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 详细处方信息以本药内容附件PDF文件（201162222514930.pdf）的“原文Priscribing Information”为准
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部分中文维拉佐酮处方资料（仅供参考）

Viibryd(维拉佐酮[vilazodone))片
适应证和用途
VIIBRYD是适用于的治疗重度抑郁症(MDD)。在2项8周安慰剂-对照试验，在MDD成年患者中确定VIIBRYD的疗效。

剂量和给药方法
（1）VIIBRYD的推荐剂量为40 mg每天1次。
（2）VIIBRYD应递增调整至40 mg剂量，开始用初始剂量10 mg每天1次共7天。接着20 mg每天1次另外7天，和然后增加至40 mg每天1次。
（3）VIIBRYD应与食物一起服用。无食物给药可能导致不适当药物浓度和可能减低疗效。
（4）当终止治疗时，逐渐减低剂量。

剂型和规格
可以得到VIIBRYD的10 mg，20 mg和40 mg片。

禁忌证
单胺氧化酶抑制剂[MAOI]：VIIBRYD不要与一种MAOI同时使用或停止或开始一种MAOI 14天内使用。

警告和注意事项
（1）临床恶化/自杀风险：监视患者临床恶化和自杀想法或行为.
（2）5-羟色胺综合征或神经阻滞剂恶性综合征[神经阻滞剂恶性综合征]：用治疗可能发生。终止和开始支持治疗。
（3）癫痫发作：用治疗可能发生。有癫痫病患者中慎用。
（4）异常出血：治疗可能增加出血的风险。伴随非甾体抗炎药(NSAIDs)，阿司匹林，或影响凝血的其它药物时慎用。
（5）躁狂的激活/轻度躁狂：用治疗可能发生。筛选双相障碍(躁郁症)患者。
（6）用VIIBRYD治疗的终止：建议逐渐减低剂量而不是突然停止。
（7）低钠血症：伴随不适当抗利尿即使分泌综合征(SIADH)可能发生。

不良反应
最常见不良反应(发生率 ≥ 5%和至少安慰剂率两倍)是：腹泻，恶心，呕吐，和失眠。

药物相互作用
（1）MAOIs：VIIBRYD不要与一种MAOI同时使用或停止或开始一种MAOI 14天内使用。
（2）CYP3A4抑制剂：当与CYP3A4强抑制剂共同给药时，VIIBRYD剂量剂量应减低至20 mg。
（3）CYP3A4诱导剂：VIIBRYD与CYP3A4的诱导剂同时使用时可能导致不适宜药物浓度和可能减低疗效。尚未评价CYP3A4诱导剂对维拉佐酮的全身暴露的影响。

特殊人群中的使用
（1）妊娠：妊娠期间无关于VIIBRYD使用的对照人资料。只有潜在效益权衡大于潜在风险时使用。
（2）哺乳母亲：没有乳汁关于VIIBRYD浓度的人资料。只有权衡潜在效益大于潜在风险妇女才应哺乳。
（3）儿童使用：尚未在患儿中研究VIIBRYD的安全性和有效性。
（4）老年人使用：建议无需根据年龄调整剂量。
（5）肝受损：有轻度或中度肝受损患者建议无需调整剂量。尚未在严重肝受损患者中研究VIIBRYD。
（6）肾受损：在轻度，中度或严重肾受损患者中建议无需调整剂量。

About Viibryd(TM)
Viibryd (vilazodone) is a novel antidepressant for the treatment of major depressive disorder (MDD). The efficacy of Viibryd was established in two 8-week, multi-center, randomized, double -blind, placebo-controlled studies in adult (18-80 years of age) outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria for MDD. The mechanism of action of Viibryd is not fully understood but is thought to be related to enhancement of serotonergic activity in the central nervous system through selective inhibition of serotonin reuptake. Viibryd is also a partial agonist of serotonergic 5-HT1a receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd antidepressant effect are unknown.

Important Safety Information
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Viibryd or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Viibryd is not approved for use in pediatric patients.

Contraindications
VIIBRYD must not be used concomitantly in patients taking MAOIs or in patients who have taken MAOIs within the preceding 14 days due to the risk of serious, sometimes fatal, drug interactions with serotonergic drugs. Allow at least 14 days after stopping VIIBRYD before starting an MAOI.

Warnings and Precautions
All patients treated with antidepressants should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the first few months of treatment and when changing the dose. Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse or includes symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, mania, or suicidality that are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants should be alerted about the need to monitor patients.

The development of potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions has been reported with antidepressants alone, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Symptoms of serotonin syndrome were noted in 0.1% of patients treated with VIIBRYD. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms while treated with VIIBRYD.
Symptoms of mania/hypomania were noted in 0.1% of patients treated with VIIBRYD in clinical studies. As with all antidepressants, VIIBRYD should be used cautiously in patients with a history or family history of mania or hypomania.

Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. VIIBRYD is not approved for use in treating bipolar depression.

Discontinuation symptoms have been reported with discontinuation of serotonergic drugs such as VIIBRYD. Gradual dose reduction is recommended, instead of abrupt discontinuation, whenever possible. Monitor patients for these symptoms when discontinuing VIIBRYD. If intolerable symptoms occur following a dose decrease or upon discontinuation of treatment, consider resuming the previously prescribed dose and decreasing the dose at a more gradual rate.

Like other antidepressants, VIIBRYD should be prescribed with caution in patients with a seizure disorder.

The use of drugs that interfere with serotonin reuptake, including VIIBRYD, may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of VIIBRYD and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding.

Advise patients that if they are treated with diuretics, or are otherwise volume depleted, or are elderly they may be at greater risk of developing hyponatremia while taking VIIBRYD. Although no cases of hyponatremia resulting from VIIBRYD treatment were reported in the clinical studies, hyponatremia has occurred as a result of treatment with SSRIs and SNRIs. Discontinuation of VIIBRYD in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.

Adverse Reactions
The most commonly observed adverse reactions in MDD patients treated with VIIBRYD in placebo-controlled studies (incidence greater-than or equal to 5% and at least twice the rate of placebo) were: diarrhea (28% vs. 9%), nausea (23% vs. 5%), insomnia (6% vs. 2%), and vomiting (5% vs. 1%).

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 详细处方信息以本药内容附件PDF文件（201162222514930.pdf）的“原文Priscribing Information”为准
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