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琥珀酸去甲文拉法辛片|Pristiq (Desvenlafaxine Tablets)

2011-03-22 23:08:23 作者：新特药房来源：中国新特药网天津分站浏览次数：2507 文字大小：【大】【中】【小】

简介： 制造商：惠氏制药药理分类：抗抑郁药（SNRI）活性成分（补）： Desvenlafaxine（如琥珀酸）50毫克，100毫克;分机- REL的标签。指示（补）：重性抑郁症（MDD）。药理作用： Desvenlafaxine，主要 ...

关键字：琥珀酸去甲文拉法辛片

制造商：
惠氏制药

药理分类：
抗抑郁药（SNRI）

活性成分（补）：
Desvenlafaxine（如琥珀酸）50毫克，100毫克;分机- REL的标签。
指示（补）：
重性抑郁症（MDD）。

药理作用：
Desvenlafaxine，主要活性代谢物的文拉法辛（怡诺思XR的也从惠氏），是一种有效和选择性血清素和去甲肾上腺素再摄取抑制剂（SNRI）。对于在中枢神经系统神经递质的影响，这些可能是其提高临床疗效负责。

临床试验：
4个8周的双盲，安慰剂控制的固定剂量进行了研究，以评估治疗严重抑郁症的疗效和desvenlafaxine安全。第一项研究相比desvenlafaxine 100毫克，200毫克，每天一次400毫克和安慰剂。在第二项研究中，患者接受200毫克或400毫克desvenlafaxine或安慰剂，每天一次，并在两个其他研究中，给予病患desvenlafaxine 50毫克或100毫克每日一次或安慰剂。 Desvenlafaxine被证明是优于安慰剂，如改善抑郁评分测量使用的四项研究的17项汉密尔顿量表，它是在三个较全面改善安慰剂（由临床整体印象量表改善的衡量）更好四个研究。上述50mg/day剂量并没有表现出更有效，但不良反应和停药是在较高剂量更频繁。

法律分类：
接收

成人：
50毫克，每日一次。严重肾功能损害（肌酐清除率<30mL/min），终末期肾病：50毫克每一天。不要给透析后补充剂量。中度肾功能损害：最大50mg/day。肝功能不全：最大100mg/day。逐步撤出。

儿童：
不推荐。

禁忌（补）：
单胺氧化抑制剂：见相互作用。

警告/注意事项：
监测血压，降低剂量或停止，如果血压持续升高。心或脑血管疾病。高胆固醇血症。增加眼内压力。躁狂/轻躁狂。严重肾功能不全。癫痫症。定期重新评估。自杀意念。写出最小的实际金额处方。老人。劳动和交付。妊娠（Cat.C，避免在第三孕期;锥形）。哺乳母亲：不推荐。

互动（补）：
允许在中止单胺氧化酶≥14天前开始desvenlafaxine;允许≥7天之后才开始一单胺氧化酶desvenlafaxine终止。避免酒精，伴随文拉法辛，其他形式的desvenlafaxine。伴随血清素前体（如色氨酸）：不推荐。会增强抗凝血剂。监测血清素与SSRI，SNRIs的，曲坦综合征。可能会增强了有力的CYP3A4的抑制剂。 CYP3A4的底物可对抗。注意与serotonergics，其他中枢神经系统活性药物。

不良反应（补）：
胃肠不适，头晕，失眠，多汗，便秘，嗜睡，食欲下降，焦虑，性功能障碍;罕见：低钠血症/ SIADH的（尤指老年人），间质性肺疾病，嗜酸性肺炎，血清素症候群，瞳孔散大。

如何提供：
制表- 14，30，90

PRISTIQ

Manufacturer:

Wyeth Pharmaceuticals

Pharmacological Class:

Antidepressant (SNRI)

Active Ingredient(s):

Desvenlafaxine (as succinate) 50mg, 100mg; ext-rel tabs.

Indication(s):

Major depressive disorder (MDD).

Pharmacology:

Desvenlafaxine, the major active metabolite of venlafaxine (Effexor XR, also from Wyeth), is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). The increase in the effects of these neurotransmitters in the CNS may be responsible for its clinical efficacy.

Clinical Trials:

Four 8-week, double-blind, placebo-controlled fixed-dose studies were conducted to assess the efficacy and safety of desvenlafaxine in treating major depressive disorder. The first study compared desvenlafaxine 100mg, 200mg, and 400mg once daily to placebo. In a second study, patients received desvenlafaxine 200mg or 400mg once daily or placebo, and in two other studies, patients were given desvenlafaxine 50mg or 100mg once daily or placebo. Desvenlafaxine was shown to be better than placebo, as measured by improvement using the 17-item Hamilton Rating Scale for Depression score in four studies, and it was better than placebo in overall improvement (measured by the Clinical Global Impressions Scale-Improvement) in three of the four studies. Doses above 50mg/day were not shown to be more effective, but adverse reactions and discontinuations were more frequent at the higher dose.

Legal Classification:

Adults:

Swallow whole. 50mg once daily. Severe renal impairment (CrCl <30mL/min), ESRD: 50mg every other day. Do not give supplemental dose after dialysis. Moderate renal impairment: max 50mg/day. Hepatic impairment: max 100mg/day. Withdraw gradually.

Children:

Not recommended.

Contraindication(s):

MAOIs: see Interactions.

Warnings/Precautions:

Monitor BP; reduce dose or discontinue if elevated BP persists. Cardio- or cerebrovascular disease. Hypercholesterolemia. Increased intraocular pressure. Mania/hypomania. Severe renal dysfunction. Seizure disorder. Reevaluate periodically. Suicidal ideation. Write prescription for smallest practical amount. Elderly. Labor & delivery. Pregnancy (Cat.C; avoid in 3rd trimester; taper). Nursing mothers: not recommended.

Interaction(s):

Allow ≥14 days after MAOI discontinuance before starting desvenlafaxine; allow ≥7 days after desvenlafaxine discontinuance before starting an MAOI. Avoid alcohol, concomitant venlafaxine, other forms of desvenlafaxine. Concomitant serotonin precursors (eg, tryptophan): not recommended. May potentiate anticoagulants. Monitor for serotonin syndrome with SSRIs, SNRIs, triptans. May be potentiated by potent CYP3A4 inhibitors. May antagonize CYP3A4 substrates. Caution with serotonergics, other CNS-active drugs.

Adverse Reaction(s):

GI upset, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, sexual dysfunction; rare: hyponatremia/SIADH (esp in elderly), interstitial lung disease, eosinophilic pneumonia, serotonin syndrome, mydriasis.