Gentamicin

FDA Drug Profile — Gentamicin

Drug Details

Generic Name
Gentamicin
Brand Names
Gentamicin
Application Number
ANDA062251
Sponsor
Hikma Pharmaceuticals USA Inc.
NDC Codes
5
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAMUSCULAR, INTRAVENOUS
Active Ingredients
GENTAMICIN SULFATE

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

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.