TOBRAMYCIN
Generic: TOBRAMYCIN
Basic Information
Manufacturer
DirectRX
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
87349ae8-4709-7f5a-e053-2a91aa0ae3d1
Indications & Usage
Tobramycin Ophthalmic Solution USP, 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 Tobramycin Ophthalmic Solution USP, 0.3%.
Clinical studies have shown tobramycin to be safe and effective for use in children
Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of Tobramycin Ophthalmic Solution USP, 0.3%.
Clinical studies have shown tobramycin to be safe and effective for use in children
Warnings
FOR TOPICAL OPHTHALMIC USE ONLY.
NOT FOR INJECTION INTO THE EYE.
Sensitivity to topically applied aminoglycosides may occur in some patients.
If a sensitivity reaction to Tobramycin Ophthalmic Solution USP, 0.3% occurs, discontinue use.
NOT FOR INJECTION INTO THE EYE.
Sensitivity to topically applied aminoglycosides may occur in some patients.
If a sensitivity reaction to Tobramycin Ophthalmic Solution USP, 0.3% occurs, discontinue use.
Adverse Reactions
The most frequent adverse reactions to Tobramycin Ophthalmic Solution USP, 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 Tobramycin Ophthalmic Solution USP, 0.3%.
Similar reactions may occur with the topical use of other aminoglycoside antibiotics.
Other adverse reactions have not been reported from Tobramycin Ophthalmic Solution USP, 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.
These reactions occur in less than three of 100 patients treated with Tobramycin Ophthalmic Solution USP, 0.3%.
Similar reactions may occur with the topical use of other aminoglycoside antibiotics.
Other adverse reactions have not been reported from Tobramycin Ophthalmic Solution USP, 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.