Data from FDA - Curated by EPG Health - Last updated 21 April 2018

Indication(s)

INDICATIONS AND USAGE TOBREX® (tobramycin ophthalmic solution) 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®. Clinical studies have shown tobramycin to be safe and effective for use in children.

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Advisory information

contraindications
CONTRAINDICATIONS TOBREX® (tobramycin ophthalmic solution) 0.3% is contraindicated in patients with known hypersensitivity to any of its components.
Special warnings and precautions
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. 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. Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the solution. Pregnancy: 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. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 months has not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Adverse reactions
ADVERSE REACTIONS: The most frequent adverse reactions to TOBREX® Ophthalmic Solution 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® (tobramycin ophthalmic solution) 0.3% therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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.
Pregnancy and lactation
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.

More information

Category Value
Authorisation number NDA050541
Agency product number VZ8RRZ51VK
Orphan designation No
Product NDC 0065-0643
Date Last Revised 05-04-2018
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Alcon Laboratories, Inc.