SPL Set ID: 2f780550-ecbf-98fc-e063-6294a90a11c0

Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension USP, contains the quinolone antimicrobial, ciprofloxacin hydrochloride USP, combined with the corticosteroid, dexamethasone USP, in a sterile, preserved suspension for otic use. Each mL of ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension contains ciprofloxacin hydrochloride USP (equivalent to 3 mg ciprofloxacin base), 1 mg dexamethasone USP, and 0.1 mg benzalkonium chloride as a preservative. The inactive ingredients are acetic acid, boric acid, edetate disodium, hydroxyethyl cellulose, sodium acetate, sodium chloride, tyloxapol and water for injection. Sodium hydroxide or hydrochloric acid may be added for adjustment of pH. Ciprofloxacin, a quinolone antimicrobial is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline carboxylic acid. The empirical formula is C 17 H 18 FN 3 O 3 ·HCl·H 2 O. The molecular weight is 385.82 g/mol and the structural formula is: Figure 1: Structure of Ciprofloxacin Dexamethasone, 9-fluoro-11(beta),17,21-trihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione, is a corticosteroid. The empirical formula is C 22 H 29 FO 5 . The molecular weight is 392.46 g/mol and the structural formula is: Figure 2: Structure of Dexamethasone ciprostructure dexstructure