Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reactions to topical ocular tobramycin are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia.
The reactions due to the steroid component are increases in IOP with possible development of glaucoma.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 1-833-4HARROW(427769) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions have occurred with steroid/anti-infective combination drugs, which can be attributed to the steroid component, the anti-infective component, or the combination.
Exact incidence figures are not available.
The most frequent adverse reactions to topical ocular tobramycin (TOBREX ® ) are hypersensitivity and localized ocular toxicity, including eye pain, eyelids pruritus, eyelid edema, and conjunctival hyperemia.
These reactions occur in less than 4% of patients.
The reactions due to the steroid component are: increased IOP with possible development of glaucoma, and infrequent optic nerve disorder;
subcapsular cataract;
5 WARNINGS AND PRECAUTIONS Intraocular Pressure (IOP) Increase : Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.
If this product is used for 10 days or longer, IOP should be monitored.
Sensitivity to topically applied aminoglycosides may occur.
( 5.2 ) Cataracts : Use of corticosteroids may result in posterior subcapsular cataract formation.
( 5.3 ) Delayed Healing : The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Like all medications, Tobradex St can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: