GENTAMICIN SULFATE - gentamicin sulfate solution/ drops
E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.

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DESCRIPTION:

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

Gentamicin Sulfate Ophthalmic Solution is a sterile, aqueous solution buffered with dibasic sodium phosphate and monobasic sodium phosphate to approximately pH 7 (pH range 6.5 - 7.5) for ophthalmic use. Each mL contains gentamicin sulfate, USP (equivalent to 3 mg gentamicin base), sodium chloride and benzalkonium chloride (0.1 mg) as a preservative.

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 structure is as follows:

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 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:

CONTRAINDICATIONS:

Gentamicin Sulfate 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.

General:

Prolonged use of topical antibiotics may give rise to overgrowth of non-susceptible 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 and 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:

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 per hour.

HOW SUPPLIED:

Gentamycin Ophthalmic Solution, USP 0.3% is a sterile solution in a plastic dropper bottle, box of one.

NDC 0168-0178-03 5 mL Bottle

STORAGE:

Store at 25oC (77oF); excursions permitted to 15-30oC (59-86oF)

[see USP Controlled room temperature].

E. FOUGERA & CO.

a division of Altana Inc.

MELVILLE, NEW YORK 11747

I2178

R2/04

#185

PRINCIPAL DISPLAY PANEL - CARTON

NDC 0168-0178-03

Fougera®

GENTAMICIN SULFATE

OPHTHALMIC SOLUTION

USP, 0.3%

(equivalent to 3 mg

gentamicin base per mL)

FOR OPHTHALMIC USE ONLY

STERILE 5 mL

Rx only

PRINCIPAL DISPLAY PANEL - CONTAINER

NDC 0168-0178-03

Fougera®

STABILITY

GENTAMICIN SULFATE

OPHTHALMIC SOLUTION

USP, 0.3%

(equivalent to 3 mg gentamicin per mL)

FOR OPHTHALMIC USE ONLY

STERILE 5mL

Rx only

GENTAMICIN SULFATE
gentamicin sulfate solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:0168-0178
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GENTAMICIN SULFATE (GENTAMICIN)	GENTAMICIN	3 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE
BENZALKONIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC
SODIUM PHOSPHATE, MONOBASIC

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:0168-0178-03	1 BOTTLE, DROPPER in 1 BOX	contains a BOTTLE, DROPPER
1		5 mL in 1 BOTTLE, DROPPER	This package is contained within the BOX (0168-0178-03)
2	NDC:0168-0178-15	1 BOTTLE, DROPPER in 1 BOX	contains a BOTTLE, DROPPER
2		15 mL in 1 BOTTLE, DROPPER	This package is contained within the BOX (0168-0178-15)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065121	01/30/2004	01/30/2004

Labeler - E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 01/2013 E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.