Tobramycin Ophthalmic Solution
Drug Details
- Generic Name
- Tobramycin Ophthalmic Solution
- Brand Names
- Tobramycin Ophthalmic Solution
- Application Number
- ANDA211847
- Sponsor
- Alembic Pharmaceuticals Inc.
- NDC Codes
- 2
- Dosage Forms
- SOLUTION/ DROPS
- Routes
- OPHTHALMIC
- Active Ingredients
- TOBRAMYCIN
Indications and Usage
INDICATIONS AND USAGE Tobramycin ophthalmic solution, 0.3 % 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. NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction to Tobramycin ophthalmic solution, 0.3% occurs, discontinue use.