Gatifloxacin Solution/ Drops Recall
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Questions & Answers
Side Effects & Adverse Reactions
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Gatifloxacin ophthalmic solution 0.5% solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms:
Aerobic Gram-Positive Bacteria:
Streptococcus mitis group*
Aerobic Gram-Negative Bacteria:
*Efficacy for this organism was studied in fewer than 10 infections.
There is currently no drug history available for this drug.
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, sesquihydrate. Its molecular formula is C19H22FN3O4 · 1½H2O, and its molecular weight is 402.42. Its chemical structure is:
Gatifloxacin 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 contains Active: gatifloxacin 0.5% (5 mg/mL); Inactives: benzalkonium chloride 0.005%; edetate disodium; purified water; and sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Gatifloxacin Solution/ Drops Manufacturers
Lupin Pharmaceuticals, Inc.
Hi-tech Pharmacal Co., Inc.
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