Gentamicin Sulfate by is a Animal medication manufactured, distributed, or labeled by Akorn Animal Health, Inc., Akorn Operating Company LLC, Akorn, Inc. Drug facts, warnings, and ingredients follow.
Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group active against a wide variety of pathogenic gram-negative and gram-positive bacteria.
Gentamicin Sulfate Ophthalmic Solution is a sterile aqueous solution for use in the eye. Each mL contains: Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin base). Inactives: 2.9 mg Disodium Phosphate, 0.1 mg Monosodium Phosphate, and 7.40 mg Sodium Chloride. The pH range is from 6.8 to 7.3. Preservative: 0.1 mg Benzalkonium Chloride as preservative.
Gentamicin sulfate, a broad spectrum antibiotic, is a highly effective topical treatment in primary and secondary bacterial infections of the eye and surrounding tissues. Gentamicin is bactericidal in vitro against a wide variety of gram-positive and gram-negative bacteria. Concentrations of gentamicin sulfate required to inhibit growth of gram-positive and gram-negative clinical and laboratory strains of bacteria tested were less than those of neomycin in most instances.1,2 Gentamicin is active against most gram-negative bacteria including Pseudomonas aeruginosa, indole positive and negative Proteus species, Escherichia coli, Klebsiella sp. and Enterobacter sp. Gentamicin is also active against strains of gram-positive bacteria including Staphylococcus species and Streptococcus species.
Antibiotic susceptibility of infecting organisms should be determined prior to the use of these preparations. Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms such as fungi. Should this occur or if irritation or hypersensitivity to any component develops, discontinue use of the preparation and institute appropriate therapy.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Gentamicin Sulfate Ophthalmic Solution is supplied in a white low density polyethylene plastic squeeze bottle with a white controlled dropper tip and a white polypropylene cap in the following sizes:
NDC: 59399-101-05 5 mL; box of one
Store solution at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
Principal Display Panel Text for Container Label:
Caution: Federal law restricts this drug
to use by or on the order of a
ANADA 200-576, Approved by FDA
Sterile 5 mL
Principal Display Panel Text for Carton Label:
Akorn Animal Health Logo
Caution: Federal law restricts
this drug to use by or on the
order of a licensed veterinarian.
ANADA 200-576, Approved
gentamicin sulfate solution/ drops
|Labeler - Akorn Animal Health, Inc. (078876357)|
|Akorn, Inc||603980319||MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL|