Cetraxal - Ciprofloxacin solution/ Drops
(Ciprofloxacin)Cetraxal - Ciprofloxacin solution/ Drops Prescribing Information
CETRAXAL is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of
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.
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.
CETRAXAL is contraindicated in persons with a 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.
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
17H
18FN
3O
3•HCl•H
2O, and molecular weight is 385.82.
The chemical structure of ciprofloxacin hydrochloride is:
