Data from FDA - Curated by EPG Health - Last updated 05 July 2018

Indication(s)

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.

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Advisory information

contraindications
CONTRAINDICATIONS Gentamicin sulfate ophthalmic solution, USP is contraindicated in patients with known hypersensitivity to any of its components.
Special warnings and precautions
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 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, 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
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.

Usage information

Dosing and administration
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.

More information

Category Value
Authorisation number ANDA062452
Agency product number 8X7386QRLV
Orphan designation No
Product NDC 68788-9921
Date Last Revised 18-06-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 310467
Marketing authorisation holder Preferred Pharmaceuticals, Inc.