GENTAMICIN SULFATE OPHTHALMIC OINTMENT USP STERILE

Rx only

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

Gentamicin Sulfate Ophthalmic Ointment USP is a sterile ointment for topical ophthalmic use. Each gram contains gentamicin sulfate (equivalent to 3 mg gentamicin) in a base of white petrolatum and mineral oil.

Gentamicin is obtained from cultures of Micromonospora purpurea. Gentamicin sulfate is a mixture of the sulfate salts of gentamicin C₁, C₂ and C_1A. 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 structural formula is as follows:

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.

Gentamicin Sulfate Ophthalmic Ointment 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.

Gentamicin Sulfate Ophthalmic Ointment is contraindicated in patients with known hypersensitivity to any of the components.

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.

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.

Apply a small amount (about ½ inch) to the affected eye(s) two to three times a day.

Gentamicin Sulfate Ophthalmic Ointment USP (equivalent to 3 mg gentamicin) is supplied as follows:

•  NDC 0168-0044-38  3.5 gram tubes

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
[see USP Controlled Room Temperature].

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747

I24438A
R4/03
#82