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拉科酰胺注射液VIMPAT(LACOSAMIDE)

2013-05-06 11:19:00  作者:新特药房  来源:互联网  浏览次数:537  文字大小:【】【】【
简介:药品信息:友情提示:VIMPAT属5级管制药品,购买时凭处方购买!Generic Name and Formulations:Lacosamide 50mg, 100mg, 150mg, 200mg; tabs. Company:UCB Inc. Indications for VIMPAT:Adjunct in partial-on ...

药品信息:
友情提示:
VIMPAT属5级管制药品,购买时凭处方购买!
Generic Name and Formulations:
Lacosamide 50mg, 100mg, 150mg, 200mg; tabs.

Company:
UCB Inc.

Indications for VIMPAT:
Adjunct in partial-onset seizures.

Adult Dose for VIMPAT:
Oral soln: use calibrated measuring device. 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's Dose for VIMPAT:
<17yrs: not recommended.

See Also:
VIMPAT INJECTION

VIMPAT ORAL SOLUTION

Pharmacological Class:
Sodium channel inactivator.

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.

Interactions:
Caution with other drugs that cause PR prolongation.

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

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

How Supplied:
Tabs—60; Oral soln—465mL; Single-use vials (20mL)—10

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. VIMPAT is generally well-tolerated, but may not be for everyone. Ask your doctor if VIMPAT is right for you.
The most common side effects with VIMPAT are dizziness, headache, nausea, and double vision.
VIMPAT may also cause problems with coordination and balance. You should not drive, operate machinery or do other dangerous activities until you know how VIMPAT affects you. Do not stop taking VIMPAT without first talking to your doctor. Stopping VIMPAT suddenly can cause serious problems. VIMPAT could make you feel faint.
Tell your doctor if you have a heart condition or if you are taking other medicines that affect the heart. In rare cases, VIMPAT may cause reactions that could affect your heart, liver or kidney. Contact your doctor immediately if you are tired, have jaundice (yellowing of skin or eyes), and have dark urine. Antiepileptic drugs, including VIMPAT, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have new or worsening symptoms of depression, any unusual changes in mood or behavior, or suicidal thoughts, behavior, or thoughts about self harm that you have never had before or may be worse than before.
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You and your neurologist might find that your current epilepsy medicine does not give you the seizure control you need. Adding Vimpat to your epilepsy treatment can mean:
Having fewer seizures More seizure-free days Seizure control, no matter how many epilepsy medicines you have taken before or are taking now Little effect on concentration, attention span, or memory Little effect on weight
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Adding another epilepsy medicine to your current treatment can help you better control your partial-onset seizures. That is why you and your neurologist have added Vimpat—a medicine that treats epilepsy.In almost 10 years of studies, the proven safety profile of Vimpat has shown:
Little effect on weight Little effect on concentration, attention span, or memory It is not likely to cause sleepiness It can be taken with most other epilepsy medicines
Lacosamide拉科酰胺(也称拉考沙胺,Vimpat)
拉科酰胺(Lacosamide)是德国Schwarz BioSciences公司研发的治疗癫痫和神经性疼痛的药物。2008年9月欧盟批准UCB公司的拉科酰胺片上市,用于辅助治疗16岁及以上有或无继发性癫痫大发作患者的癫痫部分发作。2008年10月表示美国FDA已批准拉科酰胺上市作为一种辅助药物与其它药物联合用于癫痫部分性发作,商品名为Vimpat。Vimpat获准上市的有2种剂型:薄膜片(50、100 、150和200 mg/片)、注射液(10 mg/mL,20ml/支),当患者不宜口服时可采用推注给药。
适应症:癫痫
原研单位及国外上市时间:UCB公司德国子公司Schwarz BioSciences公司(http://www.chemdrug.com/corporation/)研发(http://www.chemdrug.com/);2008年9月欧盟批准(http://www.chemdrug.com/corporation/)上市;
2008年10月美国FDA(http://www.chemdrug.com/databases/db_11_1.html)批准上市,商品名为Vimpat。
作用机制:
拉科酰胺是一种新型NMDA受体甘氨酸位点结合拮抗剂,属于新一类功能性氨基酸,是具有全新双重机制作用的抗惊厥药物。它可选择性促进钠通道缓慢失活并调节塌陷反应介导蛋白22(CRMP22) ,而 CRMP22可能减慢甚至阻止癫痫发作以及减轻糖尿病的神经性疼痛。据悉,
FDA已经同意受理拉科酰胺用于治疗糖尿病神经性疼痛的NDA申请。
癫痫是一种常见的神经系统疾病,全世界约有50万患者。中枢神经系统(CNS)药物一直是开发比较活跃的领域,其中抗癫痫药在国际市场上的年平均增长率在10%左右,位居中枢神经系统药物增长率的第三位。拉科酰胺(Lacosamide)是由比利时优时比公司(UCB Pharma)的德国子公司Schwarz BioSciences公司研发的一种新型N-甲基-D-天门冬氨酸(NMDA)受体甘氨酸位点结合拮抗剂。NMDA受体甘氨酸位点结合拮抗剂,属于新一类功能性氨基酸,是具有全新双重机制作用的抗惊厥药物。它可选择性促进钠通道缓慢失活并调节塌陷反应介导蛋白-2(CRMP-2) ,而 CRMP-2可能减慢甚至阻止癫痫发作。
附件:
20102221004515.pdf   
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产地国家: 德国
原产地英文商品名:
VIMPAT 200mg/20mL/vial 10vials/box
原产地英文药品名:
LACOSAMIDE
中文参考商品译名:
VIMPAT注射液 200毫克/20毫升/瓶 10瓶/盒
中文参考药品译名:
拉科酰胺注射液
曾用名:
拉考沙胺
生产厂家中文参考译名:
德国Schwarz Pharma公司(制造商:UCB公司)
生产厂家英文名:
Schwarz Pharma(UCB

该药品相关信息网址1:
http://www.vimpat.com/

责任编辑:admin


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