Drug Catalog - Product Detail
GATIFLOXACIN OPHTHALMIC SOLUTION SOL 0.005 2.5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 50383-0189-02 | AKORN | 2 | 0.5% | SOLUTION |
PACKAGE FILES
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Description
11 DESCRIPTION Gatifloxacin sterile ophthalmic solution is an 8-methoxyfluoroquinolone anti-infective for the treatment of bacterial conjunctivitis. Its chemical name is (±)-1-Cyclopropyl-6-fluoro-1 ,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinolinecarboxylic acid, anhydrous. Its molecular formula is C 19 H 22 FN 3 O 4 and its molecular weight is 375.4. Its chemical structure is: Gatifloxacin ophthalmic solution, 0.5% is a clear, pale yellow, sterile, preserved aqueous solution with an osmolality of 260- 330 mOsm/kg and a pH of 5.1-5.7. Gatifloxacin ophthalmic solution, 0.5% contains Active: gatifloxacin 0.5% (5 mg/mL); Inactives: benzalkonium chloride 0.005%; edetate disodium; hydrochloric acid; purified water; and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH to approximately 6. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Gatifloxacin Ophthalmic Solution, 0.5% is supplied sterile in a white, low density polyethylene (LDPE) bottle with a controlled dropper tip, and a tan cap in the following sizes: 2.5 mL in 6 mL bottle Storage: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from freezing.
Indications & Usage
1 INDICATIONS AND USAGE Gatifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: • Aerobic gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus mitis group* Streptococcus oralis* Streptococcus pneumoniae • Aerobic gram-negative bacteria: Haemophilus influenzae *Efficacy for these organisms were studied in fewer than 10 infections. Gatifloxacin ophthalmic solution is a quinolone antimicrobial indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae (1)
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Day 1: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times. • Day 2 through Day 7: Instill one drop two to four times daily in the affected eye(s) while awake. Day 1: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Days 2 through 7: Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7. (2)