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INDICATIONS AND USAGE

SIMBRINZA® (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fixed combination indicated in the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.


Dosage and Administration
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.

IMPORTANT SAFETY INFORMATION

Contraindications
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.

Warnings and Precautions

  • Sulfonamide Hypersensitivity Reactions - Brinzolamide is a sulfonamide, and although administered topically, is absorbed systemically. Sulfonamide attributable adverse reactions may occur. Fatalities have occurred, although rarely, due to severe reactions to sulfonamides. 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.

  • Corneal Endothelium - There is an increased potential for developing corneal edema in patients with low endothelial cell counts.

  • Corneal Effects - Use of topical NSAIDs may result in keratitis. In some patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use.

  • Severe Renal Impairment (CrCl <30 mL/min) or Severe Hepatic Impairment - 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 - SIMBRINZA® Suspension has been shown to have a minimal effect on blood pressure. Caution should be exercised in treating patients with severe cardiovascular disease.

  • Potentiation of Vascular Insufficiency - Brimonidine 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 thromboangitis obliterans.

  • Concomitant Administration of Potent CYP3A4 Inhibitors - Brinzolamide has not been specifically studied with concomitant administration of CYP3A4 inhibitors (ketoconazole, itraconazole, clotrimazole, and ritonavir). Caution is advised if such inhibitors are given concomitantly.

Adverse Reactions
SIMBRINZA® Suspension

In clinical trials of 3 months duration with SIMBRINZA® Suspension, the most frequent reactions associated with its use occurring in approximately 1-6% of patients in descending order of incidence included: blurred vision, ocular hyperaemia, eye irritation, dysgeusia (bad taste), dry mouth, eye allergy, conjunctivitis, eye pain, dry eye, allergic conjunctivitis, eye pruritus, lacrimation increased, foreign body sensation, fatigue, and headache.


Brinzolamide 1%
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.


Brimonidine Tartrate 0.2%
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.


Drug Interactions-Consider the following when prescribing SIMBRINZA® Suspension:
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.


For additional information about SIMBRINZA® Suspension, please click here for the full Prescribing Information.

SIMBRINZA® Suspension: A Different Combination

A discussion of a 3-month clinical study of SIMBRINZA® Suspension in patients with ocular hypertension or open-angle glaucoma with elevated intraocular pressure (IOP). The video features Jess Whitson, MD, Professor of Ophthalmology at the University of Texas Southwestern Medical Center, Dallas, and Matt McMenemy, MD, Glaucoma Specialist in private practice in Sugarland, TX.

Click Here for Full Prescribing Information