TOBREX

TOBREX ® (tobramycin ophthalmic ointment) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each gram of TOBREX (tobramycin ophthalmic ointment) 0.3% contains: Active: tobramycin 0.3% (3 mg). Preservative: chlorobutanol 0.5%. Inactives: mineral oil, white petrolatum. 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 Formula: C 18 H 37 N 5 O 9 Molecular Weight: 467.52 g/mol Chemical Name: 0-{3-amino-3-deoxy-α-D-gluco-pyranosyl-(1→4) }-0-{2,6-diamino-2,3,6-trideoxy-α-D-ribohexo-pyranosyl-(1→6) }-2-deoxystreptamine. chemical structure of tobramycin

TOBREX ® (tobramycin ophthalmic ointment) 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 TOBREX (tobramycin ophthalmic ointment) 0.3%. Clinical studies have shown tobramycin to be safe and effective for use in children.

In mild to moderate disease, apply a half-inch ribbon into the affected eye(s) 2 or 3 times per day. In severe infections, instill a half-inch ribbon into the affected eye(s) every 3 to 4 hours until improvement, following which treatment should be reduced prior to discontinuation. How to Apply TOBREX (tobramycin ophthalmic ointment) 0.3%: 1. Tilt your head back. 2. Place a finger on your cheek just under your eye and gently pull down until a ''V'' pocket is formed between your eyeball and your lower lid. 3. Place a small amount (about ½ inch) of TOBREX ® (tobramycin ophthalmic ointment) 0.3% in the ''V'' pocket. Do not let the tip of the tube touch your eye. 4. Look downward before closing your eye.

TOBREX (tobramycin ophthalmic ointment) 0.3 % is contraindicated in patients with known hypersensitivity to any of its components.

The most frequent adverse reactions to TOBREX (tobramycin ophthalmic ointment) 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 TOBREX ® (tobramycin ophthalmic ointment) 0.3%. Postmarketing Experience: Additional adverse reactions identified from postmarketing use include anaphylactic reaction, Stevens-Johnson syndrome, and erythema multiforme. The following additional adverse reactions have been reported with systemic aminoglycosides: Neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic aminoglycoside therapy. Aminoglycosides may aggravate muscle weakness in patients with known or suspected neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, because of their potential effect on neuromuscular function.