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CETRAXAL (ciprofloxacin otic solution) 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. CETRAXAL is a sterile, preservative-free solution for otic use. Each single use container of CETRAXAL delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH. Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C 17 H 18 FN 3 O 3 *HCl*H 2 O, and molecular weight is 385.82. The chemical structure of ciprofloxacin hydrochloride is: image description
CETRAXAL is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus. CETRAXAL is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus .
The contents of one single use container (deliverable volume: 0.25 mL) should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days. Wash hands before use. The solution should be warmed, by holding the container in the hands for at least 1 minute, to minimize the dizziness that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the solution should be instilled. This position should be maintained for at least 1 minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear. Contents of one single use container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.
CETRAXAL is contraindicated in persons with a history of hypersensitivity to ciprofloxacin. History of hypersensitivity to ciprofloxacin.
Because clinical studies are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. 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. The most common adverse reactions reported in 2-3% of patients treated with CETRAXAL were application site pain, ear pruritus, fungal ear superinfection and headache. To report SUSPECTED ADVERSE REACTIONS, contact WraSer Pharmaceuticals at 1-888-252-3901 or FDA at 1-800-FDA-1088 or www.fda.go/medwatch.
CETRAXAL is for otic use only. (5.1) Hypersensitivity: discontinue at the first appearance of a skin rash or any other sign of hypersensitivity. (5.2) Use of CETRAXAL may result in overgrowth of nonsusceptible organisms. (5.3) 5.1 Otic Use Only CETRAXAL is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use. 5.2 Hypersensitivity CETRAXAL should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. 5.3 Growth of Resistant Organisms with Prolonged Use 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. 5.4 Lack of Clinical Response If the infection is not improved after one week of therapy, cultures may help guide further treatment.