TOBRAMYCIN

Tobramycin Ophthalmic Solution, USP 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL contains Active : Tobramycin 3 mg (0.3%). Inactives : Boric Acid, Sodium Sulfate, Sodium Chloride, Tyloxapol and Purified Water. Sodium Hydroxide and/or Sulfuric Acid (to adjust pH). Tobramycin Ophthalmic Solution, USP 0.3% has a pH range between 7.0 and 8.0. Preservative Added : Benzalkonium Chloride 0.1 mg (0.01%). 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 Molecular weight: 467.52 Molecular formula: C 18 H 37 N 5 O 9 Chemical name: (2S,3R,4S,5S,6R)-4-amino-2-[(1S,2S,3R,4S,6R)-4,6-diamino-3-[(2R,3R,5S,6R)-3-amino-6-(aminomethyl)-5-hydroxyoxan-2-yl]oxy-2-hydroxycyclohexyl]oxy-6-(hydroxymethyl)oxane-3,5-diol;sulfuric acid Tobramycin (structural formula)

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.

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. DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. FOR TOPICAL OPHTHALMIC USE ONLY

Tobramycin Ophthalmic Solution, USP 0.3% is contraindicated in patients with known hypersensitivity to any of its components.

The most frequent adverse reactions to Tobramycin Ophthalmic Solution 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. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from tobramycin therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration. To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.