Levofloxacin / Ornidazole Tablet 250mg + 500mg, 125mg + 250mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 250mg + 500mg, 125mg + 250mg

Reference Brands: -

Category: Gastrointestinal Drugs

Levofloxacin plus ornidazole film-coated tablets, a fluoroquinolone and nitroimidazole fixed-dose combination registered mainly in India and some other markets, for importers, distributors and hospital buyers.

Product Description:

These tablets pair levofloxacin, a fluoroquinolone antibiotic, with ornidazole, a nitroimidazole. Levofloxacin blocks bacterial DNA gyrase and topoisomerase IV, so bacteria cannot copy their DNA. Ornidazole is activated inside anaerobic bacteria and protozoa and damages their DNA, covering Bacteroides, Entamoeba histolytica, Giardia and Trichomonas. The page lists 250 mg + 500 mg and 125 mg + 250 mg film-coated tablets. This fixed-dose combination is registered mainly in India and some other markets, not in the US or EU.

It is prescribed for mixed infections that may involve aerobes plus anaerobes or protozoa, such as infective diarrhoea, dysentery and some gynaecological infections. Fluoroquinolones carry class warnings for tendon damage, neuropathy, psychiatric effects, QT prolongation and blood sugar disturbance, and major regulators reserve them for cases where alternatives are unsuitable. Antacids, iron, zinc and calcium bind levofloxacin, so doses are spaced apart. Ornidazole may cause dizziness and a metallic taste; alcohol should be avoided.

Sourcing notes. Check that the combination is approved in your market, since some regulators scrutinise antibiotic combinations on stewardship grounds. It is prescription-only. A CTD or ACTD dossier is usual, with dissolution and stability data for both actives. Levofloxacin is light-sensitive, so blisters need light and moisture protection, with zone IVb data for hot, humid destinations. Ask for a CoA per batch with assay, related substances and dissolution of each active, plus GMP and CoPP. Confirm whether the 125 mg + 250 mg strength exists as a tablet. Give strength, pack count and label language in the enquiry.