For the treatment of Otitis Externa… CETRAXAL is the first Food and Drug Administration (FDA) Ciprofloxacin single agent prescription ototopical antibiotic approved for the treatment of acute otitis externa in adults and children 1 year and older in the United States. CETRAXAL individual dosing vials make it easy for accurate dosing. CETRAXAL is preservative free, which minimizes the risk of ototoxicity.
IMPORTANT SAFETY INFORMATION
CETRAXAL® is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use. CETRAXAL® is contraindicated in persons with a history of hypersensitivity to ciprofloxacin. CETRAXAL® should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. As with other anti-infectives, use of CETRAXAL® may result in overgrowth of nonsusceptible organisms, including yeast and fungi. If super-infection occurs, discontinue use and institute alternative therapy. If the infection is not improved after one week of therapy, cultures may help guide further treatment. In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with CETRAXAL®. The most frequently reported adverse reactions were application site pain, ear pruritus, fungal ear superinfection, and headache,each reported in approximately 2-3% of patients.
To report SUSPECTED ADVERSE REACTIONS, contact WraSer Pharmaceuticals at 1-888-252-3901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
CETRAXAL® is a registered trademark of Laboratorios Salvat, S.A