TOBREX® (tobramycin 0.3%) is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections.

Each gram of TOBREX Ophthalmic Ointment 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.

Chemical name:

0-{3-amino-3-deoxy-(alpha)-D-gluco-pyranosyl-(1->4)}-0-(2,6-diamino-2,3,6-trideoxy-(alpha)-D-ribohexo- pyranosyl-(1->6)}-2-deoxystrepta-mine.

Clinical Pharmacology:    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-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species. Bacterial susceptibility studies demonstrate that in some cases, microorganisms resistant to gentamicin retain susceptibility to tobramycin.

and Usage:   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.

Contraindications:   TOBREX Ophthalmic Ointment is contraindicated in patients with known hypersensitivity to any of its components.

:   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. Remove contact lenses before applying ointment.

Precautions: General. As with other antibiotic preparations, 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.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Information For Patients:   Do not touch tube tip to any surface, as this may contaminate the ointment.

Pregnancy Category B.   Reproduction studies in three types of animals at doses up to thirty-three 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.

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.

Adverse Reactions:   The most frequent adverse reactions to TOBREX Ophthalmic Ointment 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. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from 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 Ophthalmic Ointment produced significantly fewer adverse reactions (3.7%) than did GARAMYCIN® Ophthalmic Ointment (10.6%).

Overdosage:   Clinically apparent signs and symptoms of an overdose of TOBREX Ophthalmic Ointment (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

Dosage and Administration:   In mild to moderate disease, apply a half-inch ribbon into the affected eye(s) two or three times per day. In severe infections, instill a half-inch ribbon into the affected eye(s) every three to four hours until improvement, following which treatment should be reduced prior to discontinuation.

How Supplied:   3.5g STERILE ointment in ophthalmic tube (NDC 0065-0644-35), containing tobramycin 0.3% (3 mg/g).

Storage   Store at 8°-27°C (46°-80°F).

Rx Only