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  5. Label Information: Gentak

FDA Label for Gentak

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. DESCRIPTION
    3. MICROBIOLOGY
    4. INDICATIONS AND USAGE
    5. CONTRAINDICATIONS
    6. WARNINGS
    7. GENERAL PRECAUTIONS
    8. INFORMATION FOR PATIENTS
    9. CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
    10. PREGNANCY
    11. PEDIATRIC USE
    12. ADVERSE REACTIONS
    13. DOSAGE AND ADMINISTRATION
    14. HOW SUPPLIED
    15. STORAGE AND HANDLING
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gentak Product Label

The following document was submitted to the FDA by the labeler of this product Akorn. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Sterile

Rx only


Description



GENTAK® 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:


Microbiology



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 con-traindicated 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.


General 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



Information for patients: To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.


Carcinogenesis & Mutagenesis & Impairment Of Fertility



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: 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



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



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

(NDC 17478-284-35)


Storage And Handling



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

Akorn
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
GKO00N Rev. 06/16


Package Label.Principal Display Panel



Principal Display Panel Text for Container Label:

NDC 17478-284-35 Akorn Logo

Gentak®

brand of Gentamicin Sulfate

Ophthalmic Ointment USP, 0.3%

(equivalent to 3 mg gentamicin per gram)

Net Wt 3.5 g (1/8 oz) Sterile

Rx only

Principal Display Panel Text for Carton Label:

3.5 g NDC 17478-284-35

Gentak®

Brand of Gentamicin Sulfate Ophthalmic Ointment USP, 0.3%

(equivalent to 3 mg gentamicin per gram)

Net Wt 3.5 g (1/8 oz) Sterile Rx only Akorn Logo


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