Label: GENTAMICIN SULFATE solution/ drops

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

Drug Label Information

Updated January 24, 2019

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  • 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

    Product: 50090-0568

    NDC: 50090-0568-0 5 mL in a BOTTLE, DROPPER / 1 in a CARTON

  • SPL UNCLASSIFIED SECTION

    Akorn

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

    GK00N

    Rev. 06/16

  • Gentamicin Sulfate

    Label Image
  • INGREDIENTS AND APPEARANCE
    GENTAMICIN SULFATE 
    gentamicin sulfate solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50090-0568(NDC:17478-283)
    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 Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-0568-01 in 1 CARTON11/28/2014
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06416312/13/2006
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0568)