部份中文丙戊酸钠处方资料（仅供参考）
英文名：Sodium Valproate
商品名：DEPAKENE
中文名：丙戊酸钠片
生产商：协和发酵麒麟
デパケン錠100mg／デパケン錠200mg
药物类别名称
抗癫痫药,躁狂和躁狂治疗,偏头痛治疗剂
批准日期：2012年12月
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
它是一种白色结晶粉末,具有独特的气味,味道略带苦味。
本产品是吸湿性(非常高的吸湿性,逐渐在空气中潮)。
溶解度
水非常可溶性,易溶于乙醇(99.5)或醋酸(100)。
分布系数
日志P_OCT=0.26
(测量方法:烧瓶摇动法n-辛醇/pH7.4缓冲液)
处理注意事项
此代理具有很强的吸湿性,因此在服用之前,请不要将其从PTP表中取下。此外,在存储 PTP 工作表时,请注意不要损坏它(请勿将此代理从PTP纸张中拿出来,并将其放入单个包装中)。
药用药理学
1. 药理作用
(1) 最大登奇抽搐(小鼠、大鼠、兔子)、石氨酸抽搐(小鼠)、皮罗毒素抽搐(小鼠)、听力(大鼠)、无氧抽搐(小鼠)、五氯苯甲酰胺抽搐(小鼠、兔子) 抑制滑体抽搐(小鼠)。
(2) 抑制普通癫痫模型的光诱发抽搐(巴邦)和听力(小鼠)。
(3)部分癫痫模型钴聚焦攻击(猫),以抑制发刺抽搐(猫)。
(4)抑制海马出院后和杏仁核的癫痫发作。(兔子)
(5)通过中脑网络样身体刺激,明显抑制肌肉细振动的增强作用。(兔子)
(6)被认为是一种躁狂动物模型,显著抑制由德异胺和氯二氮联合给药引起的自发性多动。(老鼠,老鼠)
2. 作用机制
通过给药在大脑中GABA浓度,随着多巴胺浓度的增加,血清素代谢得到促进。 从这些事实中,估计该制剂的抗癫痫作用是基于神经递质作用在大脑中抑制系统的激活作用。
对于抗躁狂作用和偏头痛发作的抑制作用也认为GABA神经传播促进作用。
适应症
1. 治疗与癫痫有关的各类癫痫(小发作、焦点攻击、精神运动攻击、混合发作)和人格行为障碍(情绪、易怒等)
2. 躁狂和躁狂抑郁症的治疗
3. 抑制偏头痛发作
用法与用量
1. 治疗与癫痫有关的各类癫痫(小发作、焦点攻击、精神运动攻击、混合发作)和人格行为障碍(情绪、易怒等)
2. 躁狂和躁狂抑郁症的治疗
通常口服2-3次,每天400~1,200mg作为每日剂量的丙丙酸钠。
然而,它适当地增加或减少,取决于年龄和症状。
3. 抑制偏头痛发作
通常口服2-3次,每天400~800mg作为丙丙酸钠。
应该注意的是,它增加或减少酌情取决于年龄和症状,但不超过1000毫克作为每日量。
临床表现
与各类癫痫和癫痫相关的个人行为障碍
(片剂、糖浆)
在日本两例双盲比较试验的临床试验中,对1301例有效测定病例的临床结果摘要如下。
临床表现表参考。
躁狂和躁狂状态躁狂抑郁症
在日本,临床试验中,这种疗效的临床结果是明确的。
在美国获得批准时评估的两个双盲比较测试的结果如下:
(1) 在美国,对179例双相情感障碍患者,丙丙酸进行了双盲比较研究,施用锂或安慰剂3周。结果,该百分比有显著改善(在躁狂评价尺度上提高至少50%或以上),丙丙酸组48%,锂组49%,丙丙酸组和锂组25%安慰剂组均明显优于。在丙丙酸组表示的不良事件的许多事件只是呕吐和疼痛。
(2) 在美国,对36例对锂没有反应或耐受的躁郁症患者,通过双盲比较研究检查了安慰剂对照中丙丙酸的安全性和有效性。结果,躁狂评价尺度总分中位数的变化是安慰剂组丙丙酸组、5%和丙丙酸组的主要疗效评价项目。与安慰剂组相比,丙丙酸组表达不良事件的频率明显较高。
注意)
对于躁狂和躁狂状态的丙丙酸,长期使用超过三周,至今国内外临床试验尚未获得明确的证据。
临床结果表

与癫痫、自主神经攻击等相关的混合性癫痫发作、脑异常、人格和行为障碍。
包装
片
100毫克: [PTP] 100片(10片x10) 1000片(10片x100)
200mg: [PTP] 100片(10片x10) 1000片(10片x100) 3000片(10片x300)
制造厂商
KISSEI药品有限公司
注：以上中文资料不够完整，使用者以原处方资料为准。
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］）
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
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_06/?view=frame&style=SGML&lang=ja