tobramycin

FDA Drug Profile — TOBREX, tobramycin, BETHKIS

Drug Details

Generic Name
tobramycin
Brand Names
TOBREX, tobramycin, BETHKIS
Application Number
NDA050555
Sponsor
Novartis Pharmaceuticals Corporation
NDC Codes
3
Dosage Forms
OINTMENT, INJECTION, POWDER, FOR SOLUTION, SOLUTION
Routes
OPHTHALMIC, INTRAVENOUS, RESPIRATORY (INHALATION)
Active Ingredients
TOBRAMYCIN

Indications and Usage

INDICATIONS AND USAGE Tobramycin ophthalmic solution is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution. Clinical studies have shown tobramycin to be safe and effective for use in children.

Warnings

WARNINGS FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to Tobramycin ophthalmic solution occurs, discontinue use.