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Gentamicin Sulfate (Falcon Pharmaceuticals, Ltd.)

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SOLUTION 5 mL in 1 BOTTLE, PLASTIC (61314-633-05) Label Information

Complete Gentamicin Sulfate Information

  • DESCRIPTION

    Gentamicin Sulfate is a water-soluble antibiotic of the aminoglycoside group. Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered to approximately pH 7 for ophthalmic use. Gentamicin is obtained from cultures of Micromonosporapurpurea. 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 white powder and is soluble in water and insoluble in alcohol. The structure is as follows:

     chemical

    Established name: Gentamicin Sulfate

    Chemical name: 0-3-Deoxy-4-C-methyl-3-(methylamino)-β-L-arabinopyranosyl-(1→6)-0-[2,6-diamino-2,3,4,6-tetradeoxy-α-D-erythro-hexopyranosyl-(1→4)]-2-deoxy-D-streptamine.

    Ingredients: Each mL contains: Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin). Preservative: Benzalkonium Chloride 0.1 mg (0.01%). Inactives: Sodium Chloride, Dried Sodium Phosphate, Tyloxapol, Sodium Hydroxide and/or Hydrochloric Acid (to adjust pH) and Purified Water.                        


  • CLINICAL PHARMACOLOGY

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

    Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacteraerogenes, Escherichia coli, Haemophilusinfluenzae, Klebsiellapneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratiamarcescens.


  • 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, Enterobacteraerogenes, Escherichia coli, Haemophilusinfluenzae, Klebsiellapneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratiamarcescens.


  • CONTRAINDICATIONS

    Gentamicin Sulfate Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of the 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 non-susceptible 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

    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.


  • 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.


  • 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 once every hour.


  • HOW SUPPLIED

    Gentamicin Sulfate Ophthalmic Solution: 5 mL in plastic DROP-TAINER* dispenser. NDC 61314-633-05

    STORAGE: Protect from light and store away from heat. Store at controlled room temperature 15°-30°C (59°-86°F).

    To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    *DROP-TAINER is a registered trademark of Alcon Research, Ltd.

    Rx Only


  • SPL UNCLASSIFIED SECTION

    9007184-1011

    Manufactured By

    Alcon Laboratories, Inc.

    Fort Worth, Texas 76134 for

    Sandoz Inc.,

    Princeton, NJ 08540

    Rev. June 2012


  • PRINCIPAL DISPLAY PANEL

    NDC 61314-633-05         

    Gentamicin Sulfate Ophthalmic Solution USP

    Equivalent to 3 mg Gentamicin per mL

    5 mL

    Carton

  • INGREDIENTS AND APPEARANCE
    GENTAMICIN SULFATE 
    gentamicin sulfate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61314-633
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    TYLOXAPOL (UNII: Y27PUL9H56)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61314-633-05 5 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA062196 04/05/1996
    Labeler - Sandoz Inc (005387188)