Full Prescribing Info
Cefuroxime axetil.
Each film-coated tablet contains: Cefuroxime, USP 500 mg.
Each mL contains: Cefuroxime (as axetil) 125 mg/5 mL and 250 mg/5 mL.
Pharmacology: Pharmacokinetics: Cefuroxime axetil is absorbed from the gastrointestinal tract and is rapidly hydrolyzed in the intestinal mucosa and blood to cefuroxime. Absorption is enhanced in the presence of food. Peak plasma concentrations are reported about 2 to 3 hours after an oral dose. The sodium salt is given by intramuscular or intravenous injection. Peak plasma concentrations of about 27 mcg per mL have been achieved 45 minutes alter an intramuscular dose of 750 mg with measurable amounts present 8 hours after a dose. Up to 50% of cefuroxime in the circulation is bound to plasma proteins. The plasma half-life is about 70 minutes and is prolonged in patients with renal impairment and neonates.
Microbiology: Antimicrobial Action: Cefuroxime is bactericidal and has a similar spectrum of antimicrobial action and pattern of resistance to those of cefamandole. It is more resistant to hydrolysis by beta-lactamases than cefamandole, and therefore may be more active against beta-lactamase producing strains, Haemophilus influenzae and Neisseria gonorrhea. However, treatment failures have occurred in patients with H. influenzae meningitis given with cefuroxime and might be associated with a relatively high minimum bactericidal concentration when compared with the minimum inhibitory concentrations or with a significant inoculum effect. Reduced affinity of penicillin-binding proteins for cefuroxime has also been reported to be responsible for resistance in a beta-lactamase negative strain of H. influenzae.
Use in the treatment of susceptible infections including bone and joint infections, bronchitis, gonorrhea, otitis media, peritonitis, pharyngitis, sinusitis, skin and soft tissue infections, and urinary tract infections.
Dosage/Direction for Use
FC tablet: Usual oral dose for adults: 250 mg to 500 mg twice daily for respiratory tract infections or 250 mg daily for uncomplicated urinary tract infections or as prescribed by the physician.
Suspension: Children >2 year: Otitis Media: 250 mg twice daily or 15 mg/kg twice daily; >3 month: 125 mg twice daily or 10 mg/kg twice daily. Maximum: 250 mg daily.
Signs and symptoms: Overdosage of cephalosporins can cause cerebral irritation leading to convulsions.
Treatment: Serum levels of Cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
Patients with known hypersensitivity to cephalosporin antibiotics.
Special Precautions
Cefuroxime should not be given to patients who are hypersensitive to it or to other cephalosporin. About 20% of penicillin-sensitive patients may also be allergic to cephalosporins although the true incidence is uncertain; great care should be taken if cefuroxime is to be given to such patients. Care is also necessary in patients with a history of allergy.
FC tablet: Effects on ability to drive and use machines: As this medicine may cause dizziness, patients should be warned to be cautious when driving or operating machinery.
Use In Pregnancy & Lactation
FC tablet: There is no experimental evidence of embryopathic or teratogenic effects attributable to Cefuroxime but, as with all drugs, it should be administered with caution during the early months of pregnancy. Cefuroxime is excreted in human milk, and consequently caution should be exercised when Cefuroxime is administered to a nursing mother.
Adverse Reactions
The most common are hypersensitivity reactions, including skin rashes, urticaria, eosinophilia, fever, reactions resembling serum sickness, and anaphylaxis. There may be a positive response to the Coombs' test although haemolytic anaemia rarely occurs. Neutropenia and thrombocytopenia have occasionally been reported. Agranulocytosis has been associated rarely with some cephalosporins. Bleeding complications related to hypoprothrombinaemia and/or platelet dysfunctions have occurred especially with cephalosporins and cephamycins having a N-methylthiotetrazole side-chain, including cefamandole, and latamoxef. The presence of a methylthiadiazolethiol side-chain, as in cefazolin, or a N-methylthiotriazine ring, as ceftriaxone, might also be associated with such bleeding disorders.
ADR Reporting Statement: Seek medical attention immediately at the first sign of any adverse drug reaction.
Drug Interactions
Drugs which reduce gastric acidity may result in a lower bioavailability of Cefuroxime compared with that of the fasting state and tend to cancel the effect of enhanced post-prandial absorption. In common with other antibiotics, Cefuroxime may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral contraceptives. As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving Cefuroxime. This antibiotic does not interfere in the alkaline picrate assay for creatinine. Probenecid reduces the renal clearance of Cefuroxime.
Store at temperatures not exceeding 30°C.
MIMS Class
ATC Classification
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.
Rucef FC tab 500 mg
40's (P2,150/box)
Rucef granules for oral susp 125 mg/5 mL
50 mL x 1's (P307.65/bottle)
Rucef granules for oral susp 250 mg/5 mL
50 mL x 1's (P435.75/bottle)
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