Simbrinza

— THERAPEUTIC CATEGORIES —
  • Glaucoma
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Simbrinza Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Brinzolamide 1%, brimonidine tartrate 0.2%; oph susp; contains benzalkonium chloride.

    Pharmacological Class

    Carbonic anhydrase inhibitor + alpha-2 agonist.

    How Supplied

    Susp—8mL

    How Supplied

    Simbrinza (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is supplied in white low density polyethylene (LDPE) DROP-TAINER® bottles with a natural LDPE dispensing-tip and light green polypropylene cap as follows: 

    • 8 mL in a 10 mL bottle.

    Storage

    Store Simbrinza at 2°C to 25°C (36°F to 77°F). After opening, Simbrinza can be used until the expiration date on the bottle. 

    Manufacturer

    Alcon Laboratories, Inc.

    Mechanism of Action

    Brinzolamide inhibits carbonic anhydrase in the ciliary processes of the eye to decrease aqueous humor secretion, presumably by slowing the formation of bicarbonate ions with subsequent reduction in sodium and fluid transport. Brinzolamide has a peak ocular hypotensive effect occurring at 2–3 hours post-dosing. Fluorophotometric studies in animals and humans suggest that brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow. Brimonidine tartrate has a peak ocular hypotensive effect occurring at two hours post-dosing. The result is a reduction in intraocular pressure (IOP).

    Simbrinza Indications

    Indications

    Reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension.

    Simbrinza Dosage and Administration

    Adults and Children

    <2yrs: contraindicated. ≥2yrs: 1 drop three times daily.

    Simbrinza Contraindications

    Contraindications

    Neonates and infants <2yrs.

    Simbrinza Boxed Warnings

    Not Applicable

    Simbrinza Warnings/Precautions

    Warnings/Precautions

    Sulfonamide allergy. Discontinue if serious systemic or hypersensitivity reactions occur. Increased risk of corneal edema in patients with low endothelium cell counts. Severe renal impairment (CrCl <30mL/min): not recommended. Hepatic impairment. Severe cardiovascular disease. Depression. Cerebral or coronary insufficiency. Raynaud’s phenomenon. Orthostatic hypotension. Thromboangitis obliterans. Acute angle-closure glaucoma. Remove soft contact lenses before use; may reinsert 15mins later. Pregnancy. Nursing mothers: not recommended.

    Warnings/Precautions

    Sulfonamide Hypersensitivity Reactions  

    • 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. 

    • Discontinue Simbrinza if signs of serious reactions of hypersensitivity occur.

    Corneal Endothelium  

    • Carbonic anhydrase activity has been observed in both the cytoplasm and around the plasma membranes of the corneal endothelium. 

    • Patients with low endothelial cell counts have an increased risk for developing corneal edema. Use caution when prescribing Simbrinza to this patient population.

    Severe Renal Impairment

    • Patients with severe renal impairment (CrCl less than 30 mL/min): not recommended.

    Acute Angle-Closure Glaucoma  

    • Patients with acute angle-closure glaucoma: not studied. 

    Contact Lens Wear

    • Remove soft contact lenses before use; may reinsert 15mins later.

    Severe Cardiovascular Disease

    • Brimonidine tartrate, a component of Simbrinza, has a less than 5% mean decrease in blood pressure two hours after dosing in clinical studies.

    • Use caution in patients with severe cardiovascular disease. 

    Severe Hepatic Impairment 

    • Patients with hepatic impairment: not studied.

    • Use caution in this patient population.

    Potentiation of Vascular Insufficiency

    • Simbrinza may potentiate syndromes associated with vascular insufficiency.

    • Use caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.

    Pregnancy Considerations

    There are no adequate and well-controlled studies in pregnant women. Simbrinza should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Nursing Mother Considerations

    • It is not known whether brinzolamide and brimonidine tartrate are excreted in human milk following topical ocular administration. 

    • A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. 

    Pediatric Considerations

    Simbrinza is contraindicated for use in children under the age of 2 years.

    Simbrinza Pharmacokinetics

    Absorption

    Plasma concentrations peaked within 1 to 4 hours.

    Distribution

    ~60% plasma protein bound.

    Metabolism

    Hepatic.

    Elimination

    Renal. Half-life: ~3 hours.

    Simbrinza Interactions

    Interactions

    Concomitant oral carbonic anhydrase inhibitors: not recommended. Caution with antihypertensives, cardiac glycosides, tricyclic antidepressants, MAOIs. Concomitant high-dose salicylate may produce acid-base and electrolyte alterations. May be potentiated by CNS depressants (eg, alcohol, opiates, barbiturates, sedatives, anesthetics). Separate administration of other oph drugs by ≥5 minutes.

    Simbrinza Adverse Reactions

    Adverse Reactions

    Blurred vision, eye irritation, dysgeusia, dry mouth, eye allergy.

    Simbrinza Clinical Trials

    Clinical Trials

    The efficacy and safety of Simbrinza was evaluated in two clinical trials of 3 month duration in patients with open-angle glaucoma or ocular hypertension. Patients received Simbrinza 1%/0.2% dosed three times daily to individually administered 1% brinzolamide three times daily and 0.2% brimonidine tartrate three times daily.

    Results showed that treatment with Simbrinza was 1 to 3 mmHg greater than monotherapy with either 1% brinzolamide or 0.2% brimonidine tartrate.

    Simbrinza Note

    Not Applicable

    Simbrinza Patient Counseling

    Patient Counseling

    Sulfonamide Hypersensitivity Reactions  

    • Advise patients to discontinue use of Simbrinza and consult their physician immediately if serious or unusual ocular or systemic reactions or signs of hypersensitivity occur. 

    Temporary Blurred Vision

    • Simbrinza may temporarily cause blurred vision. Exercise caution in operating machinery or driving a motor vehicle.

    Effect on Ability to Drive and Use Machinery  

    • Simbrinza may cause fatigue and/or drowsiness in some patients. Use caution when engaging in hazardous activities of the potential for a decrease in mental alertness.

    Avoiding Contamination of the Product

    • Instruct patients that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, can become contaminated by common bacteria known to cause ocular infections.

    • Do not use Simbrinza if the solution changes or becomes cloudy.

    Intercurrent Ocular Conditions  

    • Advise patients to seek their physician’s advice immediately regarding the continued use of Simbrinza if they have ocular surgery or develop an intercurrent ocular condition (eg, trauma or infection).

    Concomitant Topical Ocular Therapy

    • If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.

    Contact Lens Wear

    • Remove soft contact lenses before use; may reinsert 15mins later.

    Cost Savings Program

    Simbrinza Copay Card

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