Label: GENTAMICIN SULFATE- gentamicin sulfate solution/ drops 

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

Drug Label Information

Updated 08/13

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  • DESCRIPTION

    Gentamicin sulfate ophthalmic solution, USP is a sterile, topical anti-infective agent for ophthalmic use.

    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 activity. Gentamicin sulfate occurs as a white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:

    Structural Formula

    Each mL contains: Active: gentamicin sulfate equivalent to 3 mg (0.3%) gentamicin base. Preservative: benzalkonium chloride. Inactives: edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; and hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The solution is an aqueous, buffered solution with a shelf life pH range of 6.5 to 7.5.

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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 solution, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, 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 solution, USP is contraindicated in patients with known hypersensitivity to any of its components.

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  • WARNINGS

    NOT FOR INJECTION INTO THE EYE.

    Gentamicin sulfate ophthalmic solution, USP 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 microorganisms, 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.

    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

    Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.

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  • HOW SUPPLIED

    Gentamicin sulfate ophthalmic solution, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with white high impact polystyrene (HIPS) caps as follows:

     
               5 mL in 10 mL bottle – NDC 60758-188-05

    Storage: Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above).

    Revised: 08/2013

    © 2013 Allergan, Inc.
    Irvine, CA 92612, U.S.A.
    ® mark owned by Allergan, Inc.
    Made in the U.S.A.

    Logo
    71759PY11

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  • PRINCIPAL DISPLAY PANEL

    PACIFIC
    PHARMA®

    NDC 60758-188-05

    GENTAMICIN
    SULFATE
    ophthalmic
    solution, USP
    0.3%

    5 mL

    sterile

    Rx only

    Package Label
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  • INGREDIENTS AND APPEARANCE
    GENTAMICIN SULFATE 
    gentamicin sulfate solution/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60758-188
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    gentamicin sulfate (gentamicin) gentamicin 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    edetate disodium  
    polyvinyl alcohol  
    water  
    sodium chloride  
    sodium phosphate, dibasic  
    benzalkonium chloride  
    hydrochloric acid  
    sodium hydroxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:60758-188-05 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
    ANDA ANDA062452 01/05/1998
    Labeler - Pacific Pharma, Inc. (877645267)
    Establishment
    Name Address ID/FEI Business Operations
    Allergan, Inc. 362898611 MANUFACTURE(60758-188)
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