0.5 mg/kg/8 hr x 3 doses with last dose administered 1 hr prior to extubation reported)
Longer duration of therapy may be needed with more severe cases.
Bronchopulmonary dysplasia, facilitation of ventilator wean3
PNA ≥7 days Oral, IV Initial: 0.15 mg/kg/day divided/12 hr for 3 days, followed by
0.1 mg/kg/day divided/12 hr for 3 days, then
0.05 mg/kg/day divided/12 hr for 2 days, then
0.02 mg/kg/day divided/12 hr for 2 days
A total Dexamethasone dose of 0.89 mg/kg given over 10 days
Note: Multiple regimens have been described
High doses (≈0.5 mg/kg/day) are not recommended as they are associated with higher
adverse effects (including neurodevelopmental adverse outcomes).
However, a meta-analysis reported total cumulative doses >4 mg/kg initiated after 1st week
of life produced a greater relative risk reduction compared to lower cumulative doses for
the combined outcome, mortality, or bronchopulmonary dysplasia without increasing the
risk of neurodevelopmental sequelae in ventilated preterm infants.
Pediatric 3
COVID-19, treatment IV, Oral
Infants, Children & Adolescents
0.15 – 0.3 mg/kg/dose/24 hr for up to 10 days (max. 6 mg/dose)
Equivalent dose of alternative glucocorticoid may be used if dexamethasone unavailable
Airway edema or extubation
Oral, IM, IV: 0.5 mg/kg/dose, 6 – 12 hr before extubation (max. 10 mg/dose) then/6 hr for 6
doses (total dose: 3 mg/kg after extubation)
Anti-inflammatory
Oral, IM, IV: Initial: 0.02 – 0.3 mg/kg/day (or 0.6 – 9 mg/m2/day) divided/6 – 8 hr
(Max. adult initial dose 0.75 – 9 mg /day )
Other references suggest initial oral doses: 0.01 mg /day once or divided /12hr6
Asthma exacerbation
Oral, IM, IV: 0.6 mg/kg /day as a single dose or for 2 days, max. 16 mg/dose
Single dose regimens reported range 0.3 – 1.7 mg/kg/dose
Duration >2 days is not recommended due to ↑ risk of metabolic effects
Bacterial meningitis
age >6 weeks & Children: IV: 0.15 mg/kg/6 hr for first 2 – 4 days of antibiotic treatment
Start dexamethasone 10 – 20 min before or with the first dose of antibiotic (dexamethasone
isn’t proven effective if used after starting antibiotic therapy)
Cerebral edema
Infants, Children & Adolescents Oral, IM, IV
Loading dose: 1 – 2 mg/kg/dose as a single dose
Maintenance: 1 – 2 mg/kg/day divided/4 – 6 hr, max. 16mg/day. Tapering may be required
Croup (laryngo-tracheo-bronchitis)
Infants & Children: Oral, IM, IV: 0.6 mg/kg once, max. 16 mg/dose
Reported max. dose rage 10 – 20 mg/kg dose in mild – moderate croup in infants ≥3 months
Oral 0.15 mg/kg single dose was effective in age ≥ 3 months with mild – moderate croup
Congenital adrenal hyperplasia, maintenance
Adolescents (fully grown): Oral: 0.25 – 0.5 mg once daily
For younger still growing patient, hydrocortisone or fludrocortisone are preferred.
Physiologic maintenance:
Replacement by 0.25 – 0.5 mg /m2 /12 hr IV or oral 5 adjust acc. to response.
90
Chemotherapy-induced nausea and vomiting, prevention
Refer to individual protocols and emetogenic potential:
Reduce dose by 50% if administered concomitantly with Aprepitant
Highly emetogenic: Oral, IV: 6 mg/m2/dose/6 hr, or acc. To protocol.
Moderately emetogenic: Oral, IV:
BSA ≤0.6 m2: 2 mg/12 hr.
BSA >0.6 m2: 4 mg /12 hr.
Alternate dosing: Highly emetogenic IV: 10 mg/m2 once daily on chemotherapy days
May require every – 12 hr dosing (range: 8 – 14 mg/m2/dose)
Adjunct to Chemotherapy for cell cytotoxicity : refer to individual cancer protocol
Dose adjustment3 Infants, Children, and Adolescents: IM, IV, Oral:
Renal impairment no dosage adjustments described, use with caution.
IHD,PD: Based on adult data, supplemental dose is not necessary
Hepatic Impairment no dosage adjustments described
Preparation IV: Use undiluted 4 mg/ml or dilute to 0.1 – 1 mg/ml NS, D5W, D10W 4
1 + 3 ml = 1 mg/ml 2,4
IM: use Undiluted
Oral : tablet, (IV preparation used 3.4.5 in pediatric croup & asthma exacerbation )3
Administration3 IV direct : Slow IV push, usually over 1 – 4 min in pediatric
Intermittent infusion: over 15 - 30 min for high doses
IM: use Undiluted
Oral doses may be given using parenteral sol mixed with oral flavored syrup 3,4
Oral Tablet: Administer with food or milk to decrease GIT disturbance , (oral tablet may be
dispersed in Water)5
Stability1 Tablets: Store at 30°C, protect from moisture
Ampoule: Store intact units at 30°C & Protect from light, heat, and freezing
Diluted solutions should be discarded immediately after use or used within 24 hr3
CVS: Bradycardia, arrhythmia, cardiomegaly, circulatory shock, edema, embolism (fat), heart
failure, HTN, myocardial rupture (after recent AMI), syncope, tachycardia, thromboembolism,
thrombophlebitis, vasculitis
Dermatologic: Acne vulgaris, allergic dermatitis, alopecia, atrophic striae, diaphoresis,
ecchymoses, erythema, facial erythema, hyperpigmentation, hypertrichosis, subcutaneous
atrophy hypopigmentation, perianal skin irritation, skin atrophy/rash, urticaria, xeroderma
Endocrine & metabolic: ↓Sr K+, fluid/sodium retention, growth suppression, hirsutism,
alkalosis, menstrual disease, negative nitrogen balance, weight gain
GIT: Hiccups, ↑ appetite, nausea, pancreatitis, pruritus (following IV injection)
Genitourinary: Defective spermatogenesis (↑ or decreased), glycosuria
Hematologic: Kaposi sarcoma, petechia
Hepatic: Hepatomegaly, ↑ Sr transaminases
Hypersensitivity: Anaphylaxis, angioedema, nonimmune anaphylaxis
Infection: Sterile abscess
Local: Postinjection flare (intra-articular use)
CNS: Amyotrophy, emotional liability, euphoria, headache, ↑ intracranial pressure, intracranial
hypertension (idiopathic, usually following discontinuation), malaise, myasthenia, neuritis,
neuropathy, paresthesia, personality changes, seizure, vertigo
Neuromuscular & skeletal: Charcot arthropathy, rupture of tendon
Ophthalmic: Exophthalmos
Respiratory: Pulmonary edema
Other: Wound healing impairment
Postmarketing:
CVS: Hypertrophic cardiomyopathy.
Endocrine & metabolic: Adrenal suppression , Cushing syndrome, cushingoid appearance,
diabetes mellitus, hyperglycemia, ↓glucose tolerance, moon face, redistribution of fat
GIT: Abdominal distention, intestinal perforation, peptic ulcer, ulcerative esophagitis
Hematologic: Tumor lysis syndrome
91
CNS: Apathy, depression, psychiatric disturbance (agitation, anxiety, distractibility, fear,
hypomania, insomnia, labile mood, lethargy, pressured speech, restlessness, tearfulness)
Neuromuscular & skeletal: Bone fracture, myopathy, osteonecrosis, osteoporosis, steroid
myopathy, vertebral compression fracture
Ophthalmic: Glaucoma, ↑ IOP, subcapsular posterior cataract
Contraindications Hypersensitivity to dexamethasone or any component of the formulation
Systemic fungal infections
Corticosteroid
Hydrocortisone injection /oral
Trade name Hydrocortisone/Solu-cortef vial/ampoule
Micort 10 mg tablet
Active drug Vial: Hydrocortisone sodium succinate
Tablet: hydrocortisone 10 mg
Dosage form Ampoule/ Vial: 100 mg/2 ml. Tablet 10 mg
Mechanism of Short-acting corticosteroid suppresses neutrophil migration, ↓production of inflammatory
action mediators, ↓capillary permeability.
Indications Adrenal insufficiency, anti-inflammatory
Dose Neonate
Adrenocortical insufficiency,4 adrenal hypoplesia5
Oral: 8 – 10 mg/m2/day in 3 doses, round to nearest 0.5 or 1 mg (capsule, tablet) adjust acc.
to response (caution & dose adjustment when switching between oral dosage form) 4
Higher starting doses may be needed based on disease & patient parameters
Lower starting doses may be sufficient in patients with residual cortisol production.
Congenital adrenal hyperplesia 3
start at 10 – 15 mg/m2/day divided/8hr (up to 20 mg /m2/day) oral
Acute Adisonian crisis IV 5
Initially 10 mg/dose, then continuous IV infusion 100 mg/m2 daily
Or 100 mg/m2/divided/6 – 8 hr, IV infusion adjusted according to
response, when stable reduce over 4 – 5 days to oral maintenance dose
Physiologic replacement4:
7 – 9 mg/m2/day (IV, oral), in 2 – 3 doses.
Treatment of pressor & volume-resistant hypotension (Stress doses)
IV: 20 – 30 mg/m2/day in 2 – 3 doses, or 1 mg/kg/8 hr4. reported duration 1 – 5 days 3
Body Surface Area (BSA) m2 = (0.05 x kg) + 0.054
Weight (kg) BSA (m2)
0.6 0.08
1 0.1
1.4 0.12
2 0.15
3 0.2
4 0.25
Alternate3:
0.5 mg/kg/6 – 12 hr3 or 1 mg/kg/8 – 12 hr3 (for 1 – 5 days commonly reported)
Some experts recommend test dose 1 mg /kg
After 2 – 4 hr : no response , no further dose
If response occurs test dose should be followed by
GA < 34 weeks : 0.5 mg/kg/12 hr
GA ≥ 34 weeks: 0.5 mg/kg/6 – 8 hr
Dose may be ↑ to 1 mg/kg/dose/interval guided by patient response, taper acc. to condition
Alternate5
2.5 mg/kg/dose then 2.5 mg/kg/dose after 4 hr if needed
Followed by 2.5 mg/kg/6 hr for 48 hr or recovery of BP then reduce gradually over ≥48 hr
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Bronchopulmonary dysplasia (BPD)/Chronic lung disease, treatment3
Preterm: GA <30 weeks
PNA 7 – 14 days: IV: 5 mg/kg/day divided/ 6 hr for 7 days, followed by
3.75 mg/kg/day divided/8 hr for 5 days, followed by
2.5 mg/kg/day divided/12 hr for 5 days, followed by
1.25 mg/kg/dose/24 hr for 5 days
Bronchopulmonary dysplasia (BPD)/Chronic lung disease, prophylaxis3
Preterm: GA <28 weeks PNA ≤ 48 hr IV:
1 mg/kg/day divided /12 hr for 7 days, followed by 0.5 mg/kg/day once for 3 days
Avoid using with indomethacin (GI Perforation)
Treatment of chorioamnionitis – exposed ELBW neonate to decrease risk of CLD3,4
Initially: 0.5 mg/kg /12 hr IV for 12 days, then 0.25 mg/kg/12 hr IV for 3 days
Pediatric
Adrenal insufficiency, acute (adrenal crisis): Dosage regimens variable
Infants, Children, and Adolescents: IM, IV (preferred), IO3
Initial: 2 – 3 mg/kg once max.100 mg/dose (surface area based Initial: 50 - 100 mg/m2 once)
followed by: Infants 1 – 5 mg/kg/6 hr Or
Infant, child or adolescent 50 – 100 mg/m2/day divided /6 hr
Alternate dosing 5
1 month – 11 yr: Initially 2 – 4 mg/kg, then 2 – 4 mg/kg /6 hr, adjusted according to
response, when stable reduce over 4 – 5 days to oral maintenance dose
12 – 17 yr: 100 mg every 6 – 8 hr
Age-directed dosing (fixed dosing IM, IV (IV preferred), Intraosseous
Infants: 10 – 25 mg once followed by 10 – 25 mg/day divided/6 hr for 24 hr
Children <5 years: 25 – 50 mg once followed by 25 – 50 mg/day divided /6 hr for 24 hr
Children ≥5 years: 50 – 100 mg once followed by 50 mg/day divided /6 hr for 24 hr
Adolescents: 100 mg once followed by 100 mg/day divided/6 hr for 24 hr
After 24 hr, subsequent dose reduction and rate determined by patient response.
Anti-inflammatory or immunosuppressive
Infant & children
Oral: 2.5 - 10 mg/kg/day or (75 – 300 mg/m2/day) divided 6 – 8 hr
IM, IV: Initial: 0.56 – 8 mg/kg/day or (20 – 240 mg/m2/day) in 3 – 4 divided doses.
Alternate dosing: 1 – 5 mg/kg/day or (30 – 150 mg/m2/day) divided/12 – 24 hr
Adolescents: Oral, IM, IV: 15 – 240 mg / 12 hr
Congenital adrenal hyperplasia (CAH), chronic3
BSA-directed dosing: Oral
Initial: 8 – 15 mg/m2/day divided/8hr (range: 10 – 15 mg/m2/day)
Higher initial doses (20 mg/m2/day) to achieve initial target hormone conc.
older patients may be able to switch to twice-daily dosing
Fixed dosing: Oral (tablets): Usual requirement:
Infants: 2.5 – 5 mg/dose 3 times /day.
Children: 5 – 10 mg/dose 3 times /day.
Adolescents (fully grown): 15 – 25 mg/day divided in 2 – 3 daily doses.
Physiologic replacement3
Infants & Children:
Oral: 8 – 10 mg/m2/day divided /8 hr, up to 12 mg/m2/day. Give higher doses in the
morning and midday & lower doses in the evening to replicate diurnal variation
Stress dosing, supplemental3
Dose based on patient state and continued until resolution of stressful condition (usually 24
– 48 hr). Dosing is generally 2 – 3 times physiologic replacement level
BSA-directed dosing: Oral, IM, IV
Mild–moderate: 20 – 50 mg/m2/day divided 6 – 8 hr
Doses (20 – 30 mg/m2/day) may be divided/12 hr.
Major stress – surgery: 100 mg/m2/day in divided/6 hr.
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Planned surgery: Pre-anesthesia : 50 mg/m2 IV, IM, 30 – 60 min prior to surgery followed
by second dose 50 mg/m2 as a continuous IV infusion or divided/ 6 hr for at least 24 hr
Age – directed for moderate stress in patients with congenital adrenal hyperplasia:
Initial Infants and preschool children: IV: Initial: 25 mg once
School – age children: IV Initial dose: 50 mg once.
Adolescents: IV Initial dose: 100 mg once,
After initial dose follow by a daily dose equivalent to 3 – 4 times the standard maintenance
dose/day and divide/6 hr.
Septic shock, fluid & pressor-refractory with suspected/proven adrenal insufficiency3
BSA-directed dosing: (preferred)
Infants, Children, and Adolescents IV
50 – 100 mg/m2/day. (max. adult daily dose: 200 mg/day (~100 mg/m2/day)
In some cases, doses may be titrated up to 50 mg/kg/day continuous IV infusion
Weight-directed dosing
Infants, Children, and Adolescents IV,IO
2 mg/kg as a single bolus dose, max. 100 mg/dose.
Age – directed dosing
Infants & Children <3 years: IV, IO: 25 mg as a single bolus dose.
Children ≥3 – <12 years: IV, IO: 50 mg as single bolus dose.
Children ≥12 years and Adolescents: IV, IO: 100 mg as a single bolus dose.
Dose adjustment No adjustment in renal or hepatic described, Use With caution
4
Preparation Reconstitution: Vial 100 mg + 2 ml SWFI, BWFI, NS (50 mg/mL)3
IM: use reconstituted solution3
Direct IV: preferred to use reconstituted solution 50 mg/ml 3,4
IV infusion: dilute to 1 mg/mL in D5W or NS (conc 1, 2, 5 mg/mL reported) (up to 60 mg/ml
in fluid restriction)3
1 + 4 ml = 10 mg/ml , 1 + 9 ml = 5 mg/ml are commonly used
Compatible with D10W4 ( at 0.25 mg/ml for 24 hr)3
Administration 3 IM: avoid deltoid area (subcutaneous atrophy)
IV: over 30 sec – 10 min, doses ≥500 mg over 10 min 3,4
Direct IV: preferred to use reconstituted solution 50 mg/ml
IV infusion: dilute to 1 mg/mL in D5W or NS (conc 1, 2, 5 mg/mL reported)
Oral: with food or milk to decrease GIT upset
Physiologic replacement in pediatric patients, higher doses are typically administered in the
morning and midday with lower doses in the evening to replicate diurnal variation
A suspension 2 mg/ml or 2.5 mg/ml suspension may be extemporaneously prepared from
tablets3 (review detailed reference)
Stability Store intact units at 15 – 30°C, protect from light & heat 1
Reconstituted solutions in BWFI are stable or 3 days at 25°C protect from light2
Solutions prepared for IV infusion at ≤ 1 mg /ml are stable for at least 4 hr. (using NS at 1
mg/ml stable for 24 hr at room temp)2,3
Tablet: Store at max 25°C 1
Adverse reactions CVS: Bradycardia, arrhythmia, cardiac failure, cardiomegaly, circulatory shock, embolism (fat),
HTN, hypertrophic cardiomyopathy, myocardial rupture (post-myocardial infarction), syncope,
tachycardia, thromboembolism, thrombophlebitis, vasculitis
Dermatologic: Acne vulgaris, allergic dermatitis, atrophic striae, burning sensation of skin,
diaphoresis, ecchymoses, skin/ facial erythema, hyperpigmentation, hypertrichosis,
hypopigmentation, inadvertent suppression of skin test reaction, skin rash, thinning hair,
urticaria, xeroderma
Endocrine & metabolic: Adrenocortical insufficiency, Cushing syndrome, ↓Sr. K+, Cushing’s
syndrome, fluid retention, glycosuria, growth retardation, hirsutism, HPA-axis suppression,
hyperglycemia, hypokalemic alkalosis, impaired glucose tolerance/prediabetes, lipodystrophy,
menstrual disease, moon face, negative nitrogen balance, pituitary insufficiency, protein
catabolism, sodium retention, weight gain
GIT: Abdominal distention, GIT perforation , hiccups, impaired intestinal carbohydrate
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absorption, ↑ appetite, nausea, pancreatitis, peptic ulcer, ulcerative esophagitis
Genitourinary: Asthenospermia, oligospermia
Hematologic: Leukocytosis, petechia
Hepatic: Hepatomegaly, ↑ liver enzymes (usually reversible on discontinuation)
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity, nonimmune anaphylaxis
Infection: ↑ susceptibility to infection, sterile abscess
Local: Atrophy at injection site (cutaneous and subcutaneous), post-injection flare (intra-
articular use), skin edema
CNS: Depression, emotional liability, euphoria, headache, ↑intracranial pressure (with
pseudotumor cerebri), insomnia, malaise, myasthenia, neuritis, neuropathy, paresthesia,
personality changes, psychic disorder, seizure, tingling of skin, vertigo
Neuromuscular & skeletal: Amyotrophy, aseptic necrosis of femoral/ humeral head, Charcot
arthropathy, osteoporosis, pathological fracture, rupture of tendon (Achilles), steroid myopathy,
vertebral compression fracture
Ophthalmic: Blindness (rare, periocular injection), exophthalmos, glaucoma, ↑ IOP, retinopathy
subcapsular posterior cataract
Contraindications Hypersensitivity to hydrocortisone or any component of the formulation, systemic fungal
infections, use in premature infants (formulations containing benzyl alcohol only), idiopathic
thrombocytopenic purpura (IM administration only), intrathecal administration, live or live
– attenuated virus vaccines (with immunosuppressive doses of corticosteroids).
IV Glucocorticoid
Methylprednisolone IV
Trade name Methylprednisolone
Active drug Methylprednisolone sodium succinate
Dosage form Vial 500 mg powder for IV injection or Infusion
Mechanism of action Decreases inflammation by suppression of migration of polymorphonuclear leukocytes
and reversal of ↑ capillary permeability.
Indications Anti-inflammatory or immunosuppressant agent in the treatment of a variety of diseases,
autoimmune in origin and inflammatory
Dose Pediatrics3
Anti-inflammatory or immunosuppressive
Infants, Children, and Adolescents: IV: 0.11 - 1.6 mg/kg/day divided /6 – 8 hr oral, IM, IV
Up to 1. 7 mg /kg /day divided /6 – 12 hr5
Adjunct in anaphylaxis
Infant, Child & Adolescents: IV, IM: 1 – 2 mg/kg/dose as a single dose, max: 125 mg/dose
Radiocontrast media reaction, prevention of rebound reaction:
In anaphylaxis, administer epinephrine first. Corticosteroids may be used to prevent
rebound reactions.
Infant, Child & Adolescent: IV: 1 mg/kg/dose, max: 40 mg/dose
Asthma (Emergency/acute care management)
Infants & Children <12 years Oral, IV
1 – 2 mg/kg/day divided/12 hr, max 60 mg/day, continue until peak expiratory flow is 70%
of predicted or personal best
Alternate dosing: infants & children ≤5 years may receive IV doses of 1 mg/kg/6 hr on
day1, then switch to oral corticosteroids to complete 3 – 5 days course.
Children ≥12 years & Adolescents: Oral, IV
40 – 80 mg/day divided/12 – 24 hr until peak expiratory flow is 70% of predicted or
personal best.
Status asthmaticus: Children & Adolescents: IV
Loading dose: 2 mg/kg/dose, then 0.5 – 1 mg/kg/6 hr
Immune thrombocytopenia, moderate – severe bleeding or at risk for severe bleeding
95
Infant, Child & Adolescents: IV Initial: Pulse: 30 mg/kg/dose once daily for 1 – 3 doses
Dosing depend on patient response, platelet counts when used with other therapy (max.
1g/dose) follow with oral corticosteroid therapy as clinically indicated
Juvenile idiopathic arthritis, systemic
Children & Adolescents: IV Pulse therapy
30 mg/kg once/day for 3 days, max.1g/dose. Follow pulse therapy with oral corticosteroids
Evaluate response at 1 – 2 weeks and then at 1 month, if no improvement or worsening at
both intervals, may repeat 30 mg/kg/dose at weekly intervals acc. to condition.
Alternate regimen5 10 – 30 mg/kg/dose once daily or every other day for 3 doses
Kawasaki disease
Primary adjunctive treatment, patients at high risk for(IVIG) resistance or coronary artery
aneurysms (Use in combination with IVIG and aspirin)
Infants and Children IV: 1.6 mg/kg/day in divided/8 hr for 5 days or until afebrile, (may
divide/12hr) then switch to oral prednisolone, max. 48 mg/day
Treatment, refractory/resistant disease ( Reserve for febrile patient after IVIG therapy)
Infants & Children: IV: 30 mg/kg/ once/day for 1 – 3 days (may give additional IVIG dose)
Taper dosing: Infants & Children IV: 1.6 mg/kg/day divided/8 hr for 5 days or until afebrile
(max.48 mg/day), Use in combination with IVIG & aspirin, then transition to oral prednisolone
lupus nephritis, proliferative (induction)
Children & Adolescents: IV
Initial pulse: 30 mg/kg/ once/day for 3 doses, max: 1g/dose, (range: 10 – 30 mg/kg/dose
or 0.5 – 1g/m2 once/day for 3 days. Follow with oral corticosteroids and taper.
Other reference suggest5 10 – 30 mg/kg/dose once daily or every other day for 3 doses
Multisystem inflammatory syndrome in children (MIS-C) associated with SARS-CoV-2
Initial therapy: IV 1 – 2 mg/kg/day divided /12 hr in combination with IVIG, duration is
dependent on clinical course, may then switch to oral steroids
Taper over at least 2 – 3 weeks
High-dose: 10 – 30 mg/kg/day (max.1g/dose) for 1 – 3 days in more severe disease (shock)
Intensification therapy (if no improvement within 24 hr of initial MIS-C therapy with low –
moderate dose corticosteroid therapy and IVIG)
IV: 10 – 30 mg/kg/day (max. 1g/dose) for 1 – 3 days.
Nephrotic syndrome, steroid resistant
Children & Adolescents IV
15 – 30 mg/kg/dose or (500 mg/m2/ once/day) for 3 days, max.1g/dose. switch to oral
corticosteroid and taper as clinically indicated
Additional pulse doses or multiple pulses over a few months until remission are used
Pneumocystis pneumonia (PCP), adjunctive therapy for moderate – severe infection
(when on room air PaO2 <70 mm Hg or PAO2 – PaO2 ≥35 mm Hg. Begin as soon as possible
after diagnosis and within 72 hr of PCP therapy)
Infants & Children IV
day 1 – 7: 1 mg/kg/ 6 hr then
day 8 – 9: 1 mg/kg/12hr then
day 10 – 11: 0.5 mg/kg/12 hr then
day 12 – 16: 1mg/kg/24 hr.
Adolescents:
days 1 – 5: 30 mg/12 hr then
days 6 – 10: 30 mg/24 hr then
days 11 – 21: 15 mg/kg/24 hr
Ulcerative colitis, acute, severe
Children & Adolescents IV: 1 – 1.5 mg/kg/24 hr or divided /12 hr, max. 60 mg/day.
Higher doses reserved for severe disease and/or who have failed oral steroids.
Switch to oral therapy when clinically appropriate.
If inadequate response after 3 – 5 days of IV therapy, initiate second-line therapy
96
Dose adjustment3 Renal impairment: pharmacokinetics & pharmacodynamics of methylprednisolone in renal
impairment are not well understood. Its clearance appears unaltered in patients with
uremia and it is slightly dialyzable, no adjustments provided in pediatric or adults.
Hepatic impairment no dosage adjustment provided.
Preparation IV: Vial 500 mg + 7.8 ml BWFI1 OR SWFI1,2 (conc. 500 mg/8ml)
Dilute to D5W, NS (pulse doses 15 – 30 mg/kg up to 1 g diluted in 50 – 150 ml)2,3
Administration 3 IV Push: Slow over 5 min for doses ≤ 250mg
IV infusion: 15 – 60 min (doses ≥ 250 over 30 – 60 min), severe adverse events including
death when administering doses ≥ 250 mg over less than 30 min have reported
Pulse doses : IV infusion over 1 – 4 hr
Stability 3 Vial 500 mg + 7.8 ml BWFI is stable for 48 hr at room temp. protected from light2
In SWFI: discard after use for microbiological concern
Store vial at 25 °C and protect from light
Diluted sol, use within 4 hr at room temp3 OR Stored for 24 hr at 2 – 8° C
500 mg/50 ml in NS chemically stable for 21 days refrigerated at 2 – 8° C with 4% loss2
Adverse reactions Postmarketing:
CVS: Bradycardia, cardiac arrhythmia, cardiomegaly, circulatory shock, edema, embolism (fat),
heart failure, HTN, hypertrophic cardiomyopathy, myocardial rupture (after recent myocardial
infarction), syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis, venous
thrombosis
Dermatologic: Acne vulgaris, allergic dermatitis, atrophic striae, burning sensation of skin,
diaphoresis, ecchymoses, epidermal thinning, erythema of skin, exfoliation of skin, facial
erythema, hyperpigmentation, hypertrichosis, hypopigmentation, inadvertent suppression of
skin test reaction, skin atrophy, skin rash, thinning hair (scalp), urticaria, xeroderma
Endocrine & metabolic: Adrenal suppression, calcinosis (intraarticular or intralesional),
Cushing syndrome (iatrogenic), Cushingoid appearance, ↓Sr. potassium, exacerbation of
diabetes mellitus,hydrocortifluid retention, growth retardation, hirsutism, hyperglycemia,
hypokalemic alkalosis, impaired glucose tolerance,menstrual disease, moon face, negative
nitrogen balance, prediabetes, sodium retention, weight gain
GIT: Abdominal distention ,hiccups, impaired intestinal carbohydrate absorption, ↑ appetite,
intestinal perforation, nausea, pancreatitis, peptic ulcer, ulcerative esophagitis
Genitourinary: Glycosuria, spermatozoa disorder
Hematologic: Leukocytosis, petechia
Hepatic: Hepatitis, hepatomegaly, ↑ ALT, ↑ ALP, ↑ AST
Hypersensitivity: reaction Anaphylaxis, angioedema, nonimmune anaphylaxis
Infection: Infection, sterile abscess
Local: Postinjection flare (intraarticular)
CNS: Amyotrophy, apathy, depression, emotional liability, euphoria, headache, ↑ ICP (with
papilledema), insomnia, malaise, myasthenia, neuritis, neuropathy, paresthesia, personality
changes, psychiatric disturbance (including agitation, anxiety, distractibility, euphoria, fear,
hypomania, insomnia, irritability, labile mood, lethargy, pressured speech, restlessness,
tearfulness) seizure, tingling of skin, vertigo
Neuromuscular & skeletal: Bone fracture, Charcot arthropathy, lipotrophy, myopathy,
osteonecrosis (femoral and humoral heads),osteoporosis, rupture of tendon, steroid
myopathy, vertebral compression fracture
Ophthalmic: Blindness, glaucoma , ↑ IOP , subcapsular posterior cataract
Contraindications Hypersensitivity to methylprednisolone or any component of the formulation
systemic fungal infection (except intra-articular injection for localized joint conditions),
intrathecal administration
live or attenuated virus vaccines (with immunosuppressive doses of corticosteroids)
use in premature infants
97
Oral corticosteroid
Prednisolone oral
Trade name Unipredol forte
Active drug Prednisolone
Dosage form Oral Syrup 15 mg /5ml
Mechanism of action Decreases inflammation by suppression of migration of polymorphonuclears &↓ capillary
permeability, suppresses the immune system by ↓activity & volume of lymphatic system
Indications Anti-inflammatory or immunsuppressive in therapy of allergic, hematologic, dermatologic,
GIT, inflammatory, ophthalmic, neoplastic, rheumatic, autoimmune, CNS, renal (nephrotic
syndrome), respiratory & endocrine adrenal deficiency origin, solid organ rejection (acute/
chronic), bronchopulmonary dysplasia, Bell palsy, infantile hemangioma & Kawasaki dis.
Dose Neonate 3
Bronchopulmonary dysplasia (BPD), treatment: Oral
PMA >36 weeks: Day 1 – 5: 2mg/kg/12hr
Day 6 – 8: 1 mg/kg/24 hr
Day 9: 1 mg/kg/48 hr for 3 doses (on day 9 , 11 , 13)
Infantile hemangioma, second-line
if propranolol is contraindicated or ineffective
Neonate & infant: 2 – 3 mg/kg once/day or divided/6 – 24 hr (doses up to 5 mg/kg/day)
Duration: 4 –12 weeks followed by gradual taper to complete therapy by age 9 – 12 months
pediatric 3
General dosing, anti-inflammatory or immunosuppressive
1 months – 18 yr: Oral: 0.1 – 2 mg/kg/day divided /6 – 24 hr
Asthma exacerbations
NAEEP (emergency care or hospitalized patient)
Infant & Child <12 yr: 1 – 2 mg/kg/day divided/12hr,(maybe given/24 hr)5 (max. 60 mg/day)
Child ≥12 yr & Adolescent: 40 – 80 mg in divided/12 – 24 hr
-Continue until peak expiratory flow 70% of predicted or personal best
(GINA 2020): Management in primary care or acute care facility.
Infants & Children <12 years: 1 – 2 mg/kg/day for 3 – 5 days.
Max. dose: Infants & Children ≤2 years: 20 mg/day.
3 – 5 years: 30 mg/day
6 – 11 years: 40 mg/day.
≥12 years & Adolescents: 1 mg/kg/day as a single dose for 5 – 7 days, max. 50 mg/day.
COVID-19 requiring supplemental oxygen [when dexamethasone is unavailable]5
Child: 1 mg/kg once/day (max. 40 mg/ dose) for 10 days, or until discharge if this is sooner
Bell palsy
Begin treatment within 72 hr of symptoms onset
1 month – 15 yr: 1– 2 mg/kg/day X 5 – 7 days, then taper in 7 – 10 day, usual max. 50 – 60 mg/day
≥16 years: 50 mg/day divided /12 – 24 hr for 10 day
Or 1 mg/kg/day for 7 days, max. 60 mg/day, followed by a gradual taper over 7 days
Congenital adrenal hyperplasia
Adolescents (fully grown): 4 – 6 mg/day divided/12 hr (liquid dosage form preferred)
Younger, still growing children, hydrocortisone or fludrocortisone are preferred.
Crohn's disease:
Weight-directed dosing Children & Adolescents
1 – 2 mg/kg/day, max. 60 mg/day for 2 – 4 weeks until remission, taper over 4 - 8 weeks
Fixed dosing Children & Adolescents
10 – 20 kg: 20 mg once daily until clinical remission or a max. of 4 weeks then
Tapering in 2.5 – 5 mg increments/5 – 7 days. Goal to discontinue by ≤10 weeks.
>20 – 30 kg: 30 mg once daily until clinical remission or a max. of 4 weeks then
Tapering in 5 mg increments /5 – 7 days. Goal to discontinue by ≤10 weeks.
98
>30 kg: 40 mg once daily until clinical remission or a max. of 4 weeks then
Tapering in 5 mg increments /5 – 7 days. Goal is to discontinue by ≤10 weeks.
Croup (laryngo-tracheo-bronchitis), mild – moderate (alternative agent)
Single – dose treatment: Infants & Children: 1 mg/kg/day as single dose
3 doses– treatment: Infants & Children ≤8 yr: 2mg/kg/day for 3 days. Max.60 mg/dose
Dermatomyositis, juvenile
Children & Adolescents (in combination with immune suppressive)
1 – 2 mg/kg/day, usual max. 60 mg/day, higher doses of 80 mg/day reported, continue for
4 weeks, if adequate response attained start tapering by 0.5 mg/kg increments/2 weeks
based on response until dose is 0.5 mg/kg/day, then taper/4 weeks as tolerated
Duchenne muscular dystrophy (DMD)
Age ≥4 – 18 yr: 0.75 mg/kg/day, max.40 mg/dose, If adverse effects persist, gradually taper
to as low as 0.3 mg/kg/day.
Doses as high as 1.5 mg/kg/day added no more benefits is had more adverse effects
Immune thrombocytopenia (ITP), newly diagnosed (non-life threatening bleeding)
1 month – 18 yr: 2 – 4 mg/kg/day divided/6 – 8 hr for 5 – 7 days, max. 120 mg/day (higher
max 200mg/day)
Alternate: 1 – 2 mg/kg/day, up to 80 mg/day for 1 – 2 weeks, then taper discontinue 3 weeks
Juvenile idiopathic arthritis (JIA)
Therapy should be individualized based on type of JIA , disease severity and activity
Polyarticular JIA Children & Adolescents
Severe – moderate disease, bridging with a limited course (<3 months) of oral glucocorticoids
during therapy initiation/escalation is recommended (chronic low dosing not recommended)
Low dose: 0.25 mg/kg/day, max. 20 mg/day, after 1 week start tapering as follows:
↓dose to 0.125 mg/kg/day for 3 – 4 days then
↓ dose to 0.05 mg/kg/day and discontinue after a total of 2 weeks.
Medium dose: 0.5 mg/kg/day, max.30 mg/day, after 1 week start tapering as follows:
↓dose to 0.4 mg/kg/day for 7 days then
↓ dose to 0.25 mg/kg/day for 7 days then
↓ dose to 0.1 mg/kg/day for 7 days, discontinue after a total of 4 weeks.
High dose: 1 mg/kg/day, max. 60 mg/day, after 1 – 2 week start tapering as follows:
↓dose by 0 .25 mg/kg/day/1 – 4 weeks (slower taper & taper off over 3 months reported)
Systemic JIA Infants ≥6 months, Children, and Adolescents
Initial: 1 mg/kg/day once daily (initial max. 60 mg/day, may be used in combination with
methylprednisolone pulse therapy
evaluate initial response at 1 – 2 weeks & at 1 month of therapy
if improves then taper prednisolone
if unchanged then continue current prednisolone therapy
if worsened then ↑dose to 2 mg/kg/day (max. 100 mg/day).
Evaluate after 1 month
if improvement, begin taper
if worsens/unchanged, increase or continue prednisolone dose at 2 mg/kg/day (max. 100
mg/day) and/or may add or repeat methylprednisolone pulse therapy.
After 3 months of glucocorticoid therapy
if improved (&prednisolone dose <50% starting dose), continue taper & reassess monthly
if unchanged (&dose >50% of starting dose) or worsened, consider additional therapy.
Kawasaki disease (KD), primary adjunctive treatment
for patients at high risk for (IVIG) resistance or coronary artery aneurysms
Infants & Children: 2mg/kg/day divided/8hr until (CRP) normalizes, max. 60 mg/day (may
use/12 hr). Once CRP normalizes, taper over 15 – 21 days
Nephrotic syndrome - steroid-sensitive (SSNS)
Children and Adolescent (Obese patients should be dosed based on ideal body weight)
Initial episode:2 mg/kg/day (or 60 mg/m2/day) once daily, max. 60 mg/day (or 80 mg/day)5
for 4 – 6 weeks then adjust to 1.5 mg/kg/dose (or 40 mg/m2/dose) as single dose /other
day, max.40 mg/dose (duration should be limited to 2 – 3 months in first episode of SSNS)
99
Relapse: 2 mg/kg/day (or 60 mg/m2/day) once daily, (max. 60 mg/day) continue until
complete remission for at least 3 days then:
*adjust to 1.5 mg/kg/dose (or 40 mg/m2/dose) single dose/other day max.40mg/dose
Continue for at least 4 weeks then taper.
Longer duration necessary in frequent relapse (may require up to 3 months of treatment)
Maintenance therapy for frequently relapsing SSNS
Taper previous dose* down to lowest effective dose that maintains remission on every
other day schedule, usual effective range: 0.1 – 0.5 mg/kg, up to 0.7 mg/kg/dose/other day
Prevention of relapse 5
Child: 0.5–1 mg/kg once daily or on alternate days for 3 – 6 months
Ulcerative colitis, moderate – severe
Child & Adolescent for induction only:
1 – 2 mg/kg/day in the morning for 2 – 3 weeks, max. 60 mg/day
If no response after 7 – 14 days optimal dosing and compliance should be assessed
Replacement therapy5
Age: 12 – 17 years: 2 – 2.5 mg/m2/day divided /12 – 24 hr oral
Infantile spasms5
1 month–1yr: Initially 10mg 4 times/day for 14 days, increase to 20 mg 3 times/day for 7 days
if seizures not controlled after initial 7 days, ↓dose gradually over 15 days until stopped
Infantile spasms (dose reduction in patient taking 40mg daily)
1 month –1 year: Reduced in steps of 10 mg/5 days, then stop
Infantile spasms (dose reduction in patient taking 60mg daily)
1 month–1 year: Reduced to 40 mg daily for 5 days,
then reduced to 20 mg daily for 5 days
then reduced to 10 mg daily for 5 days and then discontinue
Dose adjustment 3 Altered Kidney Function: no dosage adjustments. Use with caution.
Hemodialysis: Slightly dialyzable
IHD: Supplemental dose necessary (however adult data doesn’t recommend it)
PD: Supplemental dose is not necessary
Hepatic Impairment: Use with caution
Administration3 Oral: Administer after meals or with food or milk to decrease GI upset.
1
Stability Store bottle at Max. 30 °C
CVS: Bradycardia, cardiomegaly, cholesterol embolus syndrome, circulatory shock, edema,
heart failure, hypertrophic cardiomyopathy (premature infant), myocardial rupture (after
myocardial infarction), syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis
Dermatologic: Acne vulgaris, allergic dermatitis, atrophic striae, diaphoresis, dry scalp,
ecchymoses, facial erythema, hyperpigmentation, hypopigmentation, inadvertent suppression
of skin test reaction, skin atrophy, skin rash, thinning hair (scalp), urticaria
Endocrine & metabolic: ↓Sr K+, fluid retention, growth retardation (children), hirsutism, HPA-
axis suppression, hypokalemic alkalosis, impaired glucose tolerance, menstrual disease,
negative nitrogen balance (due to protein catabolism), sodium retention, weight gain
GIT: Hiccups, impaired intestinal carbohydrate absorption, ↑appetite, nausea, pancreatitis
Genitourinary: Asthenospermia, oligospermia
Hematologic: Petechia
Hepatic: Hepatomegaly, ↑ liver enzymes
Hypersensitivity: Nonimmune anaphylaxis
Infection: Sterile abscess
CNS: Abnormal sensory symptoms, amyotrophy, arachnoiditis, headache, ↑ ICP (with
papilledema), insomnia, malaise, meningitis, myasthenia, neuritis, neuropathy, paraplegia,
paresis (paraparesis), paresthesia, seizure, vertigo
Skeletal: Aseptic necrosis of femoral/humeral head, Charcot arthropathy, tendon rupture
Ophthalmic: Exophthalmos
100
Postmarketing:
CVS: Cardiac arrhythmia (including atrial fibrillation), HTN, venous thrombosis
Endocrine & metabolic: Cushing syndrome, diabetes mellitus, exacerbation of diabetes
mellitus, hyperglycemia, moon face, prediabetes, redistribution of body fat
GIT: Abdominal distention, peptic ulcer, ulcerative esophagitis
CNS: Psychological disorder (depression, emotional liability, euphoria, altered personality)
Neuromuscular & skeletal: Bone fracture, osteoporosis, steroid myopathy, vertebral
compression fracture
Ophthalmic: Glaucoma, ↑ IOP , subcapsular posterior cataract
Contraindications Hypersensitivity to prednisolone or any component of the formulation, Concurrent live or live
attenuated virus vaccines (with immunosuppressive doses), systemic fungal infections.
Corticosteroid/inhaled
Budesonide Inhalation
Trade name Pulmicort
Active drug Budesonide
Dosage form Unit dose 0.5 mg/2 ml suspension for nebulization
Mechanism of action Controls protein synthesis rate, depresses the migration of polymorphonuclears and
fibroblasts &reverses capillary permeability and lysosomal stabilization at cellular level to
prevent/control inflammation. Potent glucocorticoid & weak mineralocorticoid activity
Indications Maintenance and prophylactic treatment of asthma in patients ≥6 years , pseudocroup
Dose Neonate 5
Reduction of inflammation in chronic lung disease: 0.25 mg /12 hr 5
PLUSS trial13: The intratracheal mixing with surfactant for BPD: 0.25 mg/kg intratracheal
For ARDS with surfactant14 (Clinical Trials data)
0.25 mg/kg mixed with (Survanta) 4 mL/kg in infant ≤ 1.25 kg who failed CPAP & required
intubation
Infant, children
General infant ≥6 month 1
Initial: 0.25 – 0.5 mg/day up to 1 mg/day may be necessary
Maintenance : 0.25 – 2 mg /day
doses >1 mg/day are divided/hr (2 mg/dose/day only used in severe asthma)
Pseudocroup 1,5
Child: 2 mg/dose single dose or divided into 1 mg/30 min, may repeat dosage/12 hr for
max 36 hr or until clinical improvement
Bronchopulmonary dysplasia (BPD) with spontaneous Respiration 5
Neonate: 500 mcg twice daily(2 ml/12hr)
1 – 4 months: 500 mcg twice daily.(2 ml/12hr)
BPD(severe symptoms) 5 1 – 4 months (body-wt ≥2.5 kg): 1 mg twice daily (4 ml/12 hr)
Prophylaxis of asthma1,5
3 months–11 years: 500 – 1000 micrograms /12hr, reduced to 250 – 500 mcg/12hr
12 – 17 years: Initially 1–2 mg /12hr, reduced to 500 –1000 micrograms /12 hr
Alternate dosing for Prophylaxis of asthma5
6 months – 11 yr: 125 – 500 mcg (0.5 – 2 ml)/12 hr, adjusted to response, max.2 mg/day
12 –17 years: Initially 0.25 – 1 mg (1 – 4 ml) /12 hr, adjusted to response, max.2 mg/day,
doses higher than max. may be used in severe disease.
Asthma, maintenance therapy 3
titrate dose to the lowest effective dose once asthma is controlled
Infant ≥6 months: Initial: 0.25 mg /12h or 0.5 mg /24 hr, max. 1 mg/day
Children & Adolescents:
Symptoms not responding to nonsteroidal asthma medications: Initial: 0.25 mg /24 hr
Previously treated with bronchodilators only
101
Initial: 0.25 mg/12hr or 0.5 mg/24 hr max. 0.5 mg/day.
Previously treated with inhaled corticosteroids:
Initial: 0.25 mg / 12 hr or 0.5 mg /24 hr, max. 1 mg/day.
Previously treated with oral corticosteroids
Initial: 0.5 mg /12 hr or 1 mg/ 24 hr, max. 1 mg/day.
Alternate dosing3
Infant ≥3 months & Children: Initial: 0.25 - 0.5 mg/ 12 hr, may increase to 1 mg /12 hr.
Adolescents: Initial: 1 – 2 mg /12 hr, further dose increases may be necessary.
Alternate Asthma dosing from guideline3
NIH Asthma Guidelines (NAEPP ): Administer/24 hr or in divided/12 hr
Children ≤4 years: "Low" dose: 0.25 - 0.5 mg/day.
"Medium" dose: >0.5 - 1 mg/day.
"High" dose: >1 mg/day.
Children 5 - 11 years: "Low" dose: 0.5 mg/day.
"Medium" dose: 1 mg/day.
"High" dose: 2 mg/day.
Global Initiative for Asthma Guidelines (GINA)
Children ≤5 years: "Low" dose: 500 mcg/day.
Children 6 – 11 years "Low" dose: 250 - 500 mcg/day.
"Medium" dose: >500 - 1,000 mcg/day.
"High" dose: >1,000 mcg/day.
Dose adjustment3 Renal/hepatic impairment: No adjustment necessary, use with caution in liver impairment
Preparation Dose mixed with NS up to 2 ml
1,3
Administration Shake gently with a circular motion before use. Avoid eye exposure to nebulized solution
May be mixed with Farcolin, Acetylcysteine, ipratropium, & sod. cromoglycate
Rinse mouth following treatments to ↓risk of oral candidiasis (wash face if using face mask)
Stability 1 Store Intact units uprightly to prevent suspension sedimentation in outer box & foil at 30 °C
Intact Unit doses stored outside foil pouch used within 3 months protected from light
Use suspension within 12 hr
Mixed with farcolin or other nebulizer : use within 30 min
Otic: Otitis media
Respiratory: Respiratory infection, rhinitis
1% - 10%:
CVS: Syncope, chest pain
CNS: Headache, pain, hypertonia, insomnia, voice disorder, emotional liability, fatigue
Dermatologic: Skin rash, contact dermatitis, eczema, pruritus, pustular rash
Endocrine & metabolic: Weight gain
GIT: Dyspepsia, nausea, gastroenteritis, diarrhea, vomiting, abdominal pain dysgeusia,
xerostomia, anorexia, viral gastroenteritis, oral candidiasis
Hematologic: Ecchymosis, cervical lymphadenopathy, purpura
Infection: Candidiasis, viral infection, herpes simplex infection
Neuromuscular & skeletal: Arthralgia, weakness, back/neck pain, fracture, myalgia, hyperkinesia
Ophthalmic: Conjunctivitis, eye infection
Otic: Otic infection, otalgia, otitis externa
Respiratory: Nasopharyngitis, cough, epistaxis, RTI, sinusitis, nasal congestion, flu-like
symptoms, allergic rhinitis, pharyngitis, viral upper RTI
Other: Fever
Postmarketing and/or case reports: Adrenocortical insufficiency, aggressive behavior, anxiety,
avascular necrosis of femoral head, bronchitis, bruise, cataract, depression, glaucoma, growth
suppression, hypercorticoidism, ↑ IOP , irritability, nervousness, osteoporosis, pain, psychosis,
restlessness, skin irritation (facial), throat irritation, wheezing
Contraindications Hypersensitivity to budesonide, corticosteroids or any component of the formulation
Moderate-to-severe bronchiectasis, pulmonary tuberculosis (active or quiescent), untreated
respiratory infection (bacterial, fungal, or viral)
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Anticholinergic -topical-Bronchodilator
Atrovent /Ipratropium inhalation
Trade name Atrovent
Active drug Ipratropium
Dosage form Unit dose 250 mcg/2ml for nebulization
Mechanism of action Anticholinergic acts topically in bronchial air ways to cause bronchodilation
Indications Asthma, acute exacerbation, moderate to severe, bronchospasms
Dose Neonate 4
General : 75 – 175 mcg (0.6 ml – 1.4 ml) via nebulizer/6 – 8 hr
Bronchopulmonary dysplasia/(RDS), ventilated patients3 Very limited data
Weight-based dosing: 25 mcg/kg/8 hr (Data from placebo controlled, comparative trial in
17 preterm infants)
Fixed dosing: 175 mcg (1.4 ml)/8 hr, administered through the ventilator circuit (data from
a study of 10 preterm infants with BPD), recommended to be given after salbutamol
Infant, child & adolescent
Asthma, acute exacerbation3
with ß- Agonist
Child ˂12 yr: 0.25 – 0.5 mg (2 – 4 ml)/20 min for 1 hr (3 doses), then as needed/ 1 – 8hr
acc. To improvement
Adolescents: 0.5 mg (4 ml)/20 min for 3 doses, then as needed
Other reference 5 Severe or life-threatening acute asthma
1 month–11 yr: 250 mcg /20–30 min, for the first 2 hr, then 250 mcg/4 – 6 hr as needed
12 – 17 years: 500 mcg / 4–6 hr as needed
Asthma, maintenance (nonacute)3
Child ˂12 yr : 0.25 – 0.5 mg (2 – 4 ml)/6 – 8 hr
Adolescents: 0.25 – 0.5 mg (2 – 4 ml)/6 hr
Bronchospasm associated with chronic pulmonary conditions3
Adolescents: 0.5 mg (2 – 4 ml)/ 8 – 6 hr
Bronchospasm, wheezing, bronchiolitis3
Infants: 0.125 – 0.25 mg (1 – 2 ml)/4 hr (helpful in chronic, recurrent wheezing, not proven
effective in bronchiolitis)
Other reference5 Acute bronchospasm
1 month – 5 yr: 125 – 250 mcg as required, max. 1 mg/day
6 – 11 yr: 250 mcg as required, max 1 mg/day
12– 17 yr: 500 mcg as needed (doses > max. used under medical supervision, max. 2mg/day)
Dose adjustment No adjustment necessary in renal or hepatic impairment.
1,3
Preparation Dose administered with or without dilution in NS only 3,5
Administration Inhaled in 5 – 15 min, mouth piece is preferred than mask to minimize contact with eye
3
Stability Store intact unit dose in foil pouch at max 30 °C. protect from light
Use immediately after opening Any unused portion should be discarded
Compatible with Farcolin or ambroxol or budesonide, Use with in1 hr 4
Don’t mix with sod cromoglycate
Adverse reactions >10%: Respiratory: Bronchitis, exacerbation of COPD, sinusitis
1% to 10%:
CNS: Headache, dizziness
GIT: Dyspepsia, nausea, xerostomia, dysgeusia
Genitourinary: Urinary tract infection
Respiratory: Dyspnea, flu-like symptoms, cough, rhinitis, upper RTI
<1%, postmarketing,
acute eye pain, blurred vision, conjunctival hyperemia, corneal edema, glaucoma,↑ IOP
visual halos around lights, mydriasis
hypersensitivity, anaphylaxis, angioedema,
103
bronchospasm, laryngospasm, pharyngeal edema, dry/ irritated throat
constipation, ↓GIT motility, diarrhea, mouth edema, nausea, vomiting
palpitations, tachycardia, hypotension
pruritus, skin rash, stomatitis, urticaria urinary retention
Contraindications Hypersensitivity to ipratropium, atropine/ derivatives or any component in formulation
Bronchodilator
Salbutamol inhalation
Trade name Farcolin
Active drug Salbutamol : 100mg /20ml (1 ml = 28 dps = 5mg) & (0.5ml =2.5 mg = 14 dps)
Dosage form 20 ml solution for nebulization
Mechanism of action Relaxes bronchial smooth muscle by beta2-receptors with little effect on heart rate.
Indications Bronchospasm: Treatment or prevention of bronchospasm in patients with reversible
obstructive airway disease (eg, asthma), Exercise-induced bronchospasm:
Dose 1 ml of Farcolin sol = 5 mg = 28 drops
Neonate
Bronchodilation:
0.1 – 0.5 mg/kg/2 – 6 hr via nebulizer4
Dose(ml) =Dose (mg/kg) x wt
5
Or: 1.25 – 2.5 mg/dose (0.25 – 0.5 ml =7 – 14 dps)/6 – 8 hr & more if clinically indicated3
Treatment of hyperkalemia Preterm neonates 3,4
Nebulization: 0.4 mg/dose up to /2 hr until Sr K+ returns to safe level (less than 5 mEq/L)
Consider alternative therapies for k+ levels greater than 7.5 mEq/L
Alternate dosing 5: 2.5 – 5 mg, repeated if necessary, IV route preferred over nebulization.
Asthma Acute symptoms, home management: (age ˂2 years limited data)3
≤ 4 yr: 1.25 – 2.5 mg/20 min for 3 doses/as needed, then frequency adjusted as needed
may be/3 – 4 hr for 24 – 48 hr. (Dose range: 0.63 – 2.5 mg /dose)
>4 – <12 yr: 2.5 – 5 mg/20 min for 3 doses/as needed, then then frequency adjusted as
needed, may be/3 – 4 hr for 24 – 48 hr. (Dose range: 1.25 – 5 mg/dose)
> 12 yr: 2.5 mg /20 min for 3 doses/as needed, then / 3 – 4 hr for 24 – 48 hr
Dose range: 1.25 – 5 mg /dose
Asthma Primary care/acute care management:3
Intermittent: 0.15 mg/kg/dose (minimum 2.5 – max 5 mg/dose)/20 min for 3 doses then
0.15– 0.3mg/kg/1 – 4hr (/1 – 6 hr)10(max.10mg/dose, may add ipratropium in severe cases)
Alternate dosing 5
1 month – 4 years: 2.5 mg, repeat/20–30 min, or when required
5 – 11 years: 2.5 – 5 mg, repeat/20–30 min, or when required
12 – 17 years: 5 mg, repeat/20–30 min or when required
Continuous nebulization:
Infant – <12 yr: 0.5 – 1 mg/kg/hr may be needed, Adjust to response, max: 20 mg/hr
≥ 12 yr: 10 – 15 mg/hr, up to 20 mg.
Asthma, acute symptoms (non-exacerbation)3
Infants & Child≤ 4 yr: (limited data in ages <2 years) 0.63 – 2.5 mg / 4 – 6 hr as needed
Child ˃ 4 – ˂12 yr: 1.25 – 5 mg/ 4 – 8 hr as needed
≥ 12 yr: 2.5 mg/ 6 – 8 hr ( or 1.25 – 5 mg/ 4 – 8 hr)
Bronchospasm 3
Infant, child, adolescent
Prevention (high risk: history of asthma, wheezing, recent upper RTI)
2.5 mg/dose, 10 – 30 min prior to trigger exposure up to 5 mg based on history and
individual risk factors.
Treatment: 2.5 – 5 mg as needed up to/20 min for 3 doses, administer continuously if needed
104
Hyperkalemia (adjunct therapy) Nebulization3
<25 kg: 2.5 mg (= 0.5 ml) nebulized over 10 min, may repeat as needed.
25 – 50 kg: 5 mg(= 1 ml) nebulized over 10 min, may repeat as needed
>50 kg: 10 mg (= 2 ml) nebulized over 10 min may repeat as needed, may use 20 mg/Dose
Alternate dosing5
Child: 2.5 – 5 mg, repeated if necessary, IV injection route preferred over inhalation
Dose adjustment3 Renal impairment No dosage adjustment required, use the high doses with caution
Preparation3 Nebulization: Dilute 0.25 mL (1.25 mg dose) or 0.5 mL (2.5 mg dose) of solution to a total
of 3 mL with NS, also compatible with cromolyn or ipratropium nebulizer solutions.
Administration3,4 Nebulization: diluted solution Over 5 – 15 min via mask device or mouth piece.
Compatible with budesonide, fluticasone or ipratropium
Stability1 Store at 25 °C, protect from light
Close the bottle well after use
discard after one month (Farcolin), and after 3 months (salbutamol generic)
Adverse reactions3 GIT: Nausea, Vomiting, mouth sores
Musculoskeletal: muscle pain or weakness, muscle cramps, Back pain, Aches
CVS: Abnormal heartbeat, tachyarrythmia
Respiratory: runny nose, shortness of breath, cough, Chest pain /wheezing
CNS: nervousness, tremor, hyperactivity, insomnia, anxiety, headache, dizziness, Passing out
Ophthalmic : Vision changes, red or irritated eyes, eye sore
Dermatologic: SJS/ TEN, red, swollen, blistered, or peeling skin
Urinary: Painful urination, Trouble urinating
Hypersensitivity: allergic reaction(rash, hives, itching, red, swollen, blistered, or peeling skin ±
fever, trouble breathing/swallowing/talking ,unusual hoarseness, or swelling of lips mouth,
face, tongue, or throat.
Contraindications Hypersensitivity to salbutamol or any component of the nebulization formulation
mucolytic
Acetylcysteine (Fluimucil) injection/inhalation
Trade name Fluimucil
Active drug Acetylcysteine
Dosage form Ampoule 300 mg /3 ml for nebulization (10%)
Mechanism of action Lowers mucous viscosity by opening disulfide bonds in mucoproteins
Indications Mucolytic: Adjunct in abnormal cases of viscid mucous secretions in conditions such as:
chronic bronchopulmonary disease
Dose Infant, child & adolescent
Mucolytic adjuvant in Respiratory conditions
Nebulized via Face mask, mouth piece, tracheostomy3
Infants: 2 – 4 mL (undiluted) 3 – 4 times daily. (dose as low as 1.5 ml twice daily)1
Children: 6 – 10 mL (undiluted) 3 – 4 times daily.
Adolescents: 6 – 10 ml (undiluted) /6 – 8 hr (usual: 2 – 20 mL / 2 – 6 hr).
Direct instillation: Children & Adolescents 3
Endotracheal: 1 – 2 mL (of 10%) /1 – 4 hr as needed ( dose as low as 10 drops twice/day)1
Percutaneous Endotracheal catheter: 2 – 4 mL (of 10%)/1 – 4 hr via syringe into catheter
Intra-auricular, intranasal: 1 – 2 drops for 1 – 2 times/day 1
Before diagnostic procedures3
Nebulization or endotracheal : 2 – 4 mL (of 10%) given 2 – 3 times before procedure
Dose adjustment No dosage adjustments necessary for nebulized drug
Preparation May be used Undiluted via inhaler 3
May dilute 3ml Ampoule + 7 ml NS 0.9% 1 (1ml + 2ml NS)
Instruments of glass and plastic are preferred 1
Instruments of Metal or rubber parts must be rinsed immediately with water after use1
105
Administration Instillation: undiluted 3
Nebulization: Administer when patient is sitting and before meals 3
Inhalation of a bronchodilator 10 – 15 min prior to Acetylcysteine is preferred 3
Avoid use in children below 2 years of age
Avoid concurrent use with antitussive (bronchospasm and infection risk)
Avoid use in bronchospasm and discontinue if bronchospasm appears during therapy
Stability Use immediately, discard unused portion
Store intact ampoule at 30 ° C , protect from light1
Adverse reactions Related to inhalation
↑ bronchial secretions, bronchospasms, autoimmune disease, anaphylactoid reaction
Contraindications Hypersensitivity to Acetylcysteine or any component of the formulation.
mucolytic
Mucosol / Carbocysteine oral
Trade name Mucosol pediatric
Active drug Carbocysteine
Dosage form Oral syrup 125 m/5 ml
Mechanism of action lowering mucous viscosity by breaking sulfide bond in the sulfhydryl group of mucoprotein
Indications Adjunctive mucolytic in respiratory tract disorders with excessive or viscous mucous secretions
Dose Pediatrics3
Age-based dosing:
2 – 5 years: 62.5 - 125 mg 4 times daily (2.5 – 5 ml /6 hr)
6 – 11 years: 100 – 250 mg 3 times daily
12 – <15 years: 100 – 750 mg 3 times daily, if starting with 750 mg 3 times daily, may ↓ to
500 mg 3 times daily or 375 mg 4 times daily if satisfactory initial response obtained.
≥15 yr: 2.25 g/day divided/8hr, may reduce to 1.5 g/day in 2 – 4 divided doses if
satisfactory initial response obtained
Alternatively, other manufacturers labeling suggest 750 mg/day divided/8hr may be used
Alternate dosing age>2 – 18 yr: 15 – 20 mg/kg/day divided/6 – 8 hr (max 2.25 g/day).
Dose adjustment Renal/Hepatic Impairment: no dose adjustments provided
1
Administration Without regard to meals
1
Storage Store at 30° C. Protect from light and moisture.
Adverse reactions 1% - 10% : GIT: Diarrhea, nausea, stomach discomfort
Frequency not defined: CVS: Palpitations
Dermatologic: Erythema, pruritus, urticaria
Endocrine & metabolic: Hypoglycemia (mild)
GIT: GIT hemorrhage, vomiting
Hypersensitivity: Anaphylaxis, fixed drug eruption
<1%, postmarketing, and/or case reports: Abdominal pain, airway obstruction (infants),
allergic skin reaction, angioedema, anorexia, bullous dermatitis, dizziness, erythema
multiform, facial swelling, headache, insomnia, skin rash, Stevens Johnson syndrome
Contraindications3 Hypersensitivity to Carbocysteine or any component of the formulation.
Children <2 years, active peptic or duodenal ulcer & Galactose Intolerance
Bronchodilator
Aminophylline injection
Trade name Aminophylline
Active drug theophylline 107.15 mg(Aminophylline 125 mg /5ml)
Dosage form Ampoule for IV (125mg /5ml)
Mechanism of action Bronchodilator inhibits phosphodiesterase (PDE)III, to lesser extent PDE IV, enhances Ca+2
uptake via adenosine-mediated channels causing↑ diaphragmatic muscles contraction force
106
Indications Acute asthma exacerbations, reversible airflow obstruction in other chronic lung diseases
(eg, emphysema) as adjunct to inhaled β-2 selective agonists & systemic corticosteroids.
Dose Neonate 4
Loading dose IV/ oral: 8 mg/kg/dose (IV: over 30 – 60 min)
Maintenance IV/ oral: 1.5 – 3 mg/kg/ 8 – 12 hr (initiated 8 – 12 hr after loading dose)
In preterm, switch from IV aminophylline to oral theophylline requires no dose adjustment
Maintenance up to 6 – 9 mg /kg (enhanced metabolism may require higher doses)3
Infants, Children & Adolescents3
All doses expressed as aminophylline, use ideal body weight to calculate dose3 (in obese)5
Adjust dose on steady state Sr conc. Aminophylline 0.8 mg = Theophylline (anhydrous) 1mg.
Reversible airflow obstruction, acute symptoms (Not recommended)
Loading dose:
Patients not received any theophylline in the previous 24 hr, IV: 5.7 mg/kg/dose.
Or (5 mg/kg/dose with max 500 mg/dose)5
Patients who received theophylline in the previous 24 hr: Obtain Sr conc. prior to loading
The loading dose should be calculated as follows:
Dose = (C desired – C measured)x (Vd)
C desired = desired Sr theophylline conc.
C measured = measured Sr theophylline conc.
Vd= plasma volume of distribution of theophylline for age
Maintenance dosing to achieve target theophylline conc 10 mcg/mL. Patients with reduced
theophylline clearance require lower initial doses. Adjust acc. to Sr conc during first 12 – 24 hr
Infants 4 – 6 weeks: IV: 1.9 mg/kg/12 hr.
Infants 6 – 52 weeks
Continuous IV infusion: Dose (mg/kg/hr) = [(0.008 × age in weeks) + 0.21] divided by 0.8
Child 1 – <9 yr: Continuous IV infusion: 1 mg/kg/hr.
Child9 – <12 yr: Continuous IV infusion: 0.9 mg/kg/hr.
Adolescents Continuous IV infusion
12 – <16 yr (healthy, nonsmoker): 0.6 mg/kg/hr, max. 1,125 mg/day unless Sr conc.
indicate need for larger dose.
12 – <16 yr (smokers) 0.9 mg/kg/hr.
≥16 yr (healthy, nonsmoker): 0.5 mg/kg/hr, max. 1,125 mg/day unless Sr conc. indicate
need for larger dose.
In cardiac decompensation, corpulmonale, sepsis with multi-organ failure, or shock
Infants, Children & Adolescents: Continuous IV infusion: Initial: 0.25 mg/kg/hr
Max. 500 mg/day unless Sr.conc indicate need for larger dose.
Alternate dosing 5
Severe acute asthma in patients not previously treated with theophylline
Loading Child: 5 mg/kg Slow IV injection (max. 500 mg/dose), followed by IV infusion
Severe acute asthma maintenance
1 month – 11 years: 1 mg/kg/hr, adjusted according to plasma-theophylline conc.
12 – 17 years: 0.5 – 0.7 mg/kg/hr, adjusted according to plasma-theophylline Conc.
Dose adjustment due interactions is Necessary if smoking started or stopped during therapy.
3
Review detailed reference for accurate dosing
Dose adjustment 3 Renal impairment IV:
Neonate: (50% excreted unchanged in urine) Monitor & adjust acc. to Sr theophylline
conc.
1 – 3 months: no adjustments described, consider dose reduction & frequent monitoring
of Sr. conc.
>3 months – 18 yr: No adjustment necessary. (10% excreted unchanged in urine)
Hepatic Impairment:
Infants, Children, and Adolescents: (as adult ) Continuous IV infusion
Initial maintenance infusion: 0.25 mg/kg/hr, max. 500 mg/day unless sr.conc indicate
need for larger dose. Use with caution and monitor Sr. theophylline conc. frequently
Preparation IV only, undiluted (25 mg/mL) or dilute to conc ≥1 mg/mL (up to 1+24 ml)3,4 NS, D5W, D10W3,4
107
Administration 3 Neonatal apnea of prematurity Infuse dose over 15 – 30 min
Infants, Children & Adolescents Loading dose: over 30 min
Vesicant : ensure proper catheter replacement during IV infusion, avoid extravasation
Stability Store at 30°C in original carton. Protect from light, and freezing 1
Do not use if discolored or if crystals are present. 1,4. Discard any remaining after use
1+4 ml NS, D5W (= 5 mg/ml) Stable 4 days refrigerated 4
Infusion solution prepared in NS: no change of colour & stability for 48 hr at room temp2
Adverse reactions3 CNS: Headache, insomnia, irritability, restlessness, seizure
Dermatologic: Allergic skin reaction, exfoliative dermatitis
Genitourinary: Diuresis (transient)
Neuromuscular & skeletal: Tremor
Contraindications3 Hypersensitivity to aminophylline, theophylline, ethylenediamine, or any component of the
formulation. Additional contraindication is Coronary artery disease where cardiac stimulation
might prove harmful, peptic ulcer disease.
Bronchodilator
Caffeine citrate injection
Trade name Caffeinospire
Active drug Caffeine citrate (20 mg Caffeine citrate =10 mg caffeine base)
Dosage form Vial 60 mg Caffeine citrate /3 ml (= 30 mg caffeine/3ml)
Mechanism of action Antagonist of adenosine at cell surface receptors increases the chemoreceptor sensitivity
to CO2, smooth muscle relaxation, and cardiac output.
Indications Apnea of Prematurity
Dose Neonate4
Apnea of Prematurity
Loading: 20 – 25 mg/kg (caffeine citrate) IV over 30 min (orally using oral sol.)
Maintenance: started 24 hr after loading dose
5 – 10 mg/kg of (caffeine citrate)/24 hr IV slow /oral
Additional loading , Higher maintenance doses (used if Sr conc, monitoring available)
Alternate3
GA <32 weeks:
Loading dose IV: 20 – 40 mg/kg caffeine citrate (as high as 80 mg/kg of caffeine citrate
have been reported, but should be utilized with caution)
Maintenance Oral, IV: 5 – 20 mg caffeine citrate/kg/24hr starting 24 hr after loading dose
Higher doses (Load: 40 mg/kg & 80 mg/kg, maintenance dose: 20 mg/kg/dose) were
shown to significantly decrease the incidence of apnea, need for oxygen therapy, and
extubation failures (but use with caution for adverse events specially with 80 mg/kg)
Dose adjustment 4 Renal/Hepatic Impairment: Dose adjustment isn’t studied but may be recommended
preterm neonate: Use with caution in Renal or Hepatic Impairment
Preparation1,3 Administered undiluted or further diluted to 10 mg/ml with D5W
(1+4 ml ) in D5W may be used
Administration3 Loading: infused over at least 30 min.
Maintenance: infused over at least 10 min
Caffeine citrate injection may be administered by mouth or by intravenous infusion5
Stability1 Store intact vial at 30 °c, discard after Opening
Diluted solutions: discard after use (manufacturer ASPETOVENT states that dilution with D5W
to be used with in 24 hr at max 30°C)
Only 10 mg/ml in D5W is stable for 24 hr refrigerated 2,3
Adverse reactions Mild, and include restlessness, vomiting, and functional cardiac symptoms.
NEC risk but causality has never been proven
Loading doses of 50 mg/kg caffeine citrate reported to ↓cerebral and intestinal blood flow.
Contraindications No specific contraindications
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Anticonvulsant/ barbiturate
Sominaletta/Phenobarbitone injection
Trade name Sominaletta
Active drug phenobarbitone
Dosage form Ampoule 40 mg/ml IV, IM
Mechanism of A Barbiturate depresses the sensory cortex, decrease motor activity, alter cerebellar function,
action and produce drowsiness, sedation, hypnosis & In high doses anti-seizure activity,
Indications Neonatal Abstinence Syndrome, Sedation, seizures Management of generalized tonic-clonic,
status epilepticus, and partial seizures
Dose Neonate
Anticonvulsant 4
Loading: 20 mg/kg IV, repeat dose of 10 mg/kg /20 – 30 min up to a total of 40 mg/kg 4
Maintenance IV/Oral 3: 3 – 5 mg/kg/day in 1 – 2 divided doses (start 12 – 24hr after loading)
VLBW & preterm: may require lower loading dose ˂ 15 mg/kg & Maintenance ˂3 mg/kg/24hr
initiated 24 hr after loading dose
Neonatal Abstinence Syndrome oral 4
Loading: 16 mg/kg on day 1
Maintenance: 1 – 4 mg/kg/12 hr
Weaning can be achieved by decreasing dose 20% every other day.
Alternate dosing3 Neonatal Abstinence Syndrome oral, IV:
Loading: 16 mg/kg on day 1( Optional)
Maintenance: 5 mg/kg/day divided /12hr (usual 2 – 8 mg/kg/day) start 12 – 24hr after loading
Weaning can be achieved by decreasing dose 20% every other day.
Status epilepticus :
Loading3 15 – 20 mg /kg/dose single or divided, may repeat 5 – 10 mg/kg/15 – 20 min as
needed, max total loading dose 40 mg/kg/dose3 then follow with maintenance
Or other reference 5
Loading 20 mg/kg
Maintenance: 2.5 – 5 mg/kg 1 – 2 times day.
Infants, Children, and Adolescents 3
Status epilepticus:
IV: loading: 15 3 – 20 mg/kg, max. dose: 1,000 mg/dose 3,5
Additional 5 – 10 mg/kg, 10 min after loading dose may be needed 3
Maintenance IV 5 (12 hr after loading)
1 month–11 years: 2.5 – 5 mg/kg /12 – 24 hr 5
12 – 17 years: 300 mg twice daily
Dose adjustment 3 Renal Impairment
Infants, Children and Adolescents: (clinicians experience) based on 3 – 7 mg/kg/day
divided/12 – 24 hr
GFR ≥10 mL/min/1.73 m2: No adjustment necessary
GFR <10 mL/min/1.73 m2: Decrease normal dose by 50% & administer/24 hr
IHD:(20% - 50% dialyzable) Supplemental dose may be needed during and after dialysis
depending on individual seizure threshold
PD: (40% - 50% removed)
CRRT: Monitor Sr.concentrations
Hepatic Impairment: no specific dosage adjustments described but reduced doses are
recommended, use with caution.
Preparation Ampoule (40 mg) 1 + 3 ml NS ( 10 mg/ml)2,3,4 this dilution can be used orally 4
Administration IV use diluted solution over 15 – 30 min (neonate)3,4
Rapid IV injection >60 mg/min should be avoided 3 (severe RD, apnea …etc. with too rapid
administration)
In status epilepticus: a rate of 50 – 100 mg/min was used 3
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Stability Use immediately after preparation, discard any unused portion
10 mg/ml in NS is stable 4 weeks refrigerated3
Store intact ampoule at 25 °C, protect from light 1
CVS: Bradycardia, circulatory shock, hypotension, syncope
Dermatologic: Alopecia (areata universalis, associated with hypersensitivity syndrome) exfoliative
dermatitis, maculopapular rash, SJS ,TEN
Endocrine & metabolic: diabetes mellitus (associated with hypersensitivity syndrome)
GIT: Constipation, nausea, vomiting
Hematologic: Megaloblastic anemia, thrombocytopenia
Hypersensitivity: Angioedema, DRESS
CNS: Abnormality in thinking, agitation, anxiety, ataxia, CNS depression, confusion, depression,
dizziness, drowsiness, hallucination, hangover effect, headache, insomnia, lethargy, disturbed
memory, nervousness, nightmares, paradoxical CNS stimulation, psychiatric disturbance, vertigo
Neuromuscular & skeletal: Hyperkinetic muscle activity, laryngospasm, osteomalacia
Respiratory: Apnea, hypoventilation, respiratory depression
Other: Fever
Contraindications Hypersensitivity to phenobarbital, barbiturates, or any component of the formulation
Marked hepatic impairment, dyspnea or airway obstruction, porphyria (manifest & latent).
Intra-arterial or SubQ administration, use in patients with a history of sedative/hypnotic
substance use disorder, nephritic patients (large doses).
Anticonvulsant/hydantoin
Phenytoin injection
Trade name Phenytoin / Epilog
Active drug Phenytoin sodium
Dosage form Ampoule 50 mg/ml IV (250mg /5 ml)
Mechanism of Stabilizes neuronal membranes & ↓seizure activity by increasing efflux or decreasing influx
action of Na+ ions across cell membranes in the motor cortex during generation of nerve impulses
Indications Status epilepticus, focal and generalized onset seizures and seizures prophylaxis
Dose Neonate 4
Loading dose: 15 – 20 mg/kg IV infusion. (In single or divided doses) 3
Maintenance dose: 4 – 8 mg/kg/ 24 hr IV slow push, or oral3.4 (or divide/12 hr & start 12 hr
after loading)3. (Up to 8 mg/kg/ 8 – 12 hr after 1 week of age)
Infant, child and adolescent 3 expressed as phenytoin sodium
Status epilepticus:
Loading dose IV: 20 mg/kg (single or divided) (max. 1,000 mg/dose)
Additional load of 5 – 10 mg/kg if status epilepticus is not resolved
Maintenance (12 hr after loading dose)
Seizures, focal (partial) onset seizures & generalized onset seizures:
Loading dose IV, Oral: (optional, reserved for patients not currently on phenytoin)
15 – 20 mg/kg (oral loading divided in 3 doses & given/2– 4 hr to ↓GI upset & ↑absorption)
If currently on phenytoin, reloading should be based upon Sr conc. & recent dosing history
Maintenance: IV, Oral immediate release
Range: 4 – 8 mg/kg/day, max dose: 300 mg/day. divided /8 –12 hr, up to 10 mg/kg/day3,5
Extended-release form: dosed /12 hr for children and/24 hr for adolescents
Alternate dosing for maintenance in age 12 – 17 yr5: 100 mg IV /6 – 8 hr
Seizure prophylaxis, traumatic brain injury (TBI):
IV: Initial: 18 – 20 mg/kg over 20 min, followed by 6 mg/kg/day divided/ 8 hr
Dose adjustment Renal dysfunction: no adjustment specified (<5% excreted unchanged). Monitor free drug level
Hepatic Impairment: no dose adjustments described but adjustments may be necessary
Hepatic metabolism & clearance may be decreased. Monitor free phenytoin levels
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Preparation IV: (50 mg) 1ml + 9 ml NS (5 mg/ml) 2,3,4. Use only if clear, slightly yellow sol. may be used
Vesicant: ensure proper needle or catheter insertion, avoid extravasation
Administration 3,4 Loading: IV over 15 – 20 min4
maintenance: over 10 min4
Neonate: recommended rate: 0.5 – 1 mg/kg/min
infusion pump use preferred to avoid exceeding max rate:1 – 3 mg/kg/min for neonate/child
Max rate shouldn't exceed 50 mg/min for infant, child & adolescent
Flush the line with NS before and after administration
Stability Use immediately after preparation, discard any unused portion in 1 hr max. 1
Store intact ampoule at 30 ° C, protect from light 1
Adverse reactions CVS with rapid IV administration: Hypotension and severe cardiac arrhythmia: as bradycardia,
heart block, ventricular tachycardia, and ventricular fibrillation progressing to asystole, cardiac
arrest & death
CNS concentration-dependent: mild symptoms of drowsiness, fatigue, nystagmus, ataxia,
incoordination, and slurred speech in all ages. At very high concentrations, drug-induced seizure
Hepatotoxicity: hepatitis, acute hepatic failure ↑ ALT, AST, Most cases of hepatotoxicity involve
hypersensitivity features (eg, rash, fever, lymphadenopathy, eosinophilia) and occur as part
of (DRESS) generally reversible upon discontinuation of therapy and resolves within 1 – 2 months
Hypersensitivity reactions (delayed) maculopapular eruption (MPE), severe cutaneous adverse
reactions (SCARs), SJS,TEN, DRESS, AGEP
Hematologic: agranulocytosis, granulocytopenia, leukopenia, macrocytosis, megaloblastic
anemia, pancytopenia, pure red cell aplasia, and thrombocytopenia ± bone marrow depression
hyper-homocystinemia, macrocytosis, megaloblastic anemia, purpuric dermatitis
CNS Cerebral atrophy/dysfunction (elevated Sr.levels and/or long-term use), confusion, dizziness,
headache ,insomnia, nervousness, paresthesia, peripheral neuropathy (chronic treatment),
twitching, vertigo, Suicidal ideation/tendencies
Endocrine & metabolic: ↓T4, ↑GGT, vitamin D deficiency (with chronic treatment)
GIT: Constipation, dysgeusia, nausea, swelling of lips, vomiting
Genitourinary: Peyronie's disease
Local: Injection site reaction purple glove syndrome, edema, discoloration, and pain distal to
injection site, local inflammation/ irritation, local tissue necrosis, localized tenderness
Others: Fever, tissue sloughing
Contraindications Hypersensitivity to phenytoin, other hydantoins, or any component of the formulation
History of acute hepatotoxicity with phenytoin
Sinus bradycardia, sinoatrial block, 2nd & 3rd -degree heart block, Adams-Stokes syndrome
Sedative/hypnotic/anti-seizure /benzodiazepine
Midazolam injection
Trade name Midathetic / Midazolam
Active drug Midazolam 5 mg/ml
Dosage form Ampoule 5 mg/ml & ampoule 15 mg/3 ml
Mechanism of Binds to benzodiazepine receptors on postsynaptic GABA neuron at several sites in CNS,
action including the limbic system and reticular formation, increases membrane permeability to
chloride ions enhancing inhibitory effect of GABA on neuronal excitability
Indications Induction of general anesthesia, continuous sedation of intubated and mechanically
ventilated patients treatment of acute stereotypic episodes of frequent seizure activity
Dose Neonate 4
Sedation
IV: 0.05 – 0.15 mg/kg. Repeat as needed, usually/ 2 – 4 hr. May also be given IM.
Continuous IV infusion: 0.01 – 0.06 mg/kg/hr (10 – 60 mcg/kg/hr)
Dosage may need escalation after several days of therapy due to tolerance and/or ↑clearance
Intranasal: 0.2 – 0.3 mg/kg/dose using 5-mg/mL injectable form.
Sublingual: 0.2 mg/kg/dose (use 5-mg/mL injectable form + small amount of flavored syrup)
Febrile convulsions and status epilepticus alternate dose in buccal administration5
0.3 mg /kg, repeat after 10 min if needed
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Intubation sedation 3
IM, IV: 0.05 – 0.1 mg/kg/dose over 5 min
Sedation, mechanically ventilated patient 3
Gestational age dosing3
Loading dose (not highly recommended, may omit and start continuous infusion directly)
GA ≥24 weeks: IV: 0.2 mg/kg/dose once (over ≥1 hr to minimize risk of hypotension)
Continuous IV infusion:
GA 24 – 26 weeks: Initial: 0.015 – 0.03 mg/kg/hr (0.25 – 0.5 mcg/kg/min)
GA 27 – 29 weeks: Initial: 0.015 – 0.04 mg/kg/hr (0.25 – 0.67 mcg/kg/min)
GA ≥30 weeks: IV: Initial: 0.015 – 0.06 mg/kg/hr (0.25 – 1 mcg/kg/min)
Sedation tapering (after prolonged therapy): 3
Consider a slow taper of therapy to prevent signs and symptoms of withdrawal
If duration of therapy ≤ 4 days:
Taper over 1 – 2 days
Begin with dosage reduction of 30% - 50% followed by 20% - 30% reductions/6 – 8 hr, monitor
closely for signs and symptoms of withdrawal with each reduction in dose.
If duration of therapy is > 4 days
Decrease infusion rate by 25% – 50% /12 hr
then convert to an intermittent dose/4 hr
then: lastly/8 hr, monitor closely for withdrawal signs/symptoms with each reduction in dose.
PMA dosing 5
<32 weeks: 60 mcg/kg/hr for 24 hr, then reduce to 30 mcg/kg/hr, adjust to response for max.
duration of 4 days.
≥32 weeks: 60 mcg/kg/hr for 24 hr, adjusted to response for max. 4 days.
Anticonvulsant 3,4
Loading: 0.063 – 0.153.4 mg/kg (150 mcg/kg) IV, followed by IV infusion of maintenance dose,
may omit loading dose if a benzodiazepine was received shortly before
Loading may reach 0.2 mg/kg5
Maintenance: 0.06 – 0.4 mg/kg/hr (1 –7 mcg/kg/min)3,4 up to 1.1 mg/kg/hr (18 mcg/kg/min)3
Use IBW for obese patient
Sedation in ICU, mechanically ventilated patient 3
IV: Loading dose: 0.05 – 0.2 mg/kg, given slow IV over ≥2 – 3 min, then start:
Continuous IV infusion: 0.05 – 0.12 mg/kg/hr (0.8 – 2 mcg/kg/min), titrate to effect
Max. initial dose: 10 mg/hr
May omit or reduce loading dose in hypovolemia, vasoconstriction & hypothermia
Lower maintenance doses may be used if opioids are used concomitantly
Tapering (after prolonged therapy): slow tapering or conversion to a long-acting agent
If duration of therapy <3 – 5 days: ↓dose by 10% – 15% /6 – 8 hr, monitor closely for
withdrawal with each reduction in dose.
duration of therapy >5 days
Conversion to oral diazepam
After first dose of oral diazepam, ↓midazolam infusion by 50%
After the second dose of oral diazepam, discontinue the midazolam infusion & monitor.
Conversion to oral lorazepam:
After second dose of oral lorazepam, ↓midazolam infusion by 50%
After third dose of oral lorazepam, ↓ midazolam infusion by additional 50%
After fourth dose of oral lorazepam, discontinue the midazolam infusion & monitor closely
Seizures, acute treatment 3
Buccal: Reserve when no IV access, if seizure persists for 5 min doses may be repeated.
≥3 months, Children and Adolescents
Weight-directed dosing: 0.2 – 0.5 mg/kg once. Max. 10 mg/dose.
Age-directed dosing: Infants ≥3 months: 2.5 mg.
1 – 4 years: 5 mg.
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5 – 9 years: 7.5 mg.
≥10 years: 10 mg.
IM Infants, Children and Adolescents
Weight – directed dosing: 0.2 mg/kg/dose
Fixed dosing: 13 – 40 kg: 5 mg.
>40 kg: 10 mg.
Intranasal Infants, Children and Adolescents (using parenteral sol.)
0.2 mg/kg/dose, divide dose between nares, max.10 mg/dose, may repeat once to a total
max. 0.4 mg/kg, (higher dose of 0.3 mg/kg described in infant ≥6 months)
Status epilepticus 3
IV (in cases of refractory to standard treatment)
Loading dose: IV: 0.2 mg/kg followed by a continuous infusion.
Continuous IV infusion: 0.05 – 2 mg/kg/hr (0.83 –33.3 mcg/kg/min), titrate to seizures control
If a breakthrough status epilepticus during continuous infusion occurs, give a bolus of
0.1 – 0.2 mg/kg & ↑ rate by 0.05 – 0.1 mg/kg/hr (0.83 – 1.66 mcg/kg/min)/ 3 – 4 hr
IM: Infants, Children and Adolescents (Standard treatment)
Weight-based dosing: IM: 0.2 mg/kg once, max. 10 mg/dose.
Fixed dosing: 13 – 40 kg: 5 mg once.
>40 kg: 10 mg once.
Intranasal: 0.2 mg/kg once, max. dose: 10 mg/dose.
Buccal: 0.5 mg/kg once, max dose: 10 mg/dose.
Alternate dosing for febrile convulsion & Status epilepticus5
Buccal:
1 – 2 months: 0.3 mg /kg, max 2.5 mg/dose, repeat after 10 min if required
3 – 11 months: 2.5 mg/dose, repeat after 10 min if required
1 – 4 yr : 5 mg/dose, repeat after 10 min if required
5 – 9 yr : 7.5 mg/dose, repeat after 10 min if required
10 – 17 yr : 10 mg/dose, repeat after 10 min if required
IV Child
Loading: 0.15 – 0.2 mg/kg/dose then continuous IV infusion
Maintenance: continuous IV infusion 0.06 mg/kg/hr, increase in steps of 0.06 mg/kg/hr every
15 min , max 0.3 mg/kg /hr until response
Sedation, anxiolysis, and amnesia prior to procedure or before induction of anesthesia3
IM Infants, Children, and Adolescents
Usual dose: 0.1 – 0.15 mg/kg, 30 – 60 min. before surgery or procedure
Range: 0.05 – 0.15 mg/kg, (doses up to 0.5 mg/kg used), max. Total dose: 10 mg.
IV
Infants <6 months 5: Limited data in non-intubated infants <6 months, high risk for airway
obstruction & hypoventilation, titrate dose with small increments to desired effect, monitor
carefully. (May start at 0.025 – 0.05 mg/kg, titrate dose carefully to effect Total dose: 6 mg)
6 months – <6 years Initial: 0.05 – 0.1 mg/kg, titrate dose carefully in small steps to effect.
total dose: 0.6 mg/kg, (suggested Usual max: 6 mg/dose after titration)5
Children ≥6 years: Initial: 0.025 – 0.05 mg/kg, titrate dose carefully to effect
Total doses of 0.4 mg/kg, (usual max. Total dose: 10 mg.)
Adolescents3: Initial: 1 – 2.5 mg over ≥2 min, (0.5 mg dose may be used) titrate dose carefully
to effect, usual max. total dose: 10 mg
Alternate dosing: 0.025 – 0.05 mg/kg over 2 – 3 min (5 – 10 min prior), titrate to effect, max
7.5 mg/does
Induction of anesthesia in age 7 – 17 yr
0.15 mg/kg, max 7.5 mg. (doses to be given in 0.05 mg/kg steps, max 2.5 mg /step over 2 – 5
min), wait for 2 – 5 min before subsequent dosing) max. Total dose: 25 mg. or 0.5 mg/kg
Intranasal: (injection sol. In a needless syringe used)
Infants, Children and Adolescents: 0.2 mg/kg single dose, may repeat in 15 min
Range: 0.2 – 0.8 mg/kg, max: 10 mg/dose (lidocaine intranasal premedication ↓nasal irritation)
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Oral: (30 – 60 min before procedure)5
6 months – < 16 yr: 0.25 – 0.5 mg/kg single dose, usually 0.5 mg/kg, max: 20 mg/dose
Dose up to 1 mg/kg may be required in:
1- Age 6 months – < 6 yr
2- less co-operative Patients
Start at lowest dose in cardiac, respiratory compromised patient, high risk surgical patient and
in concomitant with CNS depressants
Rectal: (15 – 30 min before procedure)5
Age> 6 months: 0.25 – 0.5 mg/kg once (doses up to 1 mg/kg used in infants 7 months – 5 yr of
age but may be associated with post-procedural agitation).
Buccal :5
6 months – 9 yr: 0.2 – 0.3 mg/kg once (max. 5 mg/kg/dose)
10 – 17 yr Wt <70 kg: 6 – 7 mg/dose
Wt ≥ 70 kg: 6 – 8 mg/dose.
Dose adjustment3 Renal impairment: No pediatric adjustment provided, use with caution: t⅟2 of midazolam & its
active metabolite may be prolonged. (in adult: sedation may prolong to 10 days after cessation)
Hemodialysis: Supplemental dose is not necessary.
Peritoneal dialysis: Significant drug removal is unlikely
Hepatic Impairment no pediatric adjustments provided, use with caution, anticipate longer
duration of action.
Single dose in induction : dose adjustment are not necessary
Multiple dosing, continuous infusion : dose reductions are likely to be necessary
Preparation3 IV injection: at conc. 1mg/ml (1+4 ml) NS, D5W
Neonatal IV Infusion Conc: 0.1 mg/mL, 0.5 mg/mL, or 1 mg/mL.
Pediatric IV Infusion Conc: 0.03 mg/mL, 0.5 mg/mL, 1 mg/mL, or 5 mg/mL.
Rectal prepare from ampoule at 1 – 5 mg /ml
Administration3 Neonate:
Slow IV Push: over 10 min at dilution 1+4 ml recommended 4 avoid rapid injection
Continuous IV infusion by infusion pump, may be at dilution 0.5 mg/ml in NS or D5W 4
Consider loading dose to be given over≥ 60 min to prevent hypotension however in
mechanical ventilation over 2 – 5 min administration was described
Pediatric
IV injection: over 2 – 5 min used.
for refractory status epilepticus, the loading dose at a rate not higher than 2 mg/min
Continuous IV infusion: via an infusion pump.
IM: undiluted deep IM into large muscle, generally into anterior-lateral aspect of thigh
Intranasal using Parenteral solution for injection, administer using a needleless syringe.
Administer half of the dose into each nostril. Maximum volume: 1 mL per nostril
BuccaL: formulation is not available, trials used an injectable solution given buccally,
administer to the buccal mucosa between the gums and the cheek using an oral syringe,
gently massage cheek, dose may be divided to both sides of the mouth
Rectal: use parenteral midazolam 1 – 5 mg/ml through a small, lubricated catheter or tube
inserted rectally, hold buttocks closed for ~5 min after administration
Stability Intact ampoules stored at room temp 25 – 30 °C2 , protected from light1,2
Diluted in NS: unspecified conc. Stable 10 – 36 days at room temp.
Solutions for Continuous IV infusion: conc. 0.5 mg/ml with NS or D5W (stable 24 hr)4
1mg/ml in NS, D5W : stable for 24 hr or more
Any remaining sol. Should be discarded outside continuous infusion setting.
GIT: Vomiting
Respiratory: Apnea, bradypnea, ↓tidal volume, nasal discomfort
1% - 10%:
CVS: AV nodal arrhythmia, bigeminy, bradycardia, hypotension, syncope, tachycardia, ventricular
premature contractions.
Dermatologic: Pruritus, skin rash, urticaria, urticaria at injection site.
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GIT: Acidic taste, dysgeusia, hiccups, nausea, retching, sialorrhea.
Hematologic: Hematoma, oxygen desaturation.
Hypersensitivity: Anaphylaxis, hypersensitivity reaction.
Local: injection site adverse events: Burning sense, erythema, induration, reaction, pain, swelling,
tenderness, warm sensation
CNS: Abnormal dreams, agitation, anxiety, ataxia, athetosis, behavioral changes chills, confusion,
delirium, dizziness, drowsiness, dysarthria, dysphoria, euphoria, hallucination, headache, impaired
consciousness, insomnia, intoxicated feeling, lethargy, balance loss, mental status changes,
nervousness, nightmares, paresthesia, prolonged emergence from anesthesia, psychiatric signs &
symptoms, restlessness, retrograde amnesia, sedated state, seizure-like activity, severe sedation,
sleep disturbance, slurred speech, voice disorder, yawning.
Neuromuscular & skeletal: Asthenia, laryngospasm.
Ophthalmic: Accommodation disturbance, blurred vision, diplopia, ↑ lacrimation miosis,
nystagmus disorder, visual disturbance.
Otic: Blockage of external ear.
Renal: Acute renal failure.
Respiratory: Airway obstruction, bronchospasm, cough, dyspnea, hyperventilation, RD, rhinorrhea
rhonchi, respiratory congestion, shallow respiration, tachypnea, throat irritation, hypoxia wheezing
Other: Fever, paradoxical reaction
<1%:
Local: Injection site phlebitis
Neuromuscular & skeletal: Muscle rigidity
Respiratory: Sneezing
Postmarketing:
CNS: Aggressive behavior, cognitive dysfunction, drug dependence (physical and psychological
dependence with prolonged use), hyperactive behavior, involuntary body movements, suicidal
ideation, suicidal tendencies, tonic-clonic movements
Contraindications Hypersensitivity to midazolam or any component of the formulation
Sedative/hypnotic/anti-seizure /benzodiazepine
Diazepam injection
Trade name Epival
Active drug Diazepam
Dosage form Ampoule 10 mg /2 ml
Mechanism of Long-acting benzodiazepine. Binds to benzodiazepine receptors on postsynaptic GABA neuron in
action CNS, enhance GABA inhibitory action of on neuronal excitability
Indications Parenteral: Management of muscle spasms associated with tetanus, adjunct treatment of status
epilepticus and severe recurrent convulsive disorders
Dose Neonate5
Status epilepticus, febrile convulsions , poisoning induced convulsions
IV: 0.3 – 0.4 mg/kg over 3 – 5 min, repeat after 10 min if required (benzyl alcohol, gasping)
Status epilepticus, febrile convulsions, poisoning induced convulsions
IV (preferred route)
Weight-directed: age >30 days – 18 yr 3
0.15 – 0.2 mg/kg/dose slow IV, may repeat dose once in 5 min. max dose: 10 mg/dose.
Fixed dosing:
>30 days – <5 yr
0.2 – 0.5 mg slow IV/ 2 - 5 min up to a max total dose of 5 mg, repeat in 2 – 4 hr if needed.
Age ≥ 5 yr: 1 mg slow IV /2 – 5 min up to a max. 10 mg, repeat in 2 – 4 hr if needed.
Alternate dosing IV5
1 month – 11 yr: 0.3 – 0.4 mg/kg over 3 – 5 min (max 10 mg) repeat after 10 min if needed
12 – 17 yr: 10 mg over 3 – 5 min, repeat if needed after 10 min
Rectal (when IV access unavailable)
Children 2 – 5 yr: 0.5 mg/kg, max dose: 20 mg/dose.
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Children 6 – 11 yr: 0.3 mg/kg, max dose: 20 mg/dose.
Age ≥ 12 yr: 0.2 mg/kg, max. dose: 20 mg/dose.
Alternate dose in acute dystonia (drug induced)5
1 month – 11 yr: IV: 0.1 mg/kg over 3 – 5 min, repeat if required.
12 – 17 yr: 5 – 10 mg over 3 – 5 min, repeat if needed.
Acute seizures
Rectal (when IV access unavailable).
Using undiluted 5 mg/mL parenteral formulation (filter if using ampoule)
0.5 mg/kg/dose, then 0.25 mg/kg/dose in 10 min if needed. Max dose: 20 mg/dose
Tetanus-associated spasm
Weight-directed: IV Infants, Children, and Adolescents:
0.1 – 0.2 mg/kg/dose /2 – 6 hr titrate as needed. Initial recommended adult dose: 5 mg/dose
Alternate dosing for child 5
IV injection: 0.1 – 0.3 mg/kg/dose / 1 – 4 hr
Continuous IV infusion: 3 –10 mg/Kg over 24hr infusion (container compatibility, formulation
specific)
Fixed dosing IV, IM :
Age >30 days – <5 yr: 1 – 2 mg/3 – 4 hr as needed.
Age 5 – 18 yr: 5 – 10 mg/3 – 4 hr as needed.
Muscle spasm/spasticity associated with chronic/terminal illness (Limited data)
IM, IV: 0.05 – 0.2 mg/kg/dose /6 – 12 hr, max total dose: 0.6 mg/kg cumulative in 8 hr
In palliative situations usual initial doses are: children <5 yr is 5 mg/dose.
Age ≥5 yr: 10 mg/dose
Sedation, anxiolysis, and amnesia prior to procedure: IV
Infants & Children: Initial: 0.05 – 0.1 mg/kg over 3 – 5 min, titrate slowly to effect (max total
dose: 0.25 mg/kg).
Adolescents: 5 mg, may repeat with a 2.5 mg dose if needed
Dose adjustment3 Altered Kidney Function: no adjustments provided for pediatric & adult: use with caution.
Hemodialysis: Not dialyzable (0% - 5%), supplemental dose is not necessary.
Hepatic Impairment: no adjustments provided for pediatric & adult, use with caution
Preparation1 IV: do not mix with other solutions or medications
Manufacturer data: dilute with NS or D5w
Administration3 IV : undiluted by slow IV push at 1 – 2 mg/min. Rapid injection may cause RD or hypotension
Infusion conc: 80 mcg/ml in D5W or NS5
Vesicant: ensure proper needle insertion , avoid extravasation
IM : Deep IM
Contains benzyl alcohol (gasping syndrome in neonate)
Stability1 Intact ampoule: store at 30 ° c
Use immediately after dilution
Dilution: 1ml x 25ml NS or D5W (polyethylene & glass) stable at room temp 24 hr2
CNS: Drowsiness (23%)
1% – 10%:
CVS: Hypotension, vasodilation
GIT: Abdominal pain, diarrhea, dysgeusia, hiccups
CNS: Abnormality in thinking, agitation, ataxia, confusion, dizziness, dysarthria, emotional liability,
euphoria, headache, nervousness, pain, speech disturbance, vertigo
Neuromuscular & skeletal: Asthenia
Respiratory: Asthma, epistaxis, nasal discomfort, rhinitis
<1%:
CVS: Bradycardia, circulatory shock, syncope
Dermatologic: Diaphoresis, pruritus, urticaria
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GIT: Anorexia, vomiting
Genitourinary: Urinary tract infection
Hematologic & oncologic: Anemia, lymphadenopathy, neutropenia
CNS: Tonic clonic type of status epilepticus
Neuromuscular & skeletal: Hyperkinetic muscle activity
Ophthalmic: Mydriasis, nystagmus disorder
Respiratory: ↑ cough
CVS: ECG changes, localized phlebitis, venous thrombosis
Endocrine & metabolic: Change in libido
GIT: Altered salivation, constipation, gastrointestinal distress, nausea
Genitourinary: Urinary incontinence, urinary retention
Hematologic & oncologic: Neutropenia
Hepatic: ↑ serum alkaline phosphatase, ↑ serum transaminases, jaundice
CNS: Anterograde amnesia, CNS depression, depression, drug abuse, dependence, drug
withdrawal, fatigue, hypoactivity, lethargy, myasthenia, paradoxical central nervous system
stimulation, psychiatric signs and symptoms, rebound anxiety, slurred speech
Ophthalmic: Blurred vision, diplopia
Respiratory: Hypoventilation
Postmarketing: Paradoxical reaction
Contraindications Hypersensitivity to diazepam/any component of formulation, acute narrow-angle glaucoma.
Documentation of cross- allergy for benzodiazepines is limited but cannot be ruled out.
Anticonvulsants
Levetiracetam injection
Trade name Kepilepsi
Active drug Levetiracetam
Mechanism of Suggested to inhibit of voltage-gated calcium channels, facilitation of GABA- inhibitory
action transmission binding to synaptic proteins which modulate neurotransmitter release
Indications Status epilepticus, Focal (partial) onset & Generalized onset: Juvenile myoclonic epilepsy and
Primary generalized tonic-clonic seizures:
Dose Neonate 4
Seizure
Intravenous
Loading4 (total cumulative) doses IV: 20 – 150 mg/kg/day IV, typically divided to multiple
smaller doses administered within a 24 hr period
Proposed administration regimen3: 20 – 60 mg/kg initially (60 mg/kg preferred), repeat at
interval of 15 min with 2 – 50 mg /kg, total cumulative dose 20 – 150 mg/kg
Maintenance4: 41.7 – 65 mg/kg/day (up to 106.2 mg/kg/day) divided/ 12 hr
Switching from IV to oral: total daily IV dosage is equivalent to that of oral in age ≥ 1 month
Alternate maintenance dosing 3
IV: Initial: 20 – 60 mg/kg/day divided /8 – 12, may increase by 10 – 20 mg/kg/day based on
response, reported range is up to 120 mg/kg/day
Oral (immediate release, Oral): Initial: 10 – 30 mg/kg/day divided/ 12 hr, higher initial doses
up to 60 mg/kg/day in 2 – 3 divided doses reported. Doses may be increased by 10 – 20
mg/kg/day increments based on response, reported range from 8 – 120 mg/kg/day.
Infant, child and adolescent3
Status epilepticus, refractory, urgent therapy/second-phase therapy
Infant, child & adolescent IV: 20 – 60 mg/kg/dose, max: 4,500 mg/dose
initiate maintenance therapy based upon clinical response and type of seizure disorder
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Partial onset (focal) seizures:
IV, Oral (immediate release) monotherapy or adjunct.
Age 1 – <6 months: Initial: 7 mg/kg/dose twice daily, ↑dose /2 weeks by 7 mg/kg/dose twice
daily to the recommended dose of 21 mg/kg/dose twice daily.
≥6 months – < 4 yr: Initial: 10 mg/kg/dose twice daily, ↑dose /2 weeks by 10 mg/kg/dose
twice daily to recommended dose of 25 mg/kg/dose twice daily.
≥4 – <16 yr: Initial: 10 mg/kg/dose twice daily, ↑dose /2 weeks by 10 mg/kg/dose twice daily,
to recommended dose of 30 mg/kg/dose twice daily (max 3,000 mg/day.
Oral fixed dosing
Immediate release, oral suspension:
20 – 40 kg: Initial: 250 mg /12 hr, increase /2 weeks by 250 mg twice daily based on response
and tolerability to the max. recommended dose of 750 mg twice daily.
>40 kg: Initial: 500 mg/ 12 hr, increase /2 weeks by 500 mg twice daily based on response and
tolerability to the max. recommended dose of 1.5 g twice daily.
Extended release
≥12 yr: Initial: 1g once daily, may increase /2 weeks by 1g/day based on response and
tolerability to a max recommended dose of 3g once daily.
Adolescents ≥16 yr:
IV, oral Initial: 500 mg twice daily, ↑dose /2 weeks by 500 mg/dose twice daily to a max.
Recommended dose of 1,500 mg twice daily.
Oral Extended release Initial: 1g once daily, may increase /2 weeks by 1g/day based on
response and tolerability to a max recommended dose of 3g once daily.
Seizure prophylaxis, traumatic brain injury:
1 month – 18 yr: IV, Oral: 5 – 55 mg/kg/day divided twice daily
Tonic-clonic seizures, primary generalized, adjunct
IV, Oral (immediate release)
≥6 – <16 yr Initial: 10 mg/kg/dose twice daily, ↑dose/2 weeks by 10 mg/kg/dose twice daily
to recommended dose of 30 mg/kg/dose twice daily.
Oral fixed dosing
Disintegrated tablet
20 – 40 kg: Initial: 250 mg /12 hr, increase /2 weeks by 250 mg twice daily based on response
and tolerability to the max. recommended dose of 750 mg twice daily.
>40 kg: Initial: 500 mg/12 hr, increase /2 weeks by 500 mg twice daily based on response and
tolerability to the max. recommended dose of 1.5 g twice daily.
≥16 years: Initial: 500 mg twice daily ↑dose/2 weeks by 500 mg/dose twice daily to
recommended dose of 1,500 mg twice daily.
Myoclonic seizures with juvenile myoclonic epilepsy, adjunct
≥12 yr IV, Oral (immediate release): Initial 500 mg twice daily, ↑ dose/2 weeks by 500
mg/dose twice daily to recommended dose of 1,500 mg twice daily.
IV High-dose in children with acute seizure exacerbation in intractable epilepsy15
IV Dosing scenario in the clinical trial
day 1: 30 mg/kg / 8 hr on (90 mg/kg/day),
day 2: 30 mg / 6 hr on (120 mg/kg/day)
day 3: 30 mg/4 hr on (180 mg/kg/day), while continuing each dose at 30 mg/kg.
day 4: with close monitoring of effect & adverse effect the dose was further titrated up to the
optimal dose for seizure control, continuing at interval of / 4 hr, but increasing each dose.
Doses mean range was 228 ± 48 mg /kg /day
well tolerated dose range: 115 – 227 mg /kg /day without adverse events
Dose adjustment3 Renal impairment: Infants, Child & Adolescents: IV, Oral (immediate-release, oral sol.)
GFR <50 mL/min/1.73 m2: Administer 50% of the dose
Augmented renal clearance (CrCl >130 mL/min/1.73m2): no -specific recommendations for
pediatrics, based on adult pharmacokinetic studies, dose adjustment may be necessary.
Extended release: no adjustment provided for adolescent but adult data recommend dose
adjustment in renal dysfunction
IHD: Dialyzable(50%):IV, Oral (immediate-release) Use 50% of normal dose/24 hr, a
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supplemental dose after hemodialysis is recommended
Extended release: use Not recommended based on adult data
PD, CRRT: IV, Oral (immediate-release) Administer 50% of the dose.
Extended release: use Not recommended based on adult
(monitor closely in CRRT for response & adverse events)
Hepatic Impairment: No Pediatric dosage adjustment necessary
3
Preparation IV: prepare 1 ml + 9 ml in NS, LR, D5W = 10 mg/ml conc (max. conc: 15 mg/mL)
Neonate, concentrations 20 mg/mL in NS may be used
Age ≥6 months: 50 mg/mL in D5W, NS has also been safely used
Administration3 IV: Neonates: Conc. ≤15 mg/mL: Infuse over 10 – 15 min (use 10 mg/ml)
Conc. of 20 mg/mL: Infuse at a rate 1 mg/kg/min
IV: Infant, Child & Adolescent: Conc. ≤15 mg/mL: over 15 min (use 10 mg/ml)
in status epilepticus the rate is: 2 – 5 mg/kg/min
≥6 months Conc. 50 mg/mL infused over 5 – 10 min (with doses up to 60 mg/kg or 4,500 mg)
via a peripheral line reported.
Oral : administer without regard to meal (Oral sol : administered with calibrated syringe)
Oral immediate release tablet preferred to be swallowed whole however may be crushed
and mixed with applesauce to mask its bitter taste.
Adult use 500 mg tablet mixed in 10 ml water shaken for 5 mins to disperse
Extended-release tablets: Swallow tablets whole, do not break, crush or chew
Stability3 Store intact ampoules at max 30 ° C1
Use immediately, discard unused portion
CVS: ↑ BP (diastolic)
GIT: Vomiting
CNS: Behavioral problems (anger, anxiety, apathy, neurosis, personality disorder, drowsiness,
headache, irritability, psychotic symptoms
Respiratory: Nasopharyngitis
1% - 10%:
GIT: Anorexia, constipation, ↓appetite, diarrhea, gastroenteritis, nausea, abdominal pain
Hematologic: Bruise, eosinophilia
Infection: Influenza
CNS: Aggressive behavior, agitation, anxiety, ataxia, altered gait, confusion, depression, emotional
liability, vertigo, dizziness, falling, insomnia, lethargy, mood changes, paranoid ideation, sedation
Neuromuscular & skeletal: Arthralgia, joint sprain, neck pain
Ophthalmic: Conjunctivitis, diplopia
Otic: Otalgia
Respiratory: Cough, nasal congestion, pharyngitis, pharyngolaryngeal pain, rhinitis, sinusitis,
Others: Head trauma
Hematologic: ↓ Hct &hemoglobin, leukopenia, lymphocytosis, neutropenia
Postmarketing:
Dermatologic: AGEP, alopecia, eczema, erythema multiforme, maculopapular rash, SJS,TEN
Endocrine & metabolic: Hyponatremia, weight loss
GIT: Pancreatitis
Hematologic : Agranulocytosis, pancytopenia (sometimes with bone marrow suppression),
thrombocytopenia
Hepatic: Hepatic failure, hepatitis
Immunologic: DRESS
CNS: impaired Balance, choreoathetosis, disturbed attention, impaired memory, myasthenia,
panic attack, suicidal ideation/tendencies
Neuromuscular & skeletal: Dyskinesia, myalgia
Ophthalmic: Blurred vision
Renal: Acute kidney injury, granulomatous interstitial nephritis
Contraindications Hypersensitivity (eg, anaphylaxis, angioedema) to any component of the formulation.
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ß-adrenergic agonist
Adrenaline
Trade name Adrenaline/adrenamax
Active drug Adrenaline (L- epinephrine) (not equivalent to racemic epinephrine)
Dosage form Ampoule 1 mg /ml (1:1,000) for IV, IM
Mechanism of action ß-adrenergic agonist increases cardiac output, heart rate –action is dose dependent
Indications Cardiac arrest reversal, anaphylaxis, resuscitation, emergency hypotension & bradycardia.
Dose Neonate 4
Hypotension, Persistent Bradycardia Prevention of Arrest
IV/IO central (Low – dose): 1 mcg/kg (in ↓ BP or HR with a pulse). May repeat/5 – 10 min ±
alternative therapies
may be followed by 0.01 – 0.2 mcg/kg/min
Resuscitation and severe bradycardia
IV: (use 1+9 dilution in direct IV)3 0.01 – 0.03 mg/kg (10 – 30 mcg/kg) then flush with 0.5 –
1 mL NS3,4, may repeat /3 – 5 min as Needed3
Continuous IV infusion: Start: 0.1 mcg/kg/min & adjust to response, (max 1 mcg/kg/min)
Endotracheal (use 1+9 dilution in endotracheal)
0.05 – 0.1 mg/kg (50 – 100 mcg/kg) with several positive pressure ventilations4 may repeat
/3 – 5 min as needed3 until response or IV access available
Do not administer these higher doses IV.
Septic Shock, Fluid-Refractory, Dopamine-Resistant
IV continuous infusion 0.05 – 0.3 mcg/kg/min IV 4
In acute Hypotension5: may start at Initially 0.01mcg/kg/min, adjusted according to
response, higher doses up to 1.5 mcg/kg/min have been used
Higher doses up to 2.6 mcg/kg/min were reported 3
Asystole or pulseless arrest, Bradycardia
IV,IO: 0.01 mg/kg (of 1+9 ml dilution) max dose: 1 mg/dose, repeat/3 – 5 min till response*
Endotracheal: (not the preferred route): 0.1 mg/kg (of 1mg/ml conc), max: 2.5 mg/dose,
repeat/3 – 5 min till response* or IV/IO access established.
In bradycardia, endotracheal doses up 0.2mg/kg may be used, repeat/3 - 5 min as needed
*Response = return of spontaneous circulation.
In pulseless arrest give immediately after initiating CPR (within 5 min of starting chest compressions)
Dose <0.3 mcg/kg/min produce ß– effect, & > 0.3 mcg/kg/min produce α– vasoconstriction
Cardiac output ↑ or maintenance/post-resuscitation stabilization:
Continuous IV or IO infusion: 0.05 – 1 mcg/kg/min (doses <0.3 mcg/kg/min generally
produce beta-adrenergic effects)
Hypotension/shock, fluid-resistant:
Continuous IV or IO infusion: 0.1 – 1 mcg/kg/min (up to 1.5 mcg/kg/min)5
Hypersensitivity reaction/Anaphylaxis
IM: (preferred route): 0.01 mg/kg/dose (Use 1 mg/mL solution)
Max: Prepubertal child: 0.3 mg/dose – adolescent: 0.5 mg/dose, give dose/5 – 15 min up to
3 doses, but more doses may be needed.
Refractory: IV 0.1 mcg/kg/min titrate to response (range 0.1– 1 mcg/kg/min), max. 10
mcg/min (use dilution 1,000mcg/1,000ml)
Alternate dosing IM 5 (of 1mg/ml) infant < 6 months: 100 – 150 mcg/dose
≥ 6 months – 5 yr: 150 mcg/dose
5 – 11 yr: 300 mcg/dose
12 – 17 yr: 500 mcg/dose
Dose may be repeated after 5 min5, in life threatening state & no response to previous
adrenaline doses, administer further doses /5 mins until critical care specialist available
Croup 5 nebulization
1 month – 11 yr: 0.4 mg/kg (max.5 mg/dose), repeated after 30 min if necessary
Effect of nebulized adrenaline lasts for hours and requires monitoring for 2 – 3 hr
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Dose adjustment3 Altered Kidney Function/Hepatic Impairment: Pediatric: no adjustments provided
3
Preparation Direct IV or IO (arrest settings) Dilute to a 0.1 mg/mL (1+9ml)
Continuous IV infusion: Must be diluted to max conc. 64 mcg/mL in D5W (preferred) or NS
1 ml of adrenaline contains 1000 mcg
max recommended conc. 64mcg/ml5
Some centers prepare 3 ml (3000 mcg) diluted to 50 ml D5W (Conc: 60 mcg/ml)4,5
In neonates: standard conc. 10 mcg/mL may be recommended( 1x100 ml)
Other usual conc for neonate & pediatric: 16, 32, 64 mcg/ml
References suggest 100, 200, 700 mcg/ml are used by some institutions in pediatrics4
ET: in pediatric dilute dose (from 1 mg/ml) in 1 – 5 mL NS 21
In neonate : use 1ml + 9 ml dilution
Nebulization may dilute dose in small volume of NS 5
Administration3 Endotracheal: lower conc. may produce transient ß2 – effects which may be detrimental
(eg, hypotension, lower coronary artery perfusion pressure).
IM: in the anterolateral aspect of the middle third of the thigh5
IV infusion conc.: 10, 16, 32, or 64 mcg/mL via infusion pump, (central line preferred)
Vesicant: avoid extravasation, ensure proper catheter insertion (severe ischemic necrosis)
Ankle veins not recommended (potential for gangrene)
Avoid leg veins in patients with vascular occlusive disease
Stability Store ampoules at max 30 ° C, protect from light1
Adrenaline is light sensitive (pink and brownish discoloration indicates degradation) &
protecting infusion from light may be recommended2
Discolored solution must be discarded
CVS: Angina pectoris, cardiac arrhythmia, cardiomyopathy (stress), cerebrovascular accident,
chest pain, HTN, ↑ cardiac work, ischemic heart disease, limb ischemia, localized blanching,
myocardial infarction, palpitations, peripheral vasoconstriction, SVT, tachyarrhythmia,
vasoconstriction, ventricular arrhythmia/fibrillation, ventricular ectopy
CNS: Anxiety, apprehension, cerebral hemorrhage, disorientation, dizziness, drowsiness,
exacerbation of Parkinson disease, headache, memory impairment, panic, paresthesia,
psychomotor agitation, restlessness, tingling sensation
Dermatologic: Diaphoresis, skin/tissue gangrene (at injection site), pallor, piloerection
Endocrine & metabolic: Hyperglycemia, hypoglycemia, hypokalemia, insulin resistance, lactic
acidosis
Local: Tissue necrosis at injection site
Neuromuscular & skeletal: Asthenia, tremor
Respiratory: Dyspnea, pulmonary edema, rales
Contraindications There are no absolute contraindications to the use of injectable epinephrine
Dopaminergic & adrenergic agonist

Dopamine
Trade name Dopasunny/Dopamine
Active drug Dopamine
Dosage form Ampoule 200 mg /5 ml for IV Infusion
Mechanism of action lower doses mainly dopaminergic stimulant cause renal & mesenteric vasodilation, higher
doses are dopaminergic &beta1-adrenergic stimulant cause cardiac stimulation &renal
vasodilation, large doses stimulate α-receptors
Indications Treatment of hypotension or shock (eg, septic shock, cardiogenic shock, decompensated
heart failure, post cardiac arrest) that persists after adequate fluid volume replacement
Dose Neonate 3,4
Hemodynamic support: Continuous IV or IO infusion: 2 – 20 mcg/kg/min Start low and
titrate gradually by (5 – 10 mcg) 3 till optimal response
121
(start at < 10 mcg for fluid refractory chock)4
Pediatric 3
titrate gradually (5 – 10 mcg) till optimal response
Dose adjustment Altered Kidney Function/Hepatic Impairment: Pediatric: no adjustments provided
3
Preparation For IV continuous infusion: Dilute with NS, D5W
Neonate 1600, 3200 mcg/ml
Child: 800, 1600, 3200 mcg/ml & as high as 6000 mcg /ml
1 ml of dopamine = 40,000 mcg
Dilute as follows: 1 ml diluted to 50 ml (1x50) = 800mcg/ml
1 ml diluted to 25 ml (1x25) = 1600 mcg/ml
1 ml diluted to 12.5 ml( 1x12.5) = 3200 mcg/ml
1 ml diluted to 6.6 ml (1 x 6.6)= 6000mcg/ml
Administration Continuous IV infusion only, Via infusion pump in central line, peripheral IV line in a large
vein or via intraosseous access until central access is available
Vesicant: avoid extravasation
Stability Store ampoules at 15 – 30 ° C, Protect from light.1
Diluted in a compatible solution: Stable for a minimum of 24 hr. Avoid simultaneous
administration with alkalies (including sodium bicarbonate), Iron, oxidizing agents 2,3
CVS: Angina pectoris, AF, bradycardia, cardiac conduction disorder, ectopic beats, HTN,
hypotension, palpitations, tachycardia, vasoconstriction, ventricular arrhythmia (wide QRS)
Dermatologic: Peripheral gangrene (with prolonged or high dose, can occur with low doses
with concomitant occlusive vascular disease), piloerection
CNS: Anxiety, headache
Contraindications Hypersensitivity to sulfites (commercial preparation contains sodium bisulfite),
pheochromocytoma, uncorrected tachyarrhythmias, ventricular fibrillation
ß-adrenergic agonist
Dobutamine
Trade name Dobutamine Hameln
Active drug Dobutamine
Dosage form Ampoule 250 mg/ 20 ml for IV infusion
Mechanism of action Stimulates myocardial β1- receptors primarily by (+) enantiomer, some α1-receptor agonism
by (-) enantiomer causing ↑ contractility & HR, stimulates β1, α1 receptors in vasculature.
Indications Short-term management of cardiac decompensation due to ↓contractility
Dose Neonate 4
titrate gradually/few mins3 till optimal response (as low as 0.5 – 1mcg/kg/min used) 3.5
Pediatric 3
titrate gradually /few mins till optimal response(as low as 0.5-1mcg/kg/min used)3.5
Dose adjustment Renal/Hepatic Impairment: Pediatric: no dosage adjustments described for pediatrics
3
Preparation For continuous infusion: dilute in D5W, D10W, NS to a 1000, 2000 mcg/ml, 4000 mcg/mL
(neonate & pediatric) , max conc. 5000 mcg/ml for pediatrics
1 ml of Dobutamine = 12,500 mcg
Dilute as follows:
1 ml diluted to 12 ml (1x12) ≈ 1000mcg/ml (standard for pediatric)
1 ml diluted to 6 ml (1x6) ≈ 2000 mcg/ml (standard for neonate , pediatric)
1 ml diluted to 3 ml( 1x3) ≈ 4000 mcg/ml (standard for pediatric)
122
1 ml diluted to 2.5 ml( 1x2.5) = 5000 mcg/ml (max for pediatric-not for neonate)
3
Administration Continuous IV infusion Via infusion pump in central line, peripheral IV line in a large vein
or via intraosseous access until central access is available
Vesicant: avoid extravasation
Stability Intact ampoule Store ampoules at 25° C, Protect from light.1
Diluted for infusion: use within 24 hr. Avoid simultaneous administration with alkalies
(including sodium bicarbonate) 3,4
Pink discoloration may indicate insignificant decomposition (direct exposure to
phototherapy and sunlight must be avoided)
CVS: ↑ heart rate, ↑ systolic blood pressure, ventricular premature contractions, angina
pectoris, chest pain, palpitations
CNS: Headache
GIT: Nausea
CVS: Hypotension, ventricular ectopy
Endocrine & metabolic: ↓Sr.potassium
<1%, postmarketing, and/or case reports: Cardiomyopathy (stress), eosinophilia,
hypersensitivity reaction, localized phlebitis
Contraindications Hypersensitivity to sulfites (if commercial preparation contains sodium bisulfite),
pheochromocytoma, uncorrected tachyarrhythmias, ventricular fibrillation
α- adrenergic agonist
Noradrenaline
Trade name Levophrine
Active drug Noradrenaline
Dosage form Ampoule noradrenaline 4 mg /4 ml (8 mg noradrenaline bitratrate = 4 mg noradrenaline)
Mechanism of action Stimulates α- receptors & β 1-adrenergic causing ↑ HR, contractility & vasoconstriction,
increases systemic coronary blood flow, α effects are greater than β effects
Indications Treatment of severe, acute hypotension, shock and in neonates with persistent pulmonary
hypertension (PPHN)–induced circulatory failure
Dose Neonate 3
Septic shock (Term , preterm)
Continuous IV: initial 0.02 – 0.1 mcg/kg/min, titrate to effect
Usual Max. dose: 1 – 2 mcg/kg/min3. higher doses may be needed4
Circulatory failure (pulmonary hypertension, persistent [PPHN] induced),refractory3
GA ≥ 35 weeks Continuous IV: 0.02 – 0.5 mcg/kg/min, titrate to effect
max dose: 1.5 mcg/kg/min (up to 3.3 mcg/kg/min reported).
Pediatric 3
Hypotension/shock, fluid-resistant:
Continuous IV, IO: 0.05 – 0.1 mcg/kg/min titrate to effect
Usual max. dose: 2 mcg/kg/min higher doses may be needed
Dose adjustment3 Altered Kidney Function/Hepatic Impairment: Pediatric: no adjustments provided
3
Preparation Continuous IV infusion: Must be Diluted with D5W or NS (NS not preferred)
1 ml of noradrenaline = 1,000 mcg
Dilute as follows:
1 ml diluted to 62.5 ml(1x62.5) = 16 mcg/ml
1 ml diluted to 31 ml (1 x31 )= 32mcg/ml
1 ml diluted to 16 ml (1 x16)= 64 mcg/ml
Conc. 100 mcg/ml reported in some references4
Administration3 Continuous IV infusion Via infusion pump in central line, peripheral IV line in a large vein or
via intraosseous access until central access is available
123
Vesicant, ensure proper catheter placement prior to & during infusion, avoid extravasation
Stability Store ampoules at 30 ° C1 , Protect from light.3
Clear and colorless, Discolored solution should be discarded
Diluted sol. Diluted solution used within 24 hr. Protect from light 2
CVS: Bradycardia, cardiac arrhythmia, cardiomyopathy, peripheral vascular insufficiency
CNS: Anxiety, transient headache
<1%, postmarketing/case reports: Peripheral gangrene, peripheral digital ischemia
Contraindications No absolute contraindications
ß-adrenergic receptor blocker

Propranolol
Trade name Myestrotens
Active drug Propranolol
Dosage form Ampoule 1mg/ml
Mechanism of action Non-selective β-adrenergic receptor blocker slows HR and decreases BP
Indications Supraventricular arrhythmias (atrial fibrillation & flutter, AV nodal re-entrant tachycardias)
ventricular tachycardias (catecholamine-induced arrhythmias, digoxin toxicity),also used
for tetralogy of Fallot cyanotic spells, short-term adjunction therapy of thyrotoxicosis
Dose Neonates 4
Hypertension & Tachyarrhythmias
Oral Starting with: 0.25 – 1 mg/kg/6 hr, increase as needed to max. 3.5 mg/kg/6 hr.
IV Starting: 0.01 mg/kg/6 hr over 10 min, increase as needed max. 0.15 mg/kg/6 hr
(effective dosage vary significantly)
Infantile Hemangiomas (approved in age≥ 5 weeks)4,3 wt ≥2 kg3
Oral (Optimal maintenance dose, timing, and duration have not been established)
Week 1: 0.6 mg/kg twice daily (at least 9 hr apart)
Week 2: 1.1 mg/kg/twice daily
Week 3: 1.7 mg/kg/dose twice daily x 6 months. (Adjust dose when child's weight ↑↑)
May re-initiate if recur: dose 2.3 – 3.4 mg/kg/day was recommended
Continue till full lesion involution or till 1 yr of age, typically until at least 8 – 12 months of
age (treatment duration of 3 – 12 months)
Recurrences reported with early discontinuation of therapy
Tapering periods have ranged from 2 weeks – 1 month
Thyrotoxicosis/Congenital hyperthyroidism3
Oral immediate release: 0.5 – 2 mg/kg/day divided/6 –12 hr (higher doses may be needed)
IV5: 20 – 50 mcg/kg/6 – 8 hr over 10 min ( adjust acc to response)
Tetralogy of Fallot5
Oral: 0.25 – 1 mg/kg/ 8 – 12 hr, (max. 2 mg/kg/8hr)
IV: slow injection, initially 15 – 20 mcg/kg (max 100 mcg/kg) slow IV,
then 15 – 20 mcg/kg/12hr if needed with monitoring of ECG
Arrythmias5
Oral: 0.25 – 0.5 mg/kg/8 hr (adjusted acc to response)
IV: 20 – 50 mcg /dose, then 20 – 50 mcg/kg/6 – 8 hr if required with monitoring of ECG
Infants, children and adolescents
Hypertension
Oral:
Child ≤17 yr3: Immediate release: Initial: 1 – 2 mg/kg/day divided into 2 – 3 doses, titrate
to effect max 4 mg/kg/day up to 640 mg/day (sustained-release may be dosed once daily
(Higher max. dose of 16 mg/kg/day up to 640 mg/day suggested)
Alternate dosing 5
1 month – 11 yr 0.25 – 1mg/kg/8hr (↑ gradually /week to 5mg/kg/day divided)
12 – 17 yr:80 mg/12 hr,↑ when needed gradually /week to 160 – 320 mg /day divided
124
unless using slow release formulations
Tachyarrhythmias
Oral3 immediate release: Initial: 0.5 – 1 mg/kg/day divided/6 – 8 hr. Titrate /3 – 5 days,
usual daily dose of 2 – 4 mg/kg/day
Higher doses may be needed, max. 16 mg/ kg/day or 60 mg/day
IV3: 0.01 – 0.15 mg/kg/Dose slow IV over 10 min may repeat /6 – 8 hr
Max. infant : 1 mg/dose
Max. child and older: 3 mg/dose
Alternate dosing5
Oral: 0.25 – 0.5 mg/kg/6 – 8 hr/day (max. 1 mg/kg/6 hr or 160 mg/day)
IV: Slow injection: 25 – 50 mcg/kg then 25 – 50 mcg/ 6 – 8 hr if needed
Thyrotoxicosis3
Infant, child Oral: Immediate release: 0.5 – 2 mg/kg/day divided / 8 hr3, max. 40 mg/dose
Adolescent 10 – 40 mg/6 – 8 hr3
Alternate dosing for hyperthyroidism with autonomic symptoms/Thyrotoxicosis 5
Child Oral: 0.25 – 0.5 mg/kg/8 hr5 (up to 1mg/kg/8 hr), max. 40 mg/8hr
IV5: 25 – 50 mcg/kg/6 – 8 hr over 10 min (max. 5mg dose)
Tetralogy of Fallot5 1 month – 11yr:
Oral: 0.25 – 1 mg/kg/ 6 – 8 hr, max. 5 mg/kg/day in divided doses
IV slow: initial: 15 – 20 mcg/kg (max 100 mcg/kg) then 15 – 20 mcg/kg /6-8hr
Essential tremors3 Child & adolescent 3
Oral Immediate release: Initial: 0.5 – 1 mg/kg/day divided/8 hr max. 4 mg/kg/day
Thyroid storm3
Infant, child Oral: Immediate release: 1 – 4 mg/kg/day divided, titrate to HR, BP
Adolescent Oral 20 – 40 mg/4 – 6 hr3 (titrate, as high as 60 – 80 mg/4hr recommended)
IV: 0.5 – 1 mg over 10 min (intervals not defined )
Infantile Hemangiomas 5 child (use 5mg/5 ml oral sol
Initially: 1 mg/ kg/day divided into 3 doses, ↑dose after 24 hr to 2 mg/kg/day divided into
2 – 3 doses. Review treatment after 3 month & adjust act to weigh gain
For PHACES, segmental infantile hemangioma & other comorbidities max 3 mg/kg/day
Alternate dosing3
1 mg/kg/day in 2 – 3 doses
↑weekly by 1 mg/kg/day to usual daily maintenance dose: 1 – 3 mg/kg/day in 2 – 3 doses
Tapering over 1 – 3 weeks to prevent rebound sinus tachycardia
Dose adjustment Renal/Hepatic Impairment: Pediatric: no dosage adjustments provided
Not dialyzable, use with caution in renal impairment and in hepatic impairment
Preparation IV: undiluted3
Or 4,5: Dilution 1 mg/1 ml
1 + 9 ml NS,D5W
Oral: not available and may be prepared from tablets by soaking 10 mg propranolol
hydrochloride tablet in 10 mL water for 1 min then crush well, mix & withdraw dose from
the unfiltered solution is 20
Administration IV: Administer undiluted by slow IV injection/infusion over 10 min (not exceed 1mg/min)5
Oral: immediate release taken on empty stomach
Stability Store ampoules at max 30 ° c , protect from light1
Any unused portion should be discarded immediately after preparation
However diluted sol. Is chemically stable for 24 hr at room temp, protected from light3
Oral prepared mix: discard any remaining immediately
Adverse reactions >10%: CNS: Sleep disorder
Respiratory: Bronchiolitis (infants), bronchitis
1% - 10%: CVS: Cold extremity
GIT: Abdominal pain, constipation, ↓appetite, diarrhea
CNS: Agitation, dizziness, drowsiness , fatigue, irritability , nightmares
<1%: CVS: Second-degree atrioventricular block
Dermatologic: Alopecia, urticarial,
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Postmarketing: CVS: AMI (with withdrawal), arterial insufficiency, arterial mesenteric
thrombosis, complete AV block, exacerbation of angina pectoris (with withdrawal), first-degree
AV block, heart failure, HTN (with withdrawal), hypotension, peripheral arterial disease,
Raynaud disease, tachycardia (with withdrawal)
Dermatologic: Dermal ulcer, dermatitis, erythema multiforme, exfoliative dermatitis,
psoriasiform eruption, purpuric rash, SJS, TEN
Endocrine & metabolic: Hypoglycemia, ↑ Sr.potassium
GIT: Abdominal cramps, epigastric discomfort, ischemic colitis, nausea, sore throat, vomiting
Genitourinary: Peyronie disease, sexual disorder
Hematologic: Agranulocytosis, immune thrombocytopenia, nonthrombocytopenic purpura
Hepatic: ↑ ALP, ↑ Sr. AST
Hypersensitivity: Anaphylaxis, nonimmune anaphylaxis
CNS: Asthenia, depression, emotional liability, generalized pain, hallucination, insomnia,
lassitude, memory impairment, tingling of extremities, vivid dream, withdrawal syndrome
Neuromuscular & skeletal: Laryngospasm, lupus-like syndrome, myopathy, myotonia
Ophthalmic: Dry eye syndrome, oculomucocutaneous, visual disturbance
Respiratory: Bronchospasm, dyspnea pharyngitis, respiratory distress
Other: Fever
Contraindications Hypersensitivity to propranolol, beta-blockers, or any component in formulation
cardiac :Uncompensated heart failure (unless the failure is due to tachyarrhythmias being
treated with propranolol), cardiogenic shock, severe sinus bradycardia, sick sinus
syndrome, heart block > 1st degree (except in functioning artificial pacemaker)
Bronchial asthma.
Long acting sympathomimetic

Ephedrine
Trade name Ephedrine
Active drug Ephedrine sulfate 25 mg/ml (Ephedrine sulfate 10 mg = ephedrine base 7.6 mg)
Dosage form Ampoule 1 ml for IV, IM, Subcutaneous
Mechanism of action Releasing tissue stores of norepinephrine causing α & ß receptors stimulation, longer -
acting and less potent than epinephrine
Indications Anesthesia induced hypotension
Dose Hypotension, anesthesia-induced: (Limited data)
Slow IV push: 0.1 – 0.3 mg/kg/dose, use the lowest effective dose
Ephedrine hydrochloride is not available: doses of both sulfate or hydrochloride salt are
very different & cannot be interchangeable
Dose adjustment Renal impairment: no adjustments provided for Pediatric or adult, use with caution.
Elimination may be delayed, monitor carefully.
Hepatic Impairment: no dosage adjustments provided in Pediatric or adult.
Preparation2 IV: 1ml + 4 ml NS or D5W in PP syringe
Administration IV slow injection over few min
Storage Store ampoules at 25 ° C, discard immediately after opening
Adverse reactions Postmarketing: CNS: Dizziness, restlessness
CVS: Bradycardia, hypertension (reactive), irregular pulse (RR interval variability), palpitations,
tachycardia, ventricular ectopy
Others: Tachyphylaxis
Contraindication Allergic reaction to ephedrine or any component of the formulation, concurrently with or
within 2 weeks of discontinuing a monoamine oxidase inhibitor
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Cardiac glycoside, antiarrhythmic
Digoxin
Trade name Cardixin
Active drug Digoxin
Dosage form Ampoule 500 mcg/2 ml for IV
Mechanism of action In heart failure: Inhibition of the Na/k ATPase pump in myocardial cells causing transient
↑of intracellular Na promoting Ca influx via Na/Ca exchange pump leading to ↑contractility
Indications Therapy of mild - moderate heart failure, chronic AF (rate-control). fetal tachycardia with
or without hydrops, slow ventricular rate in SVTs excluding AV reciprocating tachycardia
Dose Neonate 4 Give Loading Dose only in acute CHF, Arrhythmia 4
Loading Maintenance
mcg/kg/total dose Dose/ interval
PMA IV Oral
IV Oral
(weeks) Divide/8hr Divide/8hr
≤29 15 20 4 mcg/kg/24 hr 5 mcg/kg/24 hr
30 – 36 20 25 5 mcg/kg/24 hr 6 mcg/kg/24 hr
37 – 48 30 40 4 mcg/kg/12 hr 5 mcg/kg/12 hr
≥ 49 40 50 5 mcg/kg/12 hr 6 mcg/kg/12 hr
Alternate dosing3
Total Loading/day (on lean wt) Maintenance Dose
give 50% of total dose first, & divide (on lean wt)
3
remaining in two doses at 6–8 hr interval mcg/kg/day
IV Oral IV Oral
neonate
mcg/kg mcg/kg Divide /12 hr Divide /12 hr
preterm 15 – 25 20 – 30 4–6 5 – 7.5
Full term 20 – 30 25 – 35 5–8 8 – 10
Body weight based – dosing 5
IV Oral
Loading Maintenance Loading Maintenance
Body weight
mcg/kg/day mcg/kg/day mcg/kg/day mcg/kg/day
(kg)
Divide/8 hr Divide/12–24 hr Divide/8 hr Divide /12–24 hr
<1.5 20 4–6 25 4–6
1.5 – 2.5 30 4–6 30 4–6
≥2.6 35 10 45 10
Daily Loading dose (optional) 3 must be divided into 3 doses over first 24 hr5
May give 50% of total dose first, then divide remaining /two doses at 6–8 hr interval3
Age Oral (mcg/kg/ day) IV (mcgkg/ day)
1 month – 1 yr 45 35
2 – 4 yr 35 35
5 – 9 yr 25 (Max 750mcg/day) 25 (max. 500 mcg/day)
10 – 17 750 – 1500 mcg/day 500 – 1000 mcg/day
Daily maintenance dose divided into 1 – 2 doses over 24 hr5
Age oral IV
1 month –1 yr 10 mcg/kg 10 mcg/kg
2 – 4 yr 10 mcg/kg 10 mcg/kg
5 –9 yr 6 mcg/kg(Max 250mcg/day) 6 mcg/kg (max. 250 mcg/day)
10 –17yr 62.5 – 250 mcg */day 62.5 – 250 mcg*/day
* higher doses may be necessary
Switching from oral to IV: doses should be reduced by 20 – 25%
127
Alternate dosing in heart failure 3
Daily Loading dose (optional) 3 Daily Maintenance Dose

give 50% of total dose first, & divide If ≤10 years divide/12 hr
remaining in two doses at 6–8 hr If >10 years give/24hr
3
interval (mcg/kg/ day) (mcg/kg/day)
Age Orl IV ral IV
1– 23 month 35 – 60 30 – 50 10 – 15 9 – 15
2 – 5 yr 30 – 45 25 – 35 8 – 10 6–9
5 – 10 yr 20 – 35 15 – 30 5 – 10 4–8
˃10 yr 10 – 15 8 – 12 2.5 – 5 2–3
Dose adjustment Renal impairement: Infants, Children & Adolescents: Oral, IV3:
Digitalizing (loading) dose : No adjustment described for pediatrics, 50% - 70% excreted
unchanged in urine so based on recommendations for adults:
ESRD: Reduce usual dose by 50%
Maintenance dose: following adjustments have been recommended
GFR >50 mL/min/1.73 m2: No dosage adjustment necessary3,5
GFR: 30 – 50 mL/min/1.73 m2: 75% of normal dose at normal intervals3
GFR: 10 – 29 mL/min/1.73 m2: 50% of normal dose & intervals3,5 or normal dose/36 hr3
GFR: <10 mL/min/1.73 m2: 25% of normal dose & intervals3,5 or normal dose/48 hr3
IDH, PD: Non dialyzable (0% - 5%): 25% of normal dose & intervals or normal dose/48 hr3
CRRT: 75% of normal dose at normal intervals, titrate to desired effect, monitor sr. conc.3
Hepatic Impairment: no dosage adjustments necessary 3
Preparation IV: may be used undiluted3
Or Diluted (1 + 4 ml = 50 mcg/ml D5W, D10W, NS or SWFI) or to 20 mcg (1+24 ml)4
Must dilute with at least 4 folds to retain drug solubility (Conc. ≥ 1+ 3 ml NS, D5W, D10W)4
Conc. ≥ 1+ 3 ml in NS, D5W, D10W,SWFI is compatible 3,4
Administration3 Neonate: Over 15 – 30 min at conc. 20 or 100 mcg/ml
Pediatric IV over ≥5 min (usually 5 – 10 min) avoid rapid IV infusion since this may result in
systemic and coronary arteriolar vasoconstriction 3,4
Vesicant, ensure proper needle or catheter placement, avoid extravasation
IM: undiluted but not recommended (tissue damage and intense pain)
Oral: Administer consistently with relationship to meals, avoid concurrent administration
with meals high in fiber or pectin and with drugs that decrease oral absorption of digoxin.
(administer digoxin 1 hour before or 2 hours after)
Stability1,3 Ampoules Stored at 15 – 30 ° C , protect all dosage forms from light
Use immediately after preparation, discard any remaining
CVS: Accelerated AV junctional rhythm, asystole, atrial tachycardia AV
dissociation/complete block, ST depression /P-R prolongation on ECG, 1st degree AV block,
2nd degree AV block, ventricular fibrillation/ tachycardia/premature contractions
Dermatologic Skin rash: bullous, erythematous, maculopapular/papular, scarlatiniform,
vesicular
Endocrine & metabolic: Gynecomastia
GIT: Abdominal pain, anorexia, diarrhea, intestinal necrosis (hemorrhagic), mesenteric
ischemia, nausea, vomiting.
Hematologic: Thrombocytopenia
CNS: Altered mental status, anxiety, apathy, confusion, delirium, depression, dizziness,
hallucination, headache, lethargy
Ophthalmic: Blurred vision, visual disturbances (blurred or yellow vision)
Contraindications Hypersensitivity to digoxin, other forms of digitalis, or any component of the formulation,
ventricular fibrillation
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Class III Anti-arrhythmic
Amiodarone
Trade name Amirone
Active drug Amiodarone
Dosage form Ampoule 150 mg /3ml
Mechanism of action Inhibits adrenergic receptors (α- & ß-blocking), affects Na+, K+ & Ca+2 channels, prolongs the
action potential & refractory period in myocardial tissue, decreases AV conduction and
sinus node function
Indications Hemodynamically unstable VT unresponsive to other therapy, VF and VT
Dose Neonate 3
Supraventricular and ventricular arrhythmias
IV Infusion: initial 5 mg /kg over 30 min, then 5 mg/kg /12 – 24 hr over 30 min
Alternate dosing 3
Loading 5 mg /kg over 20 – 60 min may repeat to max total initial load 10 mg/kg
Total daily bolus 15 mg/kg/day
Maintenance (If needed): 5 mcg/kg/min, titrate as needed up to 15 mcg/kg/min (10 – 20
mg/kg per 24 hr)
Ventricular fibrillation or pulseless ventricular tachycardia refractory to defibrillation
IV, IO injection: initial 5 mg/kg over 3 min at least, repeat once if needed5, some references
suggest to repeat twice if needed to max 15 mg/kg 3
Infant child & adolescent 3
Perfusing tachycardia
Loading 5 mg/kg over 20 – 60 min, max 300 mg/dose, may repeat twice (max total 15
mg/kg in acute treatment)
Ventricular fibrillation or pulseless ventricular tachycardia refractory to defibrillation
IV, IO injection: initial 5 mg /kg over 3 min at least (max 300 mg/dose), repeat once if
needed5, some references suggest to repeat twice if needed to max 15 mg/kg3
Supraventricular and ventricular arrhythmias
Loading 5 mg /kg over 60 min (max 300 mg/dose), may repeat to max total initial load 10
mg/kg & total daily bolus 15 mg/kg/day
Maint. (If needed) 5 mcg/kg/min, titrate as needed up to 15 mcg/kg/min (max 2.2 g/day)
Dose adjustment Renal impairment No adjustments provided, pharmacokinetic data implies that adjustment
isn't necessary, monitor closely in renal patient especially with left ventricular dysfunction.
Peritoneal & Hemodialysis: Not dialyzable, supplemental dose is not necessary
Hepatic Impairment
Baseline: no adjustment provided, closely monitor specially in ventricular dysfunction.
Hepatoxicity during therapy: no adjustments provided (based on adult data): adjust or
discontinue if liver enzymes > 3 times normal or double in patient with elevated baseline
Pulmonary toxicity (reversible following early withdrawal of amiodarone)
If new or progressive shortness of breath or cough develops in patients taking amiodarone
(or recently stopped), pulmonary toxicity should always be suspected.
Corneal microdeposits (reversible on withdrawal of treatment).
If vision is impaired or if optic neuritis or neuropathy occur, amiodarone must be stopped
Preparation Must be diluted before IV use.
Use D5W only for dilution
Usual conc. 1.5 mg /ml4 (1 ml x 33 ml D5W), Or 1.8mg/ml (1 x 28 ml)
Vesicant: ensure proper needle or catheter placement. Avoid extravasation.
peripheral infusions >3 mg/mL in D5W associated with increased phlebitis
Max. Conc. for IV infusion: 6 mg/mL.
Conc. ≤ 2.5 mg/ml (dilute to ≥ 1 ml x 20 ml) may be less irritating.
Infusion for >2 hr must be prepared in a non-PVC container (eg, glass or polyolefin).
Administration3 Pulseless VT or VF: undiluted drug may be preferred
Perfusing arrhythmias: must be diluted, central venous administration recommended
129
with conc. >2 mg/mL for infusions >1 hr is recommended
Must be infused via volumetric infusion device, drop counter-infusion sets are inaccurate
PVC tubing is recommended for administration regardless of infusion duration.
IV infusion at slower rates and higher conc. than recommended may result in leaching of
plasticizers (DEHP) from IV tubing which have serious reproductive toxicity effects
Neonates: loading dose over 60 min, may be followed by continuous IV infusion.
Age ≥ 1 month loading dose over 20 – 60 min, may be followed by continuous IV infusion
Stability1 Store intact ampoules at max 30 °C at dry place, protect from excessive heat
Colorless to pale yellowish, don’t use if discolored
1.8 mg/ml in D5W in PVC stable at RT of 24 °C in fluorescent light with ≈ 3% loss in 24 hr2
Cardiovascular: Hypotension (refractory in rare cases)
Ophthalmic: Epithelial keratopathy (98% - 99%)
Respiratory: Pulmonary toxicity (eg. hypersensitivity & interstitial/alveolar pneumonitis)
1% - 10%:
CVS: Bradycardia, cardiac arrhythmia/failure, edema, exacerbation of cardiac arrhythmia,
flushing, prolonged QT interval (associated with worsening arrhythmia), shock, sinus node
dysfunction, torsades de pointes, ventricular fibrillation
Dermatologic: Skin photosensitivity, solar dermatitis, SJS
Endocrine & metabolic: Decreased libido, hyperthyroidism, hypothyroidism
GIT: Abdominal pain, altered salivation, anorexia, constipation, diarrhea, dysgeusia
Hematologic & oncologic: Disorder of hemostatic components of blood
Hepatic: Abnormal hepatic function tests, hepatic disease
CNS: Abnormal gait, altered smell, ataxia, dizziness, fatigue, headache, insomnia, involuntary
body movements, malaise, paresthesia, sleep disorder
Ophthalmic: Blurred vision, visual disturbance, visual halos around lights
Respiratory: ARDS (higher incidence after anesthesia with high FiO2), pulmonary fibrosis
<1%:
Dermatologic: Alopecia, blue-gray skin pigmentation (incidence ↑ to ~8%), skin rash
Hematologic & oncologic: Spontaneous ecchymoses
Hepatic: Hepatic necrosis
Frequency not defined: CVS: Asystole, AV block, cardiogenic shock, VT
Postmarketing:
CVS: Cardiac conduction disorder (including bundle branch block, infra-HIS block, & antegrade
conduction via an accessory pathway), sinoatrial block, vasculitis
Dermatologic: Bullous dermatitis, eczema, erythema multiforme, skin erythema (palmer),
exfoliative dermatitis, TEN, urticaria
Endocrine/metabolic: Myxedema (eg. myxedema coma), SIADH, thyroid nodule, thyrotoxicosis
Gastrointestinal: Cholestasis, pancreatitis (eg. acute pancreatitis), xerostomia
Genitourinary: Epididymitis, impotence, orchitis
Hematologic & oncologic: Agranulocytosis, aplastic anemia, granulocytosis, granuloma (of
bone), hemolytic anemia, immune thrombocytopenia, malignant neoplasm of skin, malignant
neoplasm of thyroid, neutropenia, pancytopenia, thrombocytopenia
Hepatic: Cholestatic hepatitis, hepatic cirrhosis, hepatotoxicity (idiosyncratic)
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, nonimmune anaphylaxis
Immunologic: DRESS
Local: Infusion site reaction (eg, cellulitis, edema, erythema, granuloma, hypoesthesia,
induration, inflammation, pain, phlebitis (IV conc.>3 mg/mL into peripheral), pigment changes,
pruritus, skin sloughing, thrombophlebitis, thrombosis, urticaria
CNS: Delirium, demyelinating disease (polyneuropathy), drug-induced Parkinson's disease,
hallucination, hypoesthesia, increased ICP, intracranial hypertension, myasthenia, peripheral
neuropathy (chronic therapy, partially to completely reversible when discontinued)
Neuromuscular/skeletal: Back pain, lupus-like synd, muscle spasm, myopathy, rhabdomyolysis
Ophthalmic: Corneal deposits, dry eye syndrome, optic neuritis, optic neuropathy
Respiratory: Bronchiolitis obliterans organizing pneumonia, bronchospasm, hemoptysis,
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hypoxia, pleural effusion, pleurisy, pulmonary alveolar hemorrhage, pulmonary infiltrates
Other: Drug-induced phospholipidosis, fever, mass (pulmonary)
Contraindications Hypersensitivity to Amiodarone, iodine, or any component of the formulation, sick sinus
syndrome, second or third-degree AV block, bradycardia leading to syncope without a
functioning pacemaker, cardiogenic shock
Note: caution in patients with severe allergies to shellfish or contrast media
Vasodilator Prostaglandin
Alfaprostine
Trade name Alfaprostine
Active drug Alfaprostine (alprostadil VR)
Dosage form Ampoule 500 mcg/ml
Mechanism of action Vasodilation by means of direct effect on vascular and ductus arteriosus smooth muscle
Indications Temporary maintenance of ductus arteriosus patency in neonates with ductal-dependent
congenital heart disease until surgery can be performed
Dose Neonate3,4
Initial dose: 0.05 – 0.1 mcg/kg/min by continuous IV infusion.
Titrate to response: oxygenation VS adverse effects.
Maintenance: as low as 0.01 mcg/kg /min. (Up to 0.4 mcg/kg/min, monitor adverse effect)
Higher initial doses isn't proven more effective & have a high incidence of adverse effects
Infant3
Ductus arteriosus patency maintenance
Initial: 0.05 – 0.1 mcg/kg/min, till response, then reduce to lowest effective dose
If unsatisfactory response ↑rate gradually, (usual range 0.01 – 0.4 mcg/kg/min)
Dose adjustment No dosage adjustments Provided for pediatrics
3
Preparation Continuous IV infusion : Prepare conc 2 – 20 mcg/min4
May be irritant, avoid extravasation
ISMP recommendations3
Neonates 1ml + 49 ml of D5W, D10W, NS to a conc. of 10 mcg/ml (ISMP)
Pediatric: 1ml + 24 ml of D5W, D10W, NS to conc. of 20 mcg/ml
Direct contact of undiluted drug with plastic walls of IV containers should be avoided
Administration3 Neonate: Via large vein or UAC positioned near ductus arteriosus over 24 hr.
1
Stability Intact ampoules stored in refrigerator at 2 – 8 ° c
Diluted solution for infusion used within 24 hr 2
Adverse reactions Apnea may occur in neonates (especially weighing <2 kg at birth) with congenital heart defects
& usually appears during the first hr of infusion
Gastric obstruction may be associated with use for >120 hr (monitor)
RDS :Should not be used in neonates with confirmed diagnosis of RDS
Bone changes (Cortical hyperostosis) with long-term infusions of alprostadil occurred 4 - 6
weeks after starting alprostadil, usually resolves 6 - 12 months after stopping the drug.
Bleeding tendencies.
>10%:
CVS: Flushing
Respiratory: Apnea
Other: Fever
1% to 10%: CVS: Bradycardia, cardiac arrest, edema, HTN, hypotension, tachycardia
CNS: Dizziness, headache, seizure
Endocrine & metabolic: Hypokalemia
GIT: Diarrhea
Hematologic: Disseminated intravascular coagulation
Infection: Sepsis
Local: Local pain (in structures other than the injection site)
Respiratory: Cough, flu-like symptoms, nasal congestion, sinusitis, upper RTI
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<1%: Anemia, anuria, bradypnea, cardiac failure, cerebral hemorrhage, GERD , hematuria,
hemorrhage, hyperbilirubinemia, hyperemia, hyperirritability, hyperkalemia, hypoglycemia,
hypothermia, jitteriness, lethargy, neck hyperextension, peritonitis, 2nd degree AV block,
shock, stiffness, SVT, thrombocytopenia, ventricular fibrillation, wheezing (bronchial)
Contraindications Cyanotic neonates with: persistent circulation, with total anomalous pulmonary venous
return below the diaphragm, with polysplenia or asplenia in whom pulmonary atresia is
combined with anomalous pulmonary venous return, which may be obstructed
Antiarrhythmic/local anesthetic
Lidocaine
Trade name Lidocaine
Active drug Lidocaine
Dosage form Ampoule 40 mg/2ml
Mechanism of action Class Ib antiarrhythmic, suppresses automaticity of conduction tissue, by increasing
electrical stimulation threshold of ventricle, His-Purkinje system, blocks both initiation &
conduction of nerve impulses by decreasing the membrane permeability to sodium ions.
Indications Ventricular arrhythmia, refractory shock, neonatal seizure & Local anesthesia
Dose Neonate 4
Anti-arrhythmic 4,5
Initial dose: 0.5 – 1 mg/kg IV push over 5 min, Repeat at intervals after not less than 5 min
as necessary to control arrhythmia. (Max total bolus dose 5 mg/kg/dose)4
Maintenance IV infusion: 10 – 50 mcg/kg/min. use lowest dose in Premature neonates.
Refractory seizure3:
Loading dose: All neonates: IV: 2 mg/kg over 10 min, followed by a continuous infusion
Normothermic
GA ≥ 25 weeks
0.8 – 1.5 kg: 5 mg/kg/hr for 4 hr, then 2.5 mg/kg/hr for 6 hr, then 1.25 mg/kg/hr for 12 hr
>1.5 – < 2 kg: 6 mg/kg/hr for 4 hr, then 3 mg/kg/hr for 6 hr, then 1.5 mg/kg/hr for 12 hr
2 – < 2.5 kg: 6 mg/kg/hr for 4 hr, then 3 mg/kg/hr for 12 hr, then 1.5 mg/kg/hr for 12 hr
≥2.5 kg: 6 –7mg/kg/hr for 4 hr, then 3.5mg/kg/hr for 12 hr, then 1.75 or 2mg/kg/hr for 12hr
Therapeutic Hypothermia: Term neonates:
2 – <2.5 kg: 6 mg/kg/hr for 3.5 hr, then 3 mg/kg/hr for 12 hr, then 1.5 mg/kg/hr for 12 hr
≥2.5 kg: 7 mg/kg/hr for 3.5 hr, then 3.5 mg/kg/hr for 12 hr, then 1.75 mg/kg/hr for 12 hr
Alternate dosing for neonatal seizures 4,5
Initially 2 mg/kg over 10 min, followed by IV infusion of 6 mg/kg/hr for 6 hr, then ↓ to 4 mg
kg/hr for 12 hr, then ↓ to 2 mg/kg/hr for 12 hr. Preterm neonates may require lower doses
Refractory Shock3
And alternate dosing for Ventricular fibrillation or pulseless ventricular tachycardia
IV, IO
Loading dose: 1 mg/kg/dose, then continuous IV infusion, may repeat bolus if delay
between initial bolus and start of infusion is >15 min.
Continuous IV infusion: 20 – 50 mcg/kg/min. Don’t exceed 20 mcg/kg/min in patients with
shock, hepatic disease, cardiac arrest, or CHF
Endotracheal: Loading dose: 2 – 3 mg/kg/dose, flush with 5 mL of NS and follow with 5
assisted manual ventilations.
Infiltration anesthesia By local infiltration5
Up to 3 mg/kg/dose according to patient's weight and nature of procedure, dose may be
repeated not more than /4 hr, 3 mg/kg equivalent to 0.3 mL/kg of 1% solution.
1 month – 18 yr
Ventricular fibrillation or pulseless VT refractory shock 3,5
1 month – 11 year
Loading dose IV, IO: 0.5 – 1 mg/kg/dose, Repeat at ≥ 5 min intervals as necessary until a
132
continuous infusion is started (max 3 mg/kg/course)
Continuous IV infusion: 10 – 50 mcg/kg/min (0.6 – 3 mg/ kg/hr)5(up to 20 mcg/kg/min is
more safe for patient in shock, hepatic disease, cardiac arrest, or CHF)3
Alternate dosing in arrhythmias for age 1 months – 18 year3
IV, IO:
Loading dose: 1 mg/kg/dose then continuous IV infusion, may administer second bolus if
delay between initial bolus and start of infusion is >15 min.
Continuous IV infusion: 20 – 50 mcg/kg/min, do not exceed 20 mcg/kg/min in shock,
hepatic disease, cardiac arrest, or CHf.
Endotracheal: 2 – 3 mg/kg, flush with 5 mL NS , follow with 5 assisted manual ventilations
local Anesthesia, injectable5
Cutaneous infiltration Children & Adolescents: (Use Lidocaine <2% )
To max dose: 5 mg/kg/dose & not to exceed 300 mg/dose, don't repeat within 2 hr
Dose adjustment Renal impairment: No adjustment provided.
However in adult data with GFR< 30 ml/min/1.73m2 suggest to administer lower infusion
rate and monitor closely for toxicity
Hepatic Impairment: Use with caution, reduce dose. Monitor closely & adjust infusion
rate as necessary, consider alternative agent. (Max rate of continuous IV: 20 mcg/kg/min)
Preparation IV push conc: 1 – 20 mg/ml (up to 1 + 19 ml ) D5W , D10W ,NS
Continuous infusion : 0.8 – 8 mg/ml (1 ml x 2.5 ml dilution up to1 ml x 25 ml dilution)4
Endotracheal : use undiluted or may dilute in 1 – 5 mL NS based on patient size
Local infiltration using 1% solution: 2 ml sodium bicarbonate + 18 ml of Lidocaine 1%
Solution < 2% should be used in local infiltration for pediatric
Administration3 IV push or IO : don’t exceed 0.7 mg/kg/ min or 50mg/min total whichever is less, but rapid
IV push in acute settings may be used
Continuous infusion over 24 hr via infusion pump
Endotracheal administer undiluted and flush with 5 mL of NS after endotracheal
administration, or administer dose diluted. Follow with 5 assisted manual ventilations
Stability Store ampoules at room temperature
Diluted solutions: use within 24 hr T room temp2
CNS: Headache (positional headache following spinal anesthesia), shivering (following
spinal anesthesia), radiculopathy (transient pain, subarachnoid administration)
CVS: Bradycardia, cardiac arrhythmia, circulatory shock, coronary artery vasospasm,
edema, flushing, heart block, hypotension (including following spinal anesthesia), local
thrombophlebitis, vascular insufficiency (periarticular injections)
CNS: Agitation, anxiety, apprehension, cauda equina syndrome (following spinal
anesthesia), coma, confusion, disorientation, dizziness, drowsiness, euphoria,
hallucination, hyperesthesia, hypoesthesia, intolerance to temperature, lethargy, loss of
consciousness, metallic taste, nervousness, paresthesia, peripheral neuropathy (following
spinal anesthesia), psychosis, seizure, slurred speech, twitching
GIT: Nausea (including following spinal anesthesia), vomiting
Hypersensitivity: Anaphylactoid reaction, anaphylaxis, hypersensitivity reaction
Neuromuscular & skeletal: Tremor, weakness
Otic: Tinnitus
Respiratory: Bronchospasm, dyspnea, RD, respiratory insufficiency
<1%, postmarketing, and/or case reports: Asystole, dermatological reaction, diplopia
(following spinal anesthesia), methemoglobinemia
Contraindications Hypersensitivity to Lidocaine, amide type anesthetic or any component formulation,
Adam-Stokes syndrome, Wolff-Parkinson-White syndrome, severe degrees of SA, AV, or
intraventricular heart block (except in functioning artificial pacemaker), premixed injection
may contain corn-derived dextrose which is contraindicated in allergy to corn
Loop diuretic
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Furosemide Injection
Trade name Lasix
Active drug Furosemide 20
Dosage form Ampoule 20 mg /2ml
Mechanism of action Loop diuretic inhibits reabsorption of sodium and chloride in the ascending loop of Henle
and proximal and distal renal tubules causing its natriuretic effect
Indications Edema or volume overload associated with heart failure, cirrhosis of the liver (i.e. ascites),
or kidney disease (including nephrotic syndrome), acute pulmonary edema.
Dose Neonate 4
Start with initial dose, may increase dose but not to exceed max. dose according to table
Neonate Initial dose IV Max. IV Initial dose oral Max. oral
Premature 1 mg/kg/24 hr 2mg/kg/24 hr 1 mg/kg/24 hr 6mg/kg/24 hr
Full-term 1 mg/kg/12 hr 2 mg/kg/12 hr 1 mg/kg/12 hr 6 mg/kg/12 hr
term ˃28 days 1 mg/kg/6 – 8 hr 2 mg/kg/6 – 8 hr 1 mg/kg/6 – 8 hr 6 mg/kg/6 – 8 hr
Alternate dosing in edema 3
Oral/ IV/IM
PMA <31 weeks: Usual: 1 mg/kg/dose (range: 0.5 – 2 mg/kg/24 hr)(↑risk of toxicity with
doses >2 mg/kg/dose administered more frequently than every 24 hr)
PMA ≥31 weeks: Usual: 1 mg/kg/dose (range: 0.5 – 2 mg/kg/12 hr – 24 hr)
Continuous IV infusion dosing 3
Term neonates: Initial IV bolus dose (optional): 1 – 2 mg/kg, followed by continuous IV
infusion at 0.1 – 0.2 mg/kg/hr, titrate based on UOP /12 – 24 hr in 0.1 mg/kg/hr increments
up to the max. of 0.4 mg/kg/hr
Inhalation in chronic lung disease (Limited data) 3
1 – 2 mg/kg/dose diluted in 2 mL NS as a single dose. (doses of 1 mg/kg/ 6 hr suggested but
long-term benefits have not been established)
Infant, Child & Adolescent3
Edema
Oral
Intermittent dosing (acute): Initial: 2 mg/kg as a single dose, may ↑by 1 – 2 mg/kg/dose
after 6 – 8 hr if first dose ineffective, max: 6 mg/kg/dose.
Maintenance dose (chronic) Limited data: Initial: 0.5 – 2 mg/kg/ 6 – 24 hr, may ↑by 1 – 2 mg
/kg/dose if first dose ineffective, max: 6 mg/kg/day (not to exceed 600 mg/day)
Other reference suggests5
Max 12 mg/kg/day or 80 mg/day in age < 12 yr
Edema in Age ≥ 12 year:20 – 40 mg/ day and up to 80 – 120 mg/day in resistant edema
IV,IM
0.5 – 2 mg/kg/ 6 – 12 hr , adjust to minimal effective dose for maintenance
If initial dose ineffective after 2 hr, may ↑dose by 1 mg/kg/dose, max. 6 mg/kg/dose, not to
exceed max. adult dose: 200 mg/dose
Infant & Child Initial: IV bolus 0.1 – 2 mg/kg followed by continuous infusion of 0.05 – 0.4
mg/kg/hr (1.2 – 9.6 mg/kg/day over 24 hr infusion), titrate dose to clinical effect
Up to 2 mg/kg/hr (48 mg/kg/day) was suggested by some references 5
Adolescents: based on adult & pediatric data:
IV bolus dose of 0.1 mg/kg, usual adult bolus dose: 40 – 100 mg over 1 – 2 min,
followed by continuous IV infusion of 0.1 – 0.4 mg/kg/hr, (usual range: 10 - 40 mg/hr)
oliguria in acute or chronic renal patient with GFR< 20 ml/min5
1 month –11 yr IV: 2 – 5 mg/kg up to 4 times a day, max 1 g /day by IV infusion
12 – 17 yr: IV Initially 250 mg over 1 hr, increase to 500 mg IV over 2 hr if Target urine
output not obtained, (increase to 1 g IV over 4 hours for target urine output)
Effective doses up to 1 g may be repeated /24 hr at max rate 4 mg/min
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If no response obtained dialysis probably required
Oral: 250 mg/day, increase by 250/4 – 6hr (max 2g /dose)
Dose adjustment3 Renal impairment: no pediatric specific recommendations, but adult data with ARF
suggest very high doses to initiate diuretic effect, avoid use in oliguric states.
Dialysis: Not removed by IHD or PD, supplemental dose is not necessary.
Hepatic Impairment
Diminished natriuretic effect with ↑ sensitivity to hypokalemia and volume depletion in
cirrhosis, monitor effects, particularly with high doses
Preparation Maybe used undiluted (10 mg/ml) or diluted 1 + 9 ml D5W, NS ,D10W (1 mg/ml) 2,3,4
Neonate: may use 2 , 10 mg /ml conc
Administration3 IV: Neonate over 15 – 30 min4 other references suggest 5 – 10 min 5
Max. rate: 0.5 mg/kg/min or 4 mg/min, rapid administration ↑risk of tinnitus, deafness
IM : undiluted, not preferred if IV access is available
Oral: with food or milk to decrease GI upset
Stability3 Store ampoules at 30 °C, protect from light, don’t refrigerate3
Use immediately after preparation, discard unused portion, don’t use if appeared yellow
Conc. 1,2,4,8 mg/ml in NS stable for 24 hr (microbiological) at room temp, exposed to
florescent light in PP syringe2
Adverse reactions Renal: Acute kidney injury
CVS: Fluid/electrolyte loss, Cardiac arrhythmias.
Hypersensitivity: Immediate including angioedema, urticaria, and anaphylaxis
Delayed: range from maculopapular skin rash to rare severe SCARs including: AGEP, DRESS
,SJS,TEN
Ototoxicity: hearing loss and tinnitus, generally reversible (lasting from 30 min – 24 hr
after administration (Premature VLBW neonates)
Contraindications Hypersensitivity to furosemide or any component of the formulation, anuria.
hypersensitivity to sulfonamides, hepatic coma and precoma
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Oral pre-diagnostic Sedative and hypnotic
Chloral hydrate
Trade name Chloral hydrate
Active drug Chloral hydrate
Dosage form Oral solution 10%
Mechanism of action active metabolite trichloroethanol causes CNS depression
Indications Sedative/hypnotic for surgeries and diagnostic procedures or EEG, Echocardiogram
Dose Neonate 4:
Oral/rectal: 0.25 – 0.75 ml /kg/dose (25 – 75 mg/kg/ dose)
(Due to long t 1/2 unpredictable responses, & reported deaths, use is not recommended as
a sedating agent for procedures.
Infants and Children3
Oral: 0.25 – 1 ml /kg/dose (25 – 100 mg/kg/dose) 30 min prior to procedure, (max. 10 ml
= 1,000 mg/dose) may repeat after 30 min with 0.25 – 0.5 ml /kg/dose if necessary.
Max. total dose: 100 mg/kg/procedure or 2,000 mg/procedure = 20 ml /procedure
Dose adjustment Kidney Function/ Hepatic Impairment: no adjustments provided for pediatrics
Contraindicated in marked renal and/or hepatic impairment. Removed by dialysis
Preparation Dilute oral solution with water or formula or fruit juice to reduce GI irritation3
Administration Dilute oral solution with water or formula or fruit juice to reduce GI irritation3,4
Administer 30 min prior to surgery/procedure.
Oral may be given rectally
Stability Store between 15 - 30°C, Store in a tight, light-resistant container, don’t freeze.
Adverse reactions CVS: Atrial arrhythmia, depression of myocardial contractility, hypotension, shortening of
refractory periods, torsades de pointes, ventricular arrhythmia
CNS: Abnormal gait, ataxia, confusion, delirium, dizziness, drowsiness, drug dependence
hallucinations, hangover effect, malaise, nightmares, paradoxical excitation, somnambulism,
vertigo
Dermatologic: Skin rash (eg. erythema, eczematoid dermatitis, urticaria & others)
Endocrine & metabolic: Acute porphyria, ketonuria
GIT: Diarrhea, flatulence, gastric irritation, nausea, vomiting
Hematologic: Acute porphyria, eosinophilia, leukopenia
Ophthalmic: Allergic conjunctivitis, blepharoptosis, keratoconjunctivitis
Otic: ↑ middle ear pressure (infants and children)
Respiratory: Airway obstruction (young children), laryngeal edema (children)
Contraindications Hypersensitivity to chloral hydrate or any component of the formulation
Marked hepatic or renal impairment
General anesthesia IV
Propofol
Trade name Propofol
Active drug Propofol 1 %
Dosage form Ampoule 20 ml of 10mg/ ml
Mechanism of action Short-acting, lipophilic IV general anesthetic causes CNS depression, presumably by GABA
receptors agonism & perhaps ↓glutamatergic activity by NMDA receptor blockade
Indications Induction & maintenance of general anesthesia, sedation of intubated, mechanically
ventilated ICU patients, refractory status epilepticus and procedural sedation.
Dose Pediatric
Sedation for Mechanical Ventilation in ICU
Child: bolus: 1 – 2 mg/kg18 up to 4 mg/kg19 then continuous infusion: 1.2 – 12 mg/kg/hr
 Not recommended for sedation of pediatrics (Use caution if rate ≥ 4 mg/kg/hr)
 Emulsion vehicle is similar to IV lipid emulsions & similar precautions should be taken
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 Contraindicated in patients with allergies to eggs, soybeans or soy products.
 For short term (< 24 hours) or intermittent use only.
 Prolonged continuous use (> 24 hours) in infants and children may cause Propofol-
Related Infusion Syndrome (PRIS): metabolic acidosis, lipemia, hypotension, multi-
system organ failure, rhabdomyolysis and cardiovascular collapse.
>16 yr 0.3 – 4 mg/kg/hr. adjust acc. To response 5
Sedation for surgical & diagnostic procedures 5
1 month – 16 yr
Induction Initially 1 – 2 mg/kg SLOW IV injection, dose & rate adjusted acc. To desired level
of sedation and response
Maintenance IV infusion Usual dose 1.5 – 9 mg/kg/hr,
Dose & rate adjusted acc. to desired level of sedation and response, iv slow injection of up
to 1 mg/kg if rapid ↑in sedation needed
17 year
Induction Initially 0.5 –1 mg/kg over 1–5 min, dose & rate adjusted acc. to desired level of
sedation & response
Maintenance IV infusion Initially: 1.5 – 4.5 mg/kg/hr
Dose & rate adjusted acc. to desired level of sedation and response, slow IV injection of 10
–20 mg if rapid ↑in sedation needed
Alternate regimen for Procedural sedation3
Infants, Children & Adolescents: IV
Repeated bolus method: initial dose: 1 – 2 mg/kg (Usually 1 mg/kg) then 0.5 mg/kg /3 – 5
min as needed until adequate level of sedation achieved
IV bolus followed by continuous infusion
Initial bolus: 1 – 2 mg/kg (before continuous infusion )
Then infusion may start at initial rate of 9 mg/kg/hr (150 mcg/kg/min) & titrated as needed
supplemental doses: 1 – 2 mg/kg AS NEEDED (hypotension was observed)
OR age 3 months – 6 yr 1 mg/kg bolus, Then IV infusion: 5 mg/kg/hr (83 mcg/kg/min) and
then titrated upward in 1 mg/kg/hr increments (to a max of 8 mg/kg/hr [133 mcg/kg/min])
with additional boluses of 0.5 mg/kg given as needed.
Propofol with ketamine, emergency department procedures: IV: 0.5 – 0.75 mg/kg
Status epilepticus, refractory 3
Children & Adolescents (Propofol – related infusion syndrome in infant & child)
Loading dose (initial infusion) 1 – 2 mg/kg
then start continuous IV infusion 1.2 mg/kg/hr (20 mcg/kg/min), titrate to effect, up to 12
mg/kg/hr (200 mcg/kg/min)
high doses (>4 mg/kg/hr =65 mcg/kg/min) for extended time (> 48 hr) monitor closely for
adverse effects
Breakthrough seizure while on Propofol infusion: ↑infusion rate by 0.3 – 0.6 mg/kg/hr (5
– 10 mcg/kg/min) / 5 min with or without an additional 1 mg/kg bolus
Anesthesia using 1%injection 3
Induction
1 month–16 yr: Usual dose 2.5–4 mg/kg/dose slow IV injection or infusion
adjusted according to age, body-weight and response
17 Yr: Usual dose 1.5 – 2.5 mg/kg given at a rate of 20 – 40 mg /10 sec until response
Maintenance
1 month–16 yrs: Usual dose 9 –15 mg/kg/hr as continuous IV infusion, adjusted according
to age, body-weight and response
Child 17 yr: Usual dose 4 – 12 mg/kg/hr, adjusted according to response
Dose adjustment3 Renal /Hepatic Impairment: No dose adjustment necessary for pediatric and adult
Preparation Administering Undiluted drug: Shake before use
May be diluted in D5W to a conc. Of ≥2 mg/mL in glass set
(Stability in plastic: 95% potency after 2 hr).
Administration3 IV bolus over 20 – 30 sec for induction
Infusion : over prescribed rate
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Don’t administer with blood or plasma
To reduce pain at administration, may add Lidocaine to Propofol immediately before
administration, not to exceed 20 mg Lidocaine/200 mg Propofol. (½ ampoule Lidocaine 2%
for one ampoule Propofol 1%)
Stability 3 Store between 4 – 25°C 1,3
Discard if creaming, aggregation, large visible droplets or separation of emulsion occurs
Use within 6 hr of preparation 1,2, If necessary not longer than 12 hr 2
Adverse reactions CVS: bradycardia and convert tachycardia to sinus rhythm , associated rarely with prolonged
QT interval on ECG
Hypotension (≥30% decrease in mean arterial pressure ,especially with boluses or in setting of
hypovolemia, sepsis, or shock, intraventricular hemorrhage or periventricular leukomalacia in
neonate
Immediate hypersensitivity reactions: anaphylaxis, angioedema & bronchoconstriction
Hypertriglyceridemia can lead to acute pancreatitis.
Propofol-induced acute pancreatitis in absence of hypertriglyceridemia
Propofol-related infusion syndrome (PRIS) rare but has a high mortality rate and is
characterized by dysrhythmia (bradycardia / tachycardia), widening of the QRS complex, heart
failure, hypotension, asystole, lipemia and hypertriglyceridemia, metabolic acidosis, and/or
rhabdomyolysis or myoglobinuria with acute kidney injury and hyperkalemia
Contraindications Hypersensitivity to Propofol or any component of formulation (eggs, soybeans)
General anesthesia IV
Ketamine
Trade name Ketam
Active drug Ketamine 50 mg/ml
Dosage form Vial 10 ml
Mechanism of action Cataleptic-like state action on the cortex and limbic system, noncompetitive NMDA
receptor antagonist that blocks glutamate. Low doses cause analgesia, modulate central
sensitization, hyperalgesia & opioid tolerance Reduces polysynaptic spinal reflexes
Indications Induction & maintenance of general anesthesia & for the treatment of acute
pain/analgesia, procedural sedation/analgesia, and sedation of critically ill patients
Dose Neonate
Anesthesia, adjunct – Procedural sedation/analgesia
Initial dose: IV: 0.5 – 2 mg/kg 3,5
Maintenance for prolonged anesthesia: 8mcg /kg/min adjusted according to response
Up to 30 mcg/kg/min(for deep anesthesia)5
IM for induction : 4 mg/kg (produce anesthesia for 15 min)5
Infant, child and adolescent
Sedation/analgesia, critically ill patients: Very limited data 3
age ≥5 months – 18 yr:
Initial dose: IV: 0.5 – 2 mg/kg, then continuous IV infusion: 5 - 20 mcg/kg/min (0.3 - 1.2
mg/kg/hr) start at lower dosage & titrate to effect
↑ Doses up to 60 mcg/kg/min (3.6mg/kg/hr) used in cases with refractory bronchospasm
Sedation/analgesia, procedural3
Ketamine without Propofol
Infants ≥3 months, Children, and Adolescents:
IM: 4 - 5 mg/kg single dose, may repeat dose (range: 2 - 5 mg/kg) if sedation inadequate
after 5 – 10 min or if additional doses are required
Smaller doses (2 – 2.5 mg/kg) recommended for minor procedures (eg, wound suture with
local anesthetic).
IV: 1 – 2 mg/kg over 30 - 60 sec. If response inadequate or repeated doses are necessary
for longer procedure, may give additional doses of 0.5 – 1 mg/kg /5 – 15 min as needed
ketamine with Propofol
age ≥3 – 18 yr IV: 0.5 – 0.75 mg/kg of each agent decreases adverse effects of each
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Endotracheal intubation3
Infants, Children, and Adolescents: IV: 1 - 2 mg/kg as part of rapid sequence sedation
Anesthesia 5
Induction
age ≥3 – <16 years: Limited data available:
IM: 5 – 1 0 mg/kg has been reported
IV: 1 – 3 mg/kg has been reported.
Age ≥16 years: IM: 6.5 – 13 mg/kg.
IV: 1 – 4.5 mg/kg.
Maintenance
Age ≥16 years: May administer one-half to the full induction dose as needed.
Dose adjustment Renal/ Hepatic : No dose adjustment
3
Preparation IV push: undiluted Or dilute to 10 mg/mL (1+4ml) NS, D5W, SWFI
Continuous IV infusion: dilute to 1 mg/ml( 1+ 49) in NS, D5W
Or 1+24 in fluid restricted
Administration3 IV push: over 60 seconds ( 2 – 3 mins was suggested by some experts)
Don’t exceed 0.5 mg/kg/min (more rapid administration may result in RD & enhanced
pressor response)
Stability3 Intact vial: 15 – 30 °C , Protect form light1
Undiluted repacked in PP syringe: protected from light at Room Temp retains stability for
several days ( 180 days with 10% loss)
Diluted 1+ 4 ml SWFI : 30 Days at 25 °C in PP syringe or glass vials
Diluted 1+49 ml NS: Days at 2 – 6 °C and Up to 42 °C protected from light in PP syringe
CNS: Prolonged emergence from anesthesia (includes agitation, confusion, delirium,
dreamlike state, excitement, hallucinations, irrational behavior, vivid imagery)
CVS: Cardiac arrhythmia/decompensation, decreased BP / HR, ↑ BP/HR
Dermatologic: Erythema of skin, morbilliform rash
GIT: Anorexia, nausea, vomiting
Local: Pain, rash at injection site
CNS: Hypertonia (tonic-clonic, sometimes resembling seizures), psychiatric disturbance
Ophthalmic: Diplopia, ↑ IOP, nystagmus disorder
Respiratory: Airway obstruction
Postmarketing:
CVS: Ventricular premature contractions
Endocrine & metabolic: Central diabetes insipidus
GIT: Biliary tract disease (dilation), cholangitis, sialorrhea
Genitourinary: Bladder dysfunction (reduced capacity), cystitis (including cystitis noninfective,
cystitis interstitial, cystitis ulcerative, cystitis erosive, cystitis hemorrhagic), dysuria,
hematuria, nocturia, urinary frequency/incontinence/urgency ,
Hepatic: Abnormal hepatobiliary function (with recurrent or continuous use, including
pericholeductal fibrosis), hepatic cirrhosis, ↑direct bilirubin, ↑GGT, ↑ liver enzymes,↑ ALT,
↑ ALP, ↑ AST, ↑Sr. bilirubin, jaundice
CNS: Drug dependence, ↑CSF pressure, withdrawal syndrome
Neuromuscular & skeletal: Laryngospasm
Renal: Hydronephrosis
Respiratory: Apnea, respiratory depression
Other: Drug tolerance
Contraindications Hypersensitivity to ketamine or any component in formulation, Conditions where ↑in BP
would be hazardous. When used for procedural purposes in ER, Infants <3 months of age,
known or suspected schizophrenia (even if stable or medication – controlled)
History of cerebrovascular accident, severe cardiac decompensation, surgery of the
pharynx, larynx, or bronchial tree unless adequate muscle relaxants are used
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General inhalational anesthesia/halogenated
Isoflurane
Trade name Anahal
Active drug Isoflurane
Dosage form Liquid for inhalation (100 ml)
Mechanism of General Inhaled anesthetic, produces profound RD, alters activity of neuronal ion channels
action specially the fast synaptic nicotine, acetylcholine, GABA & glutamate receptors
Indications Induction and maintenance of general anesthesia in adults and pediatric patients for
inpatient and outpatient surgery
Dose1 Surgical anesthesia Inhalation:
Achieved with conc. 0.5%, recommended conc.1.3 – 3 % with or without concomitant use
of nitrous oxide, the conc. at which amnesia and loss of awareness occur is 0.6%.
MAC values for surgical levels of anesthesia:
Preterm neonate <32 weeks : 1.28% with 100% oxygen
Preterm neonate 32-37 weeks : 1.41% with 100% oxygen
0 - 1 month : 1.6% with 100% oxygen
1 - 6 months: 1.87% with 100% oxygen
6 months - 1 year: 1.8 % with 100% oxygen
1 – 5 years: 1.6% with 100% oxygen
Maintenance: achieved with conc. from 1.5 – 3.5% with 100% oxygen
Dose adjustment Renal/Hepatic Impairment: no dose adjustments described, use with caution
Administration Inhalation: Administer via Isoflurane - specific calibrated vaporizer or vaporizer with
calculated flow required
Storage Store at 15°C - 30°C
Adverse reactions >10%: GIT: Nausea
CNS: Agitation, chills, shivering
Respiratory: Breath-holding, cough
1 – 10 % : CVS: Atrial arrhythmia, AV nodal arrhythmia, cardiac /ventricular arrhythmia
GIT: Retching, vomiting
CNS: Delirium , involuntary muscle movements
˂ 1%: CVS: HTN, hypotension, (intraoperative / postoperative)
Dermatologic: Diaphoresis
CNS: Abnormal electroencephalogram, mood changes, nightmares, seizure
Respiratory: Change in bronchial secretions (induction and maintenance)
Frequency not defined: Endocrine & metabolic: ↓BUN, ↓Sr.cholesterol/glucose, ↑LDH
GIT: Intestinal obstruction
Hematologic: Leukocytosis
Hepatic: altered liver function (bromsulphthalein clearance ↓), ↓Sr ALP, ↑ ALT, ↑ ALP, ↑ AST,
↑ Sr bilirubin
CNS: Ataxia, cognitive dysfunction, confusion, dizziness, fatigue, nervousness
Neuromuscular & skeletal: Asthenia, myalgia
Renal: ↑ Sr Cr
Postmarketing:
CVS: AMI, atrial fibrillation, bradycardia, ↓COP complete AV block, 1st degree AV block,
flushing, ischemic heart disease, ↑ QT interval , 2nd degree AV block, tachycardia, torsades de
pointes, ventricular fibrillation/premature contractions/tachycardia
Endocrine & metabolic: Hyperkalemia, ↑GGT
GIT: Hiccups, pancreatitis
Genitourinary: Oliguria
Hematologic: ↑ hemoglobin (carboxyhemoglobin)
Hepatic: Cholestatic hepatitis, fulminant hepatitis, hepatic failure, hepatic necrosis, hepatitis,
hepatotoxicity (idiosyncratic), jaundice, liver steatosis
Hypersensitivity: Anaphylaxis, hypersensitivity reaction
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CNS: Awareness under anesthesia without pain, brain edema, headache, hypothermia, ↑ ICP,
malignant hyperthermia, migraine, myoclonus, withdrawal syndrome (multi-day exposure)
Neuromuscular & skeletal: Rhabdomyolysis
Ophthalmic: Anisocoria, nystagmus disorder
Pulmonary: Airway obstruction, apnea, bronchospasm, hypercapnia, hypoxia, RD, stridor
Contraindications Known sensitivity to Isoflurane, halogenated agents, or any component in formulation, if
general anesthesia is contraindicated, known/suspected genetic susceptibility to malignant
hyperthermia & history of: hepatitis or unexplained moderate – severe liver dysfunction (eg,
jaundice with fever and/or eosinophilia) after halogenated anesthesia
General inhalational anesthesia/halogenated

Sevoflurane
Trade name Sevoflurane
Active drug Sevoflurane
Dosage form Liquid for inhalation (250 ml)
Mechanism of Inhaled anesthetics alter activity of neuronal ion channels particularly the fast synaptic
action neurotransmitter receptors (nicotinic acetylcholine, GABA, and glutamate receptors).
Indications Induction and maintenance of general anesthesia in adults and pediatric patients for
inpatient and outpatient surgery
Dose1 Surgical anesthesia Inhalation:
Achieved with conc. from 0.5% - 3% with or without the concomitant use of nitrous oxide,
the conc. at which amnesia and loss of awareness occur is 0.6%.
MAC values for surgical levels of anesthesia:
0 - 1 month old full-term neonates: Sevoflurane in oxygen: 3.3%
1 - <6 months: Sevoflurane in oxygen: 3%
6 months - <1 year:
Sevoflurane in oxygen: 2.8%
Sevoflurane in 65% N20/35% oxygen: 2%
1 - <3 years:
Sevoflurane in oxygen: 2.8%
Sevoflurane in 60% N20/40% oxygen: 2%
3 - 12 years: Sevoflurane in oxygen: 2.5%
Maint.: achieved with conc. 0.5% - 3% with or without concomitant use of nitrous oxide
Dose adjustment3 Renal/ Hepatic Impairment: no dosage adjustments provided in use with caution
3
Administration Inhalation: via Sevoflurane-specific calibrated vaporizers, use cautiously in low-flow or
closed-circuit systems (as Sevoflurane is unstable and potentially toxic breakdown products
may be liberated)
Storage1 Store at 15°C - 30°C
CVS: Hypotension
CNS: Agitation
Respiratory: ↑ cough
1% to 10%:
CVS: Bradycardia, HTN, tachycardia
GIT: Sialorrhea
CNS: Dizziness, drowsiness, headache, hypothermia, myoclonus, shivering
Respiratory: Airway obstruction, apnea, breath-holding
Other: Fever.
<1%:CVS: Atrial arrhythmia /fibrillation, bigeminy, cardiac arrhythmia, complete AV block,
depression of ST segment, inversion T wave, 2nd degree AV block, supraventricular extrasystole,
syncope, ventricular premature contractions
141
Endocrine/metabolic: Acidosis, albuminuria, glycosuria, hyperglycemia,↓ Sr phosphate, ↑LDH
GIT: Dental fluorosis, dysgeusia, hiccups, xerostomia
Genitourinary: Oliguria, urinary retention, urination disorder, urine abnormality
Hematologic: Hemorrhage, leukocytosis, thrombocytopenia
Hepatic: Hyperbilirubinemia, ↑ ALT, ↑ ALP, ↑ AST
CNS: Confusion, hypertonia, insomnia, malignant hyperthermia, nervousness, pain
Ophthalmic: Amblyopia, conjunctivitis
Respiratory: Bronchospasm, dyspnea, hyperventilation, hypoventilation, hypoxia, ↑ bronchial
secretions, pharyngitis, stridor, wheezing
Other: Crying
Postmarketing:
CVS: Chest discomfort, prolonged QT interval on ECG, torsades de pointes
Hepatic: Hepatic failure, necrosis, hepatitis, hepatotoxicity (idiosyncratic), jaundice
CNS: Delirium, seizure
Contraindications Hypersensitivity to Sevoflurane, halogenated inhaled anesthetics, or any component of
the formulation, known or suspected genetic susceptibility to malignant hyperthermia.
Epidural /spinal anesthesia

Bupivacaine
Trade name Sunnyvacaine
Active drug Bupivacaine 0.5% and Bupivacaine 0.5% w/v with glucose solution for injection.
Dosage form Vial 100mg/20ml
Ampoule heavy (hyperbaric) 20mg/4 ml
Mechanism of Blocks the initiation & conduction of nerve impulses by decreasing neuronal membrane
action permeability to sodium ions, results in inhibition of depolarization & conduction.
Indications Vial : Local, regional & spinal anesthesia (diagnostic, therapeutic & obstetrical procedures)
heavy bupivacaine: intrathecal (subarachnoid) spinal anethesia for surgery (urological and
lower limb surgery lasting 2–3 hr, abdominal surgery lasting 45–60 min.
Dose Vial 0.5% (100 mg/20ml)
Neonate 3
Central nerve block (term) (use conc ≤ 0.25%)
Caudal : 0.5 – 1.25 ml/kg (max 2.5 mg/kg)
Epidural: 1 ml/kg (max 2.5 mg/kg)
If repeated injections necessary, decrease doses as follows
At 45 min of initial dose, reduce dose to 1/3 of the initial dose
At 90 min of initial dose, reduce dose to half of the initial dose.
If additional doses are necessary, reduce to half of the previous dose
Continuous epidural infusion
Loading 2 – 2.5 mg/kg (≤ 0.25 % sol), then infusion 0.2 – 0.25 mg/kg/hr (0.05 – 0.25% sol)
Peripheral nerve block (term neonate)
(using 0.125 – 0.25 %)max. : 2 mg /kg to all sites
Head and neck: 0.05 mL/kg.
Upper extremity: Brachial plexus: 0.2 – 0.3 mL/kg.
Digital nerve: 0.05 mL/kg.
Truncal blocks: Transversus abdominis plane: 0.2 - 0.5 mL/kg.
Rectus sheath: 0.1 mL/kg.
Ilioinguinal: 0.075 mL/kg.
Lower extremity blocks: Femoral or Sciatic nerve: 0.2 – 0.3 mL/kg.
Spinal anesthesia:
Intrathecal: 0.5 – 1 mg/kg( 0.25% ,0.5% Isobaric ) or (0.75% in 8.25% dextrose hyperbaric)
142
Infant ,child & adolescent3
Central nerve block/anesthesia:
Caudal block
Infants & Children (≤0.25%) ± epinephrine: 0.5 – 1.3 mL/kg (max. vol: 20 mL)max. 2 mg/kg
plain solution, or 3 mg/kg with epinephrine (conc. ≤0.25% in infants suggested to reduce
risk of cardiotoxicity)
Adolescents: (0.25 – 0.5%) ± epinephrine: 15 – 30 mL
Epidural block
Infants: (≤0.25%) ± epinephrine: 0.7 – 0.75 mL/kg (max. 2.5 mg/kg).
In young infant, if repeating dose necessary at
at 45 min of initial dose, ↓dose to 1/3 of the initial dose
at 90 min of initial dose, ↓dose to half of the initial.
If additional doses are necessary, reduce dose to half of the previous dose
Children: (0.25%): 0.3 – 0.6 mL/kg (max. vol: 20 mL), max. 2.5 mg/kg.
Adolescents: (0.25% or 0.5%): 10 – 20 mL administered in 3 – 5 mL increments. 0.75 % sol
may be suitable (10 - 20 ml) If higher muscle relaxation & prolonged effects needed
Epidural, continuous infusion: Limited data
Loading dose (0.25%): 2 – 2.5 mg/kg.
Infusion: <6 months: 0.2 mg/kg/hr.
Infant ≥6 months: 0.25 mg/kg/hr
Child & Adolescent: 0.3 mg/kg/hr, (range: 0.2 – 0.4 mg/kg/hr)
Local anesthesia
(0.25%) Infiltrate local area
Infants & children max. dose: 2.5 mg/kg or 150 mg, whichever is less
Adolescents: max. dose: 175 mg
Peripheral nerve block:
≥6 months and Children( 0.125% or 0.25%) ± epinephrine
Max. dose plain solution: 2 mg/kg or 150 mg, whichever is less
Max. dose with epinephrine: 3 mg/kg or 200 mg bupivacaine, whichever is less.
Commonly suggested doses
Head and neck: 0.05 mL/kg.
Upper extremity: Brachial plexus: 0.2 – 0.3 mL/kg.
Digital nerve: 0.05 mL/kg.
Truncal blocks: Transversus abdominis plane: 0.2 – 0.5 mL/kg.
Rectus sheath: 0.1 mL/kg.
Ilioinguinal: 0.075 mL/kg.
Lower extremity: Femoral nerve: 0.2 – 0.3 mL/kg.
Sciatic nerve: 0.2 – 0.3 mL/kg
Age <6 months: max. doses should be reduced by 30 %
Adolescents: (0.25% or 0.5%)± epinephrine: 5 mL, max. daily dose: 400 mg/day
Heavy bupivacaine8
intrathecal
1 day – 12 years & weight ≤ 40 kg
Body weight (kg) Dose (mg/kg)
<5 0.4 – 0.5 mg/kg
5 – 15 0.3 – 0.4 mg/kg
15 – 40 0.25 – 0.3 mg/kg
Age 12 years
Lower extremities / HIP/Lower abdominal: 2 – 4 ml (10 – 20 mg) bupivacaine hydrochloride
Urology : 1.5 – 3 ml (7.5 – 15 mg) bupivacaine hydrochloride
Dose adjustment3 Renal impairment: no adjustments, use with caution. Monitor (↑risk of adverse events)
Hepatic Impairment: no dosage adjustments in pediatric, use with caution, however adult
data recommend dose reduction in moderate & severe impairment
Preparation3 Vial: Use preservative free solutions for epidural ,caudal blocks
Epidural infusion may use undiluted or diluted with preservative-free NS.
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Slightly Yellowish color solution may be acceptable but pinkish color should be discarded
Heavy: for intrathecal injection.
Administration3 Consider incremental administration with negative aspiration prior to each injection,
however, absence of blood in syringe doesn’t guarantee IV injection has been avoide
Carried out by a licensed expert. Resuscitative tools and drugs should be already available
and the anesthetist remains in constant attendance.
IV access should be in place before anesthesia starts
Stability3 Vial: Store at 15 – 30 °C, protect from light.
Use immediately after opening
Undiluted: 5 mg/ml in PP syringe can be stored for 4 weeks at room temp. protected from
light with little or no loss.2
Ampoule (heavy Marcaine) store at 25°C.
Discard unused portion
Adverse reactions3 Very Common: Hypotension, bradycardia, Nausea
Common: Postdural puncture headache, Vomiting. Urinary retention, incontinence
Uncommon Parasthesia, paresis, dysaesthesia, Muscle weakness, back pain
Rare: Allergic reactions, anaphylactic shock, Cardiac arrest, Respiratory depression, total
unintentional spinal block, paraplegia, paralysis, neuropathy, arachnoiditis
Other serious adverse events may not be listed review detailed references
Contraindications3 Heavy intrathecal injection:
Hypersensitivity to drug or any component in formulation & the amide type local agents
Active CNS disease: meningitis, poliomyelitis, intracranial hemorrhage, sub-acute combined
degeneration of the cord due to pernicious anemia and CNS tumors
Spinal stenosis & active disease (spondylitis, tuberculosis, tumor) or recent vertebral trauma
Septicemia, Pyogenic infection of the skin at or adjacent to the site of lumbar puncture.
Cardiogenic or hypovolemic shock.
Coagulation disorders or ongoing anticoagulation treatment
Anticholinergic
Atropine
Trade name Atropine
Active drug Atropine 1 mg/ ml
Dosage form Ampoule of IV, IM
Mechanism of Blocks acetylcholine action at parasympathetic sites in smooth muscle, secretory glands, &
action CNS, ↑cardiac output, dries secretions, competitive antagonist of acetylcholine in poisoning
Indications Preoperative & intraoperative: inhibit salivation & secretions, therapy of symptomatic sinus
bradycardia, AV nodal block & bradyasystolic arrest, antidote in anticholinesterase
poisoning (organophosphate, carbamate insecticides, nerve, muscarinic poisoning)
Dose Neonate 4
Bradycardia
IV: 0.01 – 0.03 mg/kg/dose IV over 1 min, or IM. Dose can be repeated / 10 – 15 min to
achieve desired effect, cumulative maximum dose of 0.04 mg/kg.
ET: 0.01 – 0.03 mg/kg/dose immediately followed by 1 mL NS.
Oral: Begin with 0.02 mg/kg/dose given /4 – 6 hr. May ↑ gradually to 0.09 mg/kg/dose.
Premedication for Intubation
0.01 – 0.02 mg/kg IV over 1 min immediately prior to other premedications
Organophosphate or carbamate insecticide or nerve agent poisoning (IV, IM, IO)3
Initial: 0.05 – 0.1 mg/kg, repeat/3 – 5 min as needed, double the dose if atropinization was
not reached, maintain atropinization by repeating doses as needed for ≥2 – 12 hr based on
recurrence of symptoms
Continuous IV infusion: after atropinization, give 10 – 20% of total loading needed for
atropinization as a continuous IV infusion/hr, adjust to maintain effect without toxicity
Endotracheal: Increase the dose by 2 – 3 times the IV dose. Mix with 3 – 5 mL of NS &
administer, Flush with 3 – 5 mL of NS and follow with 5 assisted manual ventilations
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Bradycardia
for patients unresponsive to improved O2 and epinephrine
IV, IO: 0.02 mg/kg/dose, minimum: 0.1 mg/dose, max. 0.5 mg/dose, may repeat in 5 min,
some have suggested the minimum dose should not be used in patients < 5 kg body wt
Endotracheal: 0.04 – 0.06 mg/kg/dose, may repeat once if needed
Inhibition of salivation and secretions (preoperative/intraoperative):
Age <12 yr: IM, IV, Subcutaneous: 0.02 mg/kg/dose, max. 0.5 mg/dose, administer first
dose 30 – 60 min preoperatively ,repeat / 4 – 6 hr as needed
Max total dose: 1 mg/procedure.
≥12 yr: IM, IV, Subcutaneous: 0.02 mg/kg/dose, max. 1 mg/dose, administer first dose 30 –
60 min preoperatively, repeat/4 - 6 hr as needed, max. total dose: 2 mg /procedure.
Intubation, emergent (premedication)
not recommended but may be considered in situations with a high-risk of bradycardia (eg,
succinylcholine use or septic shock)
Infants and Children: IV: 0.02 mg/kg/dose, max. 0.5 mg/dose (other suggested max. dose
0.6 mg in premedication of child was)5
Muscarine-containing mushroom poisoning:
1 month – 18 yr: IV: 0.02 mg/kg/dose, minimum dose: 0.1 mg. Titrate and repeat as needed
to achieve ↓bronchial secretions
Organophosphate or carbamate insecticide or nerve agent poisoning
Start as soon as symptoms appear. Severely poisoned cases may exhibit tolerance to
atropine ≥2 times the suggested doses
Administer atropine via continuous IV infusion when large doses of atropine are needed.
Once patient is stable, the dose/dosing frequency may be decreased.
Atropinization : IV, IM, IO
Infants & Children 0.05 – 0.1 mg/kg. Adolescents: 1 – 3 mg
repeat / 3 - 5 min as needed, double the dose if atropinization was not reached, Maintain
atropinization by repeating doses as needed for ≥2 – 12 hr based on symptoms recurrence
Continuous IV infusion: Infants, Children, & Adolescents
after atropinization, administer 10 - 20% of total loading needed for atropinization as a
continuous IV infusion/hr, adjust to maintain effect without toxicity
Endotracheal: Infants, Children, & Adolescents
Increase the dose by 2 – 3 times the IV dose. Mix with 3 – 5 mL of NS & administer, Flush
with 3 – 5 mL of NS and follow with 5 assisted manual ventilations
Symptomatic bradycardia in acute ß–blocker overdose5
Children: IV injection: 0.02 mg/kg/dose, max. dose: 1.2 mg.
Dose adjustment3 Pediatric Renal/ Hepatic Impairment: no dosage adjustments
Preparation IV: dilutions 0.05, 0.1, 0.25, 0.4 and 1 mg/ml conc has been used 4
Use : (1+9 ml) local standard
Premedication : Dilute in 4 ml NS ,D5W4
Endotracheal: undiluted, followed by flush with 1 – 5 mL of NS3
Or dilute in NS or SWFI to 1 – 2 mg in ≤10 NS, SWFI
Administration4 IV over 1 min undiluted or diluted by rapid IV injection
Slow injection may result in paradoxical bradycardia.
Oral: may use IV form (in premedication purposes in children, neonatal bradycardia)
Endotracheal Follow with 5 assisted manual ventilations
Flush volume base on indication:
Bradycardia: Neonates: Flush with ≥1 mL NS
≥1 month: Flush with 5 mL NS
Organophosphate or carbamate or nerve agent poisoning: Flush with 3 – 5 mL
If using for cardiac arrest, stop compressions during drug administration and resume chest
compressions following manual ventilation.
Stability Store injection at room temperature 25 °C, avoid freezing1,2
Discard unused portion of the ampoule
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However in PP syringe, stability at room temperature is retained for 4 weeks2
Adverse reactions CVS: Asystole, atrial arrhythmia/ fibrillation, AV dissociation (transient), bradycardia, chest pain,
↓ or↑ BP, ECG changes, extrasystoles (nodal, ventricular, supraventricular), flushing, left heart
failure, nodal arrhythmia, palpitations, sinus/SVT tachycardia, Bigeminy, trigeminy, ventricular
arrhythmia/fibrillation/flutter
CNS: Abnormal EEG agitation, amnesia, anxiety, ataxia, behavioral changes, coma, confusion,
↓deep tendon reflex, delirium, dizziness, drowsiness, dysarthria, dysmetria, emotional
disturbance, excitement, feeling hot, hallucination, headache, hyperpyrexia, hyperreflexia,
hypertonia, insomnia, intoxicated feeling, irritability , ↓concentration, mania lethargy,
myoclonus, neurologic abnormality, nocturnal enuresis, opisthotonus, paranoia, positive Babinski
sign, restlessness, seizure (eg. tonic-clonic), stupor, vertigo
Dermatologic: Anhidrosis, cold skin, dermatitis, dry and hot skin, erythematous rash,
hyperhidrosis, macular eruption, papular/maculopapular rash, scar latiniform rash
Endocrine & metabolic: Dehydration, ↓/ ↑blood glucose, ↓ K+, Na+, ↑ thirst, loss of libido
GIT: Abdominal/bladder distension, abdominal pain, constipation, delayed gastric emptying,
diminished bowel sounds, dry mucous membranes, dysphagia, malabsorption, nausea, oral
lesion, paralytic ileus, salivation, vomiting, xerostomia
Genitourinary: Difficulty in micturition, impotence, urinary hesitancy /retention/urgency
Hematologic: Abnormal RBCs , ↓/ ↑ hemoglobin, leukocytosis, petechiae
Neuromuscular & skeletal: Laryngospasm, muscle twitching, weakness
Ophthalmic: Abnormal eye movements(cyclophoria/heterophoria), angle-closure glaucoma
(acute), blepharitis, blindness, blurred vision, conjunctivitis, crusted eyelid, cycloplegia, ↓visual
acuity, ↓ accommodation, eye irritation/dryness, lacrimation, mydriasis, photophobia, strabismus
Renal: ↑ BUN
Respiratory: Bradypnea, changes in respiration (labored respiration), cyanosis, dyspnea,
laryngitis, pulmonary edema, respiratory failure, stridor (inspiratory), tachypnea
Other: Failure to thrive, fever (secondary to decreased sweat gland activity), swelling
Contraindications GI obstruction , angle-closure glaucoma myasthenia gravis, paralytic ileus, pyloric stenosis NB:
Some anticholinergics may be used to ↓cholinergic side effects of anticholinesterases
Cholinergic agent injection

Neostigmine
Trade name Epistigmin
Active drug Neostigmine
Dosage form Vial 2.5 mg/ml for IM, IV
Mechanism of action Inhibits acetylcholinesterase causing direct cholinomimetic effect
Indications Parenteral: Reversal non-depolarizing neuromuscular blockers action after surgery
Dose Neonate 4
Myasthenia gravis
0.1 mg IM (give 30 min before feeding).
1 mg orally (give 2 hr before feeding).
Dose may have to be increased & should be titrated (up to 0.3 mg/kg/4 hr)`
Reversal of neuromuscular blockade agent3.4 (NMBA) after surgery
0.03 – 0.07 mg/kg IV, max. total dose, 0.07 mg/kg 3,4(or 5 mg whichever is less) 4
With doses of atropine 0.02 mg/kg prior or concurrently
Infant, children, adolescent 3
Myasthenia gravis: Limited data available:
Diagnosis: (Pretreatment with atropine, render atropine available).
Child <2 yr: IM: 0.04 mg/kg once, if results equivocal or negative, may repeat once in 4 hr.
Typical dose is 0.5 – 1.5 mg
Treatment: Child & Adolescent IM, IV, subcutaneous: 0.01 – 0.04 mg/kg / 2 – 6 hr
Alternate dosing5
1 month – 11yr: IM & subQ rage : 0.2 – 0.5 mg/dose, repeated at suitable intervals /day)
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12 – 17yr: 1 – 2.5 mg/dose, repeated at suitable intervals /day)
Reversal of neuromuscular blockade agent3. (NMBA) after surgery
Infant, Child, Adolescent: 0.03 – 0.07 mg/kg IV, max. total dose, 0.07 mg/kg (or 5 mg
whichever is less)
Alternate dosing: Infants & Children: 0.025 – 0.1 mg/kg/dose
Dose adjustment3 Renal: no adjustments provided, based on experience in adult recommended adjustments:
CrCl >50 mL/min: No dosage adjustment necessary
CrCl 10 – 50 mL/min: 50% of normal dose.
CrCl <10 mL/min: 25% of normal dose.
Hemodialysis or Peritoneal dialysis: No dosage adjustment necessary
(CRRT): 50% of normal dose
Hepatic Impairment no dose adjustments provided for pediatric & not studied in adults
Preparation3 Used undiluted by slow IV injection over several min
Intermittent IV infusion in acute colonic pseudo-obstruction (adult data):2.5 mg/100 ml NS3
Administration IV over at least 1 min.4 may be administered IM or Subcutaneous
Cardiac monitoring necessary for 30 min after administration
Atropine should be readily available at bedside
Stability Intact vial stored at 30° C protect from light2
Vial used within 7 days after opening1
Adverse reactions 1 - 10%:
CVS: AV block, cardiac arrhythmia (eg. AV nodal arrhythmia, bradycardia, tachycardia), flushing,
hypotension, syncope
Dermatologic: Diaphoresis, pruritus, skin rash, urticaria
GIT: Flatulence, ↑ peristalsis, nausea, vomiting, xerostomia
Genitourinary: Urinary frequency
Hematologic : Oxygen desaturation
CNS: Asthenia, dizziness, drowsiness, dysarthria, headache, insomnia, unconsciousness, seizure
Neuromuscular & skeletal: Arthralgia, muscle cramps, muscle spasm
Ophthalmic: Miosis, visual disturbance
Respiratory: Apnea, bronchospasm, dyspnea, ↑ bronchial secretions, RD
Postmarketing: CVS: ECG changes (nonspecific)
GIT: Abdominal cramps, diarrhea
Neuromuscular & skeletal: Fasciculations
Contraindications Hypersensitivity to neostigmine or any component of the formulation
Peritonitis or mechanical obstruction of the intestinal or urinary tract.
Neuromuscular blocker
Atracurium
Trade name Atracurium
Active drug Atracurium
Dosage form Ampoule 25 mg /2.5 ml for IV
Mechanism of action Blocks neural transmission at myoneural junction by binding with cholinergic receptor sites
Indications Adjunct to general anesthesia, to facilitate endotracheal intubation, and to provide skeletal
muscle relaxation during surgery or mechanical ventilation
Dose Neonate
Neuromuscular blockade during NICU care & short – Intermediate duration surgery 5
Neonate: Initially 300 –500 mcg/kg IV injection
Followed by: (by IV injection) 100–200 mcg/kg, repeated if necessary. OR alternatively
(by IV infusion) 300 – 400 mcg/kg/hr, adjusted to response, higher doses may be necessary
Neuromuscular blockade: 3
Intermittent IV: 0.25 - 0.4 mg/kg/dose may repeat/20 - 30 min as needed (lower doses
recommended for premature neonates as higher doses (0.5 mg/kg) may be toxic & fatal)
Continuous IV infusion: Initial: 6.7 mcg/kg/min(0.4 mg/kg/hr), titrate until desired
147
neuromuscular blockade is achieved
Recommended to adjust the infusion rate / 20 - 30 min
Infants, Children &Adolescents
Neuromuscular blockade in ICU 5
Child: Initially (optional) 300 – 600 mcg/kg IV injection
then (by intravenous infusion) 270 – 1770 mcg/kg/hr (usually 650–780 mcg/kg/hr)
in obese patients, dose calculated using ideal body-weight
Alternative regimen for ICU Neuromuscular blockade3
1 months - 18 years:
Initial bolus: IV: 0.3 – 0.6 mg/kg/dose, repeat as needed to maintain desired
neuromuscular blockade or begin continuous infusion.
Continuous IV infusion: Initial: 5 – 12 mcg/kg/min (0.3 – 0.7 mg/kg/hr) (range: 5 – 40
mcg/kg/min = 0.3 – 2.4 mg/kg/hr).
Adjunct to surgical anesthesia:3
Bolus doses:
1 - <2 yr: Initial: IV: 0.3 – 0.4 mg/kg once, may repeat as needed to maintain effect
≥2 -18 yr: IV initial: 0.4 – 0.5 mg/kg once,
Then 0.08 – 0.1 mg/kg/dose after 20 – 45 min to maintain neuromuscular blockade
Repeat dose / 15 – 25 min as needed. (Reduce Initial dose to 0.3–0.4 mg/kg in significant
CVS disease or history of ↑risk of histamine release eg, asthma, anaphylactoid reaction).
Continuous IV infusion in operating room during extended surgical procedures:
1 - <2 yr: 6 – 14 mcg/kg/min (0.4 - 0.8 mg/kg/hr) initiated at first signs of recovery from
initial bolus, titrate until desired neuromuscular blockade is achieved
≥2 -18 yr: Initial: 9 – 10 mcg/kg/min (0.5 – 0.6 mg/kg/hr), initiate at initial signs of recovery
from bolus dose, titrate until desired effect. Usual rate 5 – 9 mcg/kg/min (0.3 – 0.5
mg/kg/hr), range: 2 – 15 mcg/kg/min (0.1 – 0.9 mg/kg/hr)
Alternate in Neuromuscular blockade for short – Intermediate duration surgery5
Child: Initially (optional) 300 – 600 mcg/kg IV injection, then (by IV injection) 100 – 200
mcg/kg repeated if necessary or (IV infusion)300 – 600 mcg/kg/hr
Dose adjustment Pediatric Renal/ Hepatic Impairment: no dosage adjustments necessary
3
Preparation IV bolus: undiluted
Continuous IV infusions: Dilute in D5W, NS, or D5NS to a (final conc.: 0.5 – 5mg/ml)5
0.2 mg/mL (1+49) or 0.5 mg/mL. (1+19)3
Don't mix with alkaline solutions
Administration3 IV bolus: undiluted
Diluted solution Administered via an infusion pump
Stability2,3 Store intact units at 2 - 8° C, protect from light, don’t freeze
If stored at room temp: intact ampoules are stable for 14 days only even if refrigerated
Diluted solutions for continuous infusion 1 +19 & 1+49 are stable for up to 24 hr at room
temperature or under refrigeration2
Discard unused solutions immediately
Adverse reactions 1% - 10%: CVS: Flushing
<1%, postmarketing Bradycardia, bronchospasm, dyspnea, erythema, hypersensitivity,
hypotension, ↑ bronchial secretions, injection site reaction, laryngospasm, pruritus, seizure,
tachycardia, urticaria, wheezing
Contraindications Hypersensitivity to Atracurium or any component of the formulation
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Analgesic/antipyretic
Paracetamol(Acetaminophen)
Trade name Paramol/ injectmol
Active drug Paracetamol
Dosage form Vial 1g/ 100 ml for IV
Oral syrup 120mg/5 ml
Suppository 125 mg
Mechanism of Antipyretic from inhibition of the hypothalamic heat-regulating center, analgesic effect
action may be due to activation of serotoninergic receptors
Indications Mild – moderate pain & fever treatment
Dose Neonate 4
Fever (IV)
GA ≥32 weeks:4 12.5 mg/kg/6 hr
Max. 50 mg/kg/day of all routes of administration4
Fever/Pain (Oral/rectal)4
PMA (week) Doses (oral) Doses (rectal) Interval (hr)
<32 20 – 25 mg/kg then 30 mg/kg then 12
12 – 15 mg/kg 12 – 18 mg/kg
≥32 20 – 25 mg/kg then 30 mg/kg then 8
12 – 15 mg/kg 12 – 18 mg/kg
Term 20 – 25 mg/kg then 30 mg/kg then 6
12 – 15 mg/kg 12 – 18 mg/kg
Closure of ductus arteriosus 4(Oral)
Preterm infants : 15 mg/kg/dose oral/6 hr for 3 days, a second course may be needed
(may be used IV ,reported duration 2 – 7 days, oral (preferred) < 32 weeks GA) 3
Prophylaxis or treatment in early targeted treatment in 1st day of life3
GA ≤34 (IV) loading 15 – 20 mg/kg, then 7.5 mg/kg/6 hr for 3 – 5 days
Alternate dosing for Pain /fever3
Oral
(In pain some experts recommend start a loading dose of 25 mg/kg)
GA 28 – 32 weeks: 10 – 15 mg/kg /6 – 12 hr as needed max 40 mg /kg /day
33 –36 weeks or term age<10 days3 10 – 15mg/kg/6 –8 hr as needed, max 60 mg/kg /day
Term, aged ≥ 10 days: 10 – 15 mg/kg /4 – 6 hr as needed. Not to exceed 5 doses /day
max 75 mg /kg /day
(IV)
(In pain OPTIONAL start a loading dose of 20 mg/kg)
PMA <32 weeks :3 7.5 – 10 mg/kg/6 – 8 hr (max: 40 mg/kg/day)
32 – 36 weeks: 7.5 – 12.5 mg/kg/6 hr (max: 50 mg/kg/day)
> 36 weeks: 10 – 15 mg/kg/6 hr (max: 60 mg/kg/day), in pain doses start at 7.5 mg/kg
Dosing in increased risk for hepatotoxicity5
PMA ≥ 32 Week: 7.5 mg/kg/8hr (dose given over 15 min)
Term neonate: 10 mg/kg/4 – 6 hr (max: 30 mg/kg/day)
Rectal
(In pain, a loading 30 or 35 mg/kg/dose is used in GA ≥ 33 weeks and 35 mg/kg optional
dose in ≤ 32 weeks)
GA 28 – 32 weeks :3 15 – 20 mg/kg/12 hr (max: 40 mg/kg/day)
33 – 36 weeks or full term aged < 10 days: 15 – 20 mg/kg/8 hr (max: 60 mg/kg/day
Term, age ≥ 10 days: 20 mg/kg/6 – 8 hr, Not to exceed 5 doses /day (max: 75mg/kg/day)
Infant ,child, adolescent3
Oral
for Fever/ Pain (mild - moderate)
Max. 75 mg/kg/day and 5 daily doses and 4g/day
Dose: 10 - 15 mg/kg/dose / 4 - 6 hr, Max. 5 doses /24 hr and 75 mg/kg/day and 4g/day
149
IV
Fever/Pain, including peri/postoperative management, adjunct to opioid therapy
Infant and child <2 years 7.5 – 15 mg/kg/6 hr, max. 60 mg/kg/day.
Child ≥2 years
<50 kg: 15 mg/kg/dose/6 hr or 12.5 mg/kg/4 hr, max. dose 15 mg/kg/dose up to 750 mg
max/day: 75 mg/kg/day up to 3,750mg/day
≥50 kg: 15 mg/kg/dose/6 hr or 12.5 mg/kg/4 hr, max dose 15 mg/kg /dose up to 1g
max/day: 75 mg/kg/day up to 4g/day
Adolescents:
<50 kg: 15 mg/kg/dose/6 hr or 12.5 mg/kg/4 hr, max dose 15 mg/kg /dose up to 750 mg,
max/day:75 mg/kg/day to 3,750 mg/day
≥50 kg: 1g/6 hr or 650 mg /4 hr max dose: 1g/dose, max/day: 4g/day.
Dosing in increased risk for hepatotoxicity5
Child up to 10 kg : 10 mg/kg/4 – 6 hr (max: 30 mg/kg/day)
10 – 50 kg: 15 mg/kg/4 – 6 hr (max: 60 mg/kg/day)
≥50 kg: 1 g/4 – 6 hr Max. 3g/day
Rectal 3
(pain, fever)
Infants & Children <12 years: 10 – 20 mg/kg/ 4 – 6 hr as needed
Max, 5 doses /24 hr, max /day: 75 mg/kg/day and 1,625 mg/day.
Alternate Pain and fever Fixed dosing5
Child 1–2 months: 30–60 mg / 8 hr as required, max. 60 mg/kg/day
3–11 months: 60 –125 mg / 4–6 hr as required, max.4 doses /day
1–4 years: 125–250 mg / 4–6 hr as required, max.4 doses /day
5–11 years: 250–500 mg / 4–6 hr as required, max.4 doses /day
12–17 years: 500 mg every 4–6 hr
Pain including peri/postoperative management, adjunct to opioid therapy3
Rectal: Children
Loading dose: 40 mg/kg for 1 dose up to 1g max. was reported from clinical trials.
However, in one trial, max. dose 1g reported not to produce therapeutic conc. compared
to 40mg/kg with max. 2 g/dose in children ≥ 25 kg body wt.
Maintenance dose: 20 – 25 mg/kg/ 6 hr as needed for 2 – 3 days postoperatively
Max. 100 mg/kg/day and 4g/day and no longer than 5 days
Neonate , infant ,child & adolescent
IV Severe impairment (CrCl <30 mL/min): recommended to reduce total daily dose3 and
prolong dosing interval to at least /6 hr5, use with caution.
IHD, PD: No dosage necessary when used for mild to moderate pain
Oral: no accumulation in short term courses (3 days).
Hepatic Impairment: Pediatric
Use with caution. Low-dose therapy is usually well-tolerated in hepatic disease/cirrhosis
however, cases of hepatotoxicity at doses <4g/day reported.
Avoid chronic use in hepatic impairment.
Preparation IV: ready to use
Small doses : Withdrawn in syringe
Administration3 IV over 15 min at conc. 10 mg/ml
Neonate IV : diluted (1 mg/ml NS, D5W)2 or undiluted over 15 – 30 min3
Oral: Administer with food to decrease GI upset
Rectal : don’t divide suppository (unequal distribution) but round to nearest mg amount
Stability Intact vials: Store intact vials at 30°C, don’t refrigerate
IV: Dose prepared used immediately , discard any unused portion
Oral: Store bottles at 30°C
Suppositories: Store at 2 – 8 °C, excursion permitted to 27°C 3 , protect from heat
150
Adverse reactions Oral, Rectal:
Dermatologic: Erythema of skin, skin blister, skin rash
Otic: Hearing loss
IV
>10%
1% - 10%:
CVS: HTN, hypotension
Dermatologic: Pruritus
Endocrine & metabolic: ↓ Sr Albumin, ↓ K+, ↓ Mg+2, hypophosphatemia
GIT: Constipation, diarrhea
Genitourinary: Oliguria
Hematologic: Anemia
Hepatic: ↑ AST
Local: pain at injection site
CNS: Agitation, headache
Neuromuscular & skeletal: Muscle spasm
Respiratory: atelectasis, pleural effusion, pulmonary edema, stridor, wheezing
Postmarketing (all formulations):
Dermatologic: AGEP, SJS, TEN
Hepatic: Acute hepatic failure, hepatotoxicity , ↑ ALT
Contraindications Hypersensitivity to acetaminophen or any component of the formulation, severe hepatic
impairment or severe active liver disease with injection form
NSAID
Diclofenac
Trade name Epifenac
Active drug Diclofenac sodium
Dosage form Suppository 12.5 mg
Mechanism of Reversible inhibition of cyclooxygenase-1 and 2 enzyme causing ↓ formation of
action prostaglandin precursors, has antipyretic, analgesic, and anti-inflammatory properties
Indications Juvenile idiopathic arthritis, Postoperative pain, fever
Dose Pediatric 3
Juvenile idiopathic arthritis: Limited data available (12.5, 25 mg)
Children: 1 – 3 mg/kg/day divided in 2 – 3 times daily
Postoperative pain:(12.5, 25) or (50 mg)
Children & Adolescents: 1 – 2 mg/kg/dose once followed by 1 mg/kg/dose 3 times daily
Round dose to nearest strength
Max. 50 mg/dose, max/day: 3 mg/kg/day for 4 days
Dose adjustment Renal Impairment: no pediatric-specific dosage adjustments described
Child & adolescent: some experts have suggested the following:
eGFR 30 - <60 mL/min/1.73 m2: Temporarily discontinue in risk of acute kidney injury
eGFR <30 mL/min/1.73 m2: Avoid use.
Hepatic Impairment: no adjustments described but, may require dose adjustment due to
extensive hepatic metabolism.
Administration For best results, bowels should be empty prior to insertion
Stability Suppository: Store at 2 - 8°C, protect from heat.
CVS: Edema
GIT: Nausea
1% - 10%:
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CVS: HTN
Dermatologic: Diaphoresis, pruritus , skin rash
GIT: Abdominal pain, constipation, diarrhea , duodenal ulcer, dyspepsia , flatulence, GIT
hemorrhage gastric ulcer, GIT perforation, heartburn, upper abdominal pain, vomiting .
Hematologic: Anemia, prolonged bleeding time
Hepatic: ↑ liver enzymes, ↑ AST, ALT
CNS: Dizziness, drowsiness, headache
Neuromuscular & skeletal: Back pain, limb pain, musculoskeletal pain.
Otic: Tinnitus
Renal: ↑ Sr Cr, renal function abnormality
Respiratory: Sinusitis
<1%:
CVS: AMI, cardiac arrhythmia/failure, flushing, hypotension, palpitations, syncope,
tachycardia, vasculitis
Dermatologic: Alopecia, ecchymoses, erythema multiforme, exfoliative dermatitis, skin
photosensitivity, SJS, TEN, urticaria
Endocrine & metabolic: Hyperglycemia, weight changes
GIT: Change in appetite, colitis, eructation, esophagitis, gastritis, glossitis, hematemesis,
melena, pancreatitis, peptic ulcer, stomatitis, xerostomia
Genitourinary: Cystitis, dysuria, hematuria, oliguria, proteinuria
Hematological: Agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia,
leukopenia, lymphadenopathy, pancytopenia, purpuric disease, rectal hemorrhage,
thrombocytopenia
Hepatic: Fulminant hepatitis, hepatic failure, hepatic necrosis, hepatitis, jaundice
CNS: Abnormal dreams, anxiety, coma, confusion, depression, hallucination, insomnia,
malaise, meningitis, nervousness, paresthesia, seizure, vertigo
Neuromuscular: Asthenia, tremor
Ophthalmic: Blurred vision, conjunctivitis
Otic: Auditory impairment
Renal: Interstitial nephritis, polyuria, renal failure syndrome
Respiratory: Asthma, dyspnea, pneumonia, respiratory depression
Other: Fever
CVS: Cerebrovascular accident, coronary thrombosis
Endocrine & metabolic: Fluid retention
GIT: GIT inflammation
Renal: Renal papillary necrosis
Postmarketing:
Immunologic: DRESS
Contraindications Hypersensitivity to Diclofenac or any component of the formulation
History of asthma, urticaria, or other allergic-type reactions after taking aspirin or NSAID
Use in the setting of coronary artery bypass graft surgery.
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Opioid analgesic
Nalbuphine
Trade name Nalukemi
Active drug Nalbuphine
Dosage form Ampoule 20 mg/ml
Mechanism of Agonist of kappa opiate receptors & partial antagonist of µ-receptors in the CNS, causing
action ascending pain pathways inhibition, altering the perception & response to pain
Indications Relief of moderate - severe pain, preoperative analgesia, postoperative
Dose Children & Adolescents3
Analgesia for acute moderate - severe pain
IM, IV: 0.05 – 0.2 mg/kg / 3 – 6 hr as needed
Higher single doses 0.3 mg/kg used preoperatively max. 20 mg/dose, max.160 mg/day
Dose adjustment3 Renal/Hepatic Impairment: no adjustments described however, a reduced dose is
recommended. Use with caution.
Preparation3 IM: use undiluted
IV: use undiluted
Or dilution: use NS, D10W, LR (physically compatible for 48 hr at room temp.)
at 10 mg/ml (= 1+ 1 ml) to 3.3mg/ml (4 mg/ml = 1+4ml)2
Administration IM: Administer undiluted
IV: Administer undiluted or diluted over at least 2 – 3 min (10 – 15 min recommended) 16
Stability Store at 15 – 30°C, Store in original carton, protect from light.
Use immediately, discard any unused portion
Adverse reactions >10%: CNS: Sedation
1% to 10%:
CNS: Dizziness, headache
Dermatologic: Cold and clammy skin
GIT: Nausea and vomiting , xerostomia
<1%, postmarketing/ case reports: Abdominal pain, abnormal dreams, agitation, anxiety
anaphylactoid reaction, anaphylaxis, asthma, bradycardia, burning/tingling sensation, cardiac
arrest, confusion, crying, delusions, depression, derealization depersonalization, diaphoresis,
disturbed taste/vision/ speech, drowsiness, dyspepsia, dysphoria, euphoria, fever, flushing,
hallucination, hostility, hypersensitivity, HTN, hypotension hypogonadism, injection site
reaction (pain, swelling, redness, burning), intestinal cramps, laryngeal edema, consciousness
loss, nervousness, numbness, pruritus, pulmonary edema, RD, respiratory depression,
restlessness, seizure, skin rash, stridor, tachycardia, tremor, urinary urgency
Contraindications Hypersensitivity to nalbuphine or any component of the formulation
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative
tools, GI obstruction, including paralytic ileus (known or suspected)
Surgical abdomen, mild pain managed with other analgesics, severe CNS depression, ↑ICP,
delirium tremens, convulsive disorder, head injury, concurrent or within 14 days of MAOIs
Opioid analgesic
Fentanyl
Trade name Fentanyl Hameln
Active drug Fentanyl
Dosage form Ampoule 100 mcg/2 ml for IV
Mechanism of Binds with stereospecific receptors at many sites within the CNS, increases pain
action threshold, alters pain reception, inhibits ascending pain pathways
Indications Relief of pain, preoperative medication, adjunct to general or regional anesthesia (FDA
approved in ages ≥2 years and adults), has also been used for sedation
Dose Neonate 4
Anesthesia: 5 – 50mcg/kg/dose
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Analgesia
Intermittent doses: Slow IV push: 0.5 – 3 mcg/kg/dose4 repeat as needed /2 – 4 hr3,4
Continuous IV infusion: 0.5 – 2 mcg/kg/hr,(up to 3 mcg /kg/hr)3
Sedation
Intermittent IV dose: 0.5 – 4 mcg/kg /dose, repeat as needed /2 – 4 hr4
Continuous IV infusion: 1 – 5 mcg/kg/hr
Alternate regimen in NICU3
Bolus IV dose: 1 – 2 mcg/kg then
Continuous IV infusion:0.5 – 3 mcg/kg/hr
Premedication( intubation)3
1 – 4 mcg/kg /dose over at least 3 – 5 min to avoid chest wall rigidity
Pediatric
Acute severe pain3
Intermittent IV
Infants , children, Adolescents
<50 kg: Initial: IV: 0.5 – 1 mcg/kg/dose, may repeat / 1 – 2 hr, (may need up to /30-min),
max 50mcg/dose & 100 mcg /dose in critically ill ICU pediatric patient
≥50 kg: Initial: IV: 25 – 50 mcg / 1 – 2 hr although some patients may require up to /30-
min.
Continuous IV
Infants , children, Adolescents
<50 kg: Initial: IV: 0.5 – 2.5 mcg/kg/hr, start low and titrate (in ICU start at 1mcg/kg/hr)
≥50 kg: Initial: IV: 25 – 100 mcg / hr, start low and titrate(in ICU start at 50 mcg/hr)
Procedural sedation and analgesia3
Infants & Children
IV: 1 – 2 mcg/kg/dose given 3 min. before procedure max. 50 mcg/dose
May repeat 1/2 original dose/ 3 – 5 min if necessary
Adolescents
IV: 0.5 - 1 mcg/kg/dose, may repeat after 1 – 2 min
Or 25 – 50 mcg, repeat in 5 min if needed, may repeat 25 mcg /5 min for 4 – 5 times
Higher doses are used for major procedures.
Anesthesia:3
Children 2 - 12 years
Induction & maintenance: 2 – 10 mcg/kg/dose, followed by a continuous infusion in some
cases at 2 – 5 mcg/kg/hour
Adolescent
General, adjunctive: 0.5 – 50 mcg/kg/dose
Anesthesia, regional, adjunct3
Infants, Children, and Adolescents by Continuous epidural infusion: 0.3 – 1 mcg/kg/hr
admixed with bupivacaine
ICU Critically ill pain/sedation:3
Infants & Children:
Initial IV bolus: 1 - 2 mcg/kg ,then continuous IV infusion at initial: 1 mcg/kg/hr, titrate to
effect, range: 1 – 3 mcg/kg/hr (higher rates: 5 mcg/kg/hr)
Adolescents (IV)
≤50 kg: Initial bolus: 0.5 – 2 mcg/kg, then continuous infusion at: 0.5 – 2 mcg/kg/hr
>50 kg: Initial bolus: 25 – 100 mcg/dose then continuous infusion at: 25 - 200 mcg/hr
Endotracheal intubation, emergent3
Infants & Children: IV: 1 mcg/kg/dose, repeat /3 min, max 50 mcg/dose
Injection: no adjustment described but, the following guidelines described by experts
Infants, Children, and Adolescents: based on 0.5 - 2 mcg/kg/dose or 1 – 5mcg/kg/hr IV
GFR 10 – 50 mL/ min /1.73 m2: 75% of usual dose.
154
GFR <10 mL/ min /1.73 m2: 50% of usual dose.
IHD: 50% of usual dose
PD: 50% of usual dose.
CRRT: Administer 75% of usual dose.
Hepatic Impairment: no dosage adjustments described for injection form
Preparation3 Neonate & Pediatric 4,8
Continuous infusion undiluted or dilute to 2 – 25mcg/ml (use 1+9 ml: 5 mcg/ml) D5W, NS
Other concentration may be used3
Intermittent IV : conc 10 mcg/ml
Continuous IV: 10, 50 mcg /ml
Administration3 Neonates
Bolus: Intermittent infusion slowly over 15 – 30min4, some references suggest 3 – 5 min3
Bolus by slow IV push over 3 - 5 min
Larger bolus (>5 mcg/kg) by slow IV push over 5 – 10 min
Continuous IV infusion all ages: at conc. 5 mcg/ml
Stability3 Store ampoules in original carton at 15°C – 30°C Protect from light.
Undiluted fentanyl in PP syringes stable at 5 °C protected from light & at 22 °C exposed to
light for 28 days
Diluted 1 + 9ml NS (5mcg/ml) retain chemical stability during continuous infusion for more
than 24 hr at room temperature2
Dermatologic: Hyperhidrosis
Endocrine & metabolic: Dehydration, hypokalemia, weight loss
GIT: Abdominal pain, anorexia, constipation, diarrhea, dysgeusia, nausea, vomiting
Hematologic: Anemia, cancer pain
CNS: Confusion, depression, dizziness, drowsiness, fatigue, headache, insomnia
Neuromuscular & skeletal: Asthenia, back pain
Respiratory: Dyspnea, pneumonia
1% - 10%:
CVS: Bradycardia, chest pain, chest wall pain, DVT, edema, HTN, hypotension, palpitations,
sinus tachycardia, tachycardia, vascular injury, vasodilation
Dermatologic: Alopecia, cellulitis, dermal ulcer, diaphoresis, ecchymoses, erythema of skin,
night sweats, pallor, pressure ulcer, pruritus, skin lesion, skin rash
Endocrine & metabolic: Cachexia, hypercalcemia, hyperglycemia, hypoalbuminemia,
hypocalcemia, hypomagnesemia, hyponatremia, lactic acidosis
GIT: Abdominal distention, decreased appetite, delayed gastric emptying, dyspepsia,
eructation, flatulence, gastritis, gastroenteritis, GERD, GI hemorrhage , hematemesis, intestinal
obstruction (subileus),
Genitourinary: Difficulty in micturition, dysuria, erectile dysfunction, hematuria, mastalgia,
pelvic pain, scrotal edema. Urinary incontinence, retention, urgency, UTI, urinary, vaginal
hemorrhage, vaginitis
Hematologic & oncologic: Breast neoplasm, bruise, leukopenia, lymphadenopathy,
lymphedema, neutropenia, pancytopenia, rectal hemorrhage, thrombocytopenia
Hepatic: Ascites, ↑ALP, ↑AST, jaundice
Infection: Fungal infection, influenza, sepsis, tooth abscess, viral infection
CNS: Abnormal dreams/gait/thinking, agitation, altered smell, amnesia, anxiety, chills,
impaired balance, disorientation, disturbed attention, dysphoria, emotional liability, euphoria,
falling, hallucination, hypertonia, hypoesthesia, irritability, lethargy, malaise, mental status
changes, migraine, myasthenia, myoclonus, nervousness, neuropathy, paresthesia, peripheral
neuropathy, pain paranoid ideation, restlessness, sedated state, seizure, cold sensation, sleep
disturbance, disturbed speech, stupor, chest/throat tightness, vertigo, withdrawal syndrome
Neuromuscular/skeletal: Arthralgia, arthropathy, bone disease, hypokinesia, limb pain, lower
limb cramp, muscle spasm, myalgia, neck/shoulder pain, ostealgia, pathological fracture,
tremor
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Ophthalmic: visual disturbance
Otic: Ear disease (including pain), tinnitus
Renal: Hydronephrosis, renal failure syndrome
Respiratory: Asthma, bradypnea, bronchitis, cough (↑ cough), dyspnea on exertion, epistaxis,
flu-like symptoms, hemoptysis, hypoxia, ↑ bronchial secretions, nasopharyngitis,
oropharyngeal/pharyngolaryngeal pain, pharyngitis, pleural effusion, sinusitis, upper RTI,
wheezing
Other: Fever
<1%:
CVS: Angina pectoris, cerebral ischemia, facial edema, orthostatic hypotension, peripheral
vascular disease, subdural hematoma
Endocrine & metabolic: Decreased libido, hypoglycemia, ↑ thirst
GIT: Dental caries, esophagitis, fecal impaction, fecal incontinence, GIT disease, hiccups,
mucous membrane disease
Genitourinary: Nocturia, oliguria, sexual disorder
Hematologic: Granuloma, hemorrhage, prolonged bleeding time
Hepatic: Hepatorenal syndrome, liver tenderness
Infection: Bacterial infection, herpes zoster infection
CNS: Ataxia, delirium, facial nerve paralysis, flank pain, hemiplegia, voice disorder
Neuromuscular & skeletal: Amyotrophy, arthritis, foot-drop, muscle twitching, myopathy,
neck stiffness, synovitis, tendinopathy
Ophthalmic: lacrimal apparatus disease, injury to eye region (hemorrhage), miosis
Otic: Deafness, reversible hearing loss
Renal: Polyuria, pyelonephritis, renal pain
Respiratory: Cyanosis, hyperventilation, pneumothorax, pulmonary disease, respiratory
depression, respiratory failure, respiratory insufficiency
Other: Cyst
CVS: AMI, atrial fibrillation, bigeminy, cardiac arrhythmia, flushing, syncope
Infection: Abscess
CNS: Drug abuse, hypothermia, neonatal withdrawal, opioid dependence
Respiratory: Atelectasis
Other: Abnormal healing
Postmarketing:
Genitourinary: Hypogonadism
CNS: Hyperesthesia, impaired consciousness, loss of consciousness
Neuromuscular & skeletal: Laryngospasm, muscle rigidity (can be dose related)
Respiratory: Apnea, hypoventilation, respiratory distress
Contraindications Hypersensitivity (eg, anaphylaxis) to fentanyl or any component of the formulation.
Documentation of allergenic cross-reactivity for opioids is limited. But can't be ruled out
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Antiemetic/ 5HT3 receptor antagonist
Ondansetron
Trade name Danset/Emerest/danasetron
Active drug Ondansetron
Dosage form 4 mg/ 2 ml Ampoule IV,IM
Mechanism of Selective 5-HT3-receptor antagonist which blocks serotonin, both peripherally on vagal
action nerve terminals and centrally in the chemoreceptor trigger zone
Indications Prevention of nausea and vomiting associated with chemotherapy, prevention of
postoperative nausea and vomiting & in acute gastroenteritis
Dose Pediatric3
Chemotherapy-induced nausea and vomiting, prevention
Highly emetogenic chemotherapy (IV, Oral)
0.15 mg/kg/dose (5 mg/m2/dose), before chemo., then/8 hr usual max. 8 mg/dose.
Moderately emetogenic chemotherapy (IV, Oral)
0.15 mg/kg/dose (5 mg/m2/dose) before chemo., then/12 hr usual max.: 8 mg/dose.
Low emetogenic chemotherapy (IV, Oral)
0.3 mg/kg/dose once (10 mg/m2/dose) 30 min before chemo., max.16 mg/dose
Alternate dosing for any Emetogenic chemotherapy IV
0.15 mg/kg/dose/ 4 hr for total 3 doses, start 30 min before chemo., max. 32 mg/day
Single-dose regimen (all emetogenic potential) (IV)
0.3 mg/kg/dose once daily, max.16 mg/dose
patients <7 yr, the 0.15 mg/kg/8hr dosing provided better control of nausea symptoms
Higher doses may be used in certain cancer protocols
Gastroenteritis, acute vomiting treatment
Infants & Children
IV: 0.15 – 0.3 mg/kg/dose once, max. dose: 16 mg/dose.
Other reference5: 0.1 mg/kg /8 –12 hr direct IV over 30 secs at least (max. 8 mg /dose)
Or 0.15 mg/kg /8 –12 hr (max. 8 mg /dose),IV infusion over 15 min
Cyclic vomiting
0.3 – 0.4 mg/ kg /4 – 6 hr (max 8 mg/dose, 32 mg/day)
Postoperative nausea and vomiting
Prevention3
Infants & Children (IV) ≤40 kg: 0.1 mg/kg/dose as a single dose, max.: 4 mg/dose.
>40 kg: 4mg/dose as a single dose.
Adolescents: IM, IV 4 mg/dose as a single dose. Administer just before or after induction
of anesthesia, or postoperative in symptomatic patient
Treatment 0.1 mg/kg/dose as a single dose, max.: 4 mg/dose.5
Dose adjustment3 Altered Kidney Function IV: No dosage adjustment is necessary.
Hepatic Impairment: no pediatric-specific data, based on adult data, no adjustment
needed in mild–moderate impairment, for severe impairment, adjustment may be needed
as follows
Child-Pugh class C: IV
Day 1: Max. dose: 8 mg/dose however, no experience beyond first-day administration
Preparation3 infant ≤10 kg Wt and/or age: 6 months – 1yr: may dilute dose in 10 – 50 mL D5W, NS
In older pediatric: dilute 1 + 9 ml D5W or NS (0.2 mg/mL)up to (1 +1 ml)=1mg/ml
Administration3 Prevention of chemotherapy-induced nausea and vomiting: Infuse over 15 min
IV push: diluted or undiluted IV over 2 – 5 min
IM: Administer as undiluted injection.
Stability Store ampoules at 30°C, Protect from light1.
Chemically and physically stable in D5W or NS for 48 hr at room temperature3
Discard any unused portion for microbiological contamination3
157
GIT: Constipation
CNS: Fatigue, headache, malaise
1% - 10%:
GIT: Diarrhea
Genitourinary: Gynecologic disease, urinary retention
Hepatic: ↑ ALT & AST
Local: reaction, burning sensation, erythema and pain at injection site
CNS: Agitation, anxiety, dizziness, drowsiness, paresthesia, sedated state, cold sensation
Respiratory: Bronchospasm, hypoxia
Other: Fever
<1%:
CVS: Hypotension
CNS: Extrapyramidal reaction
CVS: Angina pectoris, peripheral vascular disease, tachycardia
Endocrine & metabolic: Hypokalemia
CNS: Tonic clonic epilepsy
Postmarketing:
CVS: A, altered ECG (depression of ST, prolonged QT) bradycardia, flushing, ischemic heart
disease (with oral or IV, commonly due to coronary artery spasm, occurred immediately after
and resolved with treatment), palpitations, second degree AV block, SVT, syncope, torsades de
pointes, ventricular premature contractions /tachycardia
Dermatologic: SJS, TEN, urticaria
GIT: Hiccups, intestinal obstruction
Hematologic & oncologic: Positive lymphocyte transformation test
Hepatic: Hepatic failure
Hypersensitivity: Angioedema, fixed drug eruption, hypersensitivity reaction, nonimmune
anaphylaxis
CNS: Dystonic reaction, serotonin syndrome
Ophthalmic: Accommodation disturbance, oculogyric crisis, transient blindness (lasted ≤48
hrs), transient blurred vision (following infusion)
Respiratory: Dyspnea, laryngeal edema, stridor
Contraindications Hypersensitivity to any formulation component, concomitant use with apomorphine
Prokinetic/dopamine antagonist
Domperidone
Trade name Domigest
Active drug Domperidone 1 mg/ml
Dosage form Suspension for oral administration
Mechanism of Peripheral dopamine receptor blocker, increases peristalsis & ↓ small bowel transit time.
action Dopamine receptor blocker in chemotrigger zone & at gastric level prevents vomiting
Indications Relief of nausea and vomiting, GERD symptoms
Dose Neonate 5
Gastro-esophageal reflux disease: 0.25mg/kg 3 times a day, up to 0.4 mg/kg 3 times a day,
discontinue if response is inadequate at higher dose.
Child5
Gastro-esophageal reflux disease: 0.25mg /kg 3 times daily (max. dose 10 mg), up to 0.4
mg/kg 3 times /day, (max. dose 20 mg), discontinue if response is inadequate at higher dose
Relief of nausea and vomiting
12–17yr (body wt≥35 kg): 10 mg up to 3 times/day for a max. of 1 week, max. 30 mg / day
Dose adjustment1 Renal dysfunction For repeated dose administration: Reduce to once or twice daily
depending on the severity of the impairment. The dose may also need to be reduced.
158
Generally, patients on prolonged therapy should be reviewed regularly.
Preparation Shake well before use
Oral suspension may contain sorbitol & should be avoided in fructose intolerance
Administration Administer Before feeding 15 – 30 min before a meal. For acute vomiting and nausea max.
duration 12 weeks
Stability Store at max 30 °c 1, protect from light
Adverse reactions (Domperidone) may produce hyperprolactinemia. This may
result in galactorrhea, breast enlargement and soreness and reduced libido.
Contraindications Known impaired cardiac conduction, GIT mechanical obstruction/perforation &hemorrhage
hypersensitivity to the drug & Prolactin releasing pituitary tumor (prolactinoma).
Proton pump inhibitor

Esomeprazole
Trade name Nexium
Active drug Esomeprazole
Dosage form Sachet of powder 10 mg for oral preparation
Mechanism of action PPI suppresses gastric acid secretion by inhibition of H+/K+-ATPase in gastric parietal cell
Indications short-term treatment of GERD, erosive esophagitis Associated with GERD
Dose Neonate3
GERD: Term/preterm neonates: 0.5 mg/kg/dose once/day, for 7 – 14 day
Pediatric3
Erosive esophagitis associated with GERD:
Infants:
3 – 5 kg: 2.5 mg once/day for up to 6 weeks.
>5 – 7.5 kg: 5 mg once/day for up to 6 weeks.
>7.5 kg: 10 mg once/day for up to 6 weeks.
1 – 11 years:
<20 kg: 10 mg once/day for 8 weeks. 3,5
≥20 kg: 10 - 20 mg once/day for 8 weeks3,5
≥12 years : 20 – 40 mg once/day for 4 – 8 weeks3
Alternative regimen: Initially 40 mg once/day for 4 weeks, if symptoms persist continue for
4 weeks, maintenance 20 mg daily.5
Symptomatic GERD
4 – 8 week recommended, consider wean if improvement seen after 4 – 8 weeks
Weight-based dosing
Infants, Children & Adolescents: 0.7 – 3.3 mg/kg/day (max: 40 mg/dose)
Fixed dosing
Children & Adolescents
<20 kg: 10 mg once/day.
≥20 kg: 20 mg once/day.
Alternative for GERD (in the absence of esophagitis)5
1–11 years (weight ≥10 kg ): 10 mg once daily for up to 8 weeks
12–17 years: 20 mg once daily for up to 4 weeks
Dose adjustment3 Discontinuation of therapy (Based on experience in adults)
step-down dosing to avoid worsening/rebound symptoms:↓dose by 50% over 2 - 4 weeks
If the patient is already on the lowest possible dose, give dose every other day
If worsening during treatment or after discontinuation, patient should be reevaluated
Renal impairment: Infants, Children, and Adolescents: Oral, IV: No adjustments necessary
Hepatic Impairment: no specific pediatric recommendations, based on adult data,
adjustment suggested in severe impairment.
Mild – moderate (Child-Pugh class A – B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C):
Erosive esophagitis, H. pylori eradication or prevention of NSAID–induced gastric ulcers:
159
max dose of 20 mg once daily.
Hypersecretory conditions (Zollinger-Ellison syndrome): Initial: 20 mg twice daily.
Preparation 10 mg +15 ml water in a glass
stir until granules are dispersed
leave for 3 min to thicken
Stir again then withdraw the dose in a syringe
Administration Oral: Administer at least 1 hour before food or meals
Stability Intact sachet: store at max 30 °C
Prepared drug : use within 30 min
Adverse reactions With oral formulation
1% – 10%
Endocrine/metabolic: Altered Sr thyroid hormone, ↑or↓Sr K+, Na+, ↑gastrin, TSH & uric acid
Gastrointestinal: Acid regurgitation, abdominal pain, constipation, diarrhea, flatulence, nausea,
vomiting, xerostomia.
Hematologic & oncologic: ↑ hemoglobin, quantitative disorders of platelets
Hepatic: ↑ Sr ALT, ↑ Sr ALP, ↑ Sr AST
Nervous system: Dizziness, drowsiness, irritability, vertigo
Renal: ↑Sr Cr
Respiratory: Cough, tachypnea
Miscellaneous: Fever
<1%:
CVS: Chest pain, edema, facial edema, flushing, hypertension, lower extremity/peripheral
edema, substernal pain, tachycardia
Dermatologic: Acne vulgaris, dermatitis, diaphoresis, erythematous /maculopapular rash, skin
rash, urticaria
Endocrine & metabolic: Albuminuria, glycosuria, goiter, hot flash, ↑thirst, hyperuricemia,
hyponatremia, menstrual disease, vitamin B12 deficiency, weight gain, weight loss
GIT: enlarged abdomen, Ageusia, anorexia, aphthous stomatitis, bowel habits change,
dysgeusia, dyspepsia, dysphagia, of, epigastric pain, eructation, exacerbation of constipation,
frequent bowel movements, gastroenteritis, gastrointestinal hemorrhage, hernia of abdominal
cavity, hiccups, ↑ appetite, melena, mouth disease, pruritus ani, rectal disease, tongue disease
Genitourinary: Cystitis, dysmenorrhea, dysuria, genital candidiasis, hematuria, impotence,
urinary frequency, urine abnormality, vaginitis
Hematologic & oncologic: Anemia, cervical lymphadenopathy, gastrointestinal dysplasia,
hypochromic anemia, leukocytosis, leukopenia, thrombocytopenia
Hepatic: Hyperbilirubinemia
Hypersensitivity: Angioedema, hypersensitivity reaction, tongue edema
Infection: Candidiasis (urogenital), genitourinary fungal infection
CNS: Altered sense of smell, apathy, confusion, exacerbation of depression, fatigue,
fibromyalgia syndrome, hypertonia, hypoesthesia, insomnia, malaise, migraine (including
exacerbation of migraine headache), nervousness, pain, paresthesia, rigors, sleep disorder
Neuromuscular & skeletal: Arthralgia, arthropathy, asthenia, back pain, exacerbation of
arthritis, muscle cramps, polymyalgia rheumatica, tremor
Ophthalmic: Conjunctivitis, visual disturbance, visual field defect
Otic: Otalgia, otitis media, tinnitus
Renal: Polyuria
Respiratory: Dyspnea, epistaxis, exacerbation of asthma, flu-like symptoms, laryngeal edema,
pharyngeal disease, pharyngitis, rhinitis, sinusitis
Cardiovascular: Esophageal varices
GIT: Barrett esophagus, duodenitis, esophageal stenosis/ulcer, esophagitis, gastritis, mucosal
discoloration
Hematologic & oncologic: Benign polyp of stomach
Miscellaneous: Benign gastric nodule
Postmarketing:
Dermatologic: AGEP, alopecia, cutaneous lupus erythematosus, erythema multiforme,
hyperhidrosis, skin photosensitivity, SJS, TEN
Endocrine & metabolic: Gynecomastia, hypomagnesemia
160
GIT: CDAD, colitis, gastric polyp (fundic gland), GI candidiasis, pancreatitis, stomatitis
Hematologic & oncologic: Agranulocytosis, pancytopenia
Hepatic: Hepatic encephalopathy, hepatic failure, hepatitis, hepatotoxicity, jaundice
Hypersensitivity: Anaphylactic shock, anaphylaxis, DRESS
Nervous system: Aggressive behavior, agitation, depression, hallucination, myasthenia
Neuromuscular & skeletal: Bone fracture, myalgia, systemic lupus erythematosus
Renal: Acute interstitial nephritis, interstitial nephritis, renal disease (chronic)
Respiratory: Bronchospasm
Contraindications Hypersensitivity (eg, anaphylaxis, bronchospasm) to esomeprazole, PPIs, or any
component of the formulation
Concomitant use with products that contain rilpivirine.
OTC: not used in trouble or pain when swallowing food, vomiting with blood, or bloody
or black stools, heartburn with light-headedness, dizziness, or sweating, chest pain or
shoulder pain with shortness of breath, sweating, pain spreading to arms, neck or
shoulders, or light-headedness, frequent chest pain.
H2 – receptor antagonist
Famotidine
Trade name Antodine
Active drug Famotidine 20 mg
Mechanism of Competitive inhibition of histamine at H2 receptors of the gastric parietal cells, which
action inhibits gastric acid secretion
Indications Short-term therapy in GERD, duodenal ulcer & active benign gastric ulcer until oral
famotidine can be initiated, treatment of pathological hypersecretory conditions
Dose Neonate3,4
Stress ulcer prophylaxis, gastric acid suppression IV: 0.25 – 0.5 mg/kg/24 hr.
(Adult data recommend Continuous infusion of daily dose for better response)4
Infants3 (GERD)
Age <3 months: 0.25 mg/ kg / dose once daily
3 – 12 months: 0.25 mg/ kg /12 hr. Max: 20 mg /dose
≥ 1 year and adolescent3:
( all indications) : 0 .25 – 0.5mg/ kg/ 12 hr. Max: 20 mg /dose
1 month – 18 years (stress ulcer prophylaxis and gastric acid suppression)
1 – 2 mg /kg/day divided/8 – 12 hr (Max: 40 mg /day)
Dose adjustment Altered kidney function:
Weight-based dosing: Infants ≥3 months, Children, and Adolescents: IV, Oral:
Cr Cl (ml/min/1.73m2) Based o 0.25 mg/kg/12 hr Based on 0.5 mg/kg/12 hr
≥50 No adjustment necessary No adjustment necessary
10 - <50 0.25 mg/kg/24 hr 0.5 mg/kg/24 hr
Max. 10 mg/dose. Max. 20 mg/dose.
<10 0.125 mg/kg/24 hr 0.25 mg/kg/24 hr
Max. 5 mg/dose. Max. 10 mg/dose.
2
IDH,PD: use doses of Cr Cl <10 ml/min/1.73m after hemodialysis on dialysis days
CRRT: use doses of Cr Cl 10 - < 50 ml/min/1.73m2
Hepatic Impairment: no dosage adjustments described
Preparation IV Push: Dilute to conc. of 2 mg/mL (1ml + 4ml) with 0.9% NS, D5W, D10W4
IV infusion: dilute to 0.2 mg/mL with D5W or other compatible sol. (ampoule/100 ml)
Max conc. 4 mg/ml for IV (all ages)
Administration IV push: over at least 2 min (max 10 mg/min)
Infusion: over 15 - 30 min for neonates
Stability 1 Store ampoules refrigerated at 2 – 8 ° C, Protect from light
161
If frozen allow to solubilize at room temp.
Any remaining of drug or diluted solutions should be discarded immediately after use
diluted preparation 1ml + 4ml D5W or NS is stable at 2 – 8 ° C for 48 hr 2
Ampoule /100 ml for infusion D5W or NS is stable at 2 – 8 ° and room temp for 48 hr 2
Adverse reactions Adverse Drug Reactions are for the oral formulations unless otherwise noted.
>10%:
CNS: Agitation (infants)
1% to 10%:
GIT: Constipation, diarrhea.
CNS: Dizziness, headache
<1%:
CVS: Flushing, palpitations
Dermatologic: Pruritus, skin rash, xeroderma
Endocrine & metabolic: Decreased libido
GIT: Abdominal distress, anorexia, nausea, vomiting, xerostomia
Genitourinary: Impotence
Hematologic & oncologic: Thrombocytopenia
Hepatic: ↑ liver enzymes
CNS: Anxiety, drowsiness, fatigue, hallucination, insomnia, seizure, altered taste
Neuromuscular & skeletal: Arthralgia, asthenia, musculoskeletal pain
Ophthalmic: Conjunctival injection, periorbital edema
Otic: Tinnitus
Other: Fever
Frequency not defined: Local: Irritation at injection site (IV)
Postmarketing:
CVS: Atrioventricular block, cardiac arrhythmia, facial edema, prolonged QT on ECG
Dermatologic: SJS, TEN urticaria
GIT: Necrotizing enterocolitis (very low birth weight neonates)
Hematologic & oncologic: Agranulocytosis, leukopenia, neutropenia, pancytopenia
Hepatic: Cholestatic jaundice, hepatitis
Immunologic: DRESS
CNS: Confusion, delirium, disorientation, mania, nightmares, paresthesia, restlessness
Neuromuscular & skeletal: Muscle cramps, rhabdomyolysis
Respiratory: Interstitial pneumonitis
Contraindications Serious hypersensitivity to famotidine, other H2 antagonists, or any formulation component
OTC labeling: When used for self-medication (OTC), do not use if trouble or pain when
swallowing food, vomiting with blood, or bloody or black stools, allergic to other acid
reducers, kidney impairment, administration with other acid reducers.
Proton pump inhibitor

Pantoprazole
Trade name Protofix /Futapan/pantazol
Active drug Pantoprazole
Mechanism of
Proton pump inhibitor prevents gastric acid secretion
action
Indications short-term treatment (7 - 10 days) of GERD with a history of erosive esophagitis, treatment
of pathological hypersecretory conditions
Dose3 Gastric acid suppression, oral therapy not appropriate or tolerated
Dosing based on pharmacokinetic data from 39 pediatric patients (age: 10 days - 16 yr)
Doses produced similar AUC as adults with comparable dosing, efficacy was not evaluated.
162
Parenteral therapy should be discontinued as soon as the patient tolerates oral therapy.
Weight-based dosing
Children ≥2 years and Adolescents (IV)
0.8 – 1.6 mg/kg once daily, max. single dose: 80 mg
Some clinicians used 1 – 2 mg/kg/day in single or divided doses.
Infants, Children, and Adolescents BSA-based dosing: IV: 40 – 80 mg/1.73 m2/day
Dose adjustment3 Renal/Hepatic impairment: no pediatric-specific recommendation, Adult data
recommends no dosage adjustments. Doses > 40 mg hasn’t been evaluated.
Preparation3 IV push: vial 40 mg + 10 mL NS, final concentration: 4 mg/mL.
Intermittent IV infusion: further dilute in NS, D5W, or LR to a final concentration of 0.4
mg/mL(1+ 9 ml) (0.8 mg/mL = 1 + 4 ml was reported)
Administration3 Flush IV line with NS, LR or D5W before and after administration
IV push: over 2 min at conc. of 4 mg/mL.
Intermittent IV infusion: Using a 0.4 – 0.8 mg/mL conc. (1+9 ml & 1+ 4 ml) infuse over 15
min, max. rate 7 mL/min
Stability1 Store intact vials at room temp 30° C , protect powder from light
Futapan/pantazol: 24 hr after reconstitution at room temp
Protofix: 12 hr after reconstitution at room temp
Adverse reactions 1% – 10%:
CVS: Edema, thrombophlebitis
Dermatologic: Pruritus, skin photosensitivity, skin rash, urticaria
Endocrine & metabolic: ↑Sr triglycerides
GIT: Abdominal pain, constipation, diarrhea, flatulence, nausea, vomiting, xerostomia.
Hematologic & oncologic: Leukopenia, thrombocytopenia.
Hepatic: Hepatitis, ↑ liver enzymes.
Hypersensitivity: Facial edema, hypersensitivity reaction.
Nervous system: Depression, dizziness, headache, vertigo.
Neuromuscular-skeletal: Arthralgia, ↑creatine phosphokinase in blood specimen, myalgia
Ophthalmic: Blurred vision.
Respiratory: Upper respiratory tract infection
Miscellaneous: Fever
Laboratory test abnormality (false-positive for THC)
Postmarketing:
CVS: Acute coronary syndrome
Dermatologic: AGEP, cutaneous lupus erythematosus (subacute), maculopapular rash, SJS, TEN
Endocrine & metabolic: Hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, vitamin
B12 deficiency, weight changes
GIT: Ageusia, CDAD, colitis (microscopic) , dysgeusia, gastric polyp (fundic gland, with chronic
use [>1 year]), gastroenteritis, pancreatitis
Hematologic & oncologic: Agranulocytosis, neutropenia, pancytopenia
Hypersensitivity: Anaphylaxis, angioedema, DRESS
CNS: Asthenia, confusion, dementia, drowsiness, fatigue, hallucination, insomnia
Neuromuscular & skeletal: Bone fracture, rhabdomyolysis
Renal: Acute interstitial nephritis, renal disease (chronic)
Respiratory: Pneumonia (adults and pediatric patients 4 to 36 months of age)
Contraindications Hypersensitivity (eg, anaphylaxis, bronchospasm) to pantoprazole, other PPIs, or any
component of the formulation.
Combination with rilpivirine-containing products
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Low molecular weight heparin/anti- factor X Anticoagulant
Enoxaparin
Trade name Clexane
Active drug Enoxaparin
Dosage form Prefilled syringe 20 mg/0.2 ml for subcutaneous injection
Mechanism of action Low-molecular-weight heparin strongly inhibit factor Xa with little effect on activated PTT
Indications Prophylaxis for DVT following hip or knee replacement surgery, abdominal surgery & in
severely restricted mobility during acute illness, in risk for thromboembolism, DVT therapy,
ischemic complications prevention in acute coronary syndromes, unstable angina, non-ST-
elevation and ST-segment elevation myocardial infarction
Dose Neonate 3,4
Treatment of Thrombosis: subcutaneous
Term infants: initial, 1.7 mg/kg /12 hr
Preterm infants: initial, 2 mg/kg/ 12 hr, ranging from 0.8 – 3 mg/kg/ 12 hr.
Adjust dosage to anti-factor Xa level 0.5 – 1 unit/ mL
Low-risk prophylaxis: Subcutaneous: 0.75 mg/kg/ 12 hr3,4
Adjust dosage to anti-factor Xa level 0.1 – 0.4 unit/ mL.
Pediatric3
Prophylaxis (subcutaneous)
titrate dose to achieve a 4 - 6 hr post-dose target anti-factor Xa level of 0.1 - 0.3 units/mL
Infants 1 - <2 months: 0.75 mg/kg/12 hr.
Infant ≥2 months, Children & Adolescents: 0.5 mg/kg/ 12 hr.
Other references suggest for DVT prophylaxis10
reduce therapeutic dose by 50% or give 1 mg/kg/dose once daily
Thrombosis, treatment
Once-daily dosing in pediatric patients with normal renal function is not feasible due to
faster enoxaparin clearance and lower drug exposure in pediatric compared to adults
Duration of treatment: between 6 weeks and 3 months.
Initial: (subcutaneous) Chest/AHA guidelines.
Infant 1 - <2 months: 1.5 mg/kg/12 hr.
Infant ≥2 months, Children, & Adolescents: 1 mg/kg/ 12 hr.
Alternate dosing (subcutaneous)
Where initial higher doses are required especially in young infants or critically ill
1 - <3 months: 1.8 mg/kg/12 hr.
3 - 12 months: 1.5 mg/kg/12 hr
1 - 5 years: 1.2 mg /kg/ 12 hr
6 - 18 years: 1.1 mg/kg/12 hr.
Titrate dose to achieve a 4 - 6 hr post-dose target anti-factor Xa level of 0.5 - 1 units/mL
Dose adjustment Renal Impairment: No adjustment recommendations available in pediatric. However, in
adult, adjustment necessary in severe impairment (CrCl <30 mL/min(
Not dialyzable. Use of unfractionated heparin may be preferable5
Hepatic Impairment: No dosage adjustment recommendations, use with caution
Some references may reduce dose in severe impairment
Preparation Prefilled syringe
Dispense dose for neonate and children in 100 unit insulin syringe
Administration3 Dispense neonatal and pediatric doses in a 100 unit insulin syringe for dose accuracy
Neonates: the thighs are the usual sites for injection
≥ 1 months left or right anterolateral/ posterolateral abdominal wall & the triceps
Do not rub injection site after SUBQ administration
Hold 2 doses prior to any invasive procedure such as LP10
Stability Discard unused portion
Prefilled syringes stored at room temp. 25 °c , Protect from light
Adverse reactions >10% Hematologic: Anemia, hemorrhage
164
1% - 10%:
Dermatologic: Ecchymoses
GIT: Nausea
Hematologic: Major hemorrhage (includes intracranial, retroperitoneal, or intraocular
hemorrhage, incidence varies with indication/population, thrombocytopenia.
Hepatic: ↑ ALT (>3 x ULN), AST(>3 x ULN)
Local: Bleeding, hematoma and/or pain at injection site
CNS: Confusion
Other: Fever
<1%:
CVS: Atrial fibrillation, cardiac failure
Respiratory: Pneumonia, pulmonary edema
Frequency not defined
Local: Bruising, erythema and/or irritation at injection site
Postmarketing:
CVS: Hypersensitivity angiitis, thrombosis or associated with enoxaparin-induced
thrombocytopenia, can cause limb ischemia or organ infarction
Dermatologic: Alopecia, maculopapular/vesicobullous rash, pruritus, skin necrosis, urticaria,
Endocrine & metabolic: Hyperkalemia, hyperlipidemia, hypertriglyceridemia
Hematologic: Acute posthemorrhagic anemia, purpuric disease, spinal hematoma (rare),
thrombocythemia, thrombosis in heparin-induced thrombocytopenia
Hepatic: Hepatotoxicity (hepatocellular and cholestatic, including ↑Sr ALP)
Hypersensitivity: Anaphylactic shock, anaphylaxis, angioedema, nonimmune anaphylaxis, type
IV hypersensitivity reaction
Immunologic: DRESS
Local: Injection site reaction (including nodules, inflammation, oozing)
CNS: Epidural intracranial hemorrhage, headache
Neuromuscular & skeletal: Osteoporosis (following long-term therapy)
Contraindications Known hypersensitivity to enoxaparin, heparin, or any component of the formulation,
history of immune mediated heparin-induced thrombocytopenia in the past 100 days or in
the presence of circulating antibodies, active major bleeding
Anti factor X - Anticoagulant

Heparin
Trade name Heparin
Active drug Heparin
Dosage form Ampoule 5000 unit/1ml
Mechanism of Potentiates antithrombin III action inactivating thrombin (as well as other coagulation
action factors IXa, Xa, XIa, XIIa, and plasmin) and prevents the conversion of fibrinogen to fibrin
Indications Prophylaxis and treatment of thromboembolic disorders and anticoagulant for blood
transfusions, extracorporeal circulation, and dialysis procedures
Dose Neonate 4
Prophylaxis
Maintaining patency of central venous access device
0.5 units/kg/hr3,4
Maintaining patency of peripheral vascular catheters for parenteral nutrition (PN)
0.5 – 1 unit/mL of IV fluid/Parenteral nutrition.
↓final conc. of heparin used for Parenteral nutrition in small neonates receiving larger PN
volumes to avoid approaching therapeutic amounts
Peripheral arterial catheters Thromboprophylaxis:
Continuous heparin infusion at a final conc. of 5 units/mL at 1 mL/hr.
Thromboprophylaxis in congenital heart defect (CHD) patients with systemic to pulmonary
artery shunts or central venous lines in certain CHD patients Low dose:
Continuous IV infusion: 10 – 15 units/kg/hr3
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Treatment
Thrombosis Treatment: 75 units/kg IV over 10 min, followed by 28 units/kg/hr continuous
infusion.3,4
After 4 hr measure aPTT & adjust to an aPTT of 60 – 85 sec (corresponds to an anti-factor Xa
level of 0.35 - 0.7)
Duration: 10 – 14 days. Experts recommend switching to LMWH after 3 – 5 days.
For renal vein thrombosis requiring treatment, 6 weeks to 3 months of heparin/low
molecular weight heparin therapy is recommended
Alternate dosing 5
Neonate PMA < 35 weeks: Initially IV 50 units/kg, then (by continuous IV infusion) 25 units
/kg/hr, adjusted according to APTT.
Neonate≥ 35: Initially IV : 75 units/kg, then (by continuous IV infusion) 25 units/kg/hr
Systemic to pulmonary artery shunt thrombosis treatment in CHD patients3
Bolus: 50 – 100 units/kg, ongoing continuous infusion should be considered
Pediatric
Prophylaxis3
Parenteral nutrition (PN) additive, venous access patency
Central & peripheral: 1 unit/mL (final heparin concentration in PN).
↓final concentration of heparin used for PN to 0.5 units/mL in small infants receiving larger
PN volumes to avoid approaching therapeutic amounts
Peripheral arterial catheters in situ
Intra-arterial ( arterial catheter): Continuous infusion at final conc. 5 units/mL at 1 mL/hr
Thromboprophylaxis in congenital heart defect (CHD)
patients with systemic to pulmonary artery shunts or central venous lines in certain CHD
Low Dose: Continuous IV infusion: 10 - 15 units/kg/hr
Thrombosis, treatment3
Systemic heparinization (IV) Infant, children & adolescent
Initial loading: 75 units/kg over 10 min
Maintenance: initiated as continuous after loading
Infant : 28 units/kg/hr (1 – 11 months old a dose of 25 unit/kg/hr was suggested)5
Children & Adolescents: 20 units/kg/hr
Adjust dose to maintain an anti-Xa activity of 0.35 - 0.7 units/mL
Or an aPTT range that correlates to this anti-Xa range
Or a protamine titration range of 0.2 – 0.4 units/mL
Systemic to pulmonary artery shunt thrombosis treatment in CHD patients
Infants, Children, and Adolescents (IV)
Bolus: 50 – 100 units/kg, ongoing continuous infusion should be considered.
Dose adjustment3 Renal Impairment/ Hepatic Impairment: No adjustment required, adjust therapeutic
heparin according to aPTT or anti-Xa activity
Preparation3 Preparation of a 500 unit/ml solution (1+9 ml) may facilitate dose withdrawal
Line patency for parenteral nutrition solution (central or peripheral)
Neonate: 0.5 unit /ml ( = 0.10 ml ( of 1+9)/100 IV Fluid)
Age≥ 1 months : 1unit /ml ( = 0.20 ml ( of 1+9)/100 IV Fluid)
Invert the solution at least 6 times to ensure adequate mixing & prevent heparin pooling
Administration IV bolus :IV over 10 min at conc 100 – 500 unit /ml 4
Continuous infusion: 10 -500 unit /ml
Central venous catheters: Must be flushed with heparin solution when newly inserted,
daily (at the time of tubing change), after blood withdrawal or transfusion, and after an
intermittent infusion through an injectable cap.
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Stability Store at room temperature 30°C. Protect from light
Colorless to slightly yellow. Minor color variations do not affect therapeutic efficacy.
Compatible with D5W, D10W, NS and 1/2 NS 4
CVS: Vasospasm (including cyanotic extremities, limb ischemia, and limb pain)
Dermatologic: Skin ulceration at injections site (SUBQ), transient alopecia
Endocrine & metabolic: Acute adrenocortical insufficiency, adrenal hemorrhage, hyperkalemia,
ovarian hemorrhage, suppression of aldosterone synthesis
Genitourinary: Priapism
Hematologic : Bruise, hemorrhage, heparin-induced thrombocytopenia retroperitoneal
hemorrhage, thrombocytopenia , thrombosis in heparin-induced thrombocytopenia (eg, AMI,
cerebrovascular accident, DVT, gangrene of the extremities, PE, skin necrosis)
Hypersensitivity: Anaphylactic shock, hypersensitivity reaction, nonimmune anaphylaxis, severe
infusion related reaction
Local: Erythema /hematoma/ irritation/pain/tissue necrosis at injection site (SUBQ)
Neuromuscular & skeletal: Osteoporosis (with long-term use)
Contraindications Hypersensitivity to heparin or any component of the formulation (unless use of an
alternative anticoagulant is not possible in life-threatening situation), severe
thrombocytopenia, history of heparin-induced thrombocytopenia (± thrombosis),
uncontrolled active bleeding, when appropriate blood coagulation tests cannot be obtained
at appropriate intervals (applies to full-dose heparin only).
Antifibrinolytic/hemostatic agent
Tranexamic acid
Trade name Kapron /Savibleed
Active drug Tranexamic acid
Mechanism of Forms a reversible complex that displaces plasminogen from fibrin causing inhibition of
action fibrinolysis, inhibits the proteolytic activity of plasmin also reduces activation of
complement and consumption of C1 esterase inhibitor (C1-INH), thereby decreasing
inflammation associated with hereditary angioedema.
Indications Parenteral: in hemophilia to ↓or prevent bleeding after tooth extraction, decrease
perioperative bleeding and need for transfusion in congenital heart disease corrective
surgery, scoliosis-related, craniosynostosis, & congenital diaphragmatic hernia repair
surgery. To ↓ transfusion need in trauma cases & treat intractable diffuse alveolar
hemorrhage.
Dose Neonate3
Prevention of perioperative bleeding
General dosing (non-cardiac): IV
Loading dose: 10 – 30 mg/kg followed by a continuous IV infusion at 5 – 10 mg/kg/hr
Cardiac surgery with cardiopulmonary bypass: IV
Low dose
Loading dose: 10 mg/kg followed by a continuous IV infusion at 5 mg/kg/hr
Must also be added to cardiopulmonary bypass sol. at conc. 20 mcg/mL
Pharmacokinetic analysis target conc. 20 mcg/ml proposed: Loading dose: 10 mg/kg,
followed by a continuous IV infusion: 10 mg/kg/hr until initiation of bypass, then IV priming
bolus 4 mg/kg into bypass prime volume, followed by IV infusion 4 mg/kg/hr
Intermediate dose
Tranexamic acid must also be added to cardiopulmonary bypass sol. at conc. 70 mcg/mL
High dose
Loading dose: 100 mg/kg over 15 min, then a priming dose: 100 mg/kg into the by-pass
circuit followed by a continuous IV infusion at 10 mg/kg/hr
167
Pediatric3
Diffuse alveolar hemorrhage (intractable), treatment:
Child ≤25 kg: Inhaled: 250 mg /6 hr for 3 – 4 doses (FOR 18 – 24 hr)
Child >25 kg & Adolescents: Inhaled: 500 mg inhaled /6 hr for 3 – 4 doses (for 18 – 24 hr)
*If response occurs continue treatment for another 2 - 3 doses after bleeding completely
stops, if no or minimal response or bleeding worsens, add inhaled recombinant factor VIIa,
max. duration of inhaled therapy: 3 days.
Two retrospective studies reported doses of 250 – 500 mg/ 6 – 12 hr until resolution of
bleeding for pulmonary hemorrhages(age 11 months – 15 years)
Hereditary angioedema (HAE), prophylaxis
Oral Long-term prophylaxis
reserve use for when C1-inhibitor concentrate is unavailable
Children & Adolescents: Oral: 20 – 50 mg/kg/day divided/8 –12 hr, up to 75 mg/kg/day
reported, max. dose range: 3 – 6 g/day
may consider (alternate-day) or( twice-weekly) dosing when frequency of attacks reduces
Oral Short-term prophylaxis (not recommended for indication)
prior to surgical/diagnostic procedure in head/neck region
Children & Adolescents Oral
Weight directed: 20 – 50 mg/kg/day divided/8 -12 hr, max. dose range: 3 - 6g/day
Initiate therapy at least 5 days before and continue for 2 days after procedure
Fixed dosing: (≥50 kg) 500 mg /6 hr, Initiate therapy 2 - 5 days before dental work and
continue for 2 days after the procedure.
IV slow: Children: 10 mg/kg/ 8 –12 hr (max. 1 g/dose), over at least 10 min
Continuous IV infusion children: 45 mg/kg, dose to be given over 24 hours
Menstrual bleeding, heavy
Oral tablet: 1.3 g /8 hr for up to 5 days during monthly menses max: 3.9 g/day.
Alternate dosing5
12 – 17 yr: 1 g /8hr for up to 4 days initiated with menstruation start, Max. 4 g/day
Prevention of bleeding associated with tooth extraction in hemophilic patients
hemophilic patients
Use in combination with replacement therapy.
IV: 10 mg/kg just before surgery, then 10 mg/kg/dose /6 – 8 hr for 2 – 8 days.
Alternate dosing for hemophilic and Non- hemophilic patients prevention 5
IV: Child 6 – 17 years: 10 mg/kg (max. 1.5 g/dose), pre-operatively
Oral: Child 6 –17 years: 15–25 mg/kg (max. 1.5 g/dose), pre-operatively
then 15–25 mg/kg /12– 8hr (max. 1.5 g/dose) for up to 8 days, postoperatively
Prevention of perioperative bleeding
General dosing (non-cardiac): Infants, Children, and Adolescents
IV: Loading dose: 10 – 30 mg/kg followed by a continuous IV infusion 5 – 10 mg/kg/hr
Cardiac surgery with cardiopulmonary bypass: Infants, Children, and Adolescents:
Low dose IV
Pharmacokinetic analysis target conc. 20 mcg/ml proposed: Loading dose: 10 mg/kg,
followed by a continuous IV infusion: 10 mg/kg/hr until initiation of bypass, then IV priming
bolus 4 mg/kg into bypass prime volume, followed by IV infusion 4 mg/kg/hr
Another model(age 2 month – 15 yr) 10 mg/kg into the bypass circuit after induction,
during bypass, and after protamine reversal of heparin for total of 3 doses
A third model analysis to achieve a target Sr conc. range 20 – 30 mcg/mL (in children 1 - 12
yr & weighing 5 – 40 kg) (data showed that patients weighing less should receive an initial
continuous IV infusion rate at the higher end of the range and vice versa)
IV: Loading dose: 6.4 mg/kg over 5 min. followed by a weight-adjusted continuous IV
168
infusion in the range of 2 – 3.1 mg/kg/hr
Intermediate dose
High dose
Loading dose: 50 mg/kg followed by a continuous IV infusion at 15 mg/kg/hr into the by –
pass circuit, and 50 mg/kg priming dose into the circuit when bypass initiated (target sr.
conc. 150 mcg/mL)
Spinal surgery (eg, idiopathic scoliosis): Children ≥8 years and Adolescents
IV Loading: 100 mg/kg, followed by a continuous IV infusion 10 mg/kg/hr until skin closure
Other regimens with positive results:
Loading: 20 mg/kg, followed by a continuous IV infusion at 10 mg/kg/hr,
loading : 10 mg/kg, followed by a continuous IV infusion at 1 mg/kg/ hr,
Or loading : 50 mg/kg, followed by a continuous IV infusion at 5 mg/kg/ hr
Craniosyntosis surgery: Infants ≥2 months – Children ≤6 years:
IV Loading: 50 mg/kg over 15 min prior to incision, followed by a continuous IV infusion at 5
mg/kg/hr until skin closure
Other regimens with positive results
Loading: 15 mg/kg over 15 min, followed by a continuous IV infusion at 10 mg/kg/hr
loading : 10 mg/kg over 15 min, followed by a continuous IV infusion at 5 mg/kg/ hr for 24
hr after surgery
Trauma, hemorrhagic (acute traumatic coagulopathy)
Children <12 years
IV Loading dose: 15 mg/kg over 10 min within 3 hr of injury (max: 1g/dose), followed by
continuous IV infusion 2 mg/kg/hr for ≥8 hr or until bleeding stops
Children ≥12 yr and Adolescents
IV Loading: 1g over 10 min given within 3 hr of injury, followed by 1g infused over 8 hr
Traumatic hyphema
Children & Adolescents
Oral: 25 mg/kg/8 hr for 5 – 7 days (regimen may be used for secondary hemorrhage after
an initial traumatic hyphema event)
Inhibition of fibrinolysis Children5
Oral: 15–25 mg/kg/ 8 –12 hr (max. per dose1.5 g)
IV slow: 10 mg/kg/ 8 –12 hr (max. per dose 1 g), over at least 10 min (up to /6 hr)10
Continuous IV infusion: 45 mg/kg, dose to be given over 24 hours
Dose adjustment3 Renal Impairment
Recommendations are dependent on use and route.
Oral
Menorrhagia: Female Children ≥12 years & Adolescents:
Sr cr >1.4 – ≤2.8 mg/dL: 1,300 mg /12hr for up to 5 days during monthly menstruation.
Sr cr >2.8 – ≤5.7 mg/dL: 1,300 mg /24 for up to 5 days during monthly menstruation.
Sr cr >5.7 mg/dL: 650 mg /24 hr for up to 5 days during monthly menstruation.
Prophylaxis of hereditary angioedema:
Children & Adolescents: no adjustments described however, due to risk of accumulation,
adjustments are recommended
IV
Tooth extraction in patients with hemophilia
Sr cr 1.36 – ≤2.83 mg/dL: Maintenance dose 10 mg/kg/12 hr
Sr cr >2.83 – ≤5.66 mg/dL: Maintenance dose 10 mg/kg/24 hr.
Sr cr >5.66 mg/dL: Maintenance dose 10 mg/kg/48 hr or (5 mg/kg/dose /24 hr).
Prophylaxis or treatment of mild to major bleeding secondary to trauma or surgery:
Neonate4,Infants, Children, and Adolescents: no adjustments described however, due to
risk of accumulation, adjustments are recommended
169
Adult recommendation for dose adjustment in renal impairment
Tranexamic acid is >95% eliminated by the kidney. No adjustment necessary for indications
requiring only 1 – 2 doses.
No bioavailability data on Tranexamic acid administered via nebulization so renal dose
adjustment data unavailable, use with caution.
IV:
Intermittent injection: based on a usual dose of 10 mg/kg or 1 g /6 – 8hr times daily.
Sr cr <1.4 mg/dL: No adjustment necessary.
Sr cr ≥1.4 – <2.8 mg/: usual dose twice daily.
Sr cr ≥2.8 – <5.7 mg/dL: usual dose once daily.
Sr cr ≥5.7 mg/dL: usual dose / 48 hr or 50% of the usual dose /24 hr.
Continuous infusion:
General recommendations for maintenance infusion following loading dose
should only be considered for cardiac or spinal indications, not for trauma patients
The principal that % to be administered is (actual GFR divided by normal GFR) × 100%, with
normal GFR = 90 mL/minute/1.73 m2.
eGFR ≥90 mL/min/1.73 m2: 100% of the usual maintenance rate.
eGFR 60 – <90 mL/min/1.73 m2: 66% – 100% of the usual maintenance rate.
eGFR ≥30 – <60 mL/min/1.73 m2: 33% – 66% of the usual maintenance rate.
eGFR <30 mL/min/1.73 m2: 17% – 33% of the usual maintenance rate.
eGFR-based regimen (BART regimen) - cardiac surgery specific:
eGFR ≥90 mL/min/1.73 m2: Loading: 30 mg/kg followed by 16 mg/kg/hr.
eGFR 60 – <90 mL/min/1.73 m2: Loading: 30 mg/kg followed by 11 – 16 mg/kg/hr.
eGFR >30 – <60 mL/min/1.73 m2: Loading: 25 – 30 mg/kg followed by 5 – 10 mg/kg/hr.
eGFR ≤30 mL/min/1.73 m2: Loading: 25 – 30 mg/kg followed by 3 – 5 mg/kg/hr.
Sr creatinine-based regimen (Sr Cr unit is mg/dl)
1.6 – 3.3: ↓maintenance infusion to 1.5 mg/kg/hr (based on a 25% ↓from 2 mg/kg/hr).
3.3 – 6.6: ↓maintenance infusion to 1 mg/kg/hr (based on a 50% ↓from 2 mg/kg/hr).
>6.6: ↓maintenance infusion to 0.5 mg/kg/hr (based on a 75% ↓from 2 mg/kg/hr).
Oral
(based on a usual recommended dose of 10 – 15 mg/kg or 1 – 1.5 g /6 – 8 hr)
Sr cr <1.4 mg/dL: No dosage adjustment necessary.
Sr cr ≥1.4 to <2.8 mg/dL: Administer usual dose twice daily.
Sr cr ≥2.8 to <5.7 mg/dL: Administer usual dose once daily.
Sr cr ≥5.7 mg/dL: Administer usual dose / 48 hr, or 50% of the usual dose / 24 hr.
Peritoneal dialysis or intermittent Hemodialysis (thrice weekly): Likely dialyzable, use
intermittent doses after hemodialysis when possible.
IV (intermittent), Oral: Administer usual dose/48 hr, or 50% of the usual dose/24 hr.
IV (continuous infusion): Dose as for eGFR <30 mL/min/1.73 m2.
CRRT: based on high-flux dialyzers and effluent flow rates of 20 - 25 mL/kg/hr (or ~1,500 -
3,000 mL/hr), monitoring of response/adverse reactions (eg, seizures, thrombosis)
IV (intermittent), Oral: Administer usual dose twice daily.
IV (continuous): Dose as for eGFR 30 – 60 mL/min/1.73 m2.
Hepatic Impairment
No adjustment is necessary
Preparation 3 Continuous IV infusion:
Loading dose: May diluted in (1 mL/kg =1+9 ml )) or 20 mL NS or
IV infusion: may be diluted in NS or D5W to a final concentration of 1 mg/mL ((1+9 ml )
Oral diluting ampoule 5 mL + 5 ml SWFI= solution 50 mg/ml for oral use
Prepared from tablet ( 500 mg + 20 ml water) stand for 2 – 5 min until dispersed into fine
particulate suspension
Administration3 Intermittent IV dose: undiluted by direct IV injection, max. rate of 100 mg/min (1 ml
undiluted/min or 10 ml of 1+9ml/min), faster rates may cause hypotension.
Loading dose: undiluted or diluted infusion over 5 – 15 min (Neonate over 60 min)
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Maintenance IV infusion as continuous infusion at a rate not to exceed 100 mg/min.
Inhalation: Administer undiluted (100 mg/mL) by jet nebulization
Oral: Administer without regard to meal
Stability3 Intact Ampoules: store at max 30° C
Undiluted IV sol. And diluted solution in NS used for iv continuous infusions are stable at
room temperature during 24 hr infusion(extended stability for weeks)
Oral: prepared from ampoule solution is stable for 5 days refrigerated
Prepared from tablet : use immediately after preparation
GIT: Abdominal pain
CNS: Headache
Neuromuscular & skeletal: Back pain, musculoskeletal pain
Respiratory: Nasal signs and symptoms (including sinus symptoms)
1% - 10%:
Hematologic: Anemia
CNS: Fatigue
Neuromuscular & skeletal: Arthralgia, muscle cramps, muscle spasm,
Postmarketing (all formulations):
CVS: Arterial thromboembolism, DVT, hypotension (with rapid IV), PE, venous
thromboembolism
Dermatologic: Allergic dermatitis, fixed drug eruption, pruritus, TEN, urticaria
CNS: Cerebral thrombosis, dizziness, myoclonus, seizure
Ophthalmic: Chromatopsia, conjunctivitis (ligneous), retinal artery/vein occlusion, vision
color changes, vision loss, visual impairment
Renal: Renal cortical necrosis
Respiratory: Wheezing
Contraindications3 Hypersensitivity to Tranexamic acid or any component of the formulation.
Injection: Active intravascular clotting, subarachnoid hemorrhage.
Oral: Active thromboembolic disease (eg, cerebral, DVT, or pulmonary), thrombosis or
thromboembolism history, including retinal vein/artery occlusion, intrinsic risk of
thrombosis or thromboembolism (eg, hypercoagulopathy, thrombogenic cardiac rhythm
disease/valvular disease). Not: adult contraindications not included
Anti-bleeding Vitamin k1
Phytonadione
Trade name Konakion / Epikavit
Active drug Phytonadione (vitamin K)
Dosage form Ampoule 10 mg / 1 ml for IV or IM
Mechanism of action Promotes liver synthesis of clotting factors (II, VII, IX, X).
Indications Prophylaxis & Therapy of vitamin K deficiency bleeding. Therapy of anticoagulant-induced
prothrombin deficiency, hypoprothrombinemia caused by drugs, malabsorption... etc.
Dose Neonate 4
Prophylaxis: Vit K deficiency bleeding for early and late bleeding
IM Preterm ≤1.5Kg: 0.3 – 0.5 mg/kg IM within 6 hr of birth
>1.5 kg: 1 mg IM within 6 hr of birth.
Oral route is acceptable alternative when IM is not accepted
Avoid Oral in, premature, ill, unable to take oral, cholestasis, impaired intestinal
absorption or drug that interfere with Vit.K
Dosing: 2 mg orally at birth then 1 mg once weekly for 3 months
Newborn may receive 3 doses as follows:
Or 2 mg orally at birth followed by at 2 mg at 4 – 6 days and at 4 – 6 weeks
Or 2 mg orally at 1st feeding, then2 mg at 2 – 4 weeks and at 6 – 8 weeks
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Alternate dosing 5
preterm: IM 0.4 mg/kg (max 1 mg) for 1 dose given at birth5
use IV route in preterm with VLBW when IM isn’t applicable (IV route doesn’t provide
prolonged effect compared to IM, and patient should receive subsequent oral doses)
Treatment Vitamin K deficiency bleeding (VKDB), SUBQ preferred
Inject IV slowly (Must not to exceed 1 mg/min)
Avoid IM route in the presence of coagulopathy.
Dosing: 1 mg IM, IV, subQ
Higher doses needed in infants whose mothers been on oral anticoagulants.
Infant: 1 – 10 mg IV as one dose (data from studies in infant with early or late VKDB).
Doses of 1 – 5 mg IV for a mean of 3.7 days were also used.
Alternate dosing5
IV: 1 mg/8hr if needed
Biliary atresia and liver disease: oral 1 mg/day
Pediatrics3
Vitamin K Deficiency due to Malabsorption or decreased synthesis of Vitamin K
Infants and Children10
1 – 5 mg/dose /IV, SubQ once, or 2.5 – 5 mg/24 hr PO daily
May repeat dose depending on severity of deficiency and response to treatment.
Parenteral nutrition, maintenance requirement:
Infants: IV: 10 mcg/kg/day as an additive to parenteral nutrition sol.
Children and Adolescents: IV: 200 mcg/day as an additive to parenteral nutrition sol.
Reversal of vitamin K antagonists
Weight-based dosing (preferred) IV: 0.03 mg/kg/dose is recommended for excessively
prolonged INR (usually INR >8, no evidence of bleeding) due to vitamin K-antagonist
if significant bleeding, consider use of fresh frozen plasma, prothrombin complex
concentrates, or recombinant factor VIIa
may start at 0.015 – 0.03mcg/kg (max 1 mg/dose) mat repeat as necessary 5
Fixed dosing:
Smaller pediatric should receive doses on the low end of dosing range, excessive dosages
may cause warfarin-resistance
No bleeding, rapid reversal needed, patient will require further oral anticoagulant
therapy: SubQ, IV: 0.5 – 2 mg.
No bleeding, rapid reversal needed, patient will not require further oral anticoagulant
therapy: SubQ, IV: 2 – 5 mg.
Significant bleeding, not life-threatening: SubQ, IV: 0.5 – 2 mg, + fresh frozen plasma.
Significant bleeding, life-threatening: SubQ, IV: 5 mg, Consider use with prothrombin
complex concentrate containing factors II, VII, IX, and X.
Alternate dosing5
Significant bleeding in Reversal of Coumarin anticoagulation when anticoagulation not
required — treatment of hemorrhage associated with vitamin-K deficiency
Child: 0.25 – 0.3 mg/kg for one dose. (max. 10 mg /dose)
Vitamin K deficiency, prevention, and supplementation
Biliary atresia
Infants 1 – 6 months:
INR >1.2 – 1.5: 2.5 mg once daily orally
INR >1.5 – 1.8: Initial: 2 – 5 mg IM once followed by 2.5 mg once daily orally.
INR >1.8: Initial: 2 – 5 mg IM once followed by 5 mg once daily orally.
Cholestasis: Infants, Children, and Adolescents: Oral: 2.4 – 15 mg/day
Cystic fibrosis: Infants, Children, and Adolescents: Oral: 0.3 – 0.5 mg/day
Liver disease: Infants, Children, and Adolescents: Oral: 2.5 – 5 mg/day
Dose adjustment3 Renal Impairment no dosage adjustments in adults and pediatrics
Hepatic Impairment : no dosage adjustments in adults and pediatrics
Preparation1,3 IV (10 mg) 1ml + 9 ml D5W,D10W ,NS (dilution reduces incidence of anaphylactoid
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reactions with IV administration) 4
IM: Administer undiluted
For IM use in neonatal verify conc (1 mg/0.5 mL)3(1 ml +4ml)
Administration1,3 IV :must administer 1 ml of diluted solution over 1 min 4 ( 5 ml over 5 min)
SUBQ: Administer undiluted.
Oral: The parenteral formulation may also be used for small oral doses (eg, 1 mg) may
administer undiluted or diluted in a beverage3.
Stability1 Store intact ampoules at 15 – 25° c, Protect from light, discard unused portion
Compatibility D5W, D10W, NS4
Discard any remaining of diluted solution after use
Protect from exposure to light all times. Protecting containers with aluminum foil is
recommended 2
CVS: Chest pain, flushing, hypotension, tachycardia, weak pulse
CNS: Dizziness
Dermatologic: Diaphoresis, eczematous rash, erythema, erythematous rash, pruritic
plaques of the skin, urticaria
GIT: Dysgeusia
Hepatic: Hyperbilirubinemia
Hypersensitivity: Anaphylactoid reaction, anaphylaxis, hypersensitivity reaction
Local: Injection site reaction (including pain, swelling, tenderness)
Respiratory: Cyanosis, dyspnea
Other: Lesion (scleroderma-like)
Contraindications3 Hypersensitivity to Phytonadione or any component of the formulation
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Amino acid and dietary supplement
L-carnitine
Trade name L-carnitine
Active drug L-carnitine
Dosage form Oral syrup 30% (300 mg /ml)
Mechanism of Carnitine is a natural metabolic compound which functions as a carrier molecule for long-
action chain fatty acids within the mitochondria, facilitating energy production
Indications primary or secondary carnitine deficiency, cyclic vomiting syndrome episodes prevention
Dose Neonate 3
Carnitine deficiency, treatment
Primary deficiency
Oral: Initial: 50 mg/kg/day in divided / 3 – 4 hr ,titrate slowly as needed to 50 – 100
mg/kg/day divided , (up to 400 mg/kg/day may be required)
Doses up to 200mg/kg/day may be divided/6 – 12 hr5
Secondary deficiency, (IEM)
Oral: Initial: 50 mg/kg/day in divided / 3 – 4 hr, titrate slowly as needed to 50 - 100
mg/kg/day divided , (up to 300 mg/kg/day may be required)
Doses up to200mg/kg/day may be divided/6 – 12 hr5
IV: 50 mg/kg single dose, titrate based on response.
Severe metabolic crisis loading: 50 mg/kg dose, followed by 50mg/kg/day divided/3 – 6 hr
may be needed, some conditions may require higher doses (eg. 300 mg/kg/day)
Parenteral nutrition (PN), supplement monitor carnitine level
Neonate Wt <5 kg are generally carnitine deficient and requiring supplement
IV Initial: 2 – 5 mg/kg/day in PN sol (up to 10 – 20 mg/kg/day may be necessary in ↑
triglyceride levels or patient receiving parenteral nutrition longer than 7 days)
Organic acidemias 5
Oral: Up to 200 mg/kg/ day divided/ 6 – 12hr.
By IV infusion: Initial 100 mg/kg over 30 min followed by continuous IV 4 mg/kg /hr
By IV injection: Up to 100 mg/kg divided /6 – 12 hr, administered over 2–3 min
Carnitine deficiency, treatment
**Dose from Oral solution: divided at evenly intervals (/3 – 4 hr)with or during meals
Primary deficiency:
By Oral: Initial: 50 mg/kg/day divided, may titrate slowly as needed to 100 mg/kg/day in
divided doses (/6 – 12)5(up to 400 mg/kg/day may be required) max. 3,000 mg/day
Initial dose may be up to 200 mg/kg/day5
By IV infusion: Initial 100 mg/kg over 30 min followed by continuous IV 4 mg/kg /hr5
By IV injection: Up to 100 mg/kg divided /6 – 12 hr, administered over 2–3 min5
Secondary deficiency:
Oral Initial: 50 mg/kg/day divided/ (3 – 4 hr)** may titrate slowly as needed to 100
mg/kg/day divided (up to 300 mg/kg/day), max. 3,000 mg/day
IV: 50 mg/kg single dose, titrate based on response.
In severe metabolic crisis loading: 50 mg/kg/dose, followed by 50mg/kg/day divided/3 – 6 hr
may be required, some conditions may require higher doses (eg. 300 mg/kg/day)
Regimen in hemodialysis patients5
IV: 20 mg/kg over 2–3 min, after each dialysis, dose adjusted to plasma-Carnitine level.
Then (by mouth)maintenance 1 g /day used if benefit is gained from first IV course
Carnitine deficiency in ESRD requiring dialysis
Child & adolescent: IV: 10 – 20 mg /kg of dry wt after each dialysis session
Evaluate response at 3 months intervals and titrate to lowest effective dose
Discontinue if no improvement after 9 – 12 months of therapy
Cyclic vomiting syndrome supplemental or adjunctive therapy:
Child & adolescent IV: 50 – 100 mg /kg /day divided / 8 – 12 hr usual max 1 g/12 hr
Higher doses up to 4 g/day was used based on Sr carnitine level monitoring
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Valproate Toxicity:
Child & Adolescent: dosing based on hepatic involvement & on clinical response or Sr
valproic acid
No hepatotoxicity: IV: 100 mg/kg/day divided / 6 hr until Sr ammonia and valproic acid
concentrations begin to decrease and clinical improvement is evident, max 3 g/day
Hepatotoxicity or Symptomatic hyperammonemia:
IV: Loading dose: 100 mg/kg, max dose: 6 g/loading, followed by 50 mg/kg/dose (up to
3g/dose) every 8 /hr or 15 mg/kg/ 4 hr, continue treatment until Sr ammonia concentrations
begin to decrease and clinical improvement is evident, patients may require several days of
therapy
Organic acidaemias5
Oral: Up to 200 mg/kg /day divided /6-12 hr, max. 3,000 mg / day
By IV infusion: Initial 100 mg/kg over 30 min followed by continuous IV 4 mg/kg /hr
By IV injection: Up to 100 mg/kg divided/6 – 12 hr, administered over 2–3 min
Dose adjustment3 Renal Impairment (adult/pediatric) Oral: safety/efficacy haven’t been evaluated in renal
impairment. Chronic use of high oral doses in severe renal dysfunction may cause
accumulation of potentially toxic metabolites.
IV: no dose adjustments described, adjustment should be based on Sr level & response
Hepatic Impairment: ((adult/pediatric) no dosage adjustments provided
Preparation IV: dilute in NS, D5W, D10W5
In Carnitine deficiency or valproic acid toxicity May be further diluted in LR or NS to a final
concentration of 0.5 – 8 mg/mL3
Administration3 Oral solution: taken directly or diluted in either beverages or liquid food, consume slowly,
doses should be spaced evenly throughout the day, preferably during or following meals
(every 3 – 4 hr) to improve tolerance
IV administration in Carnitine deficiency or Valproic acid toxicity undiluted (200 mg/mL) IV
push over 2 - 3 min or further diluted as IV infusion
IV in ESRD on hemodialysis: undiluted (200 mg/mL) IV push over 2 - 3 min into the venous
return line
Stability Bottle: Store at 30 °C, protect from light1
IV solution is stable for up to 24 hr when in NS or LR in PVC bags and stored at 25°C3
Adverse reactions GIT effects: result from too rapid consumption of oral carnitine, consume oral solution slowly
and space doses evenly throughout the day to maximize tolerance.
Serious hypersensitivity reactions (eg, rash, urticaria, facial edema)
Contraindications Hypersensitivity to L-carnitine or any component of the formulation
Dietary supplement – Fat soluble Vitamin

Vitamin D
Trade name V-drop
Active drug Vitamin D3
Dosage form Oral syrup 2800 unit /ml
Mechanism of A provitamin. The active metabolite, 1,25-dihydroxyvitamin D (calcitriol), stimulates Ca++ &
action phosphate absorption from the small intestine, promotes secretion of calcium from bone to
blood, promotes renal tubule phosphate resorption
Indications Prevention and treatment of vitamin D deficiency and/or rickets, dietary supplement
Dose 1mcg = 40 units
1ml= 28 drops
1 drop = 100 units
Neonate3,4
Adequate intake Oral: 400 units/day (10 mcg/day)
Vitamin D deficiency, prevention Oral
Preterm neonates:
Birth weight ≤1.5 kg Initial: 200 units/day, ↑to 400 units (4 drops) daily when weight >1.5 -
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2 kg and tolerating full enteral nutrition, experts recommend higher doses of 800 - 1,000
units daily for stable growing preterm neonates weighing 1 - 1.8 kg
Birth weight >1.5 kg: 400 units/day when tolerating full enteral nutrition, experts
recommended higher doses of 800 – 1,000 units daily for stable growing preterm neonates
up to 1.8 kg
Full-term neonates
Breastfed (fully or partially): 400 units daily beginning in the first few days of life, continue
supplementation unless infant is transitioned to full formula intake.
Vitamin D deficiency (severe, symptomatic), treatment Oral
Full-term neonates
2,000 units daily for 6 weeks to achieve Sr Vit D >20 ng/ml, (1,000 units daily reported)4
followed by a maintenance dose of 400 - 1,000 units daily, monitor vitamin D status closely
Treatment should include calcium supplement
Pediatric3
Vitamin D deficiency, prevention (eg, Rickets prevention) Oral
Breastfed infants (fully or partially)
400 units daily, begin in the first few days of life continue supplementation unless infant is
transitioned to full formula intake.
Children and Adolescents without adequate intake
600 units daily. Children with ↑risk of vitamin D deficiency (chronic fat malabsorption,
maintained on anti-seizure medications) may need higher doses, evaluate 25(OH)D, PTH,
bone mineral status levels
Vitamin D deficiency (severe, symptomatic), treatment Oral
With calcium supplement, some patients with chronic fat malabsorption, obesity, or who
are maintained on chronic anti-seizure medications, glucocorticoids, HIV medications, or
antifungals may require higher doses of Vit D, monitor vitamin D status closely.
For patients at high risk of fractures a Sr.25(OH)D level >30 ng/mL has been suggested
Infants:
2,000 units daily for 6 weeks to achieve a Sr.25(OH)D level >20 ng/mL (or >30 ng/ml in high
fracture risk patients)
followed by a maintenance dose of 400 – 1,000 units daily.
Children and Adolescents
2,000 units daily for 6 – 8 weeks to achieve Sr.25(OH) D level >20 ng/ml (or >30 ng/ml in high
fracture risk patients)
followed by a maintenance dose of 600 - 1,000 units daily
Vitamin D deficiency in cystic fibrosis, prevention and treatment Oral
to maintain Sr.25(OH)D level ≥30 ng/mL:
Infants: 400 – 500 units once daily.
Children ≤10 years: 800 – 1,000 units once daily
Children >10 years and Adolescents: 800 – 2,000 units once daily.
Dose adjustment for Sr Vit D level between 20 – 30 ng/mL & patient adherence
established (Step 1 increase):
Infants: 800 - 1,000 units once daily.
Children ≤10 years: 1,600 - 3,000 units once daily.
Children >10 years and Adolescents: 1,600 -6,000 units once daily.
Dose adjustment for Sr Vit D <20 ng/mL or between 20 - 30 ng/mL & patient adherence
established (Step 2 increase):
Infants: Increase up to a max 2,000 units once daily.
Children ≤10 years: Increase to a max of 4,000 units once daily.
Children >10 years: Increase to a max of 10,000 units once daily.
Alternate dosing in CF (Oral)
Initial dose: Sr.25(OH)D level ≤30 ng/mL.
Infants: 8,000 units once weekly.
Children and Adolescents: 800 units once daily.
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Medium-dose: Sr. 25(OH(D level remains ≤30 ng/mL & patient compliance established:
Infants and Children <5 years Oral: 12,000 units once weekly for 12 weeks.
Children ≥5 years and Adolescents Oral: 50,000 units once weekly for 12 weeks.
High-dose: Repeat 25(OH(D level remains ≤30 ng/mL & patient compliance established.
Infants and Children <5 years Oral: 12,000 units twice weekly for 12 weeks.
Children ≥5 years and Adolescents Oral: 50,000 units twice weekly for 12 weeks.
Vitamin D insufficiency or deficiency associated with CKD (stages 2 - 5, 5D) treatment
when Sr [25(OH(D] level ≤30 ng/mL
Infants Children, and Adolescents: Oral
Sr. 25(OH)D level:
16 – 30 ng/mL: 2,000 units daily for 3 months or 50,000 units /month for 3 months.
5 – 15 ng/mL: 4,000 units daily for 12 weeks or 50,000 units/ other week for 12 weeks.
<5 ng/mL: 8,000 units/day for 4 weeks then 4,000 unit/day for 2 months for total therapy of
3 months
or 50,000 units weekly for 4 weeks followed by 50,000 units 2 times/month for a total
therapy of 3 months.
Maintenance dose [once repletion of Sr. 25(OH)D level >30 ng/mL]
200 - 1,000 units daily.
Nutritional rickets, treatment Oral
with calcium supplementation:
Daily therapy (preferred):
Infant: 2,000 units daily for ≥3 months, followed by maintenance 400 units /daily.
Child: 3,000 – 6,000 units/day for ≥3 months, followed by maintenance 600 units/ day.
Adolescents: 6,000 units daily for ≥3 months, followed by maintenance 600 units daily.
Single-dose therapy:
Infants ≥3 months: 50,000 units once, or divided over several days, after 3 months, initiate
maintenance dose of 400 units daily.
Children: 150,000 units once, or divided over several days, after 3 months, initiate
Adolescents: 300,000 units once, or divided over several days, after 3 months, initiate
Dose adjustment3 Altered Kidney Function: adult/pediatric
No adjustments provided however, Cholecalciferol is not renally eliminated significantly, and
dosage adjustment is not necessary. Monitor plasma calcium level
Hepatic Impairment: adult/pediatric: no dosage adjustments provided,
Administration3 Oral: May be administered without regard to meals, for oral liquid, administer with an
accurate measuring device, do not use a household teaspoon
May be mixed with small amount of milk immediately before administration
Stability1 Store at 30° C. Protect from light.
Adverse reactions Vitamin D toxicity, May occur with excessive doses, symptoms include nausea, vomiting, loss of
appetite, constipation, dehydration, fatigue, irritability, confusion, weakness and/or weight loss.
Effects of vitamin D can last ≥2 months after therapy is discontinued.
contraindications Hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D, Williams syndrome
Documentation of cross-hypersensitivity for vitamin D is limited but can't be ruled out.
Vitamin D analog
Alfacalcidol
Trade name Bone care / Alfacalcidol (alfabonid)
Active drug Alfacalcidol
Dosage form Tablet 0.5 mcg (bone care) &
Oral solution 2mcg /ml (alfacalcidol)(bottle 20 ml) contains sorbitol
1 drop = 0.1 mcg
Mechanism of Vitamin D analog effectively bypass renal metabolic conversion, promotes intestinal Ca+2 &
action phosphorous absorption, Ca+2 resorption from the bone & possibly renal reabsorption
177
Indications Management of hypocalcemia, secondary hyperparathyroidism, and osteodystrophy in
patients with chronic renal failure, postoperative hypocalcemia, neonatal hypocalcemia.
Osteoporosis, rickets (calcipenic or phosphopenic) and osteomalacia
Dose Persistent Neonatal hypocalcemia1,5,8
Neonates and premature infants: IV, Oral Initial: 0.05 – 0.1 mcg/kg/day, higher doses up to
2 mcg/kg/day may be necessary. Note: If administering oral drops, half-drop doses should
be rounded up to the next whole number of drops
Prevention of Vit D deficiency in renal and cholestatic liver disease5
Neonate : IV, Oral Initial: 0.02 mcg/kg/day, adjusted as necessary
Chronic kidney disease-mineral and bone disorder (hypocalcemia, secondary osteodystrophy or
hyperparathyroidism)
hyperparathyroidism (Primary or tertiary)
hypoparathyroidism, rickets/osteomalacia1,8
Infants and Children <20 kg1 IV, Oral
Initial: 0.05 mcg/kg/day. Adjust to clinical response, caution to avoid hypercalcemia
If using oral drops, half-drop doses should be rounded up to the next whole number
Children and Adolescents ≥20 kg1 IV, Oral
Initial: 1 mcg once daily
If needed, titrate upward weekly by 0.25 – 0.5 mcg using caution to avoid hypercalcemia
Following initial response, maintenance doses of 0.25 – 1 mcg/day may be sufficient
depending on condition being treated, monitor therapy /2 – 4 weeks.8
If hypercalcemia occurs, interrupt therapy until plasma calcium normalizes (may be for 1
week), then restart at a reduced dose (may be 50% of previous dose)
Dose adjustment Renal Impairment adult data suggest no adjustment necessary
Hepatic Impairment no dose adjustment described for pediatric nor adult
Administration1 Oral drops with or without food /drink. Do not shake the bottle.
Oral capsule with or without food /drink. Swallow whole
Stability Oral solution: Store between 2 – 8°C. Protect from light 1,3, 8.
After opening use within 28 days (alfabonid)1,some formulations used within 4 months3,8
Oral capsule: store at 30 °C. Protect from direct sunlight
CVS: Cardiac arrhythmia, HTN
Dermatologic: Pruritus
Endocrine & metabolic: Albuminuria, ↓libido, ↑ Sr cholesterol, polydipsia, weight loss
GIT: Anorexia, constipation, diarrhea, nausea, pancreatitis, vomiting, xerostomia
Genitourinary: Ectopic calcification, nocturia
CNS: Asthenia, drowsiness, headache, hyperthermia, metallic taste, psychosis, vertigo
Neuromuscular & skeletal: Myalgia, ostealgia
Ophthalmic: Conjunctivitis, corneal deposits (calcification), photophobia
Renal: ↑ BUN, polyuria, renal insufficiency
Respiratory: Rhinorrhea
Postmarketing:
Endocrine & metabolic: Hypercalcemia, hyperphosphatemia
GIT: Abdominal pain
Genitourinary: Hypercalciuria
Renal: Nephrolithiasis, renal failure syndrome
Contraindications Hypersensitivity to 1-α-hydroxyvitamin D3, vitamin D or its analogues and derivatives, or any
component of the formulation, hypercalcemia, hyperphosphatemia, evidence of vitamin D
toxicity, Caution (oral drops contains sorbitol avoid in hereditary fructose intolerance)
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Dietary Supplement – Vitamin
Folic acid
Trade name Folic acid
Active drug Folic acid
Mechanism of Formation of coenzymes in many metabolic systems, particularly for purine & pyrimidine
action synthesis, required for nucleoprotein synthesis & maintenance in erythropoiesis, stimulates
WBC and platelet production in folate deficiency anemia.
Indications Treatment of megaloblastic/macrocytic anemias due to folate deficiency, supplement to
prevent neural tube defects & prevention of phenytoin gingival hyperplasia
Dose Nutritional supplementation11
Recommended daily allowance (PO)
0 – 6 months: 65 mcg/day
7 – 12 months:80 mcg/day
1– < 4 yr:150 – 300 mcg/day
4 – <9 yr: 200 – 400 mcg/day
9 – 14 yr: 300 mcg/day
14 – 18 yr: 400 mcg/day
Neonate 4
Adequate Intake: 65 mcg/day orally or enterally
Enteral Nutrition: Preterm: 25 - 50 mcg/kg/day orally MAX 65 mcg/day.
Term: 65 mcg/day orally.
Oral supplementation all neonates may be 50 mcg/day5
Folate-deficient megaloblastic anemia5 Oral Initial 500 mcg/kg once daily for up to 4 months
Infants, Children & Adolescents 3
Anemia (folic acid deficiency) treatment
Parenteral form necessary in severe disease or if GIT absorption is impaired.
Dosing: Oral, IM, IV, SUBQ
Initial: 0.5 - 1 mg daily for 3 - 4 weeks until hematologic response
Maintenance (A multivitamin containing 0.2 mg folic acid may be adequate)
Infants: 0.1 mg/day.
Child <4 years: 0.1 – 0.3 mg/day.
Child ≥4 years and Adolescents: 0.1 – 0.4 mg/day
Alternate dose for Folate-deficient megaloblastic anemia5
1 – 11 months: Initially 500 mcg/kg once /day for up to 4 months. (max. 5 mg/dose), up to
10mg /day may be required in malabsorption states
1– 17 yrs: 5 mg/day for 4 months, up to 15 mg /day may be required in malabsorption states
Gingival hyperplasia due to phenytoin, prevention 3
Child ≥6 years and Adolescents: Oral: 0.5 mg/day
Prevention of methotrexate side-effects in severe Crohn’s in severe psoriasis 5
Child: oral: 5 mg once/week, taken on a different day to methotrexate dose
Prophylaxis of folate deficiency in dialysis oral 5
1 month–11 yr: 250 mcg/kg once/day (max. 10 mg/dose)
12–17 years: 5–10 mg once/day
Hemolytic anemia/Metabolic disorders 5
1 month–11 years: 2.5–5 mg once daily
12–17 years: 5–10 mg once daily
Prevention of methotrexate side-effects in juvenile idiopathic arthritis5
Child: 1 mg/day, or 5 mg once/week, weekly dose taken on different day methotrexate
Dose adjustment 3 Renal/Hepatic Impairment no adjustments provided for adults or pediatrics
Preparation3 1 mg/mL Oral Solution
A 1 mg/mL folic acid oral solution can be extemporaneously prepared from be tablets
Using parabens (methylparaben 200 mg and propylparaben 20 mg) as preservative to keep
179
the solution Stable for 30 days at room temperature (consult detailed reference)
3
Administration Oral (preferred): May be administered without regard to meals
1 mg/mL Oral Solution may be extemporaneously prepared from tablets
A 1 mg/mL folic acid oral solution may be made with tablets using methylparaben 200 mg
and propylparaben 20 mg with pH sodium hydroxide 10%.
Stability Store at 25°C, protect from light.
Adverse reactions CVS: Flushing (slight)
CNS: Malaise (general)
Dermatologic: Erythema, pruritus, skin rash
Contraindications Hypersensitivity to folic acid or any component of the formulation.
Dietary mineral
Zinc Sulfate
Trade name sulfozinc
Active drug Zinc sulfate
Dosage form Powder for oral or oral solution 10mg/5ml, 20mg/ 5ml
For 10 mg /5ml formulation: 5 ml = 10 mg elemental zinc
For 20 mg /5ml formulation: 5 ml = 20 mg elemental zinc
Indications Supplement of zinc and reduce duration & severity of diarrhea in malnourished patients
Dose Neonate
Adequate intake3: oral: 2 mg /day elemental zinc
Zinc deficiency or supplement in zinc-losing states 5:1 mg/kg daily (elemental zinc)
Acrodermatitis enteropathica5: 1–2 mg/kg/day divided/8 -12 hr (elemental zinc)
Infant child & adolescent
Dosage expressed in terms of elemental zinc Oral
Diarrhea, treatment, malnourished patient 1,3
Infants <6 months: 10 mg once daily for 10 – 14 days
Infants ≥ 6 months and Children: Oral: 20 mg once daily for 10 – 14 days
Lower doses of 5 mg or 10 mg once daily for 14 days have shown non-inferior efficacy and
have been associated with less vomiting
Zinc deficiency
eg. cystic fibrosis, liver disease, sickle cell disease, short-bowel syndrome, intestinal failure
infant, child and adolescent: Oral: 0.5 - 2 mg/kg/day 3 (may be divided / 8 – 12 hr)10
Alternate dosing as supplementation in zinc-losing conditions 5
Child (<10 kg): 22.5 mg /day
Child (10 –30 kg): 22.5 mg 1–3 times /day
Child (≥31 kg (: 45 mg 1–3 times
Acrodermatitis enteropathica
Neonate, child: 1 – 2 mg/kg/8 – 12 hr, adjusted as necessary 5
Alternate dosing, infant, child & adolescent: 3 mg/kg/day, duration is typically life-long3
Dose adjustment Altered Kidney Function: adult/pediatric: no dosage adjustments provided Use with
caution (accumulation may occur in renal failure).
Hepatic Impairment: adult/pediatric: no dosage adjustments provided
Administration3 Administer with food or after meal to decrease GI upset.
Stability Store bottles at 30 °C
Adverse reactions Diarrhea, gastritis, GIT, discomfort, nausea, vomiting
Contraindications Hypersensitivity to any component in formulation
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IV Amino acids
Amino acid IV (Aminoven)
Trade name Aminoven 10%
Active drug Amino acids 100 g/1000 ml
L-leucine 13 g L-tryptophan 2.01g L-alanine 9.3 g
L-isoleucine 8g L-valine 9g L-proline 9.7 g
L-lysine 8.5 g L-histidine 4.76 g L-tyrosine 4.2 g
L-methionine 3.12g Glycine 4.15 g L-cysteine 0.52 g
L-phenylalanine 3.75 g L-taurine 0.49 g L-malic acid 2.62g
L-threonine 4.4 g L-serine 7.67
Dosage form Glass 100 ml Vial for IV infusion
Indications Part of parenteral nutrition when oral/enteral nutrition is insufficient, or contraindicated
Dose Component of parenteral nutrition IV 3
Term neonate, : Initial: 2.5 g/kg/day, Goal: 3 g/kg/day
Extremely (<1,000 g) and very (<1,500 g) low-birth-weight (stable)
Initial: 1 - 1.5 g/kg/day, Goal: 3.5 – 3.85 g/kg/day
Infants – 1 year: 1.5 – 2.5 g/kg/day
2 - 5 year: 1.5 g/kg/day
6 – 14 year: 1g/kg/day
Sepsis and hypoxia: Initial: 1 g/kg/day, goal: 3 – 3.85 g/kg/day
ASPEN 2020, ACCP (American college of clinical pharmacy )Updates 2022,
Premature Term neonate/ child Adolescent/
neonate infant adult
Initiation 1 – 4 g/kg/day 2.5 – 3 g/kg/day 1.5 – 2.5 g/kg/day 0.8 – 2 g/kg/day
Advancement 0.5 – 1 g/kg/day 0.5 – 1 g/kg/day 0.5 – 1 g/kg/day 0.5 – 1 g/kg/day
Goal 3 – 4 g/kg/day 2.5 – 3 g/kg/day 1.5 – 2.5 g/kg/day 0.8 – 2 g/kg/day
Dose adjustment Renal Impairment/Hepatic Impairment: Use with caution in patients with renal
impairment, dosage adjustment may be necessary adjusted to patient parameters.
Administration1,3 Continuous IV infusion
Aminoven max rate: max rate: 0.1g/kg/hr ( 1ml /kg/hr) via central vein1 with >5% dextrose
or osmolarity ≥900 mOsm/L
Peripheral Infusion of nutrition depends on osmolality of solution (< 900 mOsm/L).
TPN must be administered via central venous access. May require use of inline filter
Initiate & terminate TPN infusion gradually to permit endogenous insulin release adjustment
Vesicant, Avoid extravasation.
Stability1 Store intact vials at max. 25°C, avoid excessive heat, do not freeze. Protect from light.
Any unused portion should be discarded
Adverse reactions CVS: Phlebitis, thrombosis
Dermatologic: Erythema
Endocrine & metabolic: Fluid and electrolyte disturbance
Contraindications Hypersensitivity to one or more amino acids, in the formulation (review product leaflet)
Inborn errors of amino acid metabolism, ARF, hepatic coma, hypokalemia, hyperhydrosis
Parenteral fluid/nutrition
Dextrose /Glucose IV solution
Trade name glucose
Active drug Dextrose/glucose 5%, 10%, 25%
Dosage form Solution for IV 500 ml
Mechanism of action Monosaccharide, calories, stimulates the transient uptake of potassium by cells,
especially in muscle tissue, lowering Sr. potassium
Indications Source of Calories /fluid replacement
181
Dose Neonate
Hypoglycemia IV D10W3,4
0.2 g/kg/dose (2 mL/kg /dose). Followed by a continuous IV infusion of (D5W, D10W)
with maintenance electrolytes at an initial rate of 5 – 8 mg /kg/min (to maintain blood
glucose ≥40 – 50 mg/dL)3. Titrate rate to attain normoglycemia.
Abruptly discontinuing the infusion isn’t recommended (risk of rebound hypoglycemia)
Higher doses 10 – 20 mg/kg/min to maintain acceptable blood glucose in
hyperinsulinemic hypoglycemia
If plasma glucose remains low, increase infusion by 2 mg/kg/min increments consider
another strategy when > 12 – 14 mg/kg/min is needed
alternate dosing: IV, IO: 0.5 - 1 g/kg/dose (5 – 10 mL/kg/dose) 3
Hyperkalemia treatment4
Continuous IV infusion: 0.5g/kg/hr dextrose(5mL/kg/dose)+regular insulin 0.1 – 0.2
units/kg/hr. Adjust acc. to Sr k+ & glucose
Alternate dosing: 3 0.2 g/kg/dose D10W (2 mL/kg) + regular insulin, followed by a
continuous infusion 0.2 – 0.4 g/kg/hr (2 - 4 mL/kg/hr )
(2 – 4 g of glucose : 1 insulin unit)
Bolus method: initiate at 0.4 g/kg/dose (4 ml /kg D10W)3 + regular insulin
(4 g of glucose : 1 insulin unit)3
Parenteral nutrition recommendation:
ACCP Updates 2022 based on ASPEN guidelines 2020
initiation 6 – 8 mg/kg/min* 6 – 8mg/kg/min 3 – 6 mg/kg/min 2.5 – 3
mg/kg/min
# ¶
advancement 1– 2 mg/kg/min 1– 2 mg/kg/min 1 – 2 mg/kg/min 1 – 2 mg/kg/min
Goal 10–14 mg/kg/min 10–14 mg/kg/min 8 –10 mg/kg/min 5 – 6 mg/kg/min
Max 14–18 Max 14–18
mg/kg/min mg/kg/min
*may start at 4 mg/kg/mg in premature neonate4
# 3
may increase by 3.5 mg/kg/min
¶ 3
may increase by 3.5 mg/kg/min
Pediatric3
Hypoglycemia
Doses may be repeated in severe cases: IV, IO
Infant & Child: Dextrose (25%) sol: 0.5 – 1 g/kg/dose (2 - 4 mL/kg/dose) max: 25 g/dose
Adolescents: (50%): 0.5 - 1 g/kg/dose (1 - 2 mL/kg/dose), max 25 g/dose
Hyperkalemia, treatment
Infants, Children, and Adolescents: IV:
0.5 - 1 g/kg/dose (25% or 50%) with regular insulin over 15 – 30 min, may repeat.
A continuous IV infusion may be necessary, (4 – 5 g dextrose: 1 unit insulin).
10 insulin unit + 200 ml D25W = 5 g : 1 unit
parenteral nutrition: IV
<1 year: Initial: 6 - 8 mg/kg/min ,increase daily by 3.5 mg/kg/min to 10 - 14 mg/kg/min
(max. daily rate: 18 mg/kg/min)
1 – 10 yr: Initial: 3 - 6 mg/kg/min increase daily by 2 - 3 mg/kg/min to 8 - 10 mg/kg/min.
>10 – 18 yr: Initial: 2.5 - 3 mg/kg/min, ↑daily by 1 - 2 mg/kg/min to 5 - 6 mg/kg/min
Glucose tolerance test (diagnostic test for diabetes): Oral liquid
Child–Adolescent: 1.75 g/kg single dose (max:75 g/dose)assess Sr glucose 2 hr after dose
Dose adjustment Renal Impairment closely monitor (adult data)
Hepatic Impairment no adjustment (adult data)
Administration Peripheral infusion max conc. 12.5 % (in emergency may use 25% in infant & children)
Central max conc. 25% available
it is suggested that conc. > 15 % infused via central line 4
182
Continuous infusion rates vary with tolerance (range 4 - 14 mg/kg/min3
Hyperinsulinemic neonates 15 – 20 mg/kg/min may be needed3
More rapid administration of 0.2 g/kg bolus of D10W over 1 min in hypoglycemia used3
Vesicant at conc> 10%, avoid extravasation, 10 % may be irritant with vesicant like events3
Stability1 Store at 30 ° C in outer plastic package , protect from freezing and extreme heat1
CVS: Localized phlebitis, phlebitis, venous thrombosis
CNS: Confusion, loss of consciousness
Endocrine/metabolic: Dehydration, glycosuria, hyperglycemia, hyperosmolar syndrome,
hypervolemia, hypokalemia
Local: Local pain
Contraindications Hypersensitivity to dextrose, corn or corn products, or any component in formulation
hypertonic solutions in patients with intracranial or intraspinal hemorrhage, delirium,
tremens (if dehydrated) severe dehydration, clinically significant hyperglycemia, anuria
hepatic coma, dextrose solutions without electrolytes not infused with blood products
Fluid/electrolytes
Ringer's solution
Trade name Ringer's solution
Active drug Sodium: 147.5 mEq/L Potassium: 4 mEq/L
Calcium 4.5 mEq/L Chloride: 156 mEq/L
Dosage form 500 ml solution for infusion in IV bottle
Mechanism of Contents of solution causes expansion of the extracellular compartment including both the
action interstitial and intravascular fluids.
Indications Fluid replacement & Treatment of natremic dehydration
Dose Depend mainly on patient fluid and electrolyte state and losses to be replaced
Pediatric: 20 ml – 100 ml / kg / day (24 hr). according to condition 8
> 12 yr: 500 – 3000 ml/24 hr (40 ml/kg/day)
infusion rate is 5 ml/kg/hr average, varies with age 8
infants: 6 – 8 ml/kg/hr (who can't walk yet)
1 – <2 years: 4 – 6 ml/kg/hr (including any toddler below 1 year of age)
2 – 11 years: 2 – 4 ml/kg/hr
In children with burns,
average 3.4 ml/kg/percent burn at 24 hr post-burn
and 6.3 ml/kg/percent burn at 48 hr.
In severe head-injury children the dose is on average 2850 ml/m2.
surgery Infusion rate and total volume can be higher
Review therapeutic guidelines for indication specific dosing
Administration8 IV infusion
Don’t pressurize flexible bags during infusion to increase the rate(risk of air embolism)
Vented infusion sets with vent open with flexible plastic bags
Calcium in the formula may counters a risk of extravasation
Not used in neonate who receives IV ceftriaxone at any time
In infant and children may be used after or before ceftriaxone
Stability1 Store intact bottles at 30° C in outer plastic sealing to protect from dust & moisture loss
Discard unused portion after use (max microbiological stability 24 hr at 2 – 8 ° C)
Adverse reactions ≥ 10% Electrolytes disturbances.
Hyperhydration & HF in cardiac disorder or pulmonary oedema.
Contraindications Hypervolemia, Hypertonic dehydration, Hyperkalemia, Hypernatremia, Hypercalcaemia,
Hyperchloraemia, Severe renal insufficiency (with oliguria/anuria).
Uncompensated cardiac failure, Severe hypertension. Generalized edema & ascitic cirrhosis
Concomitant digitalis therapy and ( ceftriaxone in neonate ≤28 days of age)
183
Fluid/electrolytes
Lactated ringer's solution
Trade name Lactated ringer's
Active drug Sodium: 130 mEq/L Potassium: 5 mEq/L Calcium 4 mEq/L
Chloride: 111 mEq/L Lactate 29 mEq/L
Dosage form 500 ml solution for infusion in IV bottle
Mechanism of action Lactated source of water and electrolytes or an alkalinizing agent.
Indications Restore extracellular fluid / electrolytes balances or replacement of extracellular fluid
Short term volume replacement in hypovolaemia or hypotension (±colloid)
Regulation /treatment of mild - moderate metabolic acidosis (except lactic acidosis)
Dose Dose mainly depend on patient status, fluid and electrolyte requirement
Septic shock: IV: 10 – 20 mL/kg, reassess often and repeat as needed3
Generally in pediatric hypovolemia: Infants and children: 20 - 100 ml/kg/24 h 8
Administration rate: in pediatric patients8
Administered with particular caution to neonates and infants less than 6 months of age.
Pediatric infusion rates is 5 ml/kg/hr in average, varies with age:
infants: 6 – 8 ml/kg/hr (who can't walk yet)
1 – <2 years: 4 – 6 ml/kg/hr (including any toddler below 1 year of age)
children: 2 - 4 mL/kg/hr
In children with burns: 3.4 mL/kg/per cent burn at 24 hr post-burn and 6.3 mL/kg/per
cent burn at 48 hr.
In severely head-injured children: 2850 mL/m2.
Surgery: Infusion rate and total volume can be higher
Review therapeutic guidelines for indication specific dosing
Administration Via IV infusion
Stability Store at 30 °C, brief exposure up to 40°C does not adversely affect the product.
Avoid excessive heat.
Use immediately after opening, do not store for future use.
For irrigation, do not warm container over 66°C
Adverse reactions Immune System Disorders
Hypersensitivity/Infusion reactions including Anaphylactic/Anaphylactoid reaction,
possibly manifested by: Angioedema, Chest pain, Chest discomfort, ↓HR, Tachycardia,↓BP,
RD, Bronchospasm, Dyspnea, Cough, Urticaria, Rash, Pruritus, Erythema, Flushing, Throat
irritation, Paresthesias, Hypoesthesia oral, Dysgeusia, Nausea, Anxiety, Pyrexia, Headache
Metabolism and Nutrition Disorders
Hyperkalemia, Hospital acquired hyponatraemia
Acute hyponatraemic encephalopathy
Infusion Site Reactions manifested by one or more of the following symptoms: Phlebitis,
Infusion site inflammation, Infusion site swelling, Infusion site rash, Infusion site pruritus,
Infusion site erythema, Infusion site pain, Infusion site burning
Contraindications A known hypersensitivity to sodium lactate.
Extracellular hyperhydration or hypervolaemia
Severe renal insufficiency (with oliguria/anuria)
Uncompensated cardiac failure
Hyperkalaemia, Hypercalcaemia
Metabolic alkalosis. Severe metabolic acidosis
Ascitic cirrhosis
Conditions associated with ↑ lactate levels (hyperlactataemia) including lactic acidosis, or
impaired lactate utilization, such as severe hepatic insufficiency.
Concomitant digitalis therapy (concomitant ceftriaxone in neonate)
184
Fluid/ Electrolytes
Sodium chloride 0.9%
Trade name Sodium chloride
Active drug Sodium: 154 mEq/L, Chloride: 154 mEq/L
Dosage form Bottle 500 ml, 250 ml, 100 ml
Mechanism of action Major cation in fluid /electrolyte balance, osmotic pressure control & water distribution
Indications Hyponatremia , dehydration resuscitation in shock & hypovolemia
Dose Neonate
Volume expansion, resuscitation (0.9%) 3,4
IV:10 mL/kg over 5 – 10 min, may repeat a 2nd dose
Hyponatremia (0.9%)(Na + Water loss) 3
Dose (mEq) = [desired Sr Na+ (mEq/L) – actual Sr Na+ (mEq/L)] x TBW/100 x wt (kg)
For acute correction, use 125 mEq/L as "desired Sr. sodium"
TBW: Total Body Water: Premature infants: 80% & Infant ≤3 months: 70%.
Sodium replacement: ONLY 50% of sodium deficit should be replaced over 12 hr
Max. correction rate: 0.4 – 0.5 mEq/L/hr
3% solution used when Sr. sodium <120 – 125 mEq/L & symptomatic (all pediatric)
Normal daily maintenance IV12
Preterm and term : 2 – 5 mEq/kg/day
˃ 1 month – 18 year IV3
Hypovolemic shock IV: (0.9%)3
20 mL/kg/dose may repeat up to usual requirement 40 – 60 mL/kg until capillary perfusion
return normal
Septic shock(0.9%)3
10 - 20 mL/kg/dose(max 1,000 mL/dose, repeat /15 min for up to 4 hr)
Hyponatremia3
Dose (mEq) = [desired Sr Na+ (mEq/L) – actual Sr Na+ (mEq/L)] x 0.6 x wt (kg)
Severe symptomatic (3%) by Bolus IV infusion
2 – 5 mL/kg over 20 min (max.: 150 mL/dose), may repeat up to 2 times if severe
symptoms (neurologic) persists
Or estimate deficit* to correct the Sr Na+ by 4 – 6 mEq/L in 1 – 4 hr of symptom onset.
Max. correction rate: 0.5 mEq/L/hr or 10 mEq/L/24 hr
IF onset of hyponatremia is sudden (<24 hr), correction rate can match the rate of onset
without an mEq/L/hr limit
Mild – moderate or Asymptomatic symptoms (0.9%)
Replacement over 24 - 48 hr.
ONLY 50% of sodium deficit should be replaced over 12 hr
Max. correction rate: 8 mEq/24 hr (chronic hyponatremia duration >48 hr)
10 mEq/24 hr (acute hyponatremia duration <48 hr)
Normal daily maintenance IVASPEN
Infants and Children ≤50 kg: 2 - 5 mEq/kg/day.
Children >50 kg and Adolescents: 1 – 2 mEq/kg/day
Cerebral edema, diabetic ketoacidosis (3% sol.)3
as an alternative to mannitol or in those unresponsive to mannitol
Infants, Children & Adolescents: IV: 2.5 – 5 mL/kg over 10 – 15 min
Increased intracranial pressure (ICP), traumatic brain injury (TBI) (3%) 3
Monitor Sr Na + closely, avoid sustained (>72 hours) Sr Na + >170 mEq/L to avoid
thrombocytopenia and anemia and avoid Sr Na + >160 mEq/L to avoid DVT
Bolus IV: 2 – 5 mL/kg administered over 10 – 20 min.
Continuous IV infusion: 0.1 – 1 mL/kg/hr titrated to maintain ICP <20 mm Hg,
Bronchiolitis, viral (mild – moderate, inpatient)( Inhalation of 3% sol.) 3
185
Currently (3% ) not recommend to treat infants in the emergency department
Infant & Child <18 months: 4 mL/2 hr for 3 doses, followed by /4 hr for 5 doses &
continued/6 hr until discharge. (trials using doses of 2 – 4 mL/ 6 hr shown no benefit)
Cystic fibrosis (CF)( 7% sol) 3
≥2 – 8 yr: some CF centers use 3% or 3.5% inhaled solutions if patients cannot tolerate
7%.: Inhalation: 4 mL inhaled twice daily
An inhaled bronchodilator before the therapy is recommended to prevent potential
bronchospasm. (May be considered for use in symptomatic infants <2 years of age).
Preparation Ready to use as 0.9 % isotonic solution
Administration3 (>1%) is irritant with vesicant like properties, avoid extravasation
Neonate: Resuscitation over 5 – 10 min ,in GA <30 weeks consider longer duration.4
Parenteral: Central-line preferred for hypertonic saline (>0.9%). IO administration may be
used if unable to obtain IV access
Rate of administration:
0.9% isotonic solution
Hypotension, shock:
Neonates: consider slower administration to avoid IVH.
Infant, Child &Adolescent: Administer boluses by IV push or via rapid infusion device
3% hypertonic solution
Central-line administration preferred due to high osmolarity & tonicity.
If urgent use is necessary, 3% sol. may be given via peripheral line for short duration
Cerebral edema, diabetic ketoacidosis (DKA)
Bolus typically administered over 10 – 15 min. infusions of 30 min also described in DKA
Increased intracranial pressure (ICP), traumatic brain injury (TBI)
Bolus doses typically administered over 10 – 20 min
Symptomatic hyponatremia, severe
Bolus doses typically administered over 20 min
Stability Store intact bottles at 30° C in outer plastic sealing to protect from dust & moisture loss
Discard unused portion after use
CVS: Hypotension, localized phlebitis, peripheral edema, venous thrombosis
CNS: Chills
Endocrine & metabolic: Acid-base imbalance, electrolyte disturbance, hyperchloremia,
hyperchloremic metabolic acidosis, hypernatremia, hypervolemia, hyponatremia
Local: Injection site infection, infusion site reaction
Other: Fever
<1%, postmarketing, and/or case reports: Hypersensitivity, infusion related reaction
Contraindications Hypersensitivity to any component in formulation, hypernatremia and/or fluid retention.
Fluid/ Electrolytes
Paediment
Trade name Paediment
Active drug Sodium: 37 mEq/L Potassium: 20 mEq/L Calcium 18.6 mEq/L (4g/L as gluconate)
Chloride: 57 mEq/L glucose 10 %
Dosage form IV bottle 250 ml
Indications Maintenance fluid in neonate aged > 48 hr and infant with increased caloric requirement
Dose Tailored to the patient weight and fluid ,calorie and electrolyte requirement
3
Administration IV infusion
Don’t pressurize flexible bags during infusion to increase the rate(risk of air embolism
186
Calcium in the formula may counters a risk of extravasation
Not used in neonate who receives IV ceftriaxone at any time
In infant and children may be used after or before ceftriaxone
Stability1 Store intact bottles at 30° C in outer plastic sealing to protect from dust & moisture loss
Adverse reactions Review each component separately
Contraindications (review other components separately)
Electrolytes
Potassium chloride
Trade name Potassium chloride
Active drug Potassium chloride
Dosage form Ampoule 5 ml of 15% (150 mg/ml = (2mEq/ ml)
Mechanism of Intracellular cation essential for conduction of nerve impulses in heart, brain & skeletal
action muscle, contraction of cardiac, skeletal & smooth muscles, maintenance of normal renal
function, acid-base balance, carbohydrate metabolism, and gastric secretion
Indications Treatment or prevention of hypokalemia
Dose 1 g Potassium chloride = 13.4 mEq potassium
1 mEq potassium = 74.6 mg Potassium chloride
1ml of 15% kcl = 2mEq potassium
Neonate 3,4
Acute symptomatic hypokalemia: Begin with 0.5 – 1 mEq/kg IV over 1 hr, then reassess.
Daily maintenance: 2 – 4 mEq/kg/day IV of potassium
Oral replacement therapy : initial: 0.5 – 1 mEq/kg divided, administered with feeding
mild – moderate Hypokalemia treatment Oral
Initial: 1 – 2 mEq/kg/day in divided doses, titrate to desired response, usual range: 1 - 5
mEq/kg/day, don’t exceed 1 – 2 mEq/kg as a single dose up to 40 mEq/dose, evaluate Sr K+
2 hr after the dose, may repeat dose as needed based on lab values, if deficits are severe or
ongoing losses are great, IV potassium is considered as preferred route.
Severe Hypokalemia treatment
Intermittent IV infusion: 0.5 – 1 mEq/kg/dose, max: 40 mEq/dose infusion only
evaluate Sr. K+ 1 – 2 hr after infusion completion, may repeat based on lab values
Intermittent IV is reserved for severe depletion, monitor ECG for intermittent IV doses >0.5
mEq/kg/hr
Parenteral nutrition, maintenance potassium requirement 12
Infant & Child ≤50 kg: IV: 2 – 4 mEq/kg/day added to parenteral nutrition sol.
>50 kg & Adolescents: IV: 1 - 2 mEq/kg/day as an additive to parenteral nutrition sol.
Dose adjustment3 Altered Kidney Function: Pediatric
IV: There are no specific dosage adjustments provided. In adults with renal impairment, Cr
Cl <30 ml/min reducing the initial dose by at least 50% recommended Contraindicated in
patients with renal failure.
Oral: Initiate at the low end of dosing range, particularly with medications known to
increase k+ levels, use with caution & monitor plasma levels to avoid overcorrection
Dialysis (adult data)
Peritoneal dialysis or Hemodialysis, intermittent (thrice weekly): Dialyzable:
IV: Reduce initial dose by at least 50%.Use with caution, monitor K+ levels frequently Oral
preferred in patients on dialysis unless more rapid K+ repletion is necessary (eg, severe
hypokalemia associated with respiratory or cardiac instability).
Oral: Initiate at the lowest dosing range, especially if on drugs that increase K+ levels, use
with caution, monitor K+ levels frequently, avoid overcorrection, as patients receiving
dialysis have little to no residual kidney function to excrete excess potassium.
187
CRRT, PIRRT:
Follow dialysis recommendations
Hepatic Impairment: Pediatric
Infants, Children & Adolescents: IV: no dosage adjustments provided.
Oral : use with caution in cirrhosis & Initiate at the low end of dosing range, & monitor
plasma levels frequently
Preparation2,3 Must be diluted prior to IV infusion. NS, D5W, LR, D10W
Peripheral IV line: Final conc. must be ≤80 mEq/L (0.08 mEq/mL)
usual reported concentration is 40 – 60 mEq/L (0.04 – 0.06 mEq/mL).max 80 mEq/L
Central IV line: reported range: 120 – 300 mEq/L (0.12 – 0.3 mEq/mL), up to 400 mEq/L (0.4
mEq/mL) reported.
Administration3 Must be diluted. IV administration Only
Non-critical care: Usual dose: 0.2 – 0.5 mEq/kg/hr, in adults: up to 10 – 20 mEq/hr reported
Critical care settings/situations: infuse at a rate ≤0.5 mEq/kg/hr, higher rates may be used,
maximum reported rate: 1 – 2 mEq/kg/hr up to 40 mEq/hr,
1 ml/kcl 15%/100 ml IV sol. = 20 mEq/L
conc. For peripheral infusion: 40mEq/L (2ml kcl 15% /100 ml IV sol)
Max: 60 – 80 mEq/L4 (3 – 4 ml kcl 15% / 100 ml IV sol.)
conc. For Central infusion: neonate: up to 200 mEq/L4 (10 ml/kcl 15%/100 ml IV sol.)
Pediatric: 120 – 400 mEq/L (6 – 20 ml/kcl 15%/100 ml IV sol.)
requires continuous cardiac monitoring in cases of severe hypokalemia & for rates >0.5
mEq/kg/hr
Vesicant/irritant (at conc. > 0.1 mEq/ml = dilution must be > 20 fold)
Oral not available
With or immediately after meal with a full glass of water or other liquid to ↓GI irritation risk
In neonates & infants: oral potassium chloride administered at a concentration of 2.67
mEq/mL followed by an equivalent volume of sterile water
Stability Store intact ampoules at 30°C
Use diluted solution immediately after preparation. Compatible in most infusion solutions
CVS: Bradycardia, chest pain
Endocrine & metabolic: Hyperkalemia, hyponatremia
GIT: Abdominal distress, abdominal pain, diarrhea, flatulence, GIT hemorrhage, GIT irritation,
GIT obstruction, GIT perforation, GIT ulcer, nausea, vomiting
Hypersensitivity: Angioedema, hypersensitivity reaction
Local: Burning sensation at injection site, erythema at injection site, infusion-site pain,
injection-site phlebitis, irritation/swelling/ venous thrombosis at injection site
CNS: Encephalopathy (hyponatremic)
Contraindications Hypersensitivity to potassium chloride or any component of the formulation, clinically
significant hyperkalemia and /or hyperglycemia (dextrose-containing solutions only)
Renal impairment with oliguria, anuria, or azotemia, Addison disease (untreated)
ventricular fibrillation, salt-losing adrenal hyperplasia, extensive tissue breakdown
Electrolyte /calcium salt

Calcium gluconate
Trade name Calcium gluconate /calcionate
Active drug Calcium gluconate + calcium levulinate ~ 90 mg elemental Calcium
Dosage form Ampoule 10 ml calcionate = 90 mg calcium elemental ≈ 1 g calcium gluconate
Mechanism of action Moderates nerve and muscle performance via action potential threshold regulation
Indications Symptomatic hypocalcemia, calcium channel blocker toxicity, cardiac arrest,
hyperkalemia, hypermagnesemia, hydrofluoric acid burns, rickets, & parenteral nutrition.
Dose 1 g calcium gluconate = 89 – 93 mg elemental calcium = 4.65 mEq calcium
188
1 gram calcionate = 90 mg elemental calcium = 4.5 mEq calcium
Neonate 3,4
Hypocalcemia, Acute Symptomatic
Intermittent: 100 – 200mg/kg IV of calcium gluconate over 10 – 30 min3,4, repeat if
needed /6 hr or start continuous infusion at 17 – 33 mg/kg/hr calcium gluconate, adjust
based on Sr. calcium4
May reduce dosing for 1 day before discontinue(some expert recommendation)
Continuous IV method : 10 – 33 mg/kg/hr calcium gluconate
Severe hypocalcemia (seizures and tetany)3
Calcium gluconate: IV: 100 – 200 mg/kg/dose over 10 – 20 min, may repeat in 10 – 20
min, if no response follow initial dose(s) with a continuous infusion of 21 – 33 mg/kg/hr
Hypocalcemia, asymptomatic3
(oral formulations not available)
Oral: 50 – 75 mg/kg/day elemental calcium in 4 – 6 divided dose
10% calcium gluconate injection may be given orally however, oral calcium salts (eg,
carbonate, glubionate) are a more preferable option in young pediatric patients
Hyperkalemia, adjunctive treatment3
Preterm & term neonates expressed as calcium gluconate: IV infusion, IO
60–100 mg/kg/dose. As high as 200 mg/kg/dose over 30 – 60 min recommended.
Hypermagnesemia, symptomatic with severe cardiac or neurologic manifestation3
expressed as calcium gluconate: IV: 100 mg/kg/dose administered over 5 min
Parenteral Nutrition 4
Daily Requirement ASPEN 2020
Preterm: 2 – 4 mEq/kg/day IV
Full-term: 0.5 – 4 mEq/kg/day IV of calcium
Exchange transfusion
100 mg calcium gluconate 10%/100 mL citrated blood exchanged IV infusion over 10 min.
(1 mL /100 mL blood exchanged)
Enteral nutrition 3
(oral formulations not available)
carbonate, glubionate) are a more preferable option in neonate and infant
Adequate intake Elemental calcium oral 200 mg/day
Enteral nutrition, maintenance requirement: elemental calcium
Preterm neonates, birth weight <2kg: Oral: 150 – 220 mg/kg/day
Rickets, treatment3
Preterm and term neonates: elemental calcium (+ adequate vitamin D supplementation)
Oral: Initial: 20 mg/kg/day, increased as tolerated to 60 – 70 mg/kg/day, usually
administered in 4 - 6 divided doses, max: 80 mg/kg/day.
Alternatively: 30 - 75 mg/kg/day in 3 divided doses, start at higher end of range and then
titrated downward over 2 – 4 weeks is recommended
Hypocalcemia, treatment
Asymptomatic (oral formulations not available)
Oral: 30 – 75 mg/kg/day elemental calcium in 4 – 5 divided doses
carbonate, glubionate) are a more preferable option in young pediatric patients
Mild – moderate symptoms:
IV Intermittent:
1 month – <17 years: calcium gluconate: IV: 29 - 60 mg/kg/dose/ 6 hr
Adolescent ≥17 years: calcium gluconate: IV: 1 – 2 g/dose / 6 hr
189
Continuous IV Infusion:
1 month – <17 years: Initial: calcium gluconate: IV: 8 - 13 mg/kg/hr
Adolescent ≥17 years: Initial: calcium gluconate: IV: 5.4 – 21.5 mg/kg/hr
Severe symptoms (eg, seizures, tetany)
IV, IO (as calcium gluconate)100 – 200 mg/kg/dose over 5 – 1 0 min, max: 1 – 2 g/dose
may repeat as needed or follow with a continuous IV infusion of 8 – 32 mg/kg/hr
Parenteral nutrition, maintenance calcium requirement
as elemental calcium:
Infant & Child ≤50 kg: IV: 0.5 – 4 mEq/kg/day as additive to parenteral nutrition sol.
Child >50 kg & Adolescents: IV: 10 – 20 mEq/day as additive to parenteral nutrition sol.
Rickets treatment
begin at higher doses & titrate downward over 2 – 4 weeks + adequate vitamin D intake
Infant, Child & Adolescents: Oral: 30 – 75 mg/kg/day elemental calcium divided /8 hr
Oral calcium carbonate, glubionate are preferable oral option in young pediatric patients
Hyperkalemia, adjunctive treatment:
Dose expressed as calcium gluconate
IV, IO: 60 – 100 mg/kg/dose, max: 2,000 mg/dose may repeat if necessary
Dose adjustment3 Renal impairment (neonate – pediatric)3.4
Initiate at lowest recommended dose, Accumulation may occur, doses may be adjusted to
Sr. calcium conc.
Hepatic impairment: Hepatic function does not affect the availability of ionized Ca+2 after
calcium gluconate administration. However, adjust dose to calcium plasma level
Preparation3 Must be diluted in D5W, D10W, NS and used immediately.
Bolus, Intermittent IV infusion: Dilute to 10 – 50 mg/mL. (1+ 9 ml – 1 + 1 ml)3,4
Continuous IV infusion: Dilute to 5.8 – 10 mg/mL (1+16 ml – 1+9 ml)
3
Administration Neonate: max. rate for continuous infusion 8.3 – 13 mg/kg/hr recommended
IV infusion: after dilution, Infuse dose slowly (max. 100 mg/min), except emergencies
In symptomatic hypocalcemia: IV infusion: over 5 – 10 min reported
Oral: administer with plenty of fluids with or after meals
IV preparation may be given orally after meal in young pediatrics
Vesicant, avoid extravasation
Stability Store intact ampoules at 30 °C1
Use diluted solution immediately after preparation1
Precipitation in parenteral nutrition is more likely with2
1. High calcium and phosphate concentrations
2. The use of calcium chloride instead of gluconate
3. Higher solution pH
4. Lower amino acids concentration
5. Higher temperature
6. Adding calcium before phosphate
7. Extended standing and administration periods
8. Slow infusion rates
Adverse reactions CVS: Arrhythmia, bradycardia, cardiac arrest, ↓blood pressure, syncope, vasodilation
CNS: Anxiety, feeling hot
GIT: Unusual taste (chalky)
Neuromuscular & skeletal: Tingling sensation
Contraindications Hypercalcemia
Ceftriaxone concomitant use in neonates (≤28 days of age).
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Electrolyte
Magnesium sulfate
Trade name Magnisol
Active drug Magnesium sulfate
Dosage form Ampoule 100 mg/ml IV
Mechanism of Decreases acetylcholine in motor nerve terminals and slow rate of S-A node & prolong
action conduction time, necessary for the movement of calcium, sodium, & potassium across of
cells, as well as stabilizes excitable membranes.
In asthma: relaxes bronchial smooth muscle independent of Sr magnesium conc.
Indications Hypomagnesemias, ventricular tachycardias, Persistent pulmonary hypertension, severe
asthma, hypocalcemia
Dose 1g of Mg so4 = 98.6 mg elemental Mg = 8.12 mEq elemental Mg = 4.06 mmol elemental Mg
Neonate 3.4
Hypomagnesemia: expressed as magnesium sulfate IM, IV
25 – 50 mg/kg/8 – 12 hr for 2 – 3 doses) over 10 – 20 min,
Severe (Mg+2 <1.6mg/dL or seizures due to neonatal hypocalcemia)
(50 mg/kg over : 1 – 2 hr)may repeat in 12 hr if necessary
Alternate dosing5 100 mg/kg/6 – 12 hr as needed over at least 10 min
Hypocalcemia5
100 mg/kg / 12 hr for 2 – 3 doses. IM , IV infusion
Parenteral nutrition, magnesium maintenance
expressed as elemental magnesium: IV
0.25 – 0.5 mEq /kg/day added to parenteral nutrition
Torsades de pointes, ventricular tachycardia3
Dose expressed as magnesium sulfate
IV, IO: pulseless: 25 – 50 mg/kg/dose as a bolus, if there is a Pulse: over 10 – 20 min
Persistent pulmonary hypertension of the newborn 5
Initially 200 mg/kg, IV infusion given over 20–30 min
then 20 –75 mg/kg/hr as continuous IV infusion for up to 5 days, if response occurs after
initial dose (Maintain plasma conc. between 3.5 – 5.5 mmol / litre).
Pediatric3
Hypomagnesemia
Infants, Children, and Adolescents expressed as magnesium sulfate
IV, IO: 25 – 50 mg /kg/6 hr for 2 – 3 doses, max. 2g/dose evaluate Sr Conc.
Or: IV: 2.5 - 5 mg elemental Mg/kg/dose / 6 hr for 2 – 3 doses
Alternate5
1months – 11 years: 50 mg/kg/12 hr over at least 10 min
≥12 year : 1g/12 hr
Parenteral nutrition, maintenance magnesium requirement
Infants & Children ≤50 kg expressed elemental magnesium
IV: 0.3 - 0.5 mEq/kg/day as an additive to parenteral nutrition solution.
Children >50 kg & Adolescents expressed elemental magnesium
IV: 10 - 30 mEq/day as an additive to parenteral nutrition solution.
Torsade de pointes or ventricular fibrillation/pulseless ventricular tachycardia associated
with torsade de pointes
Infants, Children, and Adolescents expressed as magnesium sulfate
IV, IO: 25 – 50 mg/kg/dose over 10 – 15 min, max. 2 g/dose,(may repeat once if needed)5
Asthma, acute refractory exacerbation adjunctive agent
Infants, Children, and Adolescents magnesium sulfate:
IV: 50 mg/kg/dose as a single dose (dose range: 25 – 75 mg/kg/dose), max. dose: 2 g/dose
191
In life-threatening exacerbations remaining in the severe category after 1 hr of intensive
conventional therapy
Oral inhalation: Severe exacerbation
Children ≥2 years & Adolescents: Nebulized 150 mg isotonic magnesium sulfate +
salbutamol + ipratropium / 20 min for 3 doses in the 1ST hr of treatment to patients with
severe acute asthma who did not respond to standard inhalation treatment
Dose adjustment Renal impairment: no adjustment provided, use with caution, monitor level closely
(references suggest to avoid use or reduce the dose)5
Adult recommendation for hypomagnesemia in renal dysfunction3
Reduce dose by 50%
Hepatic impairment: no dosage adjustment necessary3
Avoid In hepatic coma with risk if renal failure exists5
Preparation2,3 IV: Conc. Must be ≤ 200 mg/ml (1.6 mEq/ml)
Dilute in D5W, NS to 60 mg/mL Mg SO 4 (0.5 mEq Mg / ml) (1x1.7 ml dilution)
Nebulization: 1.5 ml + albuterol ± ipratropium
Administration3 Hypomagnesemia:
Asymptomatic: ~12.5 mg/kg/hr magnesium sulfate ( rate ≤0.1 mEq/kg/hr)
Urgent/emergent: Infuse slowly over 15 – 20 min
Pulseless ventricular tachycardia (VT) with torsades: bolus over several min (10 min)5
VT with pulses with torsades: Infuse over 10 – 20 min, rapid infusion may cause
hypotension
Asthma exacerbation (severe): Infuse over 15 – 60 min
Continuous IV infusion: After dilution, administer via an infusion pump.
Nebulization: Mix with albuterol ± ipratropium and administer over 15 – 20 min.
Stability Store Ampoules at room temperature of 30°C 1
Discard any remaining solution after use however manufacture indicates that dilution with
NS, D5W1,3, LR3 can be used with in 24 hr
Don’t refrigerate any solution
Magnesium sulfate is reported stable in common infusion solutions as D5W, LR, NS for
extended periods of time 2
Adverse reactions Adverse effects on neuromuscular function may occur at lower concentrations in patients with
neuromuscular disease (eg, myasthenia gravis).
CVS: Flushing hypotension vasodilation (IV-rate related)
Endocrine & metabolic: Hypermagnesemia
Contraindications Hypersensitivity to any component of the formulation, heart block, myocardial damage
Parenteral Nutrition/IV lipid emulsion

Smoflipid
Trade name Smoflipid
Active drug Lipid emulsion (soybean, medium-chain triglyceride, olive, and fish oils
Dosage form Vial 20% w/v lipid emulsion
Mechanism of Metabolized and utilized as an energy source, provides fatty acids (linoleic acid, oleic acid,
action caprylic acid, palmitic acid, capric acid, stearic acid, and alpha linolenic acid) and omega-3
fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) necessary for
normal structure and function of cell membranes.
Indications Source of calories and essential fatty acids for patients requiring parenteral nutrition when
oral or enteral nutrition is not possible, insufficient, or contraindicated
Dose Neonate3
IV: Initial: 0.5 – 1 g/kg/day, increase by 0.5 - 1 g/kg/day to a max. 3 g/kg/day*
Max rate 0.15 g/kg/hr 12
Infants and Children <2 years
IV: Initial: 0.5 – 1 g/kg/day, increase by 0.5 - 1 g/kg/day to a max. 3 g/kg/day *
192
Children 2 - <12 years
IV: Initial: 1 - 2 g/kg/day, increase by 0.5 - 1 g/kg/day to a max. 3 g/kg/day*
Children ≥12 years and Adolescents
IV: Initial: 1 - 2 g/kg/day, max. 2.5 g/kg/day*
*(lipids should account for ~25% - 50% of nonprotein calories)
ASPEN 2020, ACCP recommendation updates 2022 for ILE
initiation 0.5– 1 g/kg/day 0.5 – 1 g/kg/day 1 – 2g/kg/day 1g/kg/day
0.15 g/kg/hr 0.15 g/kg/hr
advancement 0.5 – 1 g/kg/day 0.5 – 1 g/kg/day 0.5 – 1 g/kg/day 0.5 – 1 g/kg/day
Goal 3 g/kg/day 2.5 – 3 g/kg/day 2 – 2.5 g/kg/day 1 – 2 g/kg/day
Dose adjustment3 Renal Impairment: no adjustments provided , use with caution (adult/pediatric)
Hepatic Impairment: no adjustments provided, monitor liver function (adult/pediatric)
Preparation Should be prepared for administration Under aseptic condition
Do not use if discolored (should be homogenous liquid with milky appearance) or if the
emulsion contains a precipitate or phase separation
Protect from light after dose withdrawal or admixing with parenteral nutrition
Protect from light during infusion if infused alone for children under 2 years of age
But insufficient data for light protection in older age
TPN requires special consideration for preparation and sequence of component addition
Administration3 Use central line for Infusion of Parenteral nutrition sol. With > 900 mOsm/L
All ILEs should be filtered whether infused separately or as part of parenteral nutrition
using 1.2 micron inline filter only. Protect from light during infusion.
Over 24 hr in premature & LBW
In neonates, infuse over 20 – 24 hr, max. rate: 0.15 g/kg/hr ASPEN however , references
suggest max rate for smoflipid 0.125 g/kg/hr 4
In infants, children & adolescents: infuse over 12 – 24 hr, max. rate: 0.15 g/kg/hr ASPEN.
A rapid infusion of Smoflipid lead to fat overload syndrome has been reported.
Stability1 Store intact vials at ≤25°C, protect from light
Prepared doses should be used immediately after preparation (max. within 24 hr)
Hematologic: Anemia
1% - 10%:
CVS: HTN, tachycardia, thrombophlebitis.
Endocrine & metabolic: Hyperglycemia, hypertriglyceridemia, hypervolemia , ↑GGT
metabolic acidosis nutrition disorder (essential fatty acid deficiency)
GIT: Abdominal pain, cholestasis, diarrhea, dysgeusia, dyspepsia, flatulence, nausea,
vomiting
Genitourinary: Urinary tract infection.
Hematologic: C-reactive protein ↑, leukocytosis, thrombocytopenia
Hepatic: Abnormal hepatic function tests ↑ALT, hyperbilirubinemia, ↑ ALP.
Infection: Infection (including nosocomial infection), sepsis.
CNS: Dizziness, headache.
Respiratory: Dyspnea, pneumonia.
Other: Fever
Postmarketing:
CVS: Chest pain, palpitations, phlebitis
Dermatologic: Hyperhidrosis
CNS: Chills, malaise
Contraindications Hypersensitivity to fish, egg, soybean, or any other component of the formulation
Severe disorders of lipid metabolism (Sr. triglyceride concentrations >1,000 mg/dL).
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Alkalinizing agent
Sodium bicarbonate
Trade name sodium bicarbonate
Active drug Sodium bicarbonate 8.4% (1ml = 1 mEq)
Dosage form Ampoule 25 ml
Mechanism of Dissociates to provide bicarbonate ion which neutralizes hydrogen ion concentration and
action raises blood and urinary pH
Indications Parenteral: Management of metabolic acidosis, alkalinizing agent for the urine, certain
drugs overdose management, management of severe diarrhea due to bicarbonate loss
Dose Neonate4
Metabolic acidosis
the initial goal of therapy is to target a pH of ~7.2 to prevent overalkalinization
Dosage based on base deficit:
HCO3 needed (mEq) = HCO3 deficit (mEq/L) x (0.3 x body wt [kg])
Or = 0.3 to 0.5 X body wt [kg] X (desired – measured HCO3 (mEq/L))
Administer 50% of calculated dose, then assess need for remainder,
Resuscitation (routine use not recommended) 1 mEq/kg IV/IO slowly
Pediatric 3
Cardiac arrest (Routine use not recommended)
IV, IO: 1 mEq/kg/dose, repeat doses acc. To ABG (4.2 % sol.) preferred in age <2 years
Chronic kidney disease (CKD) acidosis:
Infants, Children & Adolescents Initiate if Sr. bicarbonate <22 mEq/L
Oral: Initial dose based on Sr. bicarbonate levels (see following equation)
1-calculate the deficit to determine dose needed
2-may divide dose for tolerability
3-adjust dose to maintain Sr bicarbonate within targeted range (children: 22 – 23 mEq/L)
HCO3- (mEq) deficit = 0.5 × weight (kg) × [desired HCO3– − measured Sr. HCO3– (mEq/L)]
Hyperkalemia, adjunct
IV, IO: 1 – 2 mEq/kg/dose (max. 50 mEq/dose)
Metabolic acidosis, acute
Blood-gas directed dosing (equations) the initial goal of therapy is to target a pH of ~7.2
IV: estimate replacement dose
-
HCO3 (mEq) deficit = 0.3 × weight (kg) × base deficit (mEq/L) or
- - -
HCO3 (mEq) deficit = 0.3 to 0.5 × weight (kg) × [desired HCO3 (mEq/L) − measured Sr. HCO3 (mEq/L)]
Weight-directed dosing (if acid-base status is not available)
IV, IO: 0.5 – 1 mEq/kg/dose over 5 – 15 min, max. 50 mEq/dose
Subsequent doses should be based on patient's acid-base status.
Renal tubular acidosis (RTA)
Infant, Child & Adolescent
Based on urinary bicarbonate excretion, Sr bicarbonate& age-related factors.
Distal- type 1
Oral: Usual dose: 3 – 4 mEq bicarbonate/kg/day divided
(some data suggest: infants may need higher dose of 5 – 10 mEq bicarbonate/kg/day &
growing children need 4 – 8 mEq bicarbonate/kg/day due to acid production during
growth)
Titrate to maintain normal electrolyte conc.
Proximal – type 2
Oral: Usual dose: 10 – 15 mEq/kg/day divided titrate to maintain normal electrolyte conc.
Doses as high as 20 mEq bicarbonate/kg/day have been used.
194
Dose adjustment3 Renal Impairment: no dosage adjustments provided Use with caution (sodium retention)
Hepatic Impairment: no dosage adjustments provided. Use with caution, especially in
clinical states associated with edema and sodium retention.
Preparation3 IV: standard concentrations of 0.5 mEq/mL in D5W (1+1ml) for neonate &infant
and 1 mEq/mL in D5W, NS, D10W pediatric patients (undiluted)
incompatible with Ca & phosphate salts
Administration3 Direct IV Bolus:
Neonates and Infants: use 0.5 mEq/mL solution, infusion rate : see indications
Children and Adolescents: use 1 mEq/mL solution, infusion rate as /indication, max rate:
10 mEq/min (10 ml /min of available form)
IV infusion: infusion duration is based on indication, may be added to IV infusion fluids if
urgent correction isn’t needed
Metabolic acidosis: infusions over 4 – 8 hr suggested in neonate, max. rate 1 mEq/kg/hr
Vesicant, avoid extravasation
Stability Store ampoules at 30°C
Discard any unused portion
CVS: Cardiac failure (exacerbation), edema
CNS: Cerebral hemorrhage
Endocrine & metabolic: Acidosis (intracranial), hypernatremia, hypocalcemia, hypokalemia,
metabolic alkalosis, milk-alkali syndrome (especially with renal dysfunction)
GIT: Abdominal distention, eructation, flatulence (oral administration)
Neuromuscular & skeletal: Tetany
Contraindications Chloride loss due to vomiting or from continuous GI suction, concomitant use of diuretics
known to produce a hypochloremic alkalosis.
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Antibiotic-Topical
Amikacin lotion
Trade name Amikacin
Active drug Amikacin sulfate
Dosage form Spray 250mg/ 100 ml
Mechanism of Aminoglycoside, inhibits protein synthesis of gram negative bacteria + pseudomonas. Spp.
action
Indications Skin and soft tissue infection , postoperative site infection and burns
Dose spray over wound or affected area 2 - 3 times/day
Application Shake well before use
Storage Not
Storesprayed
at roomortemp
used for ears
Adverse reactions hypersensitivity
Contraindications Hypersensitivity to Amikacin
Burn management - Topical

B-Sitosterol Ointment
Trade name Pentaburn
Active drug B-Sitosterol 0.25%
Dosage form Tube 15 g
Mechanism of
Moist exposed burn, protect wounds from infection and promote healing
action
Indications All burns, Chronic wounds, Bed ulcers, Post laser resurfacing , Surgical wounds
Dose First degree burn: 1mm layer 3 - 4 times/day in exposed burn or 2 times/ day if closed
Second & third degree burns: dose= 1mm layer
In liquifying phase: 3-4 times/day in exposed burn – or 3 mm layer 2 times / day if dressed
In repair phase: apply thin layer 2-3 times/day
In rehabilitation phase: one dose /day
Third degree burns: thin layer 3-4 times/day
Donor site: thin layer 3-4 times/day – or 2 times / day if closed
Leg ulcer: sterile gauze with pentaburn to fill ulcer cavity 2 times /day
Surgical & obstetrical wounds: 3 mm layer under dressing 2 timed/ day
Storage Store at max. temp 30°c
Adverse reactions Rare allergic reaction to sesame oil
Contraindications Hypersensitivity to any component in the formulation
Antibiotic - Topical
Fusidic Acid
Trade name Fusi cream
Active drug Fusidic Acid 2%
Dosage form Tube 15 g
Mechanism of action Antibiotic Inhibits protein synthesis in susceptible bacteria.
Indications Skin infections as Boils, Impetigo, Carbuncles, Infected wounds, Folliculitis of skin & scalp.
Dose Applied to affected area for 2-3 times / day for 7 days (Longer duration for acne)
Adverse reactions Uncommon: hypersensitivity, dermatitis, erythema, pruritus, skin irritation /rash, urticaria
Contraindications Hypersensitivity
Antimicrobial combination – Topical

Gramicidin/ neomycin/nystatin/triamcinolone acetonide
Trade name Kenacomb
Active drug 1g = Nystatin100,000 units, Neomycin sulfate 2.5 mg, Gramicidin 0.25 mg
Triamcinolone acetonide 1mg
Dosage form Tube 15 g cream
Mechanism of action Antifungal /antibacterial with corticosteroid local anti-inflammatory
Indications Relief of corticosteroid-responsive inflammatory or pruritic dermatoses associated with
bacterial and/or candida infection.
196
Dose Apply thin film to the affected area 2 - 3 times daily
Storage Store at 15-30 ° c
Adverse reactions Adrenal suppression: with high doses for prolonged periods due to hypercortisolism that may
cause adrenal crisis. Steroid withdrawal may occur with cessation after prolonged use
Immunosuppression: Prolonged use may result in fungal or bacterial superinfection
Local effects: triamcinolone or gramicidin may cause local sensitivity reactions, skin atrophy,
striae, burning, itching, erythema, dryness, hypertrichosis, hypopigmentation folliculitis,
acneiform eruptions reported with topical corticosteroids.
Systemic effects percutaneously absorption↑ by occlusive dressings, application to large
surface areas or denuded skin. Cushing's syndrome symptoms, hyperglycemia, glycosuria.
Rarely ototoxicity (tinnitus & deafness) from topical corticosteroids or topical neomycin.
Contraindications Hypersensitivity to any of the components. Atopic dermatitis. Skin lesions (eg. tuberculosis viral
as HSV, vaccinia, varicella, fungal [excluding candidiasis]), primary skin infections, ophthalmic
use, Otic use for perforated tympanic membrane or otitis media
Anti factor X – Topical

Hirudin
Trade name Extrauma DNA forte
Active drug Recombinant Hirudin
Dosage form Tube 40 g (420 unit / 100 g) Gel
Mechanism of action Direct thrombin inhibitor
Indications Traumatic hematomas treatment
Dose Apply 2 – 3 cm of gel 2 – 3 times/day
Application Shake well before use, Not sprayed or used for ears
Storage Store at room temp
Adverse reactions Sensitization
Contraindications Hypersensitivity
Antifungal – Topical
Miconazole oral gel
Trade name Miconaz/Buccazole
Active drug Miconazole 2%
Dosage form Tube 20 g gel for buccal use
Mechanism of action Fungicidal imidazole against dermophytes, Candida, dimorphic fungi
Indications Prophylaxis & treatment of oral, pharyngeal candidiasis
Dose Infant 4 –24 months: ¼ teaspoonful (= 1.25 ml)/6 hr for 1 week after symptoms disappeared
Children˃ 2 yr : ½ teaspoonful (= 2.5 ml ) /6 hrs for 1 week after symptoms disappeared
Application Keep gel in mouth as long as possible
Adverse reactions Mild GIT disturbance, Diarrhea, Vomiting, Headache, Upper abdominal pain, dry mouth
Contraindications Hypersensitivity, infant ˂4 months with GERD, concomitant administration
Topical astringent – Topical

Zinc oxide/ olive oil
Trade name Zinc olive cream
Active drug Zinc oxide/ olive oil/ castor oil
Dosage form Tube 75 g cream
Mechanism of action Mild astringent & weak antiseptic with olive & castor oil as hydrophobic barrier
Indications Prevention and treatment of diaper rash
Dose Apply suitable amount on diaper area after each diaper change
Application Gently cleanse affected area and pat dry with clean soft cloth or allow to air dry then apply,
avoid application of excess amount of the cream.
Storage Store at temperature 30°C
Adverse reactions 1% - 10%: Local hypersensitivity reaction, Local irritation
Contraindications Hypersensitivity to any component in the formulation.
197
Eye anethesia – Topical
Benoxinate hydrochloride/Eye drops
Trade name Benox
Active drug 0.4% w/v Benoxinate hydrochloride
Dosage form Sterile Solution for ophthalmic instillation
Mechanism of action Reversibly blocks the propagation and conduction of nerve impulses along nerve axons
Indications Topical ocular anaethesia before procedures
Dosage A drop is inistilled to the eye(s), one min before procedure and then titrate:
1 Drop for tonometry
2 drops at 90 sec interval for fitting contact lenses
3 drops at 90 sec interval for foreign body removal from corneal epithelium or for incision
of a meibomian cyst through the conjunctiva.
Protect the eye(s) from dust and contamination while on use
Corneal sensitivity is normal again after about 1 hr
Storage1 Store between 2 – 8 ◦ C.
Store at 2 – 8 ° C after opening and use within 28 days
Adverse reactions Rare: associated with allergic reactions (in the most severe instances, anaphylactic shock).
Very rare: with uncontrolled use (long-term and/or too frequent use), may result in
keratopathy, hypopyon, or central corneal erosion including central scarring.
Possible: Corneal perforation may also be possible.
Transient: irritation, stinging and blurring of vision may occur on instillation.
In cases, local anesthetic preparations have been
Contraindications Hypersensitivity to any component in the product
Ophthalmic mydriatic agent – Topical
Cyclopentolate + phenylephrine
Trade name Cyclophrine
Active drug Cyclopentolate 1% + Phenylephrine 10%
Dosage form Sterile Solution for ophthalmic instillation
Mechanism of action Anticholinergic effects + adrenergic effects cause a greater mydriasis with little cycloplegia.
Indications Production of mydriasis for diagnostic procedures
Dosage Neonate3
1 drop into eye(s) / 5 – 20 min for up to 3 doses starting ~45 min before the examination
Age ≥ 1 month3
1drop into eye(s) at least 15 min before examination, may repeat/ 5 – 10 min if needed
Instill into conjunctival sac of affected eye, finger pressure should be applied on the
lacrimal sac during and for 2 – 3 min following application
Storage1,3 Store between 8 – 30 ◦ C. Discard after 28 days after opening
3
Adverse reactions 1– 10 % due to Cyclopentolate component
CVS: Tachycardia
CNS: Ataxia, hallucination, hyperactivity, incoherent speech, psychosis, restlessness,
seizure
Dermatologic: Burning sensation of skin
Ophthalmic: Accommodation disturbance (loss), ↑ICP
Ophthalmic events due to Phenylephrine component
Burning, irritation, miosis (rebound), visual disturbance, vitreous opacity (transient)
<1%, postmarketing/case reports: Cardiac arrhythmia, HTN, myocardial infarction,
subarachnoid hemorrhage, syncope
Contraindications3 Hypersensitivity to any component in product, HTN & thyrotoxicosis in age ˂ 1 yr when
using 10% phenylephrine, untreated narrow-angle glaucoma/ anatomically narrow angles.
198
Volume expander /Human Albumin
Albumin 20%
Trade name Human Albumin 20% Behring's
Active drug Hyperoncotic solution of human Albumin
Dosage form Vial 50 ml for IV infusion
Mechanism of action Provides increase in intravascular oncotic pressure and causes mobilization of fluids from
interstitial into intravascular space
Indications Treatment of hypovolemic shock, hypoalbuminemia, Burn,
Dose Neonate IV 4
Hemolytic disease of the newborn, Hyperbilirubinemia (25%4 or 20% 7)
IV: 1 g/kg, administered 1 hr prior to exchange transfusion3,4(or during exchange)3.
Hypotension (5%)
0.5 g/kg (10 mL/kg) over 20 – 30 min, may be repeat up to max: 3 doses if needed
Septic shock (5%)
0.5 g/kg (10 mL/kg) over 5 – 10 min, repeat doses as needed up to max. 3 g/kg (60 mL/kg)
in the first hr until perfusion improves or hepatomegaly develop
Ascites with hypoalbuminemia 3 (25%4 or 20% 7)
0.5 – 1 g/kg/dose over 2 – 3 hr, may repeat up to 3 times /day until albumin is >2.5 g/dL
Hypovolemia, plasma volume expansion (5%)
0.5 – 1 g/kg/dose (10 – 20 mL/kg/dose) over ≥60 min (In hypovolemic shock over at 10 -
20 min)repeat if response is not adequate
Infant, child & adolescent 3
Ascites with hypoalbuminemia (25%3or 20% 7)
0.5 – 1g/kg/dose over 2 – 3 hr, may repeat up to 3 times /day until albumin is >2.5 g/dL,
max. 25 g/dose
Hypovolemia, plasma volume expansion, hypovolemic shock (5%)
0.5 – 1 g/kg/dose (10 – 20 mL/kg/dose) over 5 – 10 min repeat at 15 – 30 min if response
is not adequate
Large volume paracentesis (25%3 or 20% 7)
0.5 – 1 g/kg/dose over 1 – 2 hr after paracentesis
Nephrotic syndrome edema (25%3 or 20% 7)
0.5 – 1 g/kg/dose over 30 – 60 min followed by diuretic therapy
Dose adjustment3 Renal Impairment no adjustments, use with caution
Hepatic Impairment no adjustments
Preparation Use 20% Undiluted in hemolytic disease of newborn & hyperbilirubinemia
Hypoalbuminemia
Diluted to 5% in NS (preferred) or D5W (in salt restriction)
1ml albumin 20% x 4 ml dilution = 5% solution
Never use SWFI in dilution (hemolysis)
Administration Administration rate depend on indication described before (review dose above)
5%: Do not exceed 1 mL/min in patients with normal plasma volume
20%,25%: Do not exceed 1 – 2 mL/min in patients without shock
Stability Store at ≤25°C , do not freeze1
Use within 4 hr after opening vial 3
Discard unused portion1.
CVS: Flushing, heart failure, hypotension, tachycardia
CNS: Chills, rigors
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Respiratory: Bronchospasm, dyspnea, pulmonary edema
Other: Fever
Postmarketing:
CVS: AMI, atrial fibrillation
Endocrine & metabolic: Hyperchloremic metabolic acidosis
GIT: Dysgeusia, sialorrhea
Hypersensitivity: Anaphylactic shock, anaphylaxis, hypersensitivity reaction (severe),
nonimmune anaphylaxis, type 1 hypersensitivity reaction.
CNS: Headache
Other: Febrile reaction
Contraindications Hypersensitivity to albumin or any component of the formulation
severe anemia, heart failure, patients at risk of volume overload (kidney insufficiency,
severe anemia, stabilized chronic anemia, or heart failure)
Dilution with sterile water for injection (hemolysis / acute kidney failure).
Lung surfactant
Lung surfactant
Trade name Alveofact 108 mg / Alveofact 54 mg
Active drug Natural surfactant (Phospholipids) from bovine lung.
Essentially sod. Free(< 1 mmol [23mg]sodium)
Dosage form 108 mg : Vial contains powder 108 mg
Prefilled glass syringe contain 2.4 ml solvent for reconstitution
54 mg : Vial contains powder 54 mg
Prefilled glass syringe contain 1.2 ml solvent for reconstitution
Mechanism of action surfactant restores surface activity to the lungs by modification alveolar surface tension,
thereby stabilizing the alveoli in premature neonate with Respiratory distress syndrome
Indications Treatment of Respiratory distress syndrome in premature neonate
Dose
2.4 ml/kg (= 108 mg/kg), up to one subsequent application of 2.4 ml/kg or 2 subsequent
applications of 1.2 ml/kg
max total of 216 mg/kg (4.8 ml/kg) to be used per case during first 5 days of life
Dosing according to body weight:
Weight (gram) Dose (ml) Weight (gram) Dose (ml)

600 – 650 1.56 1301 – 1350 3.24
651 – 700 1.68 1351 – 1400 3.36
701 – 750 1.8 1401 – 1450 3.48
751 – 800 1.92 1451 – 1500 3.6
801 – 850 2.04 1501 – 1550 3.72
851 – 900 2.16 1551 – 1600 3.84
901 – 950 2.28 1601 – 1650 3.96
951 – 1000 2.4 1651 – 1700 4.08
1001 – 1050 2.52 1701 – 1750 4.2
1051 – 1100 2.64 1751 – 1800 4.32
1101 – 1150 2.76 1801 – 1850 4.44
1151 – 1200 2.88 1851 – 1900 4.56
1201 – 1250 3 1901 - 1950 4.68
1251 – 1300 3.12 1951 - 2000 4.8
Dose adjustment Overdose

It is recommended to aspirate the applied quantity of liquid as much as
possible if there is a clinical deterioration. Symptomatic therapy should be given
where necessary
200
Preparation The drug box contains:
Vial contains powder 108 mg
Prefilled syringe contain 2.4 ml solvent for reconstitution
Vial adapter / Needle 21 gauge
Preparation using the needle
1- Open the top of the needle pack. Place the

cone of the syringe on the needle
2- Insert the needle into the vial through the

rubber stopper
3-Inject the solvent into the vial. Then immediately

shake for 5 seconds
The syringe with needle remains connected to the vial
during the entire reconstitution process and used for
the removal of the reconstituted suspension.
4- Holding the suspension at an angle, withdraw it into

the syringe and then
5- Inject it back into the vial. Repeat

this procedure a total of 5 times
201
6- Thereafter remove the cannula from the suspension
(but not from the vial) in order to prevent the
suspension from rising into the syringe.
Wait about one minute until the foam and suspension
have separated.
7- Withdraw the suspension slowly. Residual foam will

remain in the vial.
Administration1 Endotracheopulmonary instillation.

A ready prepared catheter is inserted through the positioned tracheal tube and the
catheter opening positioned at the level of the tip of the tube. Using a syringe, the single
dose is administered as an intratracheal bolus via this catheter.
Additional injections of air are used to help ensure that instillation is complete.
Upon removal of the catheter the patient is reconnected to the respirator.
To promote the equal distribution of Alveofact, the patient may be gently turned from side
to side every few seconds.
Stability1 Store intact container and utensils in outer cartoon at Max 30 ° C
Reconstituted: use within 6 hr at 25 °C, Or for 24 hr at 2 – 8°C (in vial or prefilled syringe
and shaken gently once before use)
Adverse reactions1 No adverse effects are expected if used as directed however,
Due to the quantity of fluid, upper airway obstruction may occur immediately after
application: this may be reversed by increasing inspiratory pressure for 30 – 60 sec
Unlikely: hypersensitivity or anaphylactoid reaction
Case report: obstruction of the tracheal tube by viscous material
Frequency not defined: Cerebral & pulmonary hemorrhage has been described.
Contraindications Hypersensitivity to the active substance or to any of the excipients
Human immunoglobulin G
IV IG
Trade name LIV-GAMMA S/N 5% , Gamunex-C 10%
Active drug Immunoglobulin G
Dosage form liv-Gamma 5% = 2.5 g/50 ml Vial for IV Infusion
Gamunex-C 10% = 2.5 g/25 ml Vial for IV Infusion
Mechanism of action passive immunity by ↑the antibody titer and antigen-antibody reaction potential
Replacement therapy for primary and secondary immunodeficiencies
Indications therapy of humoral immunodeficiency syndromes, severe combined immunodeficiency
syndromes [SCIDS], agammaglobulinemia, ITP, CIDP, Kawasaki syndrome, Adjunctive in
bacterial infection in patients with hypogammaglobulinemia
Dose Neonate 3
Immune thrombocytopenia (ITP):
Acute: IV: 400 mg/kg/day for 2 – 5 consecutive days or 1g/kg/day for 1 – 2 days.
202
Hemolytic disease of newborn (Rh-incompatibility- ABO incompatibility)
IV: GA ≥35 weeks: 0.5 – 1g/kg/dose once, if needed, dose repeated in 12 hr
Myasthenia gravis (severe exacerbation)
IV: 400 – 1,000 mg/kg/dose/day over 2 – 5 days (total dose 2g/kg), additional dose may be
required, should be based on clinical response.
Myocarditis, acute
IV: 2g/kg as a single dose.
Sepsis, adjunctive treatment
IV: 0.5 – 1 g/kg daily for 1 – 3 days
Pediatric 3
Kawasaki disease (liv gamma)
Infants & Children: 2g/kg/dose IV over 8 – 12 hr, within 10 days of disease onset however,
may be administered >10 days after onset
If signs & symptoms persist ≥36 hr of infusion completion , a second dose of 1 – 2g/kg
(doses < 1 g /kg also considered) may be considered with or without corticosteroids
Reasonable max. dose of 100 – 140 g/dose (suggested for shortage and cost issues)
Acute disseminated encephalomyelitis (ADEM)
Children & Adolescents: IV: 1g/kg/dose once daily for 2 days
Refractory dermatomyositis
Children : IV: 1g/kg/dose once daily for 2 days, if maintenance required, max 2g/kg/course
Guillain-Barré syndrome:
Children: IV: 1 g/kg/dose/day for 2 days or 400 mg/kg/dose once daily for 5 days
Immune thrombocytopenia (ITP) Acute or chronic
Infants, Children & Adolescents:
acute or chronic therapy: IV: 400 mg/kg/dose/day for 5 days (maintain platelet ≥
30,000/mm3),may discontinue after 2 doses if adequate platelet count achieved
or 1g/kg/day for 2 days, if poor response after 1g/kg/dose, may hold subsequent dose
Multisystem inflammatory syndrome in children (MIS-C) SARS-CoV-2 associated:
Infant, Child& Adolescent IV: 2g/kg once, infused over ~12 hr (max. dose: 100 g) cardiac
patient & fluid overload, consider slower rate over ≥16 hr) or give 1g/kg/day for 2 days
infusions
Myasthenia gravis, severe exacerbation
Children: IV: 400 – 1,000 mg/kg/dose/day for 2 – 5 days (total dose of 2g/kg)
Additional doses may be required
Myocarditis, acute
Infants, Children, & Adolescents: IV: 2g/kg as single dose.
Steven Johnson syndrome, (SJS)/toxic epidermal necrolysis (TEN)
Infant, Child & Adolescent IV: 1.5 - 2g/kg/dose single or divided over 2 – 4 days
Primary immunodeficiency disorders (liv gamma)29
Age ≥ 2 years – Adolescents: IV: 400 – 600 mg/kg/dose/3 – 4 weeks
For Trough IGg ≥ 500 mg/dL
Varicella-zoster, postexposure Prophylaxis
Use only if varicella-zoster immune globulin is unavailable.
Infants, Children, & Adolescents: IV: 400 mg/kg /dose within max. 10 days of exposure
Dose adjustment1,3 Kidney Impairment
IV: Use with caution, the rate of infusion and conc. of solution should be minimized.
Discontinue if renal function deteriorates during treatment (adult/pediatric)
Hepatic Impairment: no dosage adjustments described(adult/pediatric)
Preparation1,3 Ready to use
Allow to warm to room temperature sufficient time prior to infusion
Don’t heat the products to warm to room temp.
203
Don’t use if turbid or discolored
Don’t shake
If to be mixed with diluent Withdraw the dose slowly to avoid froth
Withdraw doses with 16 g needles (large gauge needle)
Swirl gently if the product to be mixed with a diluent
Don’t mix with other drugs or with other different IV IG trade name
Gamunex 10% may be mixed with D5W only
LIV Gamma 5% may be mixed with D5W or NS
Administration 1,3 Patient should receive sufficient hydration before starting IV IG
Antecubital veins are preferred especially with 10 % Gamunex-c
Approach for LIV Gamma 5% administration (contains Maltose) (sucrose- free)
Flush line before administration with D5W or NS
Test rate: 0.6 - 1.2 ml /kg/hr (tested for 30 min)
According to patient tolerance increase the rate gradually by 0.6 ml/kg /hr as follows:
1.8 ml /kg/hr then
2.4 ml /kg/hr then
3 ml /kg/hr then
3.6 ml /kg/hr (maximum rate)
if duration of administration to be shortened, may increase rate as tolerated, no data
available for the product, however other products than liv gamma may increase rate as
tolerated/30 min
Approach for Gamunex 10% IV infusion (sucrose free)
Flush line before starting Gamunex with D5W
0.6 ml/kg/hr (tested for 30 min) then increase the rate only if tolerated as follows
1.2 ml /kg/hr (tested for 30 min)
1.8 ml /kg/hr then
2.4 ml /kg/hr then
3 ml /kg/hr then
3.6 ml /kg/hr then
4.2 ml /kg/hr then
4.8 ml /kg/hr (maximum rate)
○ If intolerance occurs at any given rate reduce to a tolerated rate, dilute or stop the
infusion, then resume at comfortable rate after symptoms subsides.
○ Patient at risk for thrombosis or renal dysfunction use the minimum infusion rate & dose.
○ In Fluid overload: 1 – 2 g/kg /dose not recommended
○ Liv gamma and Gamunex-c don’t contain: Sucrose, Fructose, hyaluronidase, human
albumin, corn extracts (these additives are contraindicated in certain diseases)
Stability 1 Liv gamma: Store at 2 – 8◦ c, use within 1 hr after opening 1 , don’t use frozen product
Gamunex stored refrigerated 2 – 8 ° c (may be stored at 25°c for 6 months not to
refrigerated after this period)1.protect from light
Pooled under aseptic conditions into sterile IV bags: use within 8 hr
Single use only. Any remaining must be discarded immediately after use
Adverse reactions 3 ˃10%:
CVS: Chest pain, ↓HR, HTN, hypotension, ↑ HR, tachycardia
Dermatologic: Dermatitis, ecchymoses, injection site pruritus
GIT: Abdominal pain, diarrhea, nausea, upper abdominal pain, viral gastroenteritis, vomiting
Hematologic: Anemia, hemolysis, positive direct Coombs test
Hepatic: ↑ALT, AST, ALP & bilirubin (direct or indirect)
Immunologic: Antibody development
Local: Bruising, erythema, irritation, nodule & swelling at injection site
CNS: Chills, dizziness, fatigue, headache, ↑body temperature, pain, rigors
Neuromuscular & skeletal: Asthenia, back / limb pain, myalgia
Respiratory: Asthma, bronchitis, cough, epistaxis, nasal congestion, pharyngitis, rhinitis, sinusitis
/acute sinusitis, upper respiratory tract infection, wheezing
Other: Fever
1% - 10%:CVS: Chest discomfort, flushing, heart murmur, peripheral edema
Dermatologic: Allergic dermatitis, eczema, erythema, hyperhidrosis, pruritus, rash, urticaria,
204
xeroderma
Endocrine & metabolic: Dehydration, ↑LDH, thyroiditis
GIT: Abdominal distention, aphthous stomatitis, dyspepsia, flatulence, gastritis, stomach
discomfort
Genitourinary: Cystitis, dysuria, UTI
Hematologic Bruise, hematoma, hemolytic anemia, leukopenia, neutropenia
Hepatic: ↑AST
Infection: Influenza, viral infection
Local: Induration / inflammation at injection site
CNS: Depression, falling, fibromyalgia syndrome (exacerbation), hypertonia, lethargy, malaise,
migraine, myasthenia, sensation of cold, vertigo
Neuromuscular & skeletal: joint pain/ effusion/swelling, muscle spasm/ pain, neck pain
Otic: Otalgia
Respiratory: Dyspnea, flu-like symptoms, oropharyngeal/ pharyngolaryngeal pain, pneumonia,
viral upper respiratory tract infection
<1%: CVS: Transient ischemic attacks
GIT: Anorexia
Infection: Subcutaneous abscess
CNS: Anxiety, aseptic meningitis, CIDP(exacerbation)
Renal: Nephrolithiasis
CVS: Facial flushing, thrombosis
Dermatologic: Cellulitis, diaphoresis, localized erythema, papules, injection site urticaria
Genitourinary: Proximal tubular nephropathy
Hematologic: Exacerbation of autoimmune PRCA, hyperproteinemia, ↑ Sr immunoglobulins
(hyperviscosity), local hemorrhage
Local: Hematoma/ irritation/residual mass at injection site
CVS: Drowsiness
Neuromuscular & skeletal: Lower limb cramp
Renal: ↑ BUN, ↑ Sr Cr, renal tubular necrosis
Respiratory: Bronchopneumonia, non-cardiogenic pulmonary edema
Postmarketing:
CVS: AMI, angina pectoris, arterial thrombosis, bradycardia, cerebrovascular accident,
circulatory shock, DVT, edema, facial edema, hot and cold flashes,↓ oxygen saturation,
palpitations, peripheral vascular insufficiency, phlebitis, PE, syncope, thromboembolism,
thrombophlebitis, venous thrombosis (retinal vein thrombosis)
Dermatologic: Alopecia, bullous dermatitis, epidermolysis, erythema multiforme, rash
(erythematous), exfoliation of skin, pallor, injection site rash/ulceration, SJS, discoloration
Endocrine & metabolic: ↓haptoglobins, hypervolemia, hyponatremia, translocational
hyponatremia pseudohyponatremia
GIT: Oral paresthesia
Genitourinary: Hematuria, hemoglobinuria, osmotic nephrosis, urine discoloration
Hematologic: Acute intravascular hemolysis, ↓neutrophils, DIC , ↑hemoglobin,
lymphadenopathy, pancytopenia, thrombocytopenia
Hepatic: Hepatic insufficiency, hepatitis (noninfectious)
Local: Tissue necrosis/ warm sensation at injection site
CNS: Agitation, burning sensation, coma, confusion, hypoesthesia, loss of consciousness,
nervousness, paresthesia, restlessness, seizure, speech disturbance, voice disorder
Neuromuscular & skeletal: Laryngospasm, muscle rigidity, polymyositis, tremor
Ophthalmic: Eye pain, photophobia, visual disturbance
Renal: Acute kidney injury, renal failure syndrome, renal insufficiency, renal pain
Respiratory: ARDS, apnea, bronchospasm, cyanosis, hyperventilation, hypoxemia, hypoxia,
pharyngeal /pulmonary edema, respiratory failure, transfusion-related acute lung injury
Contraindications 1,3 Hypersensitivity to immune globulin or any component of the formulation
IgA deficiency with anti-IgA antibodies and history of hypersensitivity.
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Osmotic laxative
lactulose
Trade name Laxolac
Active drug Lactulose 67%
Dosage form Syrup 120 ml
Mechanism of action Osmotic laxative
Indications Prevention & treatment of portal-systemic encephalopathy & treatment of constipation
Dose Infants, Children, and Adolescents3
Constipation
0.667 – 2 g/kg/day (1 – 3 mL/kg/day) divided once or twice daily
max:60 g/day (90 mL/day)may take up to 72 hr to response
Portal systemic encephalopathy, prevention (PSE)
Infants: 1.7 - 6.7 g/day (2.5 – 10 mL/day) in divided doses adjust dosage to 2 – 3 stools/day.
Child & Adolescents: 26.7 – 60 g/day (40 – 90 mL/day) divided, adjust to 2 - 3 stools/day.
Alternate dosing 12 – 17 yr5: 30 – 50 ml 3 times/day
Constipation, palliative care
2 – 30 mL/ 6 – 24 hr (some experts suggested 5 – 10 mL/ 2 hr until bowel movement)
Dose adjustment Renal Impairment no dosage adjustment (adult/pediatric)
Hepatic Impairment no dosage adjustment (adult/pediatric)
Preparation Enema: dilute with water or NS
Administration Oral solution: May mix with fruit juice, water or milk.
use with caution in diabetic patients, solution contains galactose and lactose
administer via rectal balloon
Stability1,3 Store at room temperature 30 °C, Protect from light.
Discard solution if cloudy or very dark.
Prolonged exposure to cold temperatures causes thickening that returns to normal upon
warming to room temperature, do not freeze.
Adverse reactions Abdominal cramps/ distention/ distress/ pain, anorexia, bloating, diarrhea, eructation,
flatulence, nausea, vomiting
Contraindications Patients requiring a low galactose diet
Intestinal obstruction
Anti- inflammatory
Maxilase
Trade name Maxilase
Active drug α-amylase
Dosage form Oral syrup 200 unit /ml
Mechanism of action Protease enzyme with activity in reducing swelling and oedema.
Indications Respiratory-tract inflammation, bone & joint edema/swelling including post-surgical
1,3
Dose Infant & child < 3 years (<15 kg) oral: 5ml 3 times daily
Age > 3 years ≥ (15 kg(: oral : 10 ml 3 times daily
Dose adjustment Renal Impairment /Hepatic Impairment: no data available
Administration Preferred before meals. Contains sucrose (3.2 g/5 ml)
Stability Store below 25° C
Don’t use if there is a change in taste or smell of the drug
My contain precipitates that don’t affect potency
Adverse reactions Hypersensitivity reactions (skin rash , urticaria), Contain sugars caution in diabetes
Galactose malabsorption, Sucrase enzyme deficiency, Fructose intolerance
Contraindications1 Hypersensitivity to alpha amylase or any component in the formulation
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Osmotic laxative
Glycerin
Trade name Glycerin
Active drug Glycerin 735.9 mg
Dosage form Suppository (rectal)
Mechanism of action Osmotic laxative draws fluid into colon and thus stimulates evacuation
Indication Occasional fecal impaction, constipation
Dose Neonate: one tip of pediatric suppository (≈ half suppository)
Pediatric: 1 suppository / dose when necessary
Administration1,5 Rectally: moist the tip of suppository with water before use
Stability Store at max. 25° C in cool dry place, protect from light
Adverse reactions Gastrointestinal: Abdominal cramps, rectal irritation, tenesmus
Contraindication Hypersensitivity to glycerol, intestinal obstruction
Anti-hyperuricemic- Xanthine oxidase inhibitor

Allopurinol
Trade name No- uric
Active drug Allopurinol
Mechanism of action Xanthine oxidase inhibitor prevents degradation of xanthines to uric acid
Indications Hyperuricemia chemotherapy – induced or inborn errors of purine metabolism (Lesch-
Nyhan syndrome), gout, recurrent calcium oxalate calculi in glycogen storage disease
Dose 3 Pediatric3
Hyperuricemia associated with chemotherapy management Oral
begin allopurinol 1 – 2 days before initiation of chemotherapy, may continue for 3 – 7
days after chemotherapy, daily doses > 300 mg should be administered in divided doses:
<6 years: 150 mg daily.
6 – 10 years: 300mg/day
>10 years and Adolescents: 600 – 800 mg/day for 2 – 3 days in 2 - 3 divided doses.
Tumor lysis syndrome, intermediate-risk
10 mg/kg/day divided / 8 hr (max.: 800 mg/day)
Or 50 – 100 mg/m2/ 8 hr (max.: 300 mg/m2/day)
Alternate dosing5
1month – 14 years: 10 – 20 mg/kg /day max. 400 mg/day
15 – 17 years: 100mg/day, increase dose acc. to response up to 300 mg/8 hr.
Hyperuricemia associated with inborn errors of purine metabolism (Lesch-Nyhan
syndrome) Oral
Initial: 5 – 10 mg/kg/day, adjust dose to maintain a high-normal Sr. uric acid & urinary uric
acid/creatinine ratio <1 (dose range: 3.7 - 9.7 mg/kg/day (usual max.600 mg/day)
Alternate dosing5
1month – 14 years: 10 – 20 mg/kg /day max. 400 mg/day
15 – 17 years: 100/day, increase dose acc. To response up to 300 mg/8 hr mg/day
Recurrent calcium oxalate renal stones (including glycogen storage disease) Oral
Child & Adolescents: 4 – 10 mg/kg/day divided/ 8 – 6 hr (max: 300 mg/day)
Dose adjustment 3 Renal Impairment
recommendations described by some clinicians for Infants, Children, and Adolescents in:
Hyperuricemia associated with chemotherapy: Oral, IV
GFR 30 – 50 mL/min/1.73 m2: Administer 50% of normal dose.
GFR 10 – 29 mL/min/1.73 m2: Administer 50% of normal dose.
GFR <10 mL/min/1.73 m2: Administer 30% of normal dose.
IHD: Administer 30% of normal dose.
207
PD: Administer 30% of normal dose.
CRRT: Administer 50% of normal dose.
Dosage reduction of 50% is recommended in renal impairment
Hepatic Impairment no dosage adjustments
Administration3 Fluid intake should be sufficient to yield neutral or slightly alkaline (preferably) urine
Administer tablets after meals with plenty of fluid
An extemporaneously prepared suspension may be prepared from immediate release
tablet using simple syrup3
Storage1 Store at 25°C in a dry place. Protect from light
1,3
Dermatologic: Maculopapular rash, skin rash.
GIT: Nausea, vomiting.
Neuromuscular & skeletal: Gout
Renal: Renal failure syndrome.
<1%: CVS: Bradycardia, edema, flushing, heart failure, HTN, hypotension, low cardiac output,
necrotizing angiitis, pericarditis, peripheral vascular disease, PE, thrombophlebitis, septic shock,
vasculitis, vasodilation, ventricular fibrillation
Dermatologic: Alopecia, cellulitis, diaphoresis, ecchymoses, eczema, exfoliative dermatitis,
furunculosis, lichen planus, onycholysis, purpuric rash, skin edema, SJS, TEN, urticaria,
vesicobullous dermatitis
Endocrine & metabolic: Albuminuria, ↓libido, gynecomastia, ↑ or ↓ in Ca, K, Na
hyperglycemia, hyperlipidemia, hyperphosphatemia, hyperuricemia, hypervolemia,
hypomagnesemia, lactic acidosis, metabolic acidosis, water intoxication
GIT: Abdominal pain/enlargement, Ageusia, anorexia, constipation, dysgeusia, dyspepsia,
enlarged salivary glands, flatulence, gastritis, GIT hemorrhage, hemorrhagic pancreatitis,
intestinal obstruction, proctitis, stomatitis
Genitourinary: Glycosuria, hematuria, impotence, male infertility, oliguria, uremia, UTI
Hematologic: Agranulocytosis, anemia, aplastic anemia, bone marrow aplasia/depression, CML,
DIC, eosinophilia, eosinophilic fibrohistiocytic bone marrow lesion, hemolytic anemia,
hemorrhage, leukocytosis, leukopenia, hypoprothrombinemia lymphadenopathy, TLS
lymphocytosis, neutropenia, pancytopenia, reticulocytosis, splenomegaly, thrombocytopenia,
Hepatic: Cholestatic jaundice, granulomatous hepatitis, hepatic failure/necrosis/toxicity
hepatomegaly hyperbilirubinemia, jaundice
Hypersensitivity: DRESS, facial edema, hypersensitivity angiitis, tongue edema
CNS: Agitation, amnesia, asthenia, cerebral infarction, cerebrovascular accident, chills, coma,
confusion, depression, dizziness, dystonia, headache, hypotonia, insomnia, malaise, mental
status changes, myoclonus, neuritis, pain, paralysis, vertigo paresthesia, peripheral neuropathy,
seizure, status epilepticus, tremor, twitching,
Neuromuscular & skeletal: Arthralgia, foot-drop, myalgia, myopathy
Ophthalmic: Amblyopia, cataract, conjunctivitis, iritis, macular retinitis, optic neuritis
Otic: Tinnitus
Renal: Nephritis (including interstitial nephritis)
Respiratory: ARDS, apnea, asthma, bronchospasm, epistaxis, pharyngitis, respiratory failure,
rhinitis, tachypnea
Other: Fever
GIT: Diarrhea
Hepatic: ↑ ALT, ↑ ALP, ↑ AST
Postmarketing:
Dermatologic: Sweet syndrome
Hematologic: Pure red cell aplasia
Hypersensitivity: Hypersensitivity reaction (allopurinol hypersensitivity syndrome)
Contraindications Severe hypersensitivity reaction to allopurinol or any component of the formulation.
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Osmotic diuretic
Mannitol
Trade name Mannitol
Active drug Mannitol 20%
Dosage form Bottle 500 ml for IV
Mechanism of action Osmotic diuretic inhibits tubular reabsorption of water and electrolytes and ↑ UOP
Indications Reduction of: ↑ICP with cerebral edema & ↑IOP, promoting urinary excretion of toxic
substances
Dose Neonate IV infusion 4
Elevated Intracranial Pressure (ICP)
0.25 g/kg (1.25 ml/kg) over 30 min may repeat / 6 – 8 hr, Monitor during and after
infusion, discontinue if renal, cardiac, pulmonary status worsens or CNS toxicity occurs.
Elevated Intraocular Pressure (IOP)
1.5 – 2 g/kg as a single dose over at least 30 min
Using 20% sol. 7.5 - 10 mL/kg
Using 15% sol. 10 - 13 mL/kg
when used preoperatively, administer 60 – 90 min prior to surgery
Infants, Children, and Adolescents 3 IV infusion
Acute renal failure (oliguria) (not recommended)
0.5 – 1g/kg/dose over 2 – 6 hr (range: 0.25 – 2 g/kg/dose, may repeat/ 4 - 6 hr, do not
repeat dose if oliguria persists.
Test of adequate renal function: 0.2 g/kg (max. dose: 12.5 g) over 3 - 5 min to produce
UOP at least 1 mL/kg/hr for 1 – 3 hr
Intracranial pressure (ICP), reduction
Usual range: 0.25 - 1 g/kg/dose over 20 - 30 min. repeat doses till Sr. osmolality <300 -
320 mOsm/kg (single doses up to 2 g/kg/dose)
Intraocular pressure (IOP), reduction
1 - 2 g/kg/dose or ≥30 min, administered 60 – 90 min before surgery
IOP (traumatic hyphema), reduction
1.5 g/kg/12hr over 45 min for IOP >35 mm Hg ,repeat / 8 hr in extremely high IOP
Dose adjustment Renal Impairment use with caution. Contraindicated in severe renal impairment
Hepatic Impairment No adjustment required.
Preparation Don’t use solutions containing crystals, allow to warm in room temp with agitation to
dissolve or warm the solution , don’t apply excessive heat, don’t use discolored solutions
Administration Iv infusion over time specified for each indication (review dosing)
Central line administration recommended (use inline filter set ≤ 5 micron)
Don’t administer with blood products
Vesicant at conc > 5%, avoid extravasation
Stability Store at controlled room temperature, do not freeze
CVS: Cardiac failure, chest pain, edema, HTN, localized phlebitis, palpitations, peripheral
edema, tachycardia, thrombophlebitis
CNS: Chills, coma, confusion, dizziness, headache, ↑ intracranial pressure (rebound),
lethargy, malaise, pain, seizure
Dermatologic: Diaphoresis, localized erythema/ rash, pruritus, skin necrosis/ rash, urticaria
Endocrine & metabolic: Dehydration, fluid / electrolyte disturbance, ↑ or ↓ in K, Na,
hypervolemia/ hypovolemia, ↑ thirst, metabolic acidosis, metabolic alkalosis
GIT: Nausea, vomiting, xerostomia
Genitourinary: Anuria, azotemia, diuresis, hematuria, oliguria, osmotic nephrosis, urine
retention
Hematologic: Hemoconcentration
Local: Local inflammation/pain /pruritus
Neuromuscular & skeletal: Arm and/or wrist pain, asthenia, muscle rigidity, myalgia
209
Renal: Polyuria
Respiratory: Cough, pulmonary congestion, pulmonary edema, rhinitis
Other: Fever
Postmarketing: ARF, anaphylaxis, CNS toxicity, dyspnea, hypersensitivity reaction, ↓ BP
Contraindications Hypersensitivity to mannitol or any component of the formulation
Anuria, severe hypovolemia, active intracranial bleeding except during craniotomy
Preexisting severe pulmonary vascular congestion or pulmonary edema.
Iron chelating agent

Deferasirox
Trade name JADENU
Active drug Deferasirox
Mechanism of action Iron chelating agent selectively binds iron, forming a complex excreted primarily in feces
Indications Chronic Iron Overload in transfusions & non-transfusion-dependent thalassemia syndrome
1,3
Dose Blood transfusion, chronic iron overload 3
Children ≥2 years and Adolescents oral (transfusion of ≥ 100 ml /kg packed RBCs)
Initial: 14 mg/kg once daily, round dose to the nearest whole tablet
Adjust dose / 3 – 6 months based on Sr ferritin trends
Adjust by 3.5 - 7 mg/kg/day, titrate to response & treatment goals
If no adequate control at 21 mg/kg/day dosing (Sr ferritin>2,500 mcg/L & not decreasing
over time), ↑ up to 28 mg/kg/day may be used3,5 (>28 mg/kg/day not recommended)
Alternate dosing5 to start initially at 7–21 mg/kg once daily (↑ to max 28 mg/kg/day)
Dosing adjustment:
If the Sr. ferritin <1,000 mcg/L at 2 consecutive visits: Consider dose reduction, particularly
if dose is >17.5 mg/kg/day.
If Sr. ferritin <500 mcg/L: Interrupt therapy, continue to monitor monthly.
Nontransfusion-dependent chronic iron overload, thalassemia syndromes (NTDT)3,5
(Liver iron conc (LIC) ≥5 mg Fe /g dry weight & Sr ferritin>300 mcg/L)
Age ≥10 years
Initial: 7 mg/kg/day once, after 4 weeks, if (LIC) >15 mg Fe/g dry weight, may increase to 14
mg/kg once daily.
Maintenance: Depend on Sr ferritin (monthly measured) and LIC (measured/ 6 months).
If Sr ferritin is <300 mcg/L: Interrupt therapy and obtain LIC.
If LIC: < 3 mg Fe/g dry wt: Interrupt therapy, resume therapy if LIC is >5 mg Fe/g dry wt.
3 – 7 mg Fe/g dry wt: resume therapy at ≤7 mg/kg/dose daily.
>7 mg Fe/g dry wt: ↑ to 14 mg/kg/day if not already (max: 14 mg/kg/day)
Dose adjustment 1,3 Drug toxicity Children ≥2 years and Adolescents:
Auditory disturbances: Consider dose reduction or treatment interruption.
Bone marrow suppression: Interrupt treatment, may reinitiate once cause of cytopenia
has been determined, contraindicated if platelet count <50,000/mm3.
Dermatologic toxicity:
Rash (severe): Interrupt therapy, may restart at a lower dose (with future dose escalation)
and short-term oral corticosteroids.
Severe skin reaction (SJS, erythema multiforme): Discontinue therapy, do not reinitiate.
GIT: Discontinue treatment for suspected GI ulceration or hemorrhage.
Hearing loss or visual disturbance: Consider dose reduction or treatment interruption.
Renal Impairment
Baseline: Children ≥2 years and Adolescents:
eGFR >60 mL/min/1.73 m2: No dosage adjustment necessary
eGFR 40 - 60 mL/min/1.73 m2: ↓initial dose by 50% use lowest effective dose and
monitor frequently
eGFR <40 mL/min/1.73 m2: Use is contraindicated
During therapy Children ≥2 years and Adolescents
210
Decrease in the eGFR by ≥33% below the average baseline: Reduce dose:
Transfusional iron overload reduce by 7 mg/kg/day, repeat eGFR within 1 week
eGFR <40 mL/min/1.73 m2: Use is contraindicated
Nontransfusion-dependent thalassemia syndrome
Age 10 – 17 yr: reduce by 3.5 mg/kg/day repeat eGFR in 1 week
Hepatic Impairment Children ≥2 years and Adolescents:
Baseline
Mild impairment (Child-Pugh class A): No adjustment but monitor closely
Moderate impairment (Child-Pugh class B): ↓initial dose by 50%, monitor closely for
efficacy and for adverse reactions requiring dosage reduction
Severe impairment (Child-Pugh class C): Avoid use
During therapy
Severe / persistent ↑ in transaminases/bilirubin: ↓dose or temporarily interrupt therapy
Administration1,3 Administer on empty stomach or with very light meal preferred with water or liquids
Administer at the same time each day.
In swallowing inability, crush tablets, add it to yogurt or apple sauce & consume it
completely and immediately.
Do not administer simultaneously with aluminum-containing antacids.
Storage Store At 30◦ C, protect from moisture 1,3
Adverse reactions >10%: Dermatologic: Skin rash
GIT: Abdominal pain, diarrhea, nausea, vomiting
Genitourinary: Proteinuria
Renal: ↑ Sr Cr (↑>33% from baseline at 2 consecutive visits)
1% - 10%: CVS: Edema
Dermatologic: Dyschromia
Endocrine & metabolic: Fanconi’s syndrome
GIT: Acute pancreatitis, cholelithiasis, duodenal/ gastric ulcer, gastritis, GIT hemorrhage
Hepatic: ↑ALT (>5 x ULN)
CNS: Anxiety, dizziness, fatigue, sleep disorder
Ophthalmic: Cataract, maculopathy
Otic: Hearing loss (including high frequency)
Renal: Renal tubular disease
Respiratory: Pharyngolaryngeal pain
Other: Fever
<1%: Dermatologic: Erythema multiforme
GIT: Esophagitis
Immunologic: DRESS
Ophthalmic: ↑ IOP, optic neuritis, retinopathy
Frequency not defined: Endocrine & metabolic: Glycosuria
GIT: Constipation
Hematologic: Henoch-Schönlein purpura
Hepatic: Hepatitis, ↑ Sr bilirubin
Infection: Atypical mycobacterial infection, viral infection
CNS: Drug fever, headache, hyperactive behavior, insomnia
Neuromuscular & skeletal: Arthralgia, back pain
Respiratory: Cough, nasopharyngitis, pharyngitis, respiratory tract infection.
Postmarketing:
CVS: Hypersensitivity angiitis
Dermatologic: Alopecia, SJS, TEN, urticaria
GIT: GIT perforation
Hematologic: Agranulocytosis, anemia (worsening), neutropenia, thrombocytopenia
Hepatic: Hepatic failure
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
Renal: Acute kidney injury, interstitial nephritis
Contraindications Known hypersensitivity to Deferasirox or any component of the formulation
eGFR <40 mL/min/1.73 m2 ( Cr Cl <60 mL/min), poor performance status, High-risk
myelodysplastic syndromes, advanced malignancies3, Platelet counts <50,000/mm3
211
Index
Drug Page Price L.E Drug Page Price L.E
Abbreviations 2 Corticosteroid equivalence 5
Acetyl cysteine/Fluimucil 105 8.94 Cyclophrine/cyclopentolate eye 198 8.872
Acyclovir IV 44 84.155 Daktarin oral See Miconaz 197
Adrenaline 120 2.77 Dalacin see clindamycin 37
Albumin 20% 199 430 Danset/ Ondansetron 157 4.158
Alfacalcidol/ bone care 177 77.88 Dexamethasone injection/oral 89 2.52
Alfaprostine 131 231 Diazepam IV/valium 115 1.52
Allopurinol 207 2.499 Diclofenac /dolphine 151 2.15/Box
Alveofact 108 mg 200 3248.52 Diflucan see fluconazole 49
Alveofact 54 mg 200 1538.12 Digoxin 127 2.178
Ambisome see liposomal Amphotericin 47 Dobutamine/Dobutrex 122 20.486
Amikacin Injection 24 5.89 Domperidone 158 8.66
Amikacin spray 196 20.7 Dopamine 121 7.375
Amikin see Amikacin injection 24 Dormicum see Midazolam 111
Aminophylline injection 106 2.21 Epanutin see phenytoin 110
Aminoven 181 56.11 Ephedrine 126 1.575
Amiodarone 129 3.465 Extrauma Forte see Hirudin 197
Amoxicillin/clavulanate Injection 10 17.1 Famotidine 161 6.75
Amoxicillin/clavulanate oral 11 26.44 Farcolin/Salbutamol inhalation 104 6.17
Amoxicillin/flucloxacillin IV 9 8.79 Fentanyl 153 11.25
Amphotericin- B IV 46 57.78 Flagyl see metronidazole 38
Ampicillin/sulbactam Injection 8 10.8 Fluconazole IV 49 20.85
Ampicillin Injection 7 3.675 Flumox see Amoxicillin/flucloxacillin 9
Antodine see Famotidine 161 Folic acid 179 1.75
Atracurium 147 9.48 Fortum/kefadim see ceftazidime 17
Atropine 144 1.995 Fungizone see Amphotericin- B IV 46
Atrovent /ipratropium inhalation 103 3.368 Furosemide 134 5.15
Augmentin/Emoxclav see Amox/clav 10, 11 Fusi Cream 196 11.79
Averozolid see linezolid 34 Garamycin see gentamicin 25
Avil see Chlorpheniramine 89 Gentamicin Injection 25 1.74
AWaRe / WHO antibiotic classification 6 Glucose/ Dextrose 10% 181 11.55
Azithromycin Oral 42 6.319 Glucose/ Dextrose 25% 181 11.55
Benox see Benoxinate eye 198 Glucose/ Dextrose 5% 181 13.037
Benoxinate (oxybuprocaine) eye 198 15 Glycerine 207 0.924
Body surface area in pediatric 5 Heavy Marcaine 143 9.03
Bupivacaine 142 13.409 Heparin 165 19.65
Caffeine citrate injection 108 16.93 Hirudin gel 197 20.65
Calcium gluconate 188 7.35 Hydrea see Hydroxyurea 72
Cefepime 19 17.72 Hydrocortisone injection 92 10.08
Cefixime oral 18 14.75 Hydroxyurea oral capsule 72 120.375/Box
Cefotaxime IV 15 7.07 Ideal body weight 4
Ceftazidime IV 17 11.174 Imipenem / cilastatin 22 111.313
Ceftriaxone IV/IM 14 8.93 Isoflurane 140 125.89
Child pugh Score 4 IVIG /LIV- Gamma 5% 202 1686.37
Chloral hydrate 136 50 IVIG/Gmunex 10 % 202 3071.97
Chlorpheniramine injection 89 1.55 Jadenu 210 1302.939
Ciprocin see ciprofloxacin 31 Kapron 167 6.75
Ciprofloxacin IV 31 11.54 Kenacomb Cream 196 11.041
Claforan see cefotaxime 15 Ketamine/ketalar 138 11.5
Clexane /Enoxaparin 164 42.317 Konakion see Phytomenadione 171
Clindamycin Injection 37 35.31 Lactulose 206 16.631
Colistin IV 35 154.52 Lanoxin/Cardixin see digoxin 127
212
Drug Page Price L.EDrug Page Price L.E
Lasix see Furosemide 134 Ringer's Solution 183 11.95
Laxolac see lactulose 206 Rocephin /Cefaxone see ceftriaxone 14
L-carnitine oral 174 17.87 Schwartz Equation pediatric 4
Levetiracetam 117 10.727 Septrin see SMX /TMP 40
Levofloxacin IV 32 18.62 Sevosluarane 141 1055.38
Levofloxacin oral tablet 32 7.35 Smoflipid 192 53.928
Lidocaine 132 2.23 Sodium bicarbonate 8.4% 194 6.699
linezolid 34 26.81 Sodium Chloride 0.9% 100 ml 185 13.782
Liposomal amphotericin B IV 47 1806.69 Sodium Chloride 0.9% 250 ml 185 11.17
Magnesium sulfate 191 3.11 Sodium Chloride 0.9% 500 ml 185 11.77
Mannitol 20% 209 16.8 Solu-- cortef see Hydrocortisone 92 10.08
Marcaine See Bupivacaine 142 Solu-- Medrol see methylprednisolone 95 1.75
Maxilase oral 206 14.17 Sominaletta/phenobarbitone 109 1.75
Maxipime/wincef see cefepime 19 Sulfamethoxazole /Trimethoprim 40 5.77
Mebo see Pentaburn 196 oral Oral see cefixime
Suprax 18
Medathetic see midazolam 111 3.75 Surfactant/lung see Alveofact 200
Meronem see meropenem 21 Targocid see Teicoplanin 30
Meropenem IV 21 61.23 Tavanic see Levofloxacin 32
Methylprednisolone injection 95 89.131 Tazocin see Piperacillin/Tazobactam 12
Metronidazole IV 38 15.078 Teicoplanin 30 128.4
Metronidazole oral suspension 38 4.73 Tienam see Imipenem/cilastatin 22
Miconaz Oral Gel 197 9.27 Tiratam/kepilepsy see Levetiracetam 117
Midazolam 111 10.42 Tracurium see atracurium 147
Motilium/ Motinorm see Domperidone 158 Tranexamin acid see Kapron 167
Mucosol/carbocysteine 106 7.13 Unasyn/Unictam see Ampicillin 8
Nalufin/Nalbuphine 153 6.05 /sulbactam
V- InjectionD3 Oral
drop see Vitamin 175 8.79
Neostigmin 146 10.684 Vancomycin 28 30.49
Nexium Sachet/Esomeprazole 159 251.45/B Vfend see Voriconazole 51
Noradrenaline 123 ox
10.42 Vitamin D3 Oral 175 415.8
Nystatin Oral 53 6.76 Vitamin K1 injection 171
One -Alpha see Alfacalcidol 177 Voriconazole IV 51 415.8
Paediment 186 10.71 Voriconazole Oral 51 20.204/st
Pantoprazole 162 17.325 Zinc Olive cream 197 rip
14.73
paracetamol IV 149 16.76 Zinc Sulfate 180 8.02
paracetamol oral 149 6.745 Zithromax/Zithrokan see azithromycin 42
paracetamol suppository 149 5.19/Box Zovirax see Acyclovir 44
Pentaburn/Mebo Ointment 196 31.03 Zyloric see Allopurinol 207
Perfalgan see paracetamol 149 xylocaine 132
Phenytoin 110 2.856
Phytomenadione 171 2.25
Piperacillin/Tazobactam IV 12 50.493
Potassium Chloride 187 1.96
Prednisolone 98 17.5
Predsol see prednisolone 98
Propofol 136 19.47
Propranolol 124 4.45
Prostigmine See Neostigmine 146
Protofix see Pantoprazole 162
Pulmicort/Budesonide inhalation 101 8.53
References 1
Ringer/Lactated 184 9.31
213
214

# Final Formulary November إصدار معتمد

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# Final Formulary November إصدار معتمد

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Benha Children Hospital

Hospital Drug formulary

WHO AWaRe Antibiotic classification included

Supervised by: head of pharmacy department/

Prepared by: clinical pharmacist/

Revised by Clinical pharmacists/

1– Pamphlet of available product

Ideal body weight for pediatric 25

Body surface area in pediatric

Antibiotics /Aminopenicillin+ß-lactamase inhibitor

Antibiotics /Aminopenicillin + antistaphylococcal penicillin

Antibiotics /Aminopenicillin + ß-lactamase inhibitor

Antibiotic/ Extended spectrum penicillin + ß-lactamase inhibitor

Respiratory Fluroquinolone antibiotic

Renal impairment: according to table 3

Alkylating chemotherapy agent

Tablets: Store at 25°C. Protect from light.

Dopaminergic & adrenergic agonist

ß-adrenergic receptor blocker

Long acting sympathomimetic

Daily Loading dose (optional) 3 Daily Maintenance Dose

General inhalational anesthesia/halogenated

Epidural /spinal anesthesia

Cholinergic agent injection

Proton pump inhibitor

Proton pump inhibitor

Anti factor X - Anticoagulant

Dietary supplement – Fat soluble Vitamin

Electrolyte /calcium salt

Parenteral Nutrition/IV lipid emulsion

Burn management - Topical

Antimicrobial combination – Topical

Anti factor X – Topical

Topical astringent – Topical

Weight (gram) Dose (ml) Weight (gram) Dose (ml)

Dose adjustment Overdose

1- Open the top of the needle pack. Place the

2- Insert the needle into the vial through the

3-Inject the solvent into the vial. Then immediately

4- Holding the suspension at an angle, withdraw it into

5- Inject it back into the vial. Repeat

7- Withdraw the suspension slowly. Residual foam will

Administration1 Endotracheopulmonary instillation.

Anti-hyperuricemic- Xanthine oxidase inhibitor

Iron chelating agent

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