英文药名: Banzel(Rufinamide Tablets)

中文药名: 卢非酰胺片

生产厂家: Eisai Inc.

药品简介

Banzel (卢非酰胺(rufinamide))片, 此药也称为: Inovelon
批准日期：2008年11月14日；
公司：Eisai Medical Research Inc.
一般描述：BANZEL(rufinamide)是一种三唑衍生物结构上与当前上市的抗癫痫药 (AEDs)无关。化学名1-[(2,6-difluorophenyl)methyl]-1H-1,2,3-triazole-4 carboxamide。经验式C10H8F2N4O和a相对分子量238.2。

适应症：BANZEL (rufinamide)适用于4岁和以上儿童及成年伴Lennox-Gastaut综合征癫痫发作的辅助治疗。

用法用量：
4岁和以上Lennox-Gastaut综合征儿童：开始治疗应每天剂量接近10 mg/kg/day分成等同量2次给药。每隔天剂量应增量接近10 mg/kg至目标剂量45 mg/kg/day或3200 mg/day，以较小为准，分成等同量2次给药。不清楚低于目标剂量是否有效。
Lennox-Gastaut综合征成年：开始治疗应每天剂量400?800 mg/day分成等同量2次给药。每2天应增加400-800 mg/day直至最大量每天剂量达到3200 mg/day，分成等同量2次给药。不清楚低于3200 mg是否有效。

禁忌症：家族性短QT综合征患者禁用BANZEL。

不良反应：BANZEL-治疗患者中，当在所有研究剂量(200至3200 mg/day)用作辅助治疗。发生频率高于安慰剂最常观察到(≥10%)不良反应是：头痛、眩晕、疲乏、嗜睡、和恶心。

*日本卫材公司（Eisai）的英国子公司近日接到了欧洲人用药委员会对抗癫痫药Inovelon (Rufinamide，卢非酰胺)的上市批准， 作为Lennoh-Gastaut综合征（LGS）的辅助治疗药物。LGS是一种预后不良的儿童难治性癫痫综合征，起病年龄是1～7岁。
Inovelon是一种新分子实体，作为一种广谱的抗癫痫药最先被诺华公司开发，2004年许可给卫材公司。
卫材公司目前致力于神经系统药物的开发销售，公司目前的产品包括用于治疗阿尔茨海默病的多奈哌齐（donepezil），抗癫痫药唑尼沙胺(zonisamide)。

包装规格：

·100mg 30 片
·200mg 60 片
·400mg 60 片

Banzel Generic Name: Rufinamide (roo-FIN-a-mide)Brand Name: Banzel
Banzel is used for:
Treating seizures in certain patients with Lennox-Gastaut syndrome.

Banzel is an anticonvulsant. Exactly how it works is not known, but it may work by slowing abnormal nerve impulses in the brain.

Do NOT use Banzel if:
you are allergic to any ingredient in Banzel
you or a family member has a history of certain heart problems (eg, short QT syndrome)
you have severe liver problems
Contact your doctor or health care provider right away if any of these apply to you.

Before using Banzel :
Some medical conditions may interact with Banzel . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of heart problems or if you take a medicine that affects your heart rate
if you have a history of mental or mood problems (eg, depression) or suicidal thoughts or actions
if you are on dialysis
if you have liver problems
Some MEDICINES MAY INTERACT with Banzel . Tell your health care provider if you are taking any other medicines, especially any of the following:

Valproic acid because the risk of its side effects may be increased by Banzel
Carbamazepine, phenobarbital, phenytoin, or primidone because they may decrease Banzel 's effectiveness
Phenobarbital or phenytoin because the risk of their side effects may be increased by Banzel
Carbamazepine, lamotrigine, oral contraceptives (eg, birth control pills), or triazolam because their effectiveness may decreased by Banzel
This may not be a complete list of all interactions that may occur. Ask your health care provider if Banzel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Banzel :
Use Banzel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Banzel comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Banzel refilled.
Take Banzel by mouth with food.
Do not suddenly stop taking Banzel or your other seizure medicines. You may have an increased risk of side effects (eg, seizures). If you need to stop Banzel or add a new medicine, your doctor will gradually lower your dose.
Taking Banzel at the same time each day will help you remember to take it.
Take Banzel on a regular schedule to get the most benefit from it.
Continue to take Banzel even if you feel well. Do not miss any doses.
If you miss a dose of Banzel , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Banzel .

Important safety information:
Banzel may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Banzel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Banzel ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Do NOT take more than the recommended dose without checking with your doctor.
Banzel may increase the risk for suicidal thoughts or actions in some patients. Watch patients who take Banzel closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
Contact your health care provider if your seizures become worse, if you have a new type of seizure, or if you develop a rash associated with a fever.
Tell your doctor or dentist that you take Banzel before you receive any medical or dental care, emergency care, or surgery.
Hormonal birth control (eg, birth control pills) may not work as well while you are using Banzel . To prevent pregnancy, use an extra form of birth control (eg, condoms).
Lab tests, including complete blood cell counts and liver function tests, may be performed while you use Banzel . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Banzel with caution in the ELDERLY; they may be more sensitive to its effects.
Banzel should be used with extreme caution in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Banzel while you are pregnant. Banzel is found in breast milk. Do not breast-feed while taking Banzel .
Possible side effects of Banzel :
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; drowsiness; headache; nausea; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); appetite changes; behavioral, mental, or mood changes (eg, aggression, agitation, anger, anxiety, depression, mania); blood in the urine; changes in the amount of urine produced; blurred vision or other vision changes; decreased coordination or trouble walking; fever; irregular heartbeat; new or worsening seizures; severe or persistent dizziness, drowsiness, tiredness, or weakness; sore throat; suicidal thoughts or attempts; tremor; trouble sleeping.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Banzel :
Store Banzel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Banzel out of the reach of children and away from pets.