INFORMATION FOR PATIENTS SECTION.

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

MICROBIOLOGY SECTION.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel Text for Container Label:NDC 13985-603-03Gentamicin Sulfate STERILEOphthalmic Ointment USP, 0.3% Rx Only(equivalent to mg gentamicin per gram)Apexa logoAP 704005 Net Weight: 3.5g (1/8 oz). Principal Display Panel Text for Container Label.

PEDIATRIC USE SECTION.

Pediatric Use: Safety and effectiveness in neonates have not been established.

ADVERSE REACTIONS SECTION.

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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

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.

CLINICAL PHARMACOLOGY SECTION.

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.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. Gentamicin sulfate ophthalmic ointment is contraindicated in patients with known hypersensitivity to any of the components.

DESCRIPTION SECTION.

DESCRIPTION:. Gentamicin sulfate is water soluble antibiotic of the aminoglycoside group.Gentamicin sulfate ophthalmic ointment is sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to mg gentamicin in base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives.Gentamicin is obtained from cultures of Micromonospora purpurea. It is 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 to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:. Structural Formula.

DOSAGE & ADMINISTRATION SECTION.

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

GENERAL PRECAUTIONS SECTION.

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 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Gentamicin sulfate ophthalmic ointment USP, 0.3% is supplied in 3.5 tube, box of one.(NDC 13985-603-03).

INDICATIONS & USAGE SECTION.

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.. Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

PRECAUTIONS SECTION.

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 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.

PREGNANCY SECTION.

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.

SPL UNCLASSIFIED SECTION.

Ophthalmic Ointment USP, 0.3%STERILERx Only.

STORAGE AND HANDLING SECTION.

STORAGE:. Store at to 30C (36 to 86F).apexa(TM) Manufactured by: Akorn Inc.Lake Forest, IL 60045Distributed by: MWIBoise, ID 83705MWGK00N Rev. 07/14.

WARNINGS SECTION.

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.