Lacosamide拉科酰胺（也称拉考沙胺,Vimpat）
在欧盟，Vimpat于2008年9月首次获批上市，作为一种辅助药物，用于青少年（16-18岁）和成人癫痫患者部分发作性癫痫（伴随或不伴随继发性全面性发作癫痫）的治疗。在欧盟国家中，Vimpat的剂型有薄膜衣片、糖浆、注射液。在暂时无法口服给药的患者中，Vimpat注射液是另一种可选择的剂型。
比利时制药巨头优时比（UCB）抗癫痫药Vimpat（lacosamide，拉科酰胺）近日在欧盟监管方面传来喜讯。欧盟委员会（EC）已批准Vimpat作为一种单药疗法，用于青少年（16-18岁）及成人癫痫患者部分发作性癫痫（partial-onset seizure，POS）的治疗。
Vimpat的获批是基于一项国际性、双盲、随机、主动控制、非劣效性III期临床研究的数据。该研究在888例年龄在16岁及以上癫痫患者中开展，是迄今为止在该群体中开展的最大规模的临床研究。数据显示，用于新诊POS治疗时，Vimpat作为单药疗法与控释卡马西平（carbamazepine）具有非劣效性；安全性方面，Vimpat的耐受性良好，不良事件与既往研究一致，主要包括头晕、头痛和恶心。
Vimpat是一种新型NMDA受体甘氨酸位点结合拮抗剂，属于新一类的功能性氨基酸，是具有全新双重作用机制的抗惊厥药物。与其他的抗癫痫药物相比，Vimpat具有调节钠离子通道的活性，钠离子通道在调节神经系统活性、促进神经细胞之间传导具有非常重要的功能，通过降低钠离子通道的过度活跃可控制神经细胞的活性治疗癫痫。
在美国，Vimpat片剂和注射剂于2009年5月获批上市，作为一种附加疗法，用于17岁及以上癫痫患者部分发作性癫痫的治疗；Vimpat口服溶液与2010年6月在美国上市。此外，Vimpat也已获批作为一种单药疗法，用于17岁及以上癫痫患者部分发作性癫痫的治疗。
在亚洲，Vimpat片剂、口服溶液、静脉注射液已在韩国、中国香港、马来西亚、菲律宾、泰国、日本上市。目前，Vimpat尚未获得中国食品和药品监督管理总局（CFDA）批准。 
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Medication name
Generic name: Lacosamide - Oral
Pronunciation: (la-KOE-sa-mide)
Brand name(s): Vimpat
Uses
Lacosamide is used to prevent and control seizures. It is an anticonvulsant or antiepileptic drug. It works by reducing the spread of seizure activity in the brain.
How to use
Read the Medication Guide provided by your pharmacist before you start taking lacosamide and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually twice a day with or without food.If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.Dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.This medication works best when the amount of drug in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. To help you remember, take it at the same times each day.Do not stop taking this medication without consulting your doctor. Seizures may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased. Consult your doctor or pharmacist for more details.Though it is very unlikely to occur, this medication can result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently, or use it for a longer period of time than prescribed. Properly stop this medication when so directed. This will lessen the chances of becoming addicted.Tell your doctor immediately if your seizure control worsens (such as the number of seizures increases).
Precautions
Before taking lacosamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as propylene glycol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (such as chest pain, sick sinus syndrome, heart failure, AV block, irregular heartbeat), liver problems, kidney problems (including dialysis treatment), mental/mood problems (such as depression, psychosis).This drug may make you dizzy/drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.The liquid form of this medication may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to limit/avoid aspartame (or phenylalanine) in your diet, ask your doctor or pharmacist about using this medication safely.Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Drug interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).Check the labels on all your medicines (such as cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about using those products safely.
Side effects
Dizziness, drowsiness, blurred/double vision, nausea, vomiting, tiredness, loss of balance, difficulty walking, shakiness (tremor), or memory problems may occur. These side effects are more common when you first start taking the drug and usually lessen as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Seek immediate medical attention if any of these rare but serious side effects occur: fast/slow/irregular/pounding heartbeat, shortness of breath, severe dizziness, fainting.A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.This medication may rarely cause a serious immune system problem (Drug Reaction with Eosinophilia and Systemic Symptoms). Tell your doctor immediately if you experience any of these unlikely but serious side effects: unusual fever, swollen glands, yellowing skin/eyes, unusual tiredness, dark urine, severe stomach/abdominal pain, change in amount of urine, side/back pain (flank pain), bloody/pink urine, chest pain.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Missed dose
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Overdose
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting, difficulty waking up, very slow breathing.
Notes
Do not share this medication with others. It is against the law.Laboratory and/or medical tests (such as liver/kidney tests, EKG) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Medical alert
Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
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20102221004515.pdf