英文药名：Inovelon（Rufinamide Tablets）

中文药名：卢非酰胺片

日文药名：イノベロン錠

生产厂家：卫材有限公司
治疗类别名称
抗癫痫药
商標名
Inovelon
一般名
ルフィナミド（Rufinamide）
化学名
1‐(2,6‐Difluorobenzyl)‐1H‐1,2,3‐ riazole‐4‐carboxamide
分子式
C10H8F2N4O
分子量
238.19
構造式

物理化学的性状
卢非酰胺是一种白色结晶粉末。
它是微溶于甲醇和四氢呋喃，乙醇（99.5），并在乙腈和极微溶于，和几乎不溶于水。
适应症：
治疗4岁以上及成人Lennox-Gastaut症候群的癫痫症。
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10mg/kg/day分成等同量2次给药。每隔天剂量应增量接近10mg/kg至目标剂量45mg/kg/day或3200mg/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400-800mg/day分成等同量2次给药。每2天应增加400-800mg/day直至最大量每天剂量达到3200mg/day，分成等同量2次给药。不清楚低于3200mg是否有效。
禁忌症：
家族性短QT综合征患者禁用。
不良反应：
治疗患者中，当在所有研究剂量(200至3200mg/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。
包装规格
片：100毫克100粒（PTP10T×10）
片：200毫克100粒（PTP10T×10）

生产商
日本卫材有限公司
Inovelon Tablets（Rufinamide）
Inovelon Tablets 100 mg（イノベロン錠100mg）
Brand name : Inovelon Tablets 100 mg
　Active ingredient: Rufinamide
　Dosage form: pale red tablet with split line, major axis: about 10.2mm, minor axis: about 5.4 mm, thickness: about 4.0 mm
　Print on wrapping: (Face) イノベロン100mg
(Back) イノベロン, 100mg, Inovelon, E261
Inovelon Tablets 200 mg（イノベロン錠200mg）
Brand name : Inovelon Tablets 200 mg
　Active ingredient: Rufinamide
　Dosage form: pale red tablet with split line, major axis: about 15.2mm, minor axis: about 6.2 mm, thickness: about 4.5 mm
　Print on wrapping: (Face) イノベロン200mg
(Back) イノベロン, 200mg, Inovelon, E262
Effects of this medicine
This medicine suppresses epilepsy seizures by acting on central nervous system.
It is usually used for the treatment of tonic and atonic seizures associated with Lennox-Gastaut syndrome.
Before using this medicine, be sure to tell your doctor and pharmacist
If you have previously experienced any allergic reaction (itch, rash, etc.) to any medicines.
If you have congenital short QT syndrome..
If you are pregnant or breastfeeding.
If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)
Dosing schedule (How to take this medicine)
Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>
In general, for adults and children four years of age or older with a body weight of 30.1 kg or greater, take 400 mg of the active ingredient per day divided in two doses after meals for the first two days. Then, the daily dose should be gradually increased by increments of 400 mg or less every other day. As a maintenance dose, take 1,800 mg per day for patients with a body weight of 30.1 to 50.0 kg, 2,400 mg per day for patients with a body weight of 50.1 to 70 kg, or 3,200 mg per day for patients with a body weight of 70.1 kg or greater, divided in 2 doses after meal. The dosage may be adjusted up to maintenance dose provided that increases are achieved by increments of 400 mg per day or less and no more frequently than every other day.
In general, for children four years of age or older with a body weight of 15.0 to 30.0 kg, take 200 mg of the active ingredient per day divided in two doses after meals for the first two days. Then, the daily dose should be gradually increased by increments of 200 mg or less every other day. As a maintenance dose, take 1,000 mg per day divided in two doses after meal. The dosage may be adjusted up to maintenance dose provided that total dosage not exceed 1,000 mg per day, and that increases are achieved by increments of 200 mg per day or less and no more frequently than every other day. Strictly follow the instructions.
If you miss a dose and your next regularly scheduled dose is more than 6 hours away, take a dose as soon as possible when. However, if your next regularly scheduled dose is less than 6 hours away, skip the missed dose and follow your regular dosing schedule. You should never take two doses at one time.
If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
Do not stop taking this medicine unless your doctor instructs you to do so.
Precautions while taking this medicine
The medicine may cause drowsiness and decreased attention/concentration/reflex action ability, etc. Avoid driving a car or operating dangerous machinery during the treatment.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include somnolence, loss of appetite, vomiting, constipation, and rash. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
rash, fever, swelling of lymph nodes [hypersensitivity syndrome]
fever, eye redness, erythema  [Stevens-Johnson syndrome]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.
Storage conditions and other information
Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
Discard the remainder. Do not store them.
Eisai Co., Ltd. Internal
Revised: 1/2014
The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
http://www.info.pmda.go.jp/go/pack/1139012F1023_1_04/1139012F1023_1_04?view=body