TOBREX Eye drops

TOBREX 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. Clinical studies have shown tobramycin to be safe and effective for use in children.

Dosage

Solution: In mild to moderate disease, instill 1-2 drops into the affected eye(s) every 4 hours.

In severe infection, instill 2 drops into the eye(s) hourly until improvement, following which treatment should be reduced prior to discontinuation.

In patients with known hypersensitivity to any of their components.

The most frequent adverse reactions are localized ocular toxicity and hypersensitivity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 3 of 100 patients treated with TOBREX. Similar reactions may occur with the TOBREX therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

In clinical trials, TOBREX produced significantly fewer adverse reactions (3.7%) than did Garamycin Ophthalmic Ointment (10.6%).

Pregnancy

This drug should be used during pregnancy only if clearly needed.

Reproduction studies in three 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.

Nursing Mothers

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.

NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to TOBREX occurs, discontinue use.

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. Ophthalmic ointments may retard corneal wound healing.

In Vitro Data: In vitro studies have demonstrated tobramycin is active against susceptible strains of the following microorganisms:

Staphylococci, including S.aureus and S.epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-betahemolytic species, some non-hemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis (indole-negative) and indole-positive Proteus species, Haemophilus influenzae and H.aegyptius, Moraxella lacunata, and Acinetobacter calcoaceticus (Herellea vaginacola) and some Neisseria species.

Bacterial susceptibility to tobramycin. A significant bacterial population resistant to tobramycin has not yet emerged; however, bacterial resistance may develop upon prolonged use.