Data from FDA - Curated by EPG Health - Last updated 22 November 2019

Indication(s)

INDICATIONS AND USAGE Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: 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 ointment is con-traindicated in patients with known hypersensitivity to any of the components.
Special warnings and precautions
PRECAUTIONS General: Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible 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. Ophthalmic ointments may retard corneal healing. 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 Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.

More information

Category Value
Authorisation number ANDA064093
Agency product number 8X7386QRLV
Orphan designation No
Product NDC 68788-9732
Date Last Revised 01-10-2019
Type HUMAN PRESCRIPTION DRUG
RXCUI 545236
Storage and handling STORAGE: Store at 2° to 30°C (36° to 86°F). Akorn Manufactured by: Akorn, Inc. Lake Forest, IL 60045 GKO00N Rev. 06/16 Relabeled By: Preferred Pharmaceuticals Inc.
Marketing authorisation holder Preferred Pharmaceuticals, Inc.