Label: GENTAK- gentamicin sulfate ointment

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 03/12

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  • SPL UNCLASSIFIED SECTION

    Sterile

    Rx only

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  • DESCRIPTION

    GENTAK® Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group.

    Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives.

    Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C1 C2, and C1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:

    Figure
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  • CLINICAL PHARMACOLOGY

    Microbiology: Gentamicin sulfate is active in vitro against many strains of the following microorganisms:

     
    Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
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  • INDICATIONS AND USAGE

    Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms:

     
    Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
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  • CONTRAINDICATIONS

    Gentamicin sulfate ophthalmic ointment is con-traindicated in patients with known hypersensitivity to any of the components.

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  • WARNINGS

    NOT FOR INJECTION INTO THE EYE.

    Gentamicin sulfate ophthalmic ointment is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

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  • PRECAUTIONS

    General: Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

    If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted.

    Ophthalmic ointments may retard corneal healing.

    Information for patients: To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.

    Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.

    Pregnancy: Pregnancy Category C. Gentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Pediatric Use: Safety and effectiveness in neonates have not been established.

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  • ADVERSE REACTIONS

    Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations.

    The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.

    Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.

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  • DOSAGE AND ADMINISTRATION

    Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.

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  • HOW SUPPLIED

    GENTAK® Gentamicin sulfate ophthalmic ointment USP, 0.3% is supplied in 3.5 g tube, box of one.

    (NDC 17478-284-35)

    STORAGE: Store at 2° to 30°C (36° to 86°F).

    Akorn
    Manufactured by: Akorn, Inc.
    Lake Forest, IL 60045
    GKO00N Rev. 09/08

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-284-35 Akorn Logo

    Gentak®

    brand of Gentamicin Sulfate

    Ophthalmic Ointment USP, 0.3%

    (equivalent to 3 mg gentamicin per gram)

    Net Wt 3.5 g (1/8 oz) Sterile

    Rx only

    Principal Display Panel Text for Container Label
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    3.5 g NDC 17478-284-35

    Gentak®

    Brand of Gentamicin Sulfate Ophthalmic Ointment USP, 0.3%

    (equivalent to 3 mg gentamicin per gram)

    Net Wt 3.5 g (1/8 oz) Sterile Rx only Akorn Logo

    Principal Display Panel Text for Carton Label
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  • INGREDIENTS AND APPEARANCE
    GENTAK 
    gentamicin sulfate ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-284
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Gentamicin Sulfate (Gentamicin) Gentamicin Sulfate 3 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    Gentamicin Sulfate  
    Methylparaben 0.5 mg  in 1 g
    Propylparaben 0.1 mg  in 1 g
    Petrolatum  
    Mineral Oil  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17478-284-35 1 in 1 CARTON
    1 3.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA064093 05/08/2006
    Labeler - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc. 603980319 MANUFACTURE(17478-284), ANALYSIS(17478-284), STERILIZE(17478-284), PACK(17478-284), LABEL(17478-284)
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