Drug Catalog - Product Detail
GATIFLOXACIN OPHTHALMIC SOLUTION SOL 0.005 2.5ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68180-0435-01 | LUPIN PHARMACEUTICALS | 2 | 0.5% | SOLUTION |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
11 DESCRIPTION Gatifloxacin ophthalmic solution, 0.5% is a quinolone antimicrobial topical ophthalmic solution for the treatment of bacterial conjunctivitis. Its chemical name is (±) 1-Cyclopropyl-6-fluoro-8- methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid. Its molecular formula is C 19 H 22 FN 3 O 4 and its molecular weight is 375.40. Its chemical structure is: Gatifloxacin ophthalmic solution, 0.5% is a pale yellow colored transparent, sterile, liquid with an osmolality of 260 to 330 mOsm/kg and a pH of 5.1 to 5.7. Gatifloxacin ophthalmic solution, 0.5% contains the active ingredient gatifloxacin 0.5% (5 mg/mL) and the inactive ingredients benzalkonium chloride 0.005%, edetate disodium, sodium chloride and water for injection. Gatifloxacin ophthalmic solution, 0.5% may contain hydrochloric acid and/or sodium hydroxide to adjust pH. Gatifloxacin
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Gatifloxacin Ophthalmic Solution, 0.5% is supplied sterile in a 5 mL white, low density polyethylene (LDPE) bottle fitted with a white low density polyethylene (LDPE) nozzle and sealed with a tan colored high density polyethylene (HDPE) cap in the following size: 2.5 mL in 5 mL bottle: NDC 68180-435-01 Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Protect from freezing.
Indications & Usage
1 INDICATIONS AND USAGE Gatifloxacin ophthalmic solution, 0.5% 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 ) Gatifloxacin ophthalmic solution, 0.5% 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.
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 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 ) 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.