GENTAMICIN SULFATE

Gentamicin sulfate ophthalmic solution, USP is a sterile, topical anti-infective agent for ophthalmic use. Gentamicin is obtained from cultures of Micromonospora purpurea . It is a mixture of the sulfate salts of gentamicin C 1 , C 2 , and C 1A . All three components appear to have similar antimicrobial activity. Gentamicin sulfate occurs as a 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 3 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 a shelf life pH range of 6.5 to 7.5. The structural formula for 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 simi

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 .

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.

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

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.

Storage : Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above). Revised : 1 0 /201 7 Distributed for: Allergan USA, Inc. Madison, NJ 07940 ©2017 Allergan. All rights reserved. All trademarks are the property of their respective owners. Made in the U.S.A. v1.0USPI188