Gatifloxacin Solution/ Drops label

Gatifloxacin Solution/ Drops

Gatifloxacin Solution/ Drops Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

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.

Uses

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:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus mitis
group*
Streptococcus oralis*
Streptococcus pneumoniae

Aerobic Gram-Negative Bacteria:
Haemophilus influenzae

*Efficacy for this organism was studied in fewer than 10 infections.

History

There is currently no drug history available for this drug.

Other Information

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:

Chemical Structure

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

  • Pacific Pharma
    Gatifloxacin Solution/ Drops | Pacific Pharma
    No Recall

    Gatifloxacin Solution/ Drops | Pacific Pharma

    Gatifloxacin Solution/ Drops | Pacific Pharma

    Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7.

  • Lupin Pharmaceuticals, Inc.
    Gatifloxacin Solution/ Drops | Lupin Pharmaceuticals, Inc.
    No Recall

    Gatifloxacin Solution/ Drops | Lupin Pharmaceuticals, Inc.

    Gatifloxacin Solution/ Drops | Lupin Pharmaceuticals, Inc.

    Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7.

  • Gatifloxacin Solution/ Drops | Hi-tech Pharmacal Co., Inc.
    No Recall

    Gatifloxacin Solution/ Drops | Hi-tech Pharmacal Co., Inc.

    Gatifloxacin Solution/ Drops | Hi-tech Pharmacal Co., Inc.

    Patients 1 year of age or older: Instill one drop every two hours in the affected eye(s) while awake, up to 8 times on Day 1. Instill one drop two to four times daily in the affected eye(s) while awake on Days 2 through 7.