Label: GENTAMICIN SULFATE solution/ drops
- NDC Code(s): 59399-101-05
- Packager: Akorn Animal Health, Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated October 8, 2020
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- SPL UNCLASSIFIED SECTION
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.
- DOSAGE AND ADMINISTRATION:
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].
- Weinstein MJ, Leudemann GM, Oden EM, Wagman GH. Gentamicin, a new broad spectrum antibiotic complex. Antimicrob Agents and Chemother. 1963:1-7.
- Black J, et al. Pharmacology of Gentamicin: a new broad spectrum antibiotic. Antimicrob Agents and Chemother. 1964:138-147.
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
gentamicin sulfate solution/ drops
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:59399-101 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Gentamicin Sulfate (UNII: 8X7386QRLV) (Gentamicin - UNII:T6Z9V48IKG) Gentamicin 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F) Sodium Phosphate, Monobasic (UNII: 3980JIH2SW) Sodium Chloride (UNII: 451W47IQ8X) Benzalkonium Chloride (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59399-101-05 1 in 1 CARTON 1 5 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200576 01/30/2015 Labeler - Akorn Animal Health, Inc. (117696748) Registrant - Akorn Operating Company LLC (117693100) Establishment Name Address ID/FEI Business Operations Akorn, Inc 117696840 MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL