Roxicef S125/Roxicef S250/Roxicef

Roxicef S125/Roxicef S250: Cefuroxime axetil.
Roxicef: Cefuroxime Na.

Roxicef S125/Roxicef S250: Granules for suspension: Each 5 mL (1 teaspoonful) reconstituted suspension contains: Cefuroxime (as axetil) 250 mg; Cefuroxime (as axetil) 125 mg.
Roxicef: Powd for inj: Each vial contains Cefuroxime sodium 750 mg.

Pharmacology: Roxicef S125/Roxicef S250: 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 influenza and Neisseria gonorrhea. However, treatment failures have occurred in patients with H. influenza meningitis given cefuroxime and might be associated with a relatively high minimum bactericidal concentration when compared with the minimum inhibitory concentration 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. influenza.
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 45minutes after 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 in neonates. Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid and aqueous humor, but only achieves therapeutic concentrations in the CSF when the meninges are inflamed. It crosses the placenta and has been detected in breastmilk.
Cefuroxime is excreted unchanged by glomerular filtration and renal tubular secretion, and high concentrations are achieved in the urine. On injection, most of the dose of a dose of cefuroxime is excreted within 24 hours, the majority within 6 hours probenecid competes for renal tubular secretion with cefuroxime resulting higher and more prolonged plasma concentrations of cefuroxime. Small amounts of cefuroxime are excreted in bile.

Used in the treatment of susceptible infections.
These have been included bone and joint infections, bronchitis, gonorrhea, meningitis (although treatment failures have been reported in H. influenza meningitis) otitis media, peritonitis, pharyngitis, sinusitis, skin infections (including soft-tissue infections), and urinary tract infections, it is also used for surgical infection prophylaxis.

Roxicef S125/Roxicef S250: Children more than 2 years of age with otitis media may be given 250mg twice daily or 15mg per kg twice daily to a maximum of 500mg daily or as prescribed by the physician.
Children more than 3 months of age-125mg twice daily or 10mg per kg body weight twice daily to a maximum of 250mg daily or as prescribed by the physician.
Direction for Reconstitution: To make 50mL reconstituted suspension, add approximately 25mL of water. Shake well until the granules are evenly suspended. The suspension is stable for one week at temperatures not exceeding 30°C and two weeks under refrigeration (2-8°C). Shake well before use.
Roxicef: Adult: 750 mg-1.5 g 6-8 hourly. Children: 75-150 mg/kg/day in divided doses.
Intramuscular injection: Add 3ml of water for injection to 750mg. Shake gently to produce a suspension.
Add 6ml of water for injection to 1.5g. Shake gently to produce a suspension.
Intravenous administration: Dissolve Cefuroxime in water for injection using at least 6ml for 750mg. Shake gently to produce a suspension.
Dissolve cefuroxime in water for injection using at least 15ml for 1.5g.

Hypersensitivity to any of the cephalosporins.

Roxicef S125/Roxicef S250: Cefuroxime should not be given to patients who are hypersensitive to it or to other cephalosporins. About 10% 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.
Roxicef: Penicillin-sensitive patients, gastrointestinal disease especially colitis. Monitor kidney function. Prolonged treatment. Pregnancy and lactation. Children below 3 months.

Roxicef S125/Roxicef S250: The most common are hypersensitivity reactions including skin rashes, urticarial, eosinophilia, fever, reactions resembling serum sickness and anaphylaxis.
There may be 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 dysfunction have been occurred especially with cephalosporins and cephamycins having a methylthiotetrazole side-chain, including cefamandole, cefbuperazone, cefmenoximem, cefmenoxime, cefmetazole, cefonicid, cefoperazone, ceforanide, cefotetan, cefpiramide and latamoxef. The presence of a methyliadiazolethiol side-chain, as in cefazolin or an N-methylthiotriazine ring, as in ceftriaxone, might also be associated with such bleeding disorders.
Gastrointestinal disturbances, including diarrhea, nausea and vomiting have occurred in some patients receiving cefuroxime axetil. There have been rare reports of erythema multiforme. Stevens-Johnson syndrome, and toxic epidermal necrolysis. Mild to moderate hearing loss has been reported in some children given cefuroxime for the treatment of meningitis.
Roxicef: Pain at intramuscular injection site, thrombophlebitis after intravenous administration. Pseudomembranous colitis, leukopenia, thrombocytopenia, positive Coombs' test. Hypersensitivity reactions eg, rash, urticaria and anaphylaxis.

Roxicef S125/Roxicef S250: Increased nephrotoxicity with probenecid, ethacrynic acid, furosemide, gentamycin and vancomycin. Disulfiram-like reaction with alcohol ingestion with cephalosporins with methyltetrazole-thiol (MTT) side chain; e.g. cefamandole, cefoperazone, moxalactam and cefotetan. High dose heparin, oral anticoagulants and other drugs that affect hemostasis. May increase the risk of hemorrhage with cephalosporins with MTT side chain.
Roxicef: Probenecid. Potent diuretics.

Store at temperatures not exceeding 30°C.

Cephalosporins

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

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