Zicef

Each vial contains: Cefuroxime sodium, Equivalent to Cefuroxime 750 mg.

Pharmacology: Pharmacokinetics: The serum half-life after either intramuscular or intravenous administration is approximately 70 minutes. After intramuscular injection the peak serum level occurs after about 45 minutes. The antibiotic can be found in bone, synovial fluid and aqueous humour above the minimum inhibitory levels for common pathogens. The blood-brain barrier can be passed by cefuroxime when the meninges are inflamed. Cefuroxime is excreted approximately 50% by glomerular filtration and 50% through the renal tubules. Cefuroxime is almost completely recovered unchanged in the urine within 24 hours, most being excreted within six hours.

Cefuroxime is used in the treatment of susceptible infections. These have included bone and joint infections, bronchitis (and other lower respiratory-tract Infections), gonorrhoea, meningitis (although treatment failures have been reported in H. influenzae meningitis), otitis media, peritonitis, pharyngitis, sinusitis, skin infections (including soft-tissue infections), and urinary tract infections. It is also used for surgical infection prophylaxis.

Cefuroxime sodium may be given by deep intramuscular injection, by slow intravenous injection over 3 to 5 minutes, or by intravenous infusion.
Adult dose: By injection the usual dose is 750 mg of cefuroxime every 8 hours but in more severe infections 1.5 g may be given intravenously every 8, or in some cases every 6 hours.
Infants and children: It can be given 30 to 60 mg/kg daily, increased to 100 mg/kg daily if necessary, given in 3 or 4 divided doses. Neonates may be given similar total daily doses but in 2 or 3 divided doses.
Adults with pneumonia or with acute exacerbations of chronic bronchitis: May respond to sequential therapy with parenteral cefuroxime 1.5 g twice daily or 750 mg twice daily respectively, followed by oral cefuroxime 500 mg twice daily in each case.
For the treatment of meningitis due to sensitive strains of bacteria: Cefuroxime is given intravenously in adult doses of 3 g every 8 hours. Infants and children are given 200 to 240 mg/kg daily intravenously in 3 or 4 divided doses, which may be decreased to 100 mg/kg daily after 3 days or when there is clinical improvement. For neonates, a dose of 100 mg/kg daily, decreased to 50 mg/kg daily when indicated, may be used.
In the treatment of gonorrhea: A single dose of 1.5 g by intramuscular injection, divided between 2 injection sites, has been used.
For surgical infection prophylaxis: The usual dose is 1.5 g of cefuroxime intravenously before the procedure; this may be supplemented by 750 mg intramuscularly every 8 hours for up to 24 to 48 hours depending upon the procedure.
Administration in renal impairment: Parenteral doses of cefuroxime may need to be reduced in renal impairment. Licensed product information suggests the following doses based on creatinine clearance (CC): CC 10 to 20 mL/minute: 750 mg twice daily; CC less than 10 mL/minute: 750 mg once daily.
Patients undergoing haemodialysis should receive an additional 750-mg dose following each dialysis; those undergoing continuous peritoneal dialysis may be given 750 mg twice daily.

Overdosage of cephalosporins can lead to cerebral irritation and seizures. With seizures the drug should be discontinued and appropriate anticonvulsive and supportive therapy administered. Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.

Contraindicated in patients hypersensitive to the Cephalosporin group of antibiotics.

Before cefuroxime sodium for injection therapy is started, careful inquiry should be made concerning previous hypersensitivity reactions to cephalosporins, penicillins or other medicines. Cefuroxime should be given cautiously to penicillin-sensitive patients. Care should be taken with patients who have experienced an anaphylactic reaction to penicillin.
Cefuroxime does not interfere with enzyme-based tests for glucosuria. Slight interference with copper reduction methods (Benedict's, Fehling's, Clinitest) have been observed. However this should not lead to false-positive results. It is recommended that either the glucose oxidase or hexokinase methods be used to determine blood/plasma glucose levels in patients treated with cefuroxime. In the ferricyanide test, cefuroxime may cause false-negative reactions. Some cephalosporins can cause a falsely high reading in the alkaline picrate assay for creatinine, although the degree of elevation is unlikely to be of clinical importance. It is possible that cefuroxime may also interfere with this determination. Prolonged use may result in the growth of non-susceptible organisms. Patients developing frequent loose stools should be carefully monitored for the possible development of pseudomembranous colitis.
When possible, concomitant use of furosemide and cefuroxime should be avoided. If used together renal function should be monitored closely, since furosemide may enhance the nephrotoxic potential of the cephalosporins.
The combined use of cephalosporins and aminoglycosides seems to increase the risk of nephrotoxicity, and should be undertaken with caution and with close monitoring of renal function.

Hypersensitivity reactions: Including skin rashes (maculopapular and urticarial), interstitial nephritis, drug fever and, very rarely, anaphylaxis. As with any antibiotic, prolonged use may lead to overgrowth of nonsusceptible organisms, eg, Candida. As with other cephalosporins, there have been rare reports of erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis.
Gastro-intestinal disturbance: Including, very rarely, pseudomembranous colitis, which has been reported with most broad spectrum antibiotics.
Hematological: A decrease in hemoglobin concentration, eosinophilia, leucopenia and neutropenia has been observed. Positive Coombs' tests have been reported. As with other cephalosporins, thrombocytopenia has been reported rarely.
Hepatic: Transient rises in liver enzymes or serum bilirubin have been observed, particularly in patients with pre-existing liver disease, but there is no evidence of hepatic involvement.
Renal: There may be some variation in the results of biochemical tests of renal function, but these results do not appear to be of clinical significance.
Other: Transient pain may be experienced at the site of intramuscular injection. Occasionally thrombophlebitis may occur at the site of intravenous injection. A burning sensation may be observed after intravenous injection. Mild to moderate hearing loss has been reported in some children treated for meningitis. Dizziness and headache has been reported in patients receiving cefuroxime.

Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with potent diuretics such as furosemide, aminoglycosides and amphotericin as concomitant use increases the risk of nephrotoxicity. Renal function should be monitored in these patients.
Concomitant therapy with probenecid can reduce the renal excretion of cephalosporins. Plasma concentrations are enhanced if probenecid is given concomitantly.
Since bacteriostatic drugs may interfere with the bactericidal action of cephalosporins, it is advisable to avoid giving tetracyclines, macrolides, or chloramphenicol in conjunction with cefuroxime. Urine sugar tests using reduction methods may show false positive reactions, therefore enzymatic methods should be used. Cefuroxime sodium does not interfere in enzyme-based tests for glycosuria. Slight interference with copper reduction methods (Benedict's, Fehling's, Clinitest) may be observed. However, this should not lead to false positive results, as may be experienced with some other cephalosporins.
During intravenous administration admixture with other medications in solution should be avoided. Sodium bicarbonate is not recommended for the dilution of cefuroxime.

Direction for Reconstitution: Intramuscular Injection: Add 3 mL sterile water for injection to the vial of cefuroxime sodium powder for injection 750 mg. Shake gently to produce an opaque suspension.
Intravenous injection: Dissolve cefuroxime sodium powder for injection 750 mg using at least 6 mL sterile water for injection. Shake gently to produce a clear solution. The reconstituted solution is clear. Solution which appears turbid must be discarded.

Store at temperatures not exceeding 30°C.
Reconstituted Solution: Reconstituted solution stored at temperatures between 2°C to 8°C can be used within 24 hours. If stored at temperatures below 25°C, it can be used within 6 hours.

Cephalosporins

J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.

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