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 occurring in approximately 3% to 5% of patients included blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, eye allergy.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc.
at 1-800-757-9195 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
SIMBRINZA In two clinical trials of three months duration 435 patients were treated with SIMBRINZA, and 915 were treated with the two individual components.
The most frequently reported adverse reactions in patients treated with SIMBRINZA occurring in approximately 3% to 5% of patients in descending order of incidence were blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, and eye allergy.
Rates of adverse reactions reported with the individual components were comparable.
Treatment discontinuation, mainly due to adverse reactions, was reported in 11% of SIMBRINZA patients.
Other adverse reactions that have been reported with the individual components during clinical trials are listed below.
Brinzolamide 1% In clinical studies of brinzolamide ophthalmic suspension 1%, the most frequently reported adverse reactions reported in 5% to 10% of patients were blurred vision and bitter, sour or unusual taste.
5 WARNINGS AND PRECAUTIONS Potential for sulfonamide hypersensitivity reactions because of the brinzolamide component (5.1) Potential for corneal endothelium cell loss (5.2) Severe renal impairment may limit the metabolism of the brinzolamide component (5.3) 5.1 Sulfonamide Hypersensitivity Reactions SIMBRINZA contains brinzolamide, a sulfonamide, and although administered topically is absorbed systemically.
Therefore, the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration of SIMBRINZA.
Fatalities have occurred due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias.
Sensitization may recur when a sulfonamide is re-administered irrespective of the route of administration.
If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation immediately.
Like all medications, Simbrinza 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: