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

Drug Label Information

Updated October 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Gentamicin Sulfate Ophthalmic Solution
    Sterile
    ANADA 200-576, Approved by FDA
    Veterinary
    For Use in Dogs and Cats

  • DESCRIPTION:

    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.

  • CHEMISTRY:

    Gentamicin is an aminoglycoside antibiotic mixture derived from Micromonospora purpurea of the Actinomycetes group. It is a powder, white to buff in color, readily soluble in water, and heat stable.

  • ACTION:

    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.

  • INDICATIONS:

    Gentamicin Sulfate Ophthalmic Solution is indicated for topical treatment of conjunctivitis caused by susceptible bacteria in dogs and cats.

  • DOSAGE AND ADMINISTRATION:

    Gentamicin Sulfate Ophthalmic Solution-1 or 2 drops instilled into the conjunctival sac 2 to 4 times a day.

  • PRECAUTIONS:

    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.

  • HOW SUPPLIED:

    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].

  • REFERENCES:

    1. Weinstein MJ, Leudemann GM, Oden EM, Wagman GH. Gentamicin, a new broad spectrum antibiotic complex. Antimicrob Agents and Chemother. 1963:1-7.
    2. Black J, et al. Pharmacology of Gentamicin: a new broad spectrum antibiotic. Antimicrob Agents and Chemother. 1964:138-147.

    AKORN
    Animal Health
    Manufactured by: Akorn, Inc.
    Lake Forest, IL 60045
    VTGKO0N
    Rev. 07/16

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 59399-101-05

    Gentamicin Sulfate

    Ophthalmic Solution

    Veterinary

    Caution: Federal law restricts this drug

    to use by or on the order of a

    licensed veterinarian.

    ANADA 200-576, Approved by FDA

    Sterile 5 mL

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 59399-101-05

    Akorn Animal Health Logo

    Gentamicin

    Sulfate

    Ophthalmic

    Solution

    Veterinary

    Caution: Federal law restricts

    this drug to use by or on the

    order of a licensed veterinarian.

    ANADA 200-576, Approved

    by FDA

    Sterile

    5 mL

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    GENTAMICIN SULFATE 
    gentamicin sulfate solution/ drops
    Product Information
    Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:59399-101
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Gentamicin Sulfate (UNII: 8X7386QRLV) (Gentamicin - UNII:T6Z9V48IKG) Gentamicin3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59399-101-051 in 1 CARTON
    15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20057601/30/2015
    Labeler - Akorn Animal Health, Inc. (117696748)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc117696840MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL