Ciprofloxacin Otic

1 INDICATIONS AND USAGE Ciprofloxacin otic solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus . Ciprofloxacin otic solution, 0.2% is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus . ( 1 )

2 DOSAGE AND ADMINISTRATION The contents of one single-dose 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. Discard unused portion. Contents of one single-dose container should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days. ( 2 )

5 WARNINGS AND PRECAUTIONS Ciprofloxacin otic solution, 0.2% 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 ciprofloxacin otic solution, 0.2% may result in overgrowth of nonsusceptible organisms. ( 5.3 ) 5.1 Otic Use Only Ciprofloxacin otic solution, 0.2% is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use. 5.2 Hypersensitivity Ciprofloxacin otic solution, 0.2% should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. 5.3 Growth of Rsistant Organisms with Prolonged Use As with other anti-infectives, use of ciprofloxacin otic solution, 0.2% 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.

4 CONTRAINDICATIONS Ciprofloxacin otic solution, 0.2% is contraindicated in persons with a history of hypersensitivity to ciprofloxacin. History of hypersensitivity to ciprofloxacin. ( 3 )

8.1 Pregnancy Pregnancy Category C. Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed. Animal reproduction studies have not been conducted with ciprofloxacin otic solution, 0.2%. No adequate and well controlled studies have been performed in pregnant women. Caution should be exercised when ciprofloxacin otic solution, 0.2% is used by a pregnant woman.

8.3 Nursing Mothers Ciprofloxacin is excreted in human milk with systemic use. It is not known whether ciprofloxacin is excreted in human milk following otic use. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

6 ADVERSE REACTIONS 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 ciprofloxacin otic solution, 0.2%. 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 ciprofloxacin otic solution, 0.2% were application site pain, ear pruritus, fungal ear superinfection and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . ( 6 )