SPL Set ID: 74af98f1-eb6d-473b-94a9-67920dba8c3d

Ciprofloxacin ophthalmic solution is a synthetic, sterile, multiple dose, antimicrobial for topical ophthalmic use. Ciprofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of gram-positive and gram-negative ocular pathogens. It is available as the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinoline-carboxylic acid. It is a faint to light yellow crystalline powder with a molecular weight of 385.8. Its empirical formula is C 17 H 18 FN 3 O 3 •HCL•H 2 O and its chemical structure is as follows: Ciprofloxacin differs from other quinolones in that it has a fluorine atom at the 6-position, a piperazine moiety at the 7-position, and a cyclopropyl ring at the 1-position. Each mL of ciprofloxacin ophthalmic solution contains: Active: Ciprofloxacin hydrochloride 3.5 mg equivalent to 3mg base. Preservative: Benzalkonium chloride 0.006%. Inactives: Acetic acid, edetate disodium 0.05%, mannitol 4.6%, Sodium acetate, hydrochloric acid and/or sodium hydroxide (to adjust pH) and water for injection. The pH is between 3.5 to 5.5 and the osmolality is between 290 to 300 mOsms/kg. Ciprofloxacin Structure