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Gentamicin Sulfate (Bausch & Lomb Incorporated)

Available Formats

Dosage Form Package Information Links
SOLUTION/ DROPS 1 BOTTLE, DROPPER in 1 CARTON (24208-580-60) > 5 mL in 1 BOTTLE, DROPPER Label Information
SOLUTION/ DROPS 1 BOTTLE, DROPPER in 1 CARTON (24208-580-64) > 15 mL in 1 BOTTLE, DROPPER Label Information

Complete Gentamicin Sulfate Information

  • SPL UNCLASSIFIED SECTION

    Rx only


  • DESCRIPTION

    Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered to approximately pH 7.0 and formulated for ophthalmic use.

    Each mL contains

    Active: Gentamicin Sulfate (equivalent to 3 mg gentamicin).

    Inactives: Dibasic Sodium Phosphate, Sodium Chloride, Monobasic Sodium Phosphate, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.5 - 7.5).

    Preservative Added: Benzalkonium Chloride 0.01%.

    Gentamicin is an aminoglycoside antibiotic obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of Gentamicin C1, C2, C1a and C2a. 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:

    Gentamicin Sulfate (structural formula)

  • 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.


  • INDICATIONS AND USAGE

    Gentamicin sulfate ophthalmic solution 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.


  • CONTRAINDICATIONS

    Gentamicin sulfate ophthalmic solution is contraindicated in patients with known hypersensitivity to any of its components.


  • WARNINGS

    NOT FOR INJECTION INTO THE EYE

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


  • 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.

    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

    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.


  • 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.

    To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


  • 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.


  • HOW SUPPLIED

    Gentamicin Sulfate Ophthalmic Solution, USP 0.3% is supplied in a plastic bottle with a controlled drop tip and a white polypropylene cap in the following sizes:

    NDC 24208-580-60 - 5 mL

    NDC 24208-580-64 - 15 mL


    NOT FOR INJECTION INTO THE EYE

    FOR OPHTHALMIC USE ONLY

    DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.


  • STORAGE AND HANDLING

    Storage: Store between 2°-25°C (36°-77°F). Avoid exposure to excessive heat.

    KEEP OUT OF REACH OF CHILDREN.

    Revised: August 2016

    Bausch + Lomb, a division of
    Valeant Pharmaceuticals North America LLC
    Bridgewater, NJ 08807 USA

    ©Bausch & Lomb Incorporated

    9116003 (Folded)
    9116103 (Flat)


  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

    15 mL carton

    NDC 24208-580-64

    Gentamicin
    Sulfate
    Ophthalmic
    Solution, USP
    0.3%
    (Sterile)

    FOR OPHTHALMIC USE ONLY

    Rx only

    15 mL

    BAUSCH + LOMB


  • INGREDIENTS AND APPEARANCE
    GENTAMICIN SULFATE 
    gentamicin sulfate solution/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24208-580
    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 (UNII: GR686LBA74)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    WATER (UNII: 059QF0KO0R)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:24208-580-60 1 in 1 CARTON 05/11/1994
    1 5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2 NDC:24208-580-64 1 in 1 CARTON 05/11/1994
    2 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA064048 05/11/1994
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 079587625 MANUFACTURE(24208-580)