英文药名：TOPINA（Topiramate Tablets）
中文药名：托吡酯片
生产厂家：协和发酵麒麟
トピナ錠25mg／トピナ錠50mg／トピナ錠100mg
治疗类别名称
抗癫痫药
批准上市日期：1995年7月[儿童使用：2013年11月]
欧文商標名
TOPINA Tablets
一般名
トピラマート Topiramate
化学名
（-）-2, 3：4, 5-Di-O-isopropylidene-β-D-fructopyranose sulfamate
分子式
C12H21NO8S＝339.36
化学構造式
性状
为白色结晶，而不是臭，味微苦。
可溶性
易溶于甲醇或乙醇（99.5），微溶于水。
分配系数
logP'OCT= 0.59
（测量方法：摇瓶法正辛醇/ pH7的缓冲溶液）
药效药理
1.药理作用
(1) 抑制震动抽搐（大鼠，小鼠）。
(2) 抑制部分性癫痫模型（鼠）的火种抽搐。
(3) 强直性惊厥和缺乏遗传性癫痫模型（自发癫痫大鼠）神的攻击，抑制惊厥（DBA/ 2鼠标）。
(4) 短暂性Nokyo血液和出生后抑制低氧负荷诱发惊厥（鼠）。
2.作用机制
通过这种药物，它的出现抑制受到持久性去极化脉冲发射频率，抑制L型钙电流，抑制红藻氨酸诱发内向电流，通过GABAA受体推广和GABA氯离子涌入人类碳酸酐酶观察到酶（Ⅱ型和IV型）的抑制。从这些事实，这种药物的抗癫痫作用是电压依赖性钠通道抑制作用，电压依赖性L-型钙通道抑制作用，AMPA（α氨基-3-羟基-5-甲基异恶唑-4-丙酸）/红藻氨酸盐型谷氨酸盐受体功能抑制作用，估计是基于所述GABA A受体功能增强GABA的存在效果和碳酸酐抑制作用。
适应症
联合治疗抗癫痫药物对其它抗癫痫药物中充分的效果没有观察到癫痫患者的部分发作（有或没有继发性全身性发作）
用法与用量
成人：
成年人；每日口服二次，每次50毫克。之后，逐渐在一个星期或以上的时间间隔的增加，分割的日剂量为200-400毫克的口服给药两次作为维持剂量。此外，虽然根据症状，每天多达600毫克的最高剂量调整。
小児：
2岁以上的孩子开始与每日剂量为1mg/kg的口服给药，增加至每日剂量为2mg/kg的具有两个以上周的间隔。此后，在两周的时间间隔或更逐渐增加少于为2mg/kg的作为单一的每日剂量的6毫克/千克口服给药维持剂量每日剂量。可以根据症状，每天和最多的为9mg/kg或600mg的一个小小的剂量的最高剂量调整。此外，无论分为每日两次口服。
包装规格
片剂
25毫克：[PTP]100片（10片×10）[瓶装]500粒
50毫克：[PTP]100片（10片×10）[瓶装]500粒
100毫克：[PTP]100片（10片×10）[瓶装]500粒
制造厂商
协和发酵麒麟有限公司
完整资料附件：http://www.info.pmda.go.jp/go/pack/1139008F1027_1_12/
New release of anti epileptic drug "Topina ® tablets 50 mg, 100 mg"
September 26, 2007
Kyowa Hakko (President: Chiyoda-ku, Tokyo: President: Joe Matsuda) began selling on September 26, 2007 on "Topina ® Tablets 50 mg" and "Topina ® Tablets 100 mg" (Generic name: Topiramate) I will let you know.
Topiramate is an antiepileptic drug created in the United States, was approved in the United Kingdom in 1995 and then in the United States in 1996 and is currently approved in more than 100 countries.
In Japan, our company has undergone clinical development and "efficacy of combination therapy with antiepileptic drugs for partial seizures (including secondary generalized seizures) of epilepsy patients who are not adequately effective with other antiepileptic drugs" · Acquired approval on July 31st this year with effect, listed on the drug price standard on September 21st.
Since 1975, we have sought to market antiepileptic drugs "Depapen ®", and we have various types of tablets (syrup, fine grain, sustained release formulation), mainly contributing to the treatment of general epilepsy, We believe that by adding "Topina ® tablets" which have an effect of suppressing the seizure of partial epilepsy of intractable epilepsy, we can contribute and contribute to the field of epilepsy treatment even more.
【Product summary of Anti epileptic drug Topin® tablet 50mg, same 100mg】 Product name "Topina ® tablet 50mg", "Topina ® tablet 100mg" (common name: Topiramate / Topiramate)
Indications / Combination therapy with antiepileptic drugs for partial seizures (including secondary generalized seizures) of epilepsy patients who are not adequately effective with other antiepileptic drugs
Dosage / dosage Usually for adults start as a single dose of 50 mg once daily or twice daily orally as topiramate. Thereafter, it gradually increases at intervals of 1 week or more, and the daily dose of 200 to 400 mg is orally administered as a maintenance dose in two divided doses. Incidentally, depending on the symptoms, it will be increased or decreased appropriately, but the maximum daily dose should be 600 mg.
Main features Anti-convulsant action with a wide range of action mechanisms including AMPA / kainate type glutamate receptor function inhibitory action etc.
Side effects The side effects in domestic II / III phase and long-term administration tests are recognized in 228 cases (75.2%) out of 303 cases. The main side effects were somnolence 90 cases (29.7%), weight loss 75 cases (24.8%), floating dizziness 44 cases (14.5%), anorexia and bulimia syndrome 32 cases (10.6%),
Approval Date of acquisition July 31, 2007
Drug price standard
Listing date September 21, 2007
Sales start date September 26, 2007
Manufacturer Distributor Kyowa Hakko Kogyo Co., Ltd.