Fluconazole Eye Drops 0.3% w/v Suppliers & Bulk Manufacturers

Available Forms: Drops

Available Strengths: 0.3% w/v

Reference Brands: Diflucan (US/EU)

Category: Anti-fungal

Fluconazole 0.3% w/v eye drops, a sterile ophthalmic antifungal solution used by eye specialists for fungal keratitis, for importers, distributors and hospital pharmacies where the product is registered.

Product Description:

Fluconazole is a triazole antifungal. It inhibits the fungal enzyme lanosterol 14-alpha-demethylase, blocking ergosterol synthesis and weakening the fungal cell membrane. This page covers fluconazole 0.3% w/v eye drops, a sterile ophthalmic solution usually preserved with benzalkonium chloride. Fluconazole is water soluble and penetrates the cornea, which makes a topical form workable. These drops are not authorised in every market, and some hospital pharmacies prepare an equivalent from the IV solution.

Eye specialists use topical fluconazole for fungal keratitis and other superficial fungal eye infections, chiefly those caused by yeasts such as Candida. Filamentous fungi often respond better to other agents, so treatment follows microscopy or culture where possible. Dosing is frequent at first, often hourly, then tapered by the specialist. Patients should not wear contact lenses during treatment, as benzalkonium chloride is absorbed by soft lenses. The dropper tip must not touch the eye. Deep infections usually need systemic therapy as well.

Sourcing notes. First check whether fluconazole eye drops hold a marketing authorisation in your country. Where they do, they are prescription-only and registered through a CTD or ACTD dossier. As a sterile product, ask for the sterilisation method, sterility results, preservative content and preservative efficacy data. Confirm pH, osmolality and the in-use shelf life after opening, often 28 days for multi-dose drops. Ask for zone IVb stability data for hot humid markets and the dropper bottle material. Request a batch CoA, a GMP certificate for sterile ophthalmic production and a CoPP. In your enquiry, state fill volume, pack and label language.