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Zegen

Manufacturer Distributor Contents Indications Dosage Overdosage Administration Contraindications Warnings Special Precautions Adverse Drug Reactions Drug Interactions Pregnancy Category (US FDA) Caution For Usage Storage Mechanism of Action MIMS Class ATC Classification Poison Schedule Presentation/Packing

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Zegen Full Info

Abbreviati on Index UAP UAP Cefuroxime (tab: axetil; inj: sodium). Tablet: Treatment of the following infections caused by susceptible microorganisms: Upper respiratory tract infections including acute sinusitis, acute otitis media and acute tonsillopharyngitis; lower respiratory tract infections including acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis; uncomplicated skin and skin structure infections including furunculosis, pyodema and impetigo; uncomplicated UTI including pyelonephritis; uncomplicated gonorrhea; earlyLyme disease (erythema migrans); step-down treatment for infections due to susceptible organisms, initially given antimicrobial therapy, particularly parenteral cefuroxime. Powder for Injection (Vial): Treatment of infections due to cefuroxime-sensitive organisms: Lower respiratory tract infections including pneumonia, urinary tract infections (UTI), skin and skin structure infections, septicemia, meningitis,gonorrhea, bone and joint infections, surgical prophylaxis. Tablet: In general, most infections in adults and adolescents (13 years) will respond to 250 mg every 12 hrs. However, for more severe infections, 500 mg every 12 hrs may be recommended. Acute Sinusitis, Acute Tonsillopharyngitis and Uncomplicated Skin and Skin Structure Infections: Adults and Adolescents 13 years: 250 or 500 mg every 12 hrs for 10 days. Children 7-12 years: 250 mg every 12 hrs for 10 days. Acute Otitis Media: Adults and Adolescents 13 years: 500 mg every 12 hrs for 10 days. Children 7-12 years: 250 mg every 12 hrs for 10 days. Acute Bacterial Exacerbations of Chronic Bronchitis: Adults and Adolescents

Manufacturer Distributor Contents Indications

Dosage

13 years: 250 or 500 mg every 12 hrs for 10 days*. Children 7-12 years: 250 mg every 12 hrs for 10 days*. Secondary Bacterial Infections of Acute Bronchitis: Adults and Adolescents 13 years: 250 or 500 mg every 12 hrs for 5-10 days. Children 7-12 years: 250 mg every 12 hrs for 5-10 days. Uncomplicated Urinary Tract Infections: Adults and Adolescents 13 years:250 or 500 mg every 12 hrs for 7-10 days. Children 7-12 years: 250 mg every 12 hrs for 7-10 days. Uncomplicated Gonorrhea: Adults and Adolescents 13 years: 1000 mg once as a single dose. Early Lyme Disease: Adults and Adolescents 13 years: 500 mg every 12 hrs for 20 days. Children 7-12 years: 250 mg every 12 hrs for 20 days. *The safety and effectiveness of cefuroxime axetil administered for <10 days in patients with acute exacerbations of chronic bronchitis have not been established. Powder for Injection (Vial): Adults: Usual Dose: 750 mg to 1.5 g every 6-8 hrs for 5-10 days depending on the type and severity of infection. Uncomplicated Urinary Tract Infections, Skin and Skin Structure Infections, Disseminated Gonococcal Infections, Uncomplicated Pneumonia: 750 mg IV every 8 hrs. In severe infections, 1.5 g IV every 8 hrs. Bone and Joint Infections: 1.5 g IV every 8 hrs. Bacterial Meningitis: Not to exceed 3 g IV every 8 hrs. Uncomplicated Gonococcal Infections: 1.5 g IM as a single dose at 2 different sites + 1 g oral probenecid. Life-Threatening Infections or Infections due to Less Susceptible Organisms: 1.5 g IV every 6 hrs. Preventive Use for Clean-Contaminated or Potentially Contaminated Surgical Procedures: 1.5 g IV before surgery, thereafter give 750 mg IV or IM every 8 hrs when procedure is prolonged. Preventive Use During Open Heart Surgery: 1.5 g IV upon anesthesiainduction and every 12 hrs thereafter, for a total of 6 g. Children >3 months: Usual Dose: 50-100 mg/kg body weight/day in equally divided doses every 6-8 hrs (see Table 1).

Click on icon to see table/diagram Adults with Renal Impairment: Use a reduced dosage when renal function is impaired. Dosage should be determined based on the degree of renal impairment and the susceptibility of the causative organism (see Table 2).

Click on icon to see table/diagram Children with Impaired Renal Function: It is recommended that the frequency of administration of parenteral cefuroxime be modified based on the recommendation for adults with renal impairment. Treatment is continued for a minimum of 48-72 hrs after the patient becomes asymptomatic or after evidence of bacterial eradication has been obtained. A minimum of 10 days treatment is recommended in infections caused byStreptococcus pyogenes in order to prevent rheumatic fever or glomerulonephritis. Frequent bacteriologic and clinical appraisal is necessary during treatment of chronic UTI and may be required for several months after therapy has been

completed. In staphylococcal and other infections, surgical drainage should be carried out where indicated. Administration: Tablet: To be taken orally after meals. Powder for Injection (Vial): After constitution, cefuroxime may be given IV or by deep IM injection into a large muscle mass (eg, the gluteus or lateral part of the thigh). Before injecting IM, aspiration is necessary to avoid inadvertent injection into a blood vessel (see Table 3).

Click on icon to see table/diagram Administration Overdosage Should be taken with food. Take immediately after food. Limited information is available on the acute toxicity of cefuroxime in humans. Overdosage of cephalosphorins can cause cerebral irritation leading to convulsions. If acute overdosage occurs, cefuroxime may be removed by hemodialysis or peritoneal dialysis. Known hypersensitivity to cefuroxime or other cephalosporins or any component of Zegen. Before cefuroxime therapy is instituted, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins and penicillins. Generally, cephalosporins may be given safely to patients who are hypersensitive to penicillins, although cross-reactions have been reported. Any patient who has demonstrated some form of allergy to any drug, particularly to other cephalosporins and penicillins, should receive cefuroxime cautiously. Although it has not been established, allergic reactions to antibiotics may occur more frequently in atopic individuals. Discontinue cefuroxime if an allergic reaction occurs. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures including oxygen, IV fluids and antihistamines, corticosteroids, pressor amines and airway management, as clinically indicated. Like most broad-spectrum antibiotics, prolonged use may give rise to pseudomembranous colitis due to overgrowth of Clostridium difficile. Mild cases usually respond to drug discontinuation; moderate to severe cases may need fluid and electrolyte supplementation. If diarrhea is still severe, oral metronidazole or vancomycin may be given. Tablet: Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including cefuroxime, and may range in severity from mild diarrhea to fatal colitis. It is important to consider the diagnosis in patients who present with diarrhea following administration of antibacterial agents. As with other broad-spectrum antibacterial agents, cefuroxime should be used with caution in patients with a history of gastrointestinal disease, particularly colitis. As with other antibacterial agents, long-term or repeated use may result in overgrowth of nonsusceptible organisms, including fungi. Cephalosporins, including cefuroxime, have been associated with the development of seizures, particularly in patients with renal impairment, in whom dosage of the drug was not reduced. If seizures due to cefuroxime develop, Zegen should be discontinued and treatment with an anticonvulsant be given as clinically indicated. Cephalosphorins may be associated with a fall in prothrombin activity. Patients

Contraindications Warnings

Special Precautions

who are at risk are those with kidney or liver impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated. The patient's renal function should be carefully monitored when cefuroxime is given concurrently with aminoglycosides and/or diuretics because adverse renal effects may occur (see Interactions). The Jarisch-Herxheimer reaction, a transient immunological reaction lasting 1-2 days, has been observed following cefuroxime treatment of Lyme disease. Cefuroxime is considered to be unsafe in patients with porphyria although there is conflicting experimental evidence of porphyrinogenicity. Prescribing cefuroxime in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of antibiotic resistance. Renal Impairment: The safety and efficacy of oral cefuroxime axetil in patients with renal impairment have not been established. Since cefuroxime is renally eliminated, its t will be prolonged in patients with reduced renal function. Powder for Injection (Vial): Superinfection should always be considered a possibility in a patient being treated with a broad-spectrum antimicrobial. Careful observation of the patient is essential. If superinfection occurs during therapy, institute appropriate measures. Use with caution in patients receiving concurrent treatment with potent diuretics as these regimens are suspected of adversely affecting renal function. Nephrotoxicity has been reported following concomitant administration of aminoglycosides and cephalosporins. Mild-to-moderate hearing loss has been reported in some pediatric patients treated with cefuroxime against meningitis. Persistence of positive CSF cultures at 18-36 hrs has also been noted with cefuroxime injection, as well as with other antibiotic therapies. However, the clinical significance is unknown. Effects on the Ability to Drive or Operate Machinery: Since cefuroxime may cause dizziness, patients should be advised to avoid performing tasks which require complete mental alertness eg, driving and operating machinery. Carcinogenicity, Mutagenicity & Impairment of Fertility: Although no longterm studies in animals have been performed to evaluate carcinogenic potential, no mutagenic potential of cefuroxime was found in standard laboratory tests. Reproductive studies revealed no impairment of fertility in animals. Use in pregnancy: Pregnancy Category B: Since there are no adequate and well controlled studies to date using cefuroxime in pregnant women, use in pregnancy only if the potential benefit justifies the potential risk to the fetus. Use in lactation: Cefuroxime is distributed into human milk and should be used with caution in breastfeeding women. Use in children: Cefuroxime's serum t is inversely proportional to age when given in children and neonates. Use in the elderly: There are no apparent differences in efficacy and safety of cefuroxime between the elderly and younger adults. However, since elderly patients have increased risk of renal impairment, dose adjustment and renal function monitoring may be necessary. Adverse Drug Reactions Tablet: The following adverse events have been reported with the use of cefuroxime, although in many instances the causal relationship to the drug has not been established: Dermatologic/Hypersensitivity Reactions: Rash (eg, morbilliform), pruritus/itch, erythema, urticaria/hives, drug fever, chills, edema, facial edema, exfoliative dermatitis, erythema multiforme, Stevens-Johnson

syndrome, toxic epidermal necrolysis (exanthemic necrolysis), serum sicknesslike reactions, shock, hypotension, vasodilatation, shortness of breath, bronchospasm, angioedema, anaphylaxis, Candida overgrowth. Gastrointestinal: Nausea, vomiting, diarrhea or loose stools, gagging, abdominal/epigastric pain, abdominal cramps, dyspepsia, flatulence, heartburn, indigestion, GI bleeding and infection, tenesmus, decreased salivation, ptyalism, glossitis/swollen tongue, taste alteration, mouth ulcers/candidiasis, decreased appetite/anorexia, thirst, CDAD and colitis (antibiotic-associated pseudomembranous colitis). Hematologic: Decreased hematocrit and hemoglobin concentrations, transient eosinophilia and neutropenia, pancytopenia, thrombocytopenia, leukopenia, lymphocytopenia, agranulocytosis, leukocytosis, lymphocytosis, monocytosis, thrombocytosis, basophilia, anemia, aplastic and hemolytic anemia, epistaxis or hemorrhage, increased erythrocyte sedimentation rate, prolonged prothrombin time (PT) and activated partial thromboplastin time (APTT), and/or hypoprothrombinemia (with or without bleeding). Nervous System: Headache, dizziness, vertigo, malaise, fatigue, drowsiness, somnolence or sleepiness, weakness, insomnia, nightmares, irritable behavior, seizures, myoclonic jerks, generalized hyperexcitability, hyperactivity, nervousness or anxiety, agitation, confusion, hallucinations, alteration in color perception, hot flushes, hypertonia. Musculoskeletal: Muscle spasm of the neck, muscle cramps or stiffness, arthralgia/joint pain or swelling. Genitourinary: Acute renal failure and interstitial nephritis, transient increases in BUN and serum creatinine concentrations, decreased creatinine clearance, renal dysfunction, toxic nephropathy, bilateral renal cortical necrosis, kidney pain, UTI, urethral pain or bleeding, dysuria, vaginitis, vaginal candidiasis, discharge or irritation, vulvovaginal pruritus, menstrual irregularities. Hepatic: Hepatic impairment including hepatitis and cholestasis, jaundice, transient increase in AST, ALT, -glutamyl transferase, alkaline phosphatase, LDH and bilirubin concentrations, decreased serum albumin and/or total protein. Respiratory: Pleural effusion, pulmonary infiltrate, dyspnea or respiratory distress, upper respiratory infection, rhinitis, sinusitis, cough. Cardiovascular: Chest pain or tightness, tachycardia. Other Adverse Effects: Jarisch-Herxheimer reaction, mild to severe hearing loss, increased or decreased serum glucose concentration, lock jaw-type reaction, viral illness. Powder for Injection (Vial): Cefuroxime is generally well tolerated. The most common adverse effects have been local reactions following IV administration. Other adverse reactions have been encountered only rarely. Local Reaction: Thrombophlebitis has occurred with IV administration in 1 in 60 patients. Hypersensitivity: Hypersensitivity reactions have been reported in fewer than 1% of patients treated and include rash (1 in 125). Pruritus, urticaria and positive Coombs' test each occurred in fewer than 1 in 250 patients, and, as with other cephalosporins, rare cases of anaphylaxis, drug fever, erythema multiforme, interstitial nephritis, toxic epidermal necrolysis and Stevens-Johnson syndrome have occurred. Gastrointestinal: Gastrointestinal symptoms occurred in 1 in 150 patients and included diarrhea (1 in 220 patients) and nausea (1 in 440 patients). Pseudomembranous colitis may occur during or after antibacterial treatment. Hematologic: A decrease in hemoglobin and hematocrit has been observed in 1 in 10 patients and transient eosinophilia in 1 in 14 patients. Less common reactions

seen were transient neutropenia (<1 in 100 patients), leukopenia (1 in 750 patients), and rarely, thrombocytopenia. Hepatic: Transient rise in serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (1 in 25 patients), alkaline phosphatase (1 in 50 patients), lactate dehydrogenase (LDH) (1 in 75 patients) and bilirubin (1 in 500 patients) levels have been noted. Renal: Elevations in serum creatinine and/or blood urea nitrogen (BUN) and a decreased creatinine clearance have been observed, but their relationship to cefuroxime is unknown. Post-Marketing Experience: In addition to adverse events reported from clinical trials, the following events have been identified during post-approval use of cefuroxime. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to combination of their seriousness, frequency of reporting or potential causal connection to cefuroxime. Neurologic: Seizure. Nonsite Specific: Angioedema. Click to view ADR Monitoring Website Drug Interactions Probenecid: Probenecid, when given together or right before administration with cefuroxime, slows down tubular secretion of cefuroxime and produces higher and more prolonged serum cefuroxime concentrations. This drug interaction is usually used beneficially in treating gonorrhea. Cefuroxime's peak serum concentrations and t are increased by up to 30% with concomitant administration of probenecid. Area under the concentration-time curve of cefuroxime is also increased by 50%. A decrease in cefuroxime's apparent volume of distribution by about 20% has been reported with concurrent administration of probenecid. Aminoglycosides: The risk of nephrotoxicity may increase when aminoglycosides and cephalosphorins are given concomitantly. This has not been reported with cefuroxime use to date. Monitoring of the patient's renal function is advisable when these drugs are given together. Diuretics: Studies suggest that the concomitant use of potent diuretics, including furosemide and ethacrynic acid, may increase the risk of renal toxicity with cephalosphorins. Renal impairment has been reported with concurrent treatment with potent diuretics eg, furosemide or aminoglycosides. Oral Antacids: These drugs may result in lower bioavailability of cefuroxime compared with that of the fasting state and tend to cancel the effect of enhanced postprandial absorption. Oral Contraceptives: As with other antibacterial agents, cefuroxime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral contraceptives. Interference with Laboratory Tests: A false-positive reaction for glucose in the urine may occur with copper reduction tests (Benedict's or Fehling's solution, or with Clinitest tablets) but not with enzyme-based tests for glycosuria. As a falsenegative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase method be used to determine blood plasma glucose levels in patients receiving cefuroxime. Positive direct antiglobulin (Coombs') test results have also been reported in a few patients receiving oral cefuroxime, however, it is not clear whether the mechanism of this reaction is immunologic in nature. This phenomenon can interfere with cross matching of blood. View more drug interactions with Zegen

Pregnancy Category (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 st not confirmed in controlled studies in women in the 1 trimester (and there is no evidence of a risk in later trimesters). Caution For Usage Inspect parenteral drug products visually for particulate matter and discoloration before administration whenever solution and container permit. Like other cephalosporins, cefuroxime powder, as well as solutions and suspensions, tend to darken, depending on storage conditions, without adversely affecting product potency. Compatibility and Stability: IM: When constituted as directed with sterile water for injection, suspensions of cefuroxime for IM injection maintain satisfactory potency for 24 hrs at room temperature and for 48 hrs under refrigeration (5C). Discard any unused suspension after periods stated. IV: When the 750 mg and 1.5 g vials are constituted as directed with sterile water for injection, solutions of cefuroxime for IV administration maintain a satisfactory potency for 24 hrs at room temperature and for 48 hrs under refrigeration (5C). More dilute solutions eg, 750 mg or 1.5 g plus 100 mL of sterile water for injection, 5% dextrose injection, or 0.9% sodium chloride injection, also maintain satisfactory potency for 24 hrs at room temperature or for 7 days under refrigeration (5C). These solutions may be further diluted to concentrations of between 1 and 30 mg/mL in the following solutions and will lose not more than 10% activity for 24 hrs at room temperature or for at least 7 days under refrigeration (5C): 0.9% sodium chloride injection, 1/6 M sodium lactate injection, USP Ringer's solution, USP Lactated Ringer's solution, 5% dextrose and 0.9% sodium chloride injection, 5% dextrose injection, 5% dextrose and 0.45% sodium chloride injection, 10% dextrose injection, 10% invert sugar in water for injection. Cefuroxime is also compatible for 24 hrs at room temperature when admixed with heparin (10 and 50 units/mL) in 0.9% sodium chloride injection and potassium chloride (10 and 40 mEq/L) in 0.9% sodium chloride injection. USP sodium bicarbonate injection is not recommended for dilution of cefuroxime. Tablet: Store in a cool, dry and dark place at temperatures not exceeding 25C. Powder for Injection: 750-mg Vial: Store at temperatures not exceeding 30C. 1.5-g Vial: Store at temperatures not exceeding 25C.

Storage

Mechanism of Action Pharmacology: Pharmacodynamics: Cefuroxime, a semisynthetic, broadspectrum 2nd generation cephalosporin antibiotic, has antibacterial activity similar to penicillins, carbacephems and cephamycins. It exerts its bactericidal activity by interfering with the synthesis of the bacterial cell wall. It binds to specific penicillinbinding proteins responsible for the synthesis of peptidoglycan, a heteropolymeric structure that gives the cell wall its mechanical stability. The final stage of the peptidoglycan synthesis involves the completion of the cross-linking of the terminal glycine residue of the pentaglycine bridge to the 4th residue of the pentapeptide. The transpeptidase that catalyzes this step is inhibited by cephalosphorins. Thus, inhibition of the transpeptidase interrupts peptidoglycan synthesis, causing formation of defective cell walls and osmotically unstable spheroplasts and lysis of the bacteria. Microbiology: Spectrum of Activity: Tablet: Cefuroxime has demonstrated activity against most strains of the following microorganisms both in vitro and in clinical

infections: Gram-Positive Aerobes: Staphylococcus aureus*,Streptococcus pneumoniae, Streptococcus pyogenes. Gram-Negative Aerobes: Escherichia coli, Haemophilus influenzae*,Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis*,Neisseria gonorrhoeae*. Spirochetes: Borrelia burgdorferi. Cefuroxime has also demonstrated in vitro activity against most strains of the following microorganisms, however, clinical significance is unknown: GramPositive Aerobes: Staphylococcus epidermidis, Staphylococcus saprophyticus,Streptococcus agalactiae. Gram-Negative Aerobes: Morganella morganii, Proteus inconstans, Proteus mirabilis, Providencia rettgeri. Spirochetes: Peptococcus niger. Listeria monocytogenes and certain strains of enterococci, eg Enterococcus faecalis (formerly Streptococcus faecalis), are resistant to cefuroxime. Methicillinresistant staphylococci are resistant to cefuroxime. Pseudomonas spp, Campylobacter spp, Acinetobacter calcoaceticus,Legionella spp, and most strains of Serratia spp and Proteus vulgaris are resistant to most 1st- and 2nd-generation cephalosphorins. Some strains ofMorganella morganii, Enterobacter cloacae and Citrobacter spp have been shown by in vitro tests to be resistant to cefuroxime and other cephalosphorins. Most strains of Clostridium difficile and Bacteroides fragilis are resistant to cefuroxime. Powder for Injection (Vial): Cefuroxime is active in vitro against the following organisms: Gram-Positive Aerobes: Staphylococcus aureus*, Staphylococcus epidermidis, Staphylococcus saprophyticus, Streptococcus agalactiae,Streptococcus pneumoniae, Streptococcus pyogenes (and other Streptococci). Gram-Negative Aerobes: Citrobacter sp, Enterobacter sp, Escherichia coli,Haemophilus influenzae*, Haemophilus parainfluenzae, Klebsiella sp (including Klebsiella pneumoniae), Moraxella catarrhalis*, Morganella morganii, Neisseria gonorrhoeae*, Neisseria meningitidis, Proteus mirabilis,Proteus inconstans, Providencia rettgeri, Salmonella sp, Shigella sp. Anaerobes: Gram-positive and gram-negative cocci (including Peptococcusand Peptostreptococcus sp), gram-positive bacilli (including Clostridium sp, gram-negative bacilli (including Bacteroides and Fusobacterium sp). Spirochetes: Borrelia burgdorferi. *Including -lactamase-producing strains. Pharmacokinetics: Tablet: The bioavailability of cefuroxime axetil after oral administration is variable and depends on the formulation used. The tablet/capsule formulations should not, therefore, be substituted with powder for oral suspension formulations on a mg/mg basis. The bioavailability of cefuroxime axetil is significantly increased from 37-52% by co-administration with food. Average peak serum cefuroxime concentrations of 4.1, 7 or 13.6 mcg/mL are attained approximately 2-3 hrs after oral administration in adults of a single 250 mg, 500 mg or 1 g dose, respectively. Average serum concentrations after 6 hrs are 0.7, 2.2 or 3.4 mcg/mL, respectively. The area under the curve (AUC) of the drug averaged 12.9, 27.4 or 50 mcghr/mL, respectively. Cefuroxime's apparent volume of distribution in healthy adults ranges from 9.32 15.8 L/1.73 m . The drug is 33-50% protein-bound. Cefuroxime readily crosses

the placenta and can also be detected in human milk. After oral administration of cefuroxime axetil, the drug undergoes rapid hydrolysis by nonspecific esterases in the intestinal mucosa and blood to yield the active parent drug cefuroxime, which is released into the systemic circulation. The axetil moiety of the drug is metabolized to acetaldehyde and acetic acid. Cefuroxime itself is not metabolized and its serum level is much closer to the minimum inhibitory concentration (MIC) of important pathogens than cefuroxime axetil. Cefuroxime is excreted unchanged primarily in the urine by both glomerular filtration and tubular secretion. In adults, the serum or plasma t after oral administration of cefuroxime axetil ranges from 1.2-1.6 hrs and about 50% of an administered dose is recovered in the urine within 12 hrs. In patients with renal impairment, the serum t of the drug is prolonged and generally ranges from 1.9-16.1 hrs depending on the degree of renal impairment. Powder for Injection (Vial): Following IM injection of a 750-mg dose of cefuroxime to normal volunteers, mean peak serum concentration was 27 mcg/mL at approximately 45 min. Following IV doses of 750 mg and 1.5 g, serum concentrations were approximately 50 mcg/mL and 100 mcg/mL, respectively, at 15 min, while the therapeutic serum concentrations of approximately 2 mcg/mL or more were maintained for 5.3 and 8 hrs or more, respectively. There was no evidence of cefuroxime accumulation in the serum following IV administration of 1.5-g doses every 8 hrs to normal volunteers. Serum t after either IM or IV injections is approximately 80 min. Approximately 89% of a dose of cefuroxime is excreted by the kidneys over an 8hr period, resulting in high urinary concentrations. Following IM administration of a 750-mg single dose, urinary concentrations averaged 1300 mcg/mL during the first 8 hrs. Intravenous doses of 750 mg and 1.5 g produced urinary levels averaging 1150 and 2500 mcg/mL, respectively, during the first 8 hrs. Cefuroxime is detectable in therapeutic concentrations in pleural and joint fluids, bile, sputum, bone, aqueous humor, and in the cerebrospinal fluid (CSF) of adults and pediatric patients with meningitis. It does not pass the blood-brain barrier in patients without inflamed meninges. Cefuroxime is approximately 50% bound to serum protein. MIMS Class ATC Classification Poison Schedule Cephalosporins J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections. Rx

Presentation/Packing Tab (film-coated, white to off-white, biconvex, capsule-shaped, with break line on one side) 250 mg x 100's. 500 mg x 60's. Powd for inj (vial) 750 mg x 1's. 1.5 g x 1's.

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