Label: GENTAMICIN SULFATE solution/ drops

  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated March 29, 2024

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  • DESCRIPTION

    Gentamicin sulfate ophthalmic solution, USP is a sterile, aqueous solution buffered to approximately pH 7.0 and formulated for ophthalmic use.

    Each mL contains:

    Active:gentamicin sulfate, USP (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: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 vitroagainst 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.

    Repackaged By / Distributed By: RemedyRepack Inc.

    625 Kolter Drive, Indiana, PA 15701

    (724) 465-8762

    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 Incorporated at 1-800-553-5340 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 sterile in a white LDPE plastic bottle, with a white LLDPE extended controlled drop tip and white polypropylene cap in the following size:

    NDC: 70518-3785-00

    PACKAGING: 1 in 1 CARTON, 5 mL in 1 BOTTLE, DROPPER TYPE 0

    NOT FOR INJECTION INTO THE EYE

    FOR OPHTHALMIC USE ONLY

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

    KEEP OUT OF REACH OF CHILDREN.

    Repackaged and Distributed By:

    Remedy Repack, Inc.

    625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

  • PRINCIPAL DISPLAY PANEL

    DRUG: Gentamicin Sulfate

    GENERIC: Gentamicin Sulfate

    DOSAGE: SOLUTION/ DROPS

    ADMINSTRATION: OPHTHALMIC

    NDC: 70518-3785-0

    PACKAGING: 5 mL in 1 BOTTLE, DROPPER

    OUTER PACKAGING: 1 in 1 CARTON

    ACTIVE INGREDIENT(S):

    • GENTAMICIN SULFATE 3mg in 1mL

    INACTIVE INGREDIENT(S):

    • SODIUM CHLORIDE
    • SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
    • WATER
    • HYDROCHLORIC ACID
    • SODIUM HYDROXIDE
    • BENZALKONIUM CHLORIDE
    • SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM

    Remedy_Label

  • INGREDIENTS AND APPEARANCE
    GENTAMICIN SULFATE 
    gentamicin sulfate solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70518-3785(NDC:24208-580)
    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 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)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70518-3785-01 in 1 CARTON07/11/2023
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06404807/11/2023
    Labeler - REMEDYREPACK INC. (829572556)