SIMBRINZA® Suspension safety profile
SIMBRINZA Suspension is contraindicated in patients who are hypersensitive to any component of this product and neonates and infants under the age of 2 years.
Sulfonamide Hypersensitivity Reactions—Brinzolamide is a sulfonamide, and although administered topically, is absorbed systemically. Sulfonamide attributable adverse reactions may occur. Fatalities have occurred due to severe reactions to sulfonamides. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation.
Corneal Endothelium—There is an increased potential for developing corneal edema in patients with low endothelial cell counts.
Severe Hepatic or Renal Impairment (CrCl <30 mL/min)—SIMBRINZA® Suspension has not been specifically studied in these patients and is not recommended.
Acute Angle-Closure Glaucoma—The management of patients with acute angle-closure glaucoma requires therapeutic interventions in addition to ocular hypotensive agents. SIMBRINZA® Suspension has not been studied in patients with acute angle-closure glaucoma.
Contact Lens Wear—The preservative in SIMBRINZA® Suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of SIMBRINZA® Suspension but may be reinserted 15 minutes after instillation.
Severe Cardiovascular Disease—Brimonidine tartrate, a component of SIMBRINZA® Suspension, had a less than 5% mean decrease in blood pressure 2 hours after dosing in clinical studies; caution should be exercised in treating patients with severe cardiovascular disease.
Potentiation of Vascular Insufficiency—Brimonidine tartrate, a component of SIMBRINZA® Suspension, may potentiate syndromes associated with vascular insufficiency. It should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
Contamination of Topical Ophthalmic Products After Use—There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers have been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.