Adult: IV Nosocomial Pneumonia Empiric Therapy For Febrile Neutropenic Patients 4.5

Indications Listed in Dosage.
Dosage Adult : IV Nosocomial pneumonia; Empiric therapy for febrile neutropenic patients 4.5
g 6 hrly for 5-14 days. Complicated intra-abdominal infections; Complicated urinary
tract infections; Skin and soft tissue infections 4.5 g 8 hrly for 5-14 days.
Dosage Details Intravenous

Empiric therapy for febrile neutropenic patients
Adult: Each vial contains 4.5 g (piperacillin 4 g and tazobactam 0.5 g): 4.5 g 6 hrly for 5-14
days by infusion over 30 min.
Child: 2-12 yr 90 mg/kg (piperacillin 80 mg/kg and tazobactam 10 mg/kg) 6 hrly for 5-14 days
by infusion over 30 min. Max: 4.5 g per dose; >12 yr Same as adult dose.
Intravenous
Nosocomial pneumonia
days by infusion over 30 min. When used empirically, combination w/ aminoglycoside or
antipseudomonal fluoroquinolone is recommended.
Child: 2-12 yr 90 mg/kg (piperacillin 80 mg/kg and tazobactam 10 mg/kg) 6 hrly for 5-14 days
by infusion over 30 min. Max: 4.5 g per dose; >12 yr Same as adult dose.
Intravenous
Complicated intra-abdominal infections
Child: 2-12 yr 112.5 mg/kg (piperacillin 100 mg and tazobactam 12.5 mg) 8 hrly for 5-14
days by infusion over 30 min. Max: 4.5 g per dose.
Intravenous
Complicated urinary tract infections, Skin and soft tissue infections
Renal Impairment Nosocomial pneumonia:
Haemodialysis patients: 2.25 g 8 hrly; additional dose of 0.75 g after each dialysis session.
CAPD: 2.25 g 8 hrly.
CrCl (mL/min) Dosage
<20 2.25 g 6 hrly.
20-40 3.375 g 6 hrly.

Empiric therapy for febrile neutropenic patients; Complicated intra-abdominal
infections; Complicated urinary tract infections; Skin and soft tissue infections:
Haemodialysis patients: 2.25 g 12 hrly; additional dose of 0.75 g after each dialysis session.
CAPD: 2.25 g 12 hrly.
CrCl (mL/min) Dosage
<20 2.25 g 8 hrly.
20-40 2.25 g 6 hrly.

Reconstitution Reconstitute initially (2.25 g in 10 mL, 4.5 g in 20 mL) w/ water for inj, glucose 5% or NaCl
0.9%, then further dilute to 50-150 mL w/ compatible infusion soln.
Incompatibility Y-site: Aciclovir, amiodarone, amphotericin B cholesteryl sulfate complex, amphotericin B,
azithromycin, chlorpromazine, cisplatin, dacarbazine, daunorubicin, dobutamine, doxorubicin
liposome, doxorubicin, EDTA formulated product (caspofungin, pantoprazole and
tobramycin), doxycycline, droperidol, famotidine, ganciclovir, gemcitabine, haloperidol,
hydroxyzine, idarubicin, minocycline, mitomycin, mitoxantrone, nalbuphine, prochlorperazine
edisylate, promethazine, streptozocin.
Contraindications Hypersensitivity to piperacillin, tazobactam or any other penicillin-antibacterial agent. History
of acute severe allergic reaction to any other -lactam active substances (e.g. cephalosporin,
monobactam or carbapenem).
Special Precautions Patient w/ cystic fibrosis, history of seizure disorder. Renal impairment. Childn. Pregnancy
and lactation.
Adverse Drug GI effects (e.g. diarrhoea, nausea, constipation), rash (maculopapular, bullous, urticarial,
Reactions eczemoid), pruritus, fever, headache, insomnia; adverse reactions at inj site (phlebitis, pain,
inflammation, thrombophlebitis, oedema). Decreases in Hb and haematocrit,
thrombocytopenia, increases in platelet count, transient eosinophilia, leucopenia,
neutropenia; positive Coombs test results, prolonged prothrombin time and partial
thromboplastin time. Increases in serum concentrations of creatinine and BUN, changes in
serum electrolytes, transient increases in AST, ALT, alkaline phosphatase and bilirubin.
Potentially Fatal: Serious, anaphylactic reactions, antibiotic-induced pseudomembranous
colitis, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Pregnancy Category ROUTE(S) : Parenteral
(US FDA)
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there
are no controlled studies in pregnant women or animal-reproduction studies have shown an
adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies
in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Monitoring Assess hematopoietic function periodically. Perform periodic electrolyte determinations in
Parameters patients w/ low K reserves. Monitor creatinine, BUN, CBC w/ differential, prothrombin time,
partial thromboplastin time, LFTs, urinalysis, signs of bleeding, signs of anaphylaxis during
1st dose.
Overdosage Symptoms: Nausea, vomiting, diarrhoea, neuromuscular excitability or convulsions.
Management: Symptomatic and supportive treatment. Haemodialysis may reduce excessive
serum concentrations.
Drug Interactions Interacts w/ high doses of heparin, oral anticoagulants or other drugs that affect blood
coagulation or thrombocyte function. Prolongs the neuromuscular blockade of vecuronium
and non-depolarising muscle relaxants. Prolongs half-lives w/ probenecid. Increased risk of
methotrexate toxicity.
Lab Interference May lead to false-positive results in Bio-Rad Laboratories Platelia Aspergillus EIA tests and
also in urinary glucose determinations w/ tests that use copper reduction.
Mechanism of Action Description: Piperacillin inhibits bacterial septum formation and cell wall synthesis in
susceptible bacteria. Tazobactam is a penicillanic acid sulfone derivative w/ -lactamase
inhibitory properties. In combination, tazobactam enhances the activity of piperacillin against
-lactamase-producing bacteria. Piperacillin and tazobactam has a wide range of activity and
is active against gm+ve and gm-ve aerobic and anaerobic bacteria.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: Immediately after completion of IV infusion.
Distribution: Widely distributed into body tissues and fluids; both cross the placenta;
distributed into milk (piperacillin). Plasma protein binding: Approx 30%.
Metabolism: Piperacillin: Metabolised to a desethyl metabolite. Tazobactam: Metabolised to
a single metabolite that lacks pharmacological and antibacterial activities.
Excretion: Via kidney by glomerular filtration and tubular secretion as unchanged in urine,
68% (piperacillin) and 80% (tazobactam). Plasma half-life: 0.7-1.2 hr.
Storage Powd for inj: Store between 20-25C. Reconstituted soln: Store between 2-8C (for up to 48
hr) or 20-25C (for up to 24 hr).
MIMS Class Penicillins
Approval date: October 22, 1993

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Indications Listed in Dosage.

Dosage Details Intravenous

<20 2.25 g 6 hrly.

20-40 3.375 g 6 hrly.

<20 2.25 g 8 hrly.

20-40 2.25 g 6 hrly.

Approval date: October 22, 1993

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