Ofloxacin Ear Drops 0.3% Suppliers & Bulk Manufacturers

Available Forms: Ear drops

Available Strengths: 0.3%

Reference Brands: Floxin Otic(US)

Category: ENT

Ofloxacin 0.3% ear drops, a sterile fluoroquinolone otic solution used for otitis externa and otitis media with a perforated eardrum. For importers, distributors, ENT clinics and hospital pharmacies.

Product Description:

Ofloxacin ear drops are a 0.3% (3 mg/mL) sterile solution of the fluoroquinolone for use in the ear canal. The drug acts on bacterial DNA gyrase and topoisomerase IV and covers the usual ear pathogens, including Pseudomonas aeruginosa and Staphylococcus aureus. Local use gives concentrations far above those from tablets, with very little reaching the bloodstream. Unlike aminoglycoside drops, ofloxacin is not regarded as ototoxic, so ENT specialists use it when the eardrum is perforated or grommets are in place.

Approved uses are otitis externa, chronic suppurative otitis media with a perforated eardrum, and acute otitis media in children with tympanostomy tubes, with age limits by indication. The bottle is warmed in the hand first, as cold drops can cause dizziness. The patient lies with the ear up for about five minutes; with a perforation, pressing the tragus helps the drops through. Courses usually last 7 to 14 days. Prolonged use can let fungi overgrow, and persistent discharge needs review.

Sourcing notes. Ofloxacin otic solution is prescription-only in most markets. Some registrations cover one 0.3% solution labelled for both eye and ear, while others register an ear-only product, so check which your market expects. Ask for a CTD or ACTD dossier with sterility, preservative efficacy and in-use stability data. LDPE dropper bottles of 5 mL or 10 mL are common, at room temperature and protected from light. Ask for a CoA with every lot, a GMP certificate for sterile liquids and a CoPP. Give bottle size, dropper type, label language and quantity.