CETRAXAL?
(ciprofloxacin otic solution) 0.2%
A single medicine with the power to soothe and the power to cure
Now Available
*
Unique dosing system
*
Eases pain
*
Eradicates pathogens
*
pH level of 4.5-5.0
*
Preservative-Free
First FDA approved single agent ciprofloxacin otic solution in the United States of America
CETRAXAL?
(ciprofloxacin otic solution) 0.2%
A single medicine with the power to soothe and the power to cure
Now Available
*
Unique dosing system
*
Eases pain
*
Eradicates pathogens
*
pH level of 4.5-5.0
*
Preservative-Free
First FDA approved single agent ciprofloxacin otic solution in the United States of America
For additional information on CETRAXAL please visit www.cetraxal.net
Rx Only
DOSAGE AND ADMINISTRATION
The contents of one single use container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.
CETRAXAL is a sterile, preservative-free, otic solution of ciprofloxacin hydrochloride equivalent to 0.2% ciprofloxacin (0.5 mg in 0.25 mL) in each single use container.
Pregnancy Category C
HOW SUPPLIED
14 single use containers are packaged in a foil overwrap pouch in a carton. Discard used containers. Store unused containers in pouch to protect from light.
NDC # 66992-450-14
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.
