部份中文沃替西汀处方资料（仅供参考） 【药品名称】沃替西汀（vortioxetine） 【商品名称】Brintellix 【原研厂家】Takeda Pharma（武田）/Lundbeck（灵北） 【剂型及规格】片剂，5mg、10mg、15mg、20mg 【适应病症】适用为成人重度抑郁障碍（MDD）的治疗。 【用法用量】 （1）推荐开始剂量是10mg口服给予每天1次不受食物影响 （2）当耐受剂量应增加至20mg/day。 （3）对不能耐受较高剂量患者考虑5mg/day。 （4）BRINTELLIX可突然停药。但是，建议如可能完全终止前1周15mg/day或20mg/day剂量减低至10mg/day。 （5）在已知CYP2D6代谢差患者中最大推荐剂量为10mg/day。 【药理作用】氢溴酸沃替西汀可抑制五羟色胺再摄取，具有5-HT1A受体激动剂、5-HT1B受体部分激动剂及 5-HT3’、5-HT1D及5-HT7受体拮抗剂的作用。沃替西汀作用的多样性使其在几个系统中的神经传递产生调节作用，主要调节五羟色胺，推测也可调节去甲肾上腺素、多巴胺、组胺、乙酰胆碱、GABA及谷氨酸盐系统。每种作用机制的相对贡献尚未确定。沃替西汀是第一个具备如此多种药效活性的抗抑郁药物。 【国外上市】 沃替西汀（VORTIOXETINE，BRINTELLIX™）于 2013年9月获得FDA)批准，用于治疗成人重度抑郁症（MDD。同年10月欧洲药品管理局 (EMA)下属人用药物委员会 (CHMP) 建议沃替西汀用于治疗重症抑郁颁发欧洲上市许可。商品名均为Brintellix 完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4b0700c9-b417-4c3a-b36f-de461e125bd3 包装规格[注：以下产品不同规格和不同价格，采购以在线咨询为准] 德国包装 5mg*28  98片 10mg*28 98片 20mg*28 98片 瑞士包装 片 5mg* 28 10mg*28 98片 15mg*28 98片 20mg*28 98片 口服液 20mg/ml 15ml 美国包装 BRINTELLIX TAB 10MG 30  VORTIOXETINE HYDROBROMIDE  64764-0560-30 BRINTELLIX TAB 20MG 30  VORTIOXETINE HYDROBROMIDE  64764-0580-30 BRINTELLIX TAB 5MG 30  VORTIOXETINE HYDROBROMIDE   64764-0550-30 另需要丹麦上市包装请点击网站：https://www.medicines.org.uk/emc/medicine/30904 BRINTELLIX(vortioxetine)tablets WARNINGS   WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. •Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. •Monitor for worsening and emergence of suicidal thoughts and behaviors. •BRINTELLIX has not been evaluated for use in pediatric patients DESCRIPTION   BRINTELLIX (vortioxetine) tablets, for oral use Initial U.S. Approval: 2013 BRINTELLIX is an immediate-release tablet for oral administration that contains the beta (ß) polymorph of vortioxetine hydrobromide (HBr), an antidepressant. Vortioxetine HBr is known chemically as 1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine, hydrobromide. The empirical formula is C18 H22 N2 S, HBr with a molecular weight of 379.36 g/mol. Vortioxetine HBr is a white to very slightly beige powder that is slightly soluble in water. Each BRINTELLIX tablet contains 6.355 mg, 12.71 mg, 19.065 mg, or 25.42 mg of vortioxetine HBr equivalent to 5 mg, 10 mg, 15 mg, or 20 mg of vortioxetine, respectively. The inactive ingredients in BRINTELLIX tablets include mannitol, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate and film coating which consists of hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide red (5 mg, 15 mg, and 20 mg) and iron oxide yellow (10 mg and 15 mg). CLINICAL PHARMACOLOGY:  Mechanism of Action: The mechanism of the antidepressant effect of vortioxetine is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism. The contribution of these activities to vortioxetine’s antidepressant effect has not been established.  INDICATIONS AND USAGE: BRINTELLIX is indicated for the treatment of major depressive disorder (MDD) CONTRAINDICATIONS  Hypersensitivity to vortioxetine or any components of the BRINTELLIX formulation. Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with BRINTELLIX or within 21 days of stopping treatment with BRINTELLIX. Do not use BRINTELLIX within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start BRINTELLIX in a patient who is being treated with linezolid or intravenous methylene blue. PRECAUTIONS  WARNINGS AND PRECAUTIONS 1.Serotonin Syndrome has been reported with serotonergic antidepressants (SSRIs, SNRIs, and others), including with BRINTELLIX, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort). If such symptoms occur, discontinue BRINTELLIX and initiate supportive treatment. If concomitant use of BRINTELLIX with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases. 2.Treatment with serotonergic antidepressants (SSRIs, SNRIs, and others) may increase the risk of abnormal bleeding. Patients should be cautioned about the increased risk of bleeding when BRINTELLIX is coadministered with nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin, or other drugs that affect coagulation. 3.Activation of Mania/Hypomania can occur with antidepressant treatment. Screen patients for bipolar disorder. 4.Hyponatremia can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH). ADVERSE REACTIONS  Most common adverse reactions (incidence 5% and at least twice the rate of placebo) were: nausea, constipation and vomiting. To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS >Strong inhibitors of CYP2D6: Reduce BRINTELLIX dose by half when a strong CYP2D6 inhibitor (e.g., bupropion, fluoxetine, paroxetine, or quinidine) is coadministered. >Strong CYP Inducers: Consider increasing BRINTELLIX dose when a strong CYP inducer (e.g., rifampin, carbamazepine, or phenytoin) is coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose. USE IN SPECIFIC POPULATIONS > Pregnancy: Based on animal data, BRINTELLIX may cause fetal harm. >Nursing Mothers: Discontinue BRINTELLIX or nursing. See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.   DOSAGE AND ADMINISTRATION: The recommended starting dose is 10 mg administered orally once daily without regard to meals. The dose should then be increased to 20 mg/day, as tolerated. Consider 5mg/day for patients who do not tolerate higher doses. BRINTELLIX can be discontinued abruptly. However, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible. The maximum recommended dose is 10 mg/day in known CYP2D6 poor metabolizers HOW SUPPLIED  DOSAGE FORMS AND STRENGTHS BRINTELLIX is available as 5 mg, 10 mg, 15 mg, and 20 mg immediate release tablets BRINTELLIX is a trademark of H. Lundbeck A/S and is used under license by Takeda Pharmaceuticals America, Inc.