Source: FDA, National Drug Code (US) Revision Year: 2020
CILOXAN (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 C17H18FN3O3•HCl•H2O 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 CILOXAN (ciprofloxacin ophthalmic solution) 0.3% contains:
Active: ciprofloxacin HCl 3.5 mg equivalent to 3 mg base.
Preservative: benzalkonium chloride 0.006%.
Inactives: sodium acetate, acetic acid, mannitol 4.6%, edetate disodium 0.05%, hydrochloric acid and/or sodium hydroxide (to adjust pH) and purified water. The pH is approximately 4.5 and the osmolality is approximately 300 mOsm.
| How Supplied |
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As a sterile ophthalmic solution in Alcon’s DROP-TAINER dispensing system consisting of a natural low density polyethylene bottle and dispensing plug and tan polypropylene closure. Tamper evidence is provided with a shrink band around the closure and neck area of the package. 5 mL in 8 mL bottle – NDC 0065-0656-05 Distributed by: ALCON LABORATORIES, INC., Fort Worth, Texas 76134 USA |
| Drug | Countries | |
|---|---|---|
| CILOXAN | Austria, Australia, Brazil, Canada, Cyprus, Estonia, France, Croatia, Ireland, Israel, Lithuania, Malta, New Zealand, Poland, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa |
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