SIMBRINZA® Suspension is a fixed combination indicated in the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
The recommended dose is one drop of SIMBRINZA® Suspension in the affected eye(s) three times daily. Shake well before use. SIMBRINZA® Suspension may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.
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.
Angle-closure, Inflammatory or Neovascular Glaucoma - TRAVATAN Z® Solution has not been evaluated for the treatment of angle-closure, inflammatory or neovascular 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.
In two clinical trials of 3 months’ duration with SIMBRINZA® Suspension, the most frequent reactions associated with its use occurring in approximately 3-5% of patients in descending order of incidence included: blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, and eye allergy. Adverse reaction rates with SIMBRINZA® Suspension were comparable to those of the individual components. Treatment discontinuation, mainly due to adverse reactions, was reported in 11% of SIMBRINZA® Suspension patients.
In clinical studies of brinzolamide ophthalmic suspension 1%, the most frequently reported adverse events reported in 5-10% of patients were blurred vision and bitter, sour, or unusual taste. Adverse events occurring in 1-5% of patients were blepharitis, dermatitis, dry eye, foreign body sensation, headache, hyperemia, ocular discharge, ocular discomfort, ocular keratitis, ocular pain, ocular pruritus, and rhinitis.
In clinical studies of brimonidine tartrate 0.2%, adverse events occurring in approximately 10-30% of the subjects, in descending order of incidence, included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus.
Events occurring in approximately 3-9% of the subjects, in descending order, included corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms, asthenia, conjunctival blanching, abnormal vision, and muscular pain.
Concomitant administration with oral carbonic anhydrase inhibitors is not recommended due to the potential additive effect. Use with high-dose salicylate may result in acid-base and electrolyte alterations. Use with CNS depressants may result in an additive or potentiating effect. Use with antihypertensives/cardiac glycosides may result in additive or potentiating effect on lowering blood pressure. Use with tricyclic antidepressants may blunt the hypotensive effect of systemic clonidine and it is unknown if use with this class of drugs interferes with IOP lowering. Use with monoamine oxidase inhibitors may result in increased hypotension.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.