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当前位置:药品说明书与价格首页 >> 神经内科 >> 癫痫 >> 药品推荐 >> 拉科酰胺片剂VIMPAT(lacosamide)-癫痫病最新治疗药

拉科酰胺片剂VIMPAT(lacosamide)-癫痫病最新治疗药

2010-12-06 11:13:32  作者:新特药房  来源:中国新特药网天津分站  浏览次数:1090  文字大小:【】【】【
简介: Important Safety Information VIMPAT (lacosamide) is a medicine that is used with other medicines to treat partial onset seizures in patients 17 years of age and older with epilepsy. VIMP ...

制造商:
联合银行公司

药理分类:
抗癫痫(钠通道灭活)

活性成分(补):
Lacosamide 50毫克,100毫克,150毫克,200毫克;标签。

另外:
VIMPAT注射
Lacosamide 10mg/ml的;溶液的静脉注射。

指示(补):
标签:兼职在部分发作。
注射液:兼职在部分发作时口服是不可行的。

药理作用:
Lacosamide选择性地提高了电压门控钠通道失活慢,在hyperexcitable神经细胞膜和抑制神经元放电重复性稳定造成的。它还结合collapsin反应蛋白调停- 2,这是在神经轴突的生长分化和参与控制。对在治疗癫痫lacosamide确切作用机制尚不清楚。

Lacosamide已被证明没有与卡马西平或丙戊酸钠重要的药代动力学的相互作用。伴随抗癫痫药物的稳态血浆水平(抗癫痫药)由lacosamide不受影响。

Lacosamide是口服后完全吸收。它有一个约100%生物利用度。 30 - 60分钟静脉注射生物等效的口服片剂。

临床试验:
3个12周的试验是进行树立lacosamide疗效。这些研究共收集了部分发作或不泛化谁没有得到充分1至3抗癫痫药物控制,随之而来的约1300例。在每一个研究,一个8周的基线阶段其次是随机和一个调整期,那么维修阶段,历时12周,在此期间,患者的lacosamide稳定剂量仍然存在。研究一比较lacosamide 200毫克,400毫克,并600mg/day安慰剂,研究2相比lacosamide 400毫克和600mg/day安慰剂,研究3比lacosamide 200毫克和400mg/day安慰剂。在28天的发作频率比安慰剂(基线到维护阶段)减少在每个研究的主要疗效变量。

在200毫克,400毫克,600毫克和每天lacosamide剂量被证明是减少发作次数显着优于安慰剂。该600mg/day剂量不超过400mg/day剂量有效。

法律分类:
简历

成人:
注射液:可给予不削弱,或在适当的稀释剂混合,通过静脉注射给予30 - 60分钟。对于口服和交感:≥17yrs:最初50毫克,每天两次;可能增加100mg/day剂量除以2日在每周一班。维持剂量:200-400mg/day。肾功能损害(肌酐清除率≤30mL/min),终末期肾病,轻度,中度肝功能损害:最大300mg/day。血液透析后考虑追加剂量(50%)。避免突然停止(退出超过1周)。

儿童:
<17yrs:不推荐。

警告/注意事项:
严重肝功能不全:不推荐。心脏传导障碍(例如,第二度房室传导阻滞)。严重的心脏疾病(例如,心肌缺血,心脏衰竭)。监控自杀意念,抑郁症。糖尿病神经病变。老人。妊娠(Cat.C)。哺乳母亲:不推荐。

互动(补):
注意与公关延长,导致其他药物。

不良反应(补):
头晕,共济失调,复视,头痛,胃肠不适,晕厥;罕见:多器官超敏反应。

注释:
报名参加脐血迪拉姆妊娠登记处电话:(888)537-7734。

如何提供:
制表- 60,180
一次性使用瓶(加入20mL)-10

最后更新:
2010年6月14日

Manufacturer:

UCB Inc.

Pharmacological Class:

Antiepileptic (sodium channel inactivator)

Active Ingredient(s):

Lacosamide 50mg, 100mg, 150mg, 200mg; tabs.

Also:

VIMPAT INJECTION
Lacosamide 10mg/mL; soln for IV infusion.

Indication(s):

Tabs: Adjunct in partial-onset seizures.
Inj: Adjunct in partial-onset seizures, when oral administration is not feasible.

Pharmacology:

Lacosamide selectively enhances the slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing. It also binds to collapsin response mediator protein-2, which is involved in neuronal differentiation and control of axonal growth. The exact mechanism of action of lacosamide in treating epilepsy is not known.

Lacosamide has been shown to have no significant pharmacokinetic interactions with carbamazepine or valproate. Steady-state plasma levels of concomitant antiepileptic drugs (AEDs) were unaffected by lacosamide.

Lacosamide is completely absorbed after oral administration. It has a bioavailability of about 100%. The 30- and 60-minute IV infusions are bioequivalent to the oral tablets.

Clinical Trials:

Three 12-week trials were conducted to establish the efficacy of lacosamide. These studies enrolled approximately 1300 patients with partial onset seizures with or without generalization who were not adequately controlled with 1 to 3 concomitant AEDs. In each study, an 8-week baseline phase was followed by randomization and a titration phase, then a maintenance phase that lasted 12 weeks during which patients remained on a stable dose of lacosamide. Study 1 compared lacosamide 200mg, 400mg, and 600mg/day to placebo; study 2 compared lacosamide 400mg and 600mg/day to placebo, and study 3 compared lacosamide 200mg and 400mg/day to placebo. The reduction in 28-day seizure frequency (baseline to maintenance phase) compared to placebo was the primary efficacy variable in each study.

At doses of 200mg, 400mg, and 600mg daily, lacosamide was shown to be significantly superior to placebo in reducing seizure frequency. The 600mg/day dose was not more effective than the 400mg/day dose.

Legal Classification:

CV

Adults:

Inj: may give without diluting, or mix in appropriate diluent and give by IV infusion over 30–60min. For oral and inj: ≥17yrs: initially 50mg twice daily; may increase at weekly intervals by 100mg/day in 2 divided doses. Maintenance dose: 200–400mg/day. Renal impairment (CrCl ≤30mL/min), ESRD, mild-moderate hepatic impairment: max 300mg/day. Consider supplemental dose (50%) after hemodialysis. Avoid abrupt cessation (withdraw over 1 week).

Children:

<17yrs: not recommended.

Warnings/Precautions:

Severe hepatic impairment: not recommended. Cardiac conduction disturbances (eg, 2nd degree AV block). Severe cardiac disease (eg, myocardial ischemia, heart failure). Monitor for suicidal ideation, depression. Diabetic neuropathy. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interaction(s):

Caution with other drugs that cause PR prolongation.

Adverse Reaction(s):

Dizziness, ataxia, diplopia, headache, GI upset, syncope; rare: multiorgan hypersensitivity reaction.

Notes:

To enroll in the UCB AED Pregnancy Registry call (888) 537-7734.

How Supplied:

Tabs—60, 180
Single-use vials (20mL)—10

责任编辑:admin


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