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Gentamicin Sulfate (Akorn, Inc.)

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SOLUTION/ DROPS 1 BOTTLE, DROPPER in 1 CARTON (17478-283-10) > 5 mL in 1 BOTTLE, DROPPER Label Information

Complete Gentamicin Sulfate Information

  • SPL UNCLASSIFIED SECTION

    Sterile

    Rx only


  • DESCRIPTION

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

    Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution for ophthalmic use.

    Each mL contains:
    Active: Gentamicin Sulfate USP (equivalent to 3 mg gentamicin base)
    Preservative: Benzalkonium Chloride
    Inactives: Disodium Phosphate, Monosodium Phosphate, and Sodium Chloride. The pH range is from 6.8 to 7.3.

    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 powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:

    Chemical Structure

  • 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 Sterile 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 Sterile 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 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

    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

    Gentamicin Sulfate sterile ophthalmic solution; 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 - Sterile, 5-mL plastic dropper bottle, box of one. (NDC 17478-283-10)

    STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

    Avoid exposure to excessive heat.


  • SPL UNCLASSIFIED SECTION

    Akorn

    Manufactured by: Akorn, Inc.
    Lake Forest, IL 60045

    GK00N

    Rev. 06/16


  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 17478-283-10

    Gentamicin

    Sulfate Ophthalmic

    Solution, USP

    0.3%

    (equivalent to 3 mg

    gentamicin per mL)

    Sterile

    Rx only 5 mL

    Principal Display Panel Text for Container Label

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 17478-283-10

    Gentamicin

    Sulfate

    Ophthalmic

    Solution, USP

    0.3%

    (equivalent to 3 mg

    gentamicin per mL)

    5 mL

    Sterile

    Rx only Akorn Logo

    Principal Display Panel Text for Carton Label

  • INGREDIENTS AND APPEARANCE
    GENTAMICIN SULFATE 
    gentamicin sulfate solution/ drops
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-283
    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, Anhydrous (UNII: 22ADO53M6F)  
    Sodium Phosphate, Monobasic (UNII: 3980JIH2SW)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17478-283-10 1 in 1 CARTON 12/13/2006
    1 5 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 ANDA064163 12/13/2006
    Labeler - Akorn, Inc. (062649876)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc. 603980319 MANUFACTURE(17478-283) , ANALYSIS(17478-283) , STERILIZE(17478-283) , PACK(17478-283) , LABEL(17478-283)