Drug Facts
Composition & Profile
Identifiers & Packaging
5 mL sterile solution is packaged in a 5 mL white plastic DROP-TAINER* bottle with a plastic dispensing plug and white plastic closure (NDC 61314-643-05) containing tobramycin 0.3% (3 mg/mL). Storage: Store at 2° - 25°C (36° - 77°F). Rx Only *DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.; 598-05; 642-05
- 5 mL sterile solution is packaged in a 5 mL white plastic DROP-TAINER* bottle with a plastic dispensing plug and white plastic closure (NDC 61314-643-05) containing tobramycin 0.3% (3 mg/mL). Storage: Store at 2° - 25°C (36° - 77°F). Rx Only *DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.
- 598-05
- 642-05
Overview
Tobramycin Ophthalmic Solution USP, 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of Tobramycin Ophthalmic Solution USP, 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and purified water. Tobramycin Ophthalmic Solution USP, 0.3% has a pH range between 7.0 and 8.0. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. The chemical structure of tobramycin is: [chemical] MW=467.2 Molecular Formula C18H37N5O9 Chemical name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4)} -0- {2,6-diamino-2,3,6-trideoxy-α-D-ribohexopyranosyl-(1→6) }-2-deoxystreptamine.
Indications & Usage
Tobramycin Ophthalmic Solution USP, 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 USP, 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children
Dosage & Administration
In mild to moderate disease, instill one or two drops into the affected eye(s) every four hours. In severe infections, instill two drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.
Warnings & Precautions
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 USP, 0.3% occurs, discontinue use.
Contraindications
Tobramycin Ophthalmic Solution USP, 0.3% is contraindicated in patients with known hypersensitivity to any of its components.
Adverse Reactions
The most frequent adverse reactions to Tobramycin Ophthalmic Solution USP, 0.3% are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with Tobramycin Ophthalmic Solution USP, 0.3%. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from Tobramycin Ophthalmic Solution USP, 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
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