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 solution, USP is contraindicated in patients with known hypersensitivity to any of its components.

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.

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.

DESCRIPTION SECTION.

DESCRIPTION. Gentamicin sulfate ophthalmic solution, USP is sterile, topical anti-infective agent for ophthalmic use.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 activity. Gentamicin sulfate occurs as white to buff powder and is soluble in water and insoluble in alcohol. The structural formula is as follows:Each mL contains: Active: gentamicin sulfate equivalent to mg (0.3%) gentamicin base. Preservative: benzalkonium chloride. Inactives: edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; and hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The solution is an aqueous, buffered solution with shelf life pH range of 6.5 to 7.5.. Structural Formula.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. 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 every hour.

GENERAL PRECAUTIONS SECTION.

General. Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms, 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.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Gentamicin sulfate ophthalmic solution, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with white high impact polystyrene (HIPS) caps as follows: mL NDC 33261-0604-01Storage: Store at or below 25C (77F). Avoid exposure to excessive heat (40C/104F or above).Revised: 08/2013(C) 2013 Allergan, Inc.Irvine, CA 92612, U.S.A.(R) mark owned by Allergan, Inc.Made in the U.S.A. Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 9288071759PY11. mL NDC 33261-0604-01. Logo.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE. Gentamicin sulfate ophthalmic solution, USP 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.

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.

NDC 33261-0604-01GENTAMICINSULFATEophthalmicsolution, USP0.3%5 mLsterileRx only. IMAGE LABEL.

PEDIATRIC USE SECTION.

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

PRECAUTIONS SECTION.

PRECAUTIONS. General. Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms, 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.. 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 CGentamicin 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 CGentamicin 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.

Pregnancy Category CGentamicin 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.

WARNINGS SECTION.

WARNINGS. NOT FOR INJECTION INTO THE EYE.Gentamicin sulfate ophthalmic solution, USP is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.