TOBREX 0.3% Ophthalmic solution Ref.[50522] Active ingredients: Tobramycin

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 TOBREX (tobramycin ophthalmic solution) 0.3% occurs, discontinue use.

The most frequent adverse reactions to TOBREX (tobramycin ophthalmic solution) 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.

Postmarketing Experience

Additional adverse reactions identified from post-marketing 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.

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.

Do not touch dropper tip to any surface, as this may contaminate the solution.

Reproduction studies in 3 types of animals at doses up to 33 times the normal human systemic dose have revealed no evidence of impaired fertility or harm to the fetus due to tobramycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Because of the potential for adverse reactions in nursing infants from TOBREX, a decision should be made whether to discontinue nursing the infant or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in pediatric patients below the age of 2 months has not been established.

No overall differences in safety or effectiveness have been observed between elderly and younger patients.