Drug Catalog - Product Detail
CIPROFLOXACIN HCL OPHTH. SOLUTION SOL 3.5MG/ML 2.5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 17478-0714-25 | AKORN | 2 | 0.3% | SOLUTION |
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Description
DESCRIPTION Ciprofloxacin Ophthalmic Solution, USP 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, USP contains: Active: Ciprofloxacin HCl, USP 3.5 mg equivalent to 3 mg 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 approximately 4.5 and the osmolality is approximately 300 mOsm. Chemical Structure
How Supplied
HOW SUPPLIED As a sterile ophthalmic solution: 2.5 mL, 5 mL and 10 mL in white opaque plastic dropper bottles. 2.5 mL - NDC 17478-714-25 5 mL - NDC 17478-714-10 10 mL - NDC 17478-714-11 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.
Indications & Usage
INDICATIONS AND USAGE Ciprofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below: Corneal Ulcers: Pseudomonas aeruginosa Serratia marcescens* Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus (Viridans Group)* Conjunctivitis: Haemophilus influenzae Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae *Efficacy for this organism was studied in fewer than 10 infections.
Dosage and Administration
DOSAGE AND ADMINISTRATION Corneal Ulcers The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first six hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill two drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred. Bacterial Conjunctivitis The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.