Cefuroxime & Potassium Clavulanate Tablets 625 mg, 312.5 mg , 156.25 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 625 mg, 312.5 mg , 156.25 mg

Reference Brands: -

Category: Antibiotics

Cefuroxime axetil with potassium clavulanate tablets in 625 mg, 312.5 mg and 156.25 mg totals, an oral cephalosporin combination for importers and distributors in markets where it is registered.

Product Description:

This tablet combines cefuroxime axetil, an oral second-generation cephalosporin, with potassium clavulanate, a beta-lactamase inhibitor. Cefuroxime binds penicillin-binding proteins and stops bacteria building cell walls; the axetil ester is absorbed and released as active cefuroxime. Clavulanic acid shields it from some beta-lactamases. The figures 625 mg, 312.5 mg and 156.25 mg are totals: 500, 250 or 125 mg cefuroxime with 125, 62.5 or 31.25 mg clavulanic acid. Major reference regulators approve cefuroxime axetil alone, not this pairing.

Where registered, it is prescribed for respiratory tract infections, sinusitis, otitis media, skin infections and uncomplicated urinary infections caused by susceptible organisms. Cefuroxime already resists many beta-lactamases, so the value of added clavulanate is debated. Tablets are taken twice daily after food, which improves absorption, and swallowed whole because crushed cefuroxime axetil tastes very bitter. Beta-lactam allergy must be checked. Diarrhoea is common and Clostridioides difficile infection can occur. Clavulanate is linked to cholestatic liver injury.

Sourcing notes. Confirm the combination and the strength you need are registered in your market. Clavulanate is very hygroscopic, so manufacture under low humidity and alu-alu blisters or desiccated packs are standard; ask for zone IVb stability data if you supply hot humid markets. Beta-lactams require segregated manufacturing, so ask how cross-contamination is controlled. Request a CTD or ACTD dossier, a CoA per batch with assay of both actives, water content and dissolution, the GMP certificate and a CoPP. It is prescription-only. Name the strength, pack size and label language in your enquiry.