英文药名：DEPAKENE Tablet(Sodium Valproate)

中文药名：丙戊酸钠片

生产厂家：协和发酵麒麟

デパケン錠100mg／デパケン錠200mg

治疗类别名称
抗癫痫药，躁狂，躁狂状态的治疗剂，治疗偏头痛
欧文商標名
DEPAKENE Tablet
一般名
バルプロ酸ナトリウム　Sodium Valproate
化学名
Monosodium 2-propylpentanoate
分子式
C8H15NaO2=166.19
化学構造式

性状
白色结晶性粉末，有一种特有的气味，味道微苦。
本产品是吸湿（高吸湿性强，逐渐在空气中潮解）。
可溶性
非常易溶于水，易溶于乙醇（99.5）或乙酸（100）。
分配系数
logP'OCT=0.26
（测量方法：摇瓶法正辛醇/pH7.4缓冲溶液）
操作注意事项
由于这种药物是吸湿性强，它不会从PTP片服用之前删除直到而已。此外，（不要试图收拾配药取出从PTP片这种药物的）请注意，不要损坏存储上的PTP表。
适应病症
1. 治疗各种癫痫（小发作，局灶性发作，精神运动性发作，以及混合性发作），并与人格行为障碍癫痫（情绪不好，烦躁等）
2. 躁狂症和躁狂抑郁症的躁狂状态的治疗
3. 抑制偏头痛发作的发病
用法用量与每次疗效或作用
1. 治疗各种癫痫（小发作，局灶性发作，精神运动性发作，以及混合性发作），并与人格行为障碍癫痫（情绪不好，烦躁等）
2. 躁狂症和躁狂抑郁症的躁狂状态的治疗
每日剂量分为每天400-1,200mg，分二到三次报用。然而，适当增加或根据患者的年龄和症状减少。
3. 抑制偏头痛发作的发病
每天口服为400-800毫克，分二到三次服用。此外，虽然适当增加或者根据患者的年龄和症状有所下降，但不超过1000毫克作为每日剂量。
药效药理
1. 药理作用
(1) 最大冲击抽搐（小鼠，大鼠，兔），士的宁惊厥（小鼠），印防己毒素抽搐（小鼠），听源性惊厥（鼠），无氧惊厥（小鼠），笔四唑惊厥（小鼠，兔），Bemeguraido抽搐（小鼠）压制。
(2) 抑制全身性癫痫模型（狒狒），惊厥（鼠标）的光致惊厥。
(3) 钴重点癫痫部分性癫痫模型（CAT）的，镇压点燃惊厥（猫）。
(4) 在出院后海马和抑制杏仁核的阵发性排出。 （兔子）
(5) 大幅抑制肌精振动的促进作用，由于脑网状刺激。 （兔子）
(6) 躁狂症的动物模型，显著抑制因右苯丙胺和氯齐亚零丙醇的组合施用的自发运动促进效果。 （小鼠，大鼠）
2.作用机序
通过这种药物的给药脑GABA浓度，与多巴胺浓度的上升沿，已观察到的血清素代谢加速。从这些事实，这种药物的抗癫痫作用已被估计的基础上在脑中通过神经递质的作用抑制系统的活化作用。
GABA神经传递促进作用被认为可能也为抗躁作发展的抑制作用，对偏头痛发作作用。
包装规格
片剂
100毫克：
[PTP]100片（10片×10）[PTP]1000片（10片×100）

200毫克：
[PTP]100片（10片×10）[PTP]1000片（10片×100）[PTP]3000片（10片×300）

制造厂商
协和发酵麒麟有限公司

DEPAKENE Tablets 100mg [antiepileptic drug, medication for mania and manic state/medication for migraine]（デパケン錠100mg［抗癫痫药，躁狂，躁狂状态的治疗剂/偏头痛治疗剂］） 
Brand name : DEPAKENE Tablets 100mg [antiepileptic drug, medication for mania and manic state]
　Active ingredient: Sodium valproate
　Dosage form: yellow tablet, φ: 8.2 mm, thickness: 4.2 mm
　Print on wrapping: KH102 100mg デパケン
DEPAKENE Tablets 200mg [antiepileptic drug, medication for mania and manic state/medication for migraine]（デパケン錠200mg［抗癫痫药，躁狂，躁狂状态的治疗剂/偏头痛治疗剂］）
Brand name : DEPAKENE Tablets 200 mg[medication for migraine]
　Active ingredient: Sodium valproate
　Dosage form: yellow tablet, φ: 9.2 mm, thickness: 4.9 mm
　Print on wrapping: KH103 200mg デパケン
Effects of this medicine
This medicine is considered to suppress development of migraine via gamma-aminobutyric acid (GABA, an inhibitory neurotransmitter) in the brain.
It is usually used in the treatment of migraine to prevent or relieve development of migraine. It does not improve migraine which has already developed.
Before using this medicine, be sure to tell your doctor and pharmacist
•If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
If you are a patient with hepatic disorder, encephalopathy or coma of unknown cause, or urea cycle disorder.
If you have a family history of infant death of unknown cause.
•If you are pregnant, possible 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, take 2 to 4 tablets (400-800 mg of the active ingredient) daily, in two or three divided doses. The dosage may be adjusted according to the age or symptoms. However, the dosage is restricted up to 5 tablets (1,000 mg) a day. Strictly follow the instructions.
•If you missed a dose, take a dose as soon as possible. After taking the medicine, wait about 4 hours to take the next dose. You should never take two doses at one time.
•If you accidently took too much of the medicine (more than instructed), check with your doctor/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, lowering of attentiveness, concentration and reflex motor activities. Avoid driving a car or operating dangerous machinery.
Possible adverse reactions to this medicine
The most commonly reported adverse reactions include somnolence, ataxia or light-headed feeling, nausea, vomiting, loss of appetite, gastrointestinal disorder and general malaise. 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.
•general malaise, loss of appetite, nausea, yellowing in skin and white of eyes  [hepatic disorder such as fulminant hepatitis]
•general malaise, loss of appetite, somnolence, light-headed feeling  [consciousness disturbance associated with hyperammonemia]
•general malaise, dizziness, bruise  [hemolytic anemia, pure red-cell aplasia, pancytopenia, thrombocytopenia, granulocytopenia]
•intense abdominal pain, fever, nausea  [acute pancreatitis]
•fever, general malaise, loss of appetite, rash  [oculomucocutaneous syndrome, toxic epidermal necrolysis]
•dry cough, shortness of breath, fever [interstitial pneumonia, eosinophilic pneumonia]
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
•This medicine is susceptible to moisture. Store with care, do not take out the tablet from the sheet or damage the package.
•Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
•Discard the remainder. Do not store them.
Kyowa Hakko Kirin Co.,LtdInternal
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/1139004F1096_1_03/