TOBRAMYCIN

Tobramycin ophthalmic solution is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external 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 may be added to adjust pH (7.0 - 8.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.1 mg (0.01%). The structural formula of tobramycin is Molecular formula: C 18 H 37 N 5 O 9 Molecular weight: 467.52 Chemical name: O-[3-amino-3-deoxy—α-D-gluco-pyranosyl-(1 → 4)]-O-[2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl- (1 → 6)]-2-deoxystreptamine. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens. Tobramycin (structural formula)

: 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.

: 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 OPHTHALMIC USE ONLY

: Tobramycin Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.

The most frequent adverse reactions to tobramycin ophthalmic solution is localized ocular toxicity and hypersensitivity, 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.

Storage: Store at 2°-25°C (36°-77°F). Avoid excessive heat. KEEP OUT OF REACH OF CHILDREN. Revised August 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9116801 (Folded) 9116901 (Flat) Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320