Country: United States
Language: English
Source: NLM (National Library of Medicine)
CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U), HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)
Alcon Laboratories, Inc.
CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN 2 mg in 1 mL
AURICULAR (OTIC)
PRESCRIPTION DRUG
CIPRO® HC OTIC is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa , Staphylococcus aureus , and Proteus mirabilis . CIPRO® HC OTIC is contraindicated in persons with a history of hypersensitivity to hydrocortisone, ciprofloxacin or any member of the quinolone class of antimicrobial agents. This nonsterile product should not be used if the tympanic membrane is known or suspected to be perforated. Use of this product is contraindicated in viral infections of the external canal including varicella and herpes simplex infections. The safety and efficacy of CIPRO® HC OTIC have been established in pediatric patients 2 years and older (131 patients) in adequate and well-controlled clinical trials. Efficacy has been extrapolated for patients, age 1 year and above based on studies in adults and older pediatric patients.
CIPRO® HC OTIC is supplied as a white to off-white opaque suspension in a 10 mL bottle with a dropper dispenser. NDC 0065-8531-10 Store below 77° F (25° C). Avoid freezing. Protect from light. U.S. Pat.: www.alconpatents.com CIPRO is a registered trademark of Bayer Intellectual Property GmbH, licensed to Alcon by Bayer Intellectual Property AG. Distributed by: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 © 2006, 2009, 2016 Novartis T2017-38 March 2017
New Drug Application
CIPRO HC- CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE SUSPENSION ALCON LABORATORIES, INC. ---------- CIPRO® HC OTIC (CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE OTIC SUSPENSION) DESCRIPTION CIPRO® HC OTIC (ciprofloxacin hydrochloride and hydrocortisone otic suspension) contains the synthetic broad spectrum antibacterial agent, ciprofloxacin hydrochloride, combined with the anti-inflammatory corticosteroid, hydrocortisone, in a preserved, nonsterile suspension for otic use. Each mL of CIPRO® HC OTIC contains ciprofloxacin hydrochloride (equivalent to 2 mg ciprofloxacin), 10 mg hydrocortisone, and 9 mg benzyl alcohol as a preservative. The inactive ingredients are polyvinyl alcohol, sodium chloride, sodium acetate, glacial acetic acid, phospholipon 90H (modified lecithin), polysorbate, and purified water. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Ciprofloxacin, a fluoroquinolone, is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C H FN O •HCI•H O and its chemical structure is as follows: Hydrocortisone, pregn-4-ene-3, 20-dione, 11, 17, 21-trihydroxy-(11(β)-, is an anti- inflammatory corticosteroid. Its empirical formula is C H O and its chemical structure is: 17 18 3 3 2 21 30 5 CLINICAL PHARMACOLOGY The plasma concentrations of ciprofloxacin were not measured following three drops of otic suspension administration because the systemic exposure to ciprofloxacin is expected to be below the limit of quantitation of the assay (0.05 μg/mL). Similarly, the predicted C of hydrocortisone is within the range of endogenous hydrocortisone concentration (0-150 ng/mL), and therefore cannot be differentiated from the endogenous cortisol. Preclinical studies have shown that CIPRO® HC OTIC was not toxic to the guinea pig cochlea when administered intratympanically twice daily for 30 days and was only weakly irritating to rabbit skin upon repeated exposure. Hydrocort Read the complete document