Each film-coated tablets contains: Cefuroxime axetil equivalent to Cefuroxime 250/500 mg.
Excipients/Inactive Ingredients: Microcrystalline cellulose, Croscarmellose sodium, Maize starch, Magnesium stearate, Talc, Hypromellose, Titanium dioxide, Isopropyl alcohol, Dichloromethane.
Pharmacology: Cefuroxime axetil is an oral prodrug of cefuroxime, cephalosporin antibiotic, second generation, for oral administration. The antibacterial activity of the drug results from inhibition of cell wall synthesis.
Cefuroxime has good stability to bacterial beta-lactamase, is active against a wide range of common pathogens; including beta-lactamase producing strains, ampicillin resistant or amoxicillin resistant strains.
In vitro, cefuroxime has broad spectrum: Haemophilus influenzae (including ampicillin resistant strains); Escherichia coli; Klebsiella spp; Haemophilus parainfluenzae; Branhamella catarrhalis; Providencia sp; Proteus mirabilis; Proteus rettgeri; Neisseria gonorrhoeae (including penicillinase producing strains); Staphylococcus aureus (including penicillinase producing strains but excluding methicillin resistant strains); Staphylococcus epidermidis; Streptococcus pyogenes; Streptococcus pneumoniae; Propionibacterium sp; Gram-positive and Gram-negative cocci.
After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the intestinal mucosa and blood to release cefuroxime into the circulation.
Optimum absorption occurs when it is administered following a meal. The drug is widely distributed into body tissues fluids, readily cross the placenta, distributed in low concentrations into milk. About 50% of cefuroxime bound to serum proteins. The plasma half-life is approximately 70 mins. Cefuroxime is not metabolised and is excreted by glomerular filtration and tubular secretion. Concurrent administration of probenecid increases the AUC by 50%. Serum levels of cefuroxime are reduced by dialysis.
Lower respiratory tract infections: pneumonia, bronchitis.
Upper respiratory tract infections: Otitis media, sinusitis, tonsillitis, pharyngitis.
Genitourinary tract infections: Pyelonephritis, cystitis and urethritis.
Skin and soft tissue infections: furunculosis, pyoderma, impetigo.
Gonorrhoea: acute uncomplicated gonococcal urethritis and cervicitis.
Adults: Bronchitis, pneumonia: 500 mg twice daily.
For most infections: 250 mg twice daily.
For urinary tract infections: 125 mg twice daily.
For the treatment of uncomplicated gonorrhoea: a single dose of 1 g.
Children: The usual recommended dosage: 125 mg twice daily; or 10 mg/kg twice daily, a maximum dosage of 250 mg/day.
In children 2 years or older with otitis media: 250 mg twice daily; or 15 mg/kg twice daily, a maximum dosage of 500 mg/day.
Patients with known allergy to the cephalosporin group of antibiotics.
Cefuroxime should be used with caution in the patients with anaphylactic reaction to penicillin, in the presence of markedly impaired renal function.
In individuals with a history of gastrointestinal disease, particularly colitis.
Cefuroxime should be used during pregnancy or lactation only if clearly needed.
The major adverse reactions observed in clinical trials of cefuroxime were mild and transient: nausea, vomiting, colitis.
Eosinophilia and transient increases of hepatic enzyme levels have been reported.
Probenecid inhibits tubular secretion of cefuroxime.
Keep in cool, dry place, tight containers.
Expiry date: 24 months.
J01DC02 - cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic treatment of infections.