Ciprofloxacin Otic 0.2% Suppliers & Bulk Manufacturers

Available Forms: Ear drops

Available Strengths: 0.2%

Reference Brands: Cetraxal (US)

Category: ENT

Ciprofloxacin 0.2% otic solution in single-dose containers, a fluoroquinolone ear drop for acute otitis externa in adults and children, for importers, distributors and hospital ENT buyers.

Product Description:

Ciprofloxacin 0.2% otic solution is a fluoroquinolone antibiotic made for the ear canal. Ciprofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, so bacteria cannot copy their DNA, and it covers the usual causes of outer ear infection, Pseudomonas aeruginosa and Staphylococcus aureus. Ear drops put a high concentration at the infection with very little absorbed into the blood. The reference product uses preservative-free single-dose containers, each holding one dose, which avoids contamination of a shared bottle.

It is used for acute otitis externa, often called swimmer's ear, in adults and children from one year of age. One container is instilled into the affected ear twice daily for seven days. Warming the container in the hand first avoids the dizziness cold drops can cause. The patient lies with the ear up for about a minute. This strength is not the product licensed for middle ear infection through tympanostomy tubes. Quinolone hypersensitivity is a contraindication. Prolonged use can allow fungal overgrowth.

Sourcing notes. Do not confuse this presentation with ciprofloxacin 0.3% eye drops or with ear drops that add a corticosteroid; specify otic use and strength. Expect a CTD or ACTD dossier with sterility assurance and container closure data, and stability for your climatic zone, including zone IVb for hot humid markets. Single-dose LDPE containers in protective pouches and cartons are typical; store at room temperature, away from light, with no cold chain. Ask for a CoA per batch with assay, pH, sterility and fill volume, the GMP certificate and a CoPP. It is prescription-only.