SIMBRINZA®(brinzolamide/brimonidine tartrate ophthalmic suspension)(布林佐胺1.0%/酒石酸溴莫尼定0.2%)复方悬液 2013年4月19日，美国食品药品管理局(FDA)已批准Simbrinza悬液上市，适用于降低原发性开角型青光眼或高眼压症患者的高眼压。Simbrinza是一种固定剂量复方制剂，包含一种碳酸酐酶抑制剂(布林佐胺1.0%)和一种α2肾上腺素能受体激动剂(酒石酸溴莫尼定0.2%)。用法为患眼每次1滴，每日3次。 FDA批准Simbrinza是基于2项关键3期临床试验的数据。这2项研究共招募了大约1,300例患者，评估了布林佐胺1.0%与溴莫尼定0.2%固定剂量复方制剂每日给药3次的安全性与有效性，并与仅给予其中一种成分进行了比较。这2项研究均达到了其主要终点，证明在3个月内所有时间点的平均眼压方面，Simbrinza相对于单一成分具有统计学优势。在这2项研究中，Simbrinza组患者的3个月时眼压比基线时(22~36 mmHg)下降了5~9 mmHg。 在这2项为期3个月的临床试验中，接受Simbrinza治疗的患者最常报告的不良反应为视力模糊、眼刺激、味觉障碍、口干和眼过敏。Simbrinza组患者有11%停药，主要原因是不能耐受不良反应。Simbrinza的安全性特征与其所含的2种活性成分一致。此外，在接受Simbrinza治疗的患者中未发生明显的心血管或肺部事 Combines two eye pressure-lowering medicines into a single bottle. How SIMBRINZA® Suspension Works SIMBRINZA® (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% combines two proven medications into a single treatment. The first (brinzolamide) decreases the production of the clear fluid inside your eye. The second (brimonidine) also decreases fluid production while increasing fluid outflow. Together, they can reduce high pressure in the eye.1 Take SIMBRINZA® Suspension as your doctor prescribes: the recommended dose is one drop in the affected eye(s) 3 times a day. If you are already using another type of eyedrop they should be taken at least 5 minutes apart.1 Some Possible Side Effects of SIMBRINZA® Suspension The most commonly reported side effects include blurred vision, eye irritation, bad taste, dry mouth, and eye allergy.1 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. See below for additional safety information Important information about SIMBRINZA® (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% INDICATIONS AND USAGE SIMBRINZA® Suspension 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 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 eva luated 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. Adverse Reactions SIMBRINZA® Suspension 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. 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. Click here for full prescribing information for SIMBRINZA® Suspension 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. SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension), 1%/0.2% SIMBRINZA Rx Generic Name and Formulations: Brinzolamide 1%, brimonidine tartrate 0.2%; oph susp; contains benzalkonium chloride. Company: Alcon Laboratories, Inc. Indications for SIMBRINZA: Reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension. Adults and Children's Dose: <2yrs: contraindicated. ≥2yrs: 1 drop three times daily. Pharmacological Class: Carbonic anhydrase inhibitor + alpha-2 agonist. Contraindications: Neonates and infants <2yrs. 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 (Cat.C). Nursing mothers: not recommended. 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. Adverse Reactions: Blurred vision, eye irritation, dysgeusia, dry mouth, eye allergy. How Supplied: Susp—8mL