Label: GENTAMICIN SULFATE ointment

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

Drug Label Information

Updated October 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Ophthalmic Ointment USP, 0.3%

    STERILE

    Rx Only

  • DESCRIPTION:

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

    Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives.

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

    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 ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis, 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 ointment is contraindicated in patients with known hypersensitivity to any of the components.

  • WARNINGS:

    NOT FOR INJECTION INTO THE EYE.

    Gentamicin sulfate ophthalmic ointment 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.

    Ophthalmic ointments may retard corneal healing.

    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:

    Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.

  • HOW SUPPLIED:

    Gentamicin sulfate ophthalmic ointment USP, 0.3% is supplied in 3.5 g tube, box of one.

    (NDC 13985-603-03)

  • STORAGE:

    Store at 2° to 30°C (36° to 86°F).

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

    Distributed by: MWI
    Boise, ID 83705

    MWGK00N       Rev. 07/14

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    NDC 13985-603-03

    Gentamicin Sulfate STERILE

    Ophthalmic Ointment USP, 0.3% Rx Only

    (equivalent to 3 mg gentamicin per gram)

    Apexa logo

    AP 704005 Net Weight: 3.5g (1/8 oz)

    Principal Display Panel Text for Container Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    NDC 13985-603-03

    Gentamicin

    Sulfate

    Ophthalmic

    Ointment

    USP, 0.3%

    (equivalent to

    3 mg gentamicin

    per gram)

    STERILE

    Rx Only

    Apexa logo

    AP 704005

    Net Weight: 3.5g (1/8 oz)

    Principal Display Panel Text for Carton Label
  • INGREDIENTS AND APPEARANCE
    GENTAMICIN SULFATE 
    gentamicin sulfate ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:13985-603
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Gentamicin Sulfate (UNII: 8X7386QRLV) (Gentamicin - UNII:T6Z9V48IKG) Gentamicin3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Methylparaben (UNII: A2I8C7HI9T) 0.5 mg  in 1 g
    Propylparaben (UNII: Z8IX2SC1OH) 0.1 mg  in 1 g
    Petrolatum (UNII: 4T6H12BN9U)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13985-603-031 in 1 CARTON03/23/2015
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06416303/23/2015
    Labeler - MWI (019926120)
    Registrant - Akorn Operating Company LLC (117693100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Akorn, Inc117696840MANUFACTURE(13985-603) , ANALYSIS(13985-603) , STERILIZE(13985-603) , PACK(13985-603) , LABEL(13985-603)