部份中文丙戊酸钠处方资料（仅供参考） 药品英文名 Valproate Sodium 药品别名 德巴金、丙戊酸钠、二丙二乙酸钠、抗癫灵、扑癫灵、易平痫、丙戊酸、丙戊酸半钠、二丙乙酸、Depakene、Depakin、Depakine、Depakine Chrono、Epilim、Leptilan、Na Valproate、Sodium Valproate 药物剂型 1.片剂：100mg，200mg； 2.肠溶片(相当于丙戊酸)：250mg，500mg； 3.胶囊：200mg，250mg； 4.糖浆剂：200mg(5ml)，500mg(5ml)； 5.注射剂(粉)：400mg； 6.注射剂：400mg(4ml)。 药理作用 丙戊酸钠为一种不含氮的广谱抗癫痫药。动物实验证明，本药对多种方法引起的惊厥，均有不同程度的对抗作用。对人的各型癫痫均有效。抗癫痫作用的机制尚未阐明，可能与影响脑内抑制性神经递质γ-氨基丁酸(GABA)的代谢有关。另外，丙戊酸作用于突触后感受器部位，模拟或加强GABA的抑制作用。 药动学 本药口服后迅速吸收，饭后服用将延迟吸收。口服胶囊与普通片剂后，约1～4h血药浓度达峰值；肠溶片则需3～4h；缓释片在胃内可有少量释放，在肠道缓慢吸收，达峰时间较长，峰浓度较低。各种剂型的生物利用度都接近100%。有效血药浓度为50～100μg/ml。本药主要分布在细胞外液，在血中大部分与血浆蛋白结合，其结合率约为80%～94%，脑脊液中药物浓度为血浆浓度的10%。本药主要在肝中代谢，半衰期为7～10h。主要经肾排泄，少量随粪便排出。 适应证 1.主要用于癫痫失神发作、肌阵挛发作。对全身性强直阵挛发作(大发作)，有时对复杂部分性发作也有一定疗效，但效果较差。 2.预防性治疗偏头痛。 禁忌证 1.对本药过敏者。 2.有肝病或明显肝功能损害者。 3.卟啉病患者。 注意事项 1.慎用： (1)血液疾病患者； (2)有肝病史者； (3)肾功能损害者； (4)器质性脑病患者； (5)孕妇； (6)系统性红斑狼疮患者，因有服用本药后产生免疫异常的报道。 2.药物对儿童的影响：3岁以下的儿童使用本药有肝脏中毒的危险，应避免同时使用水杨酸盐。 3.药物对哺乳的影响：本药可分泌入乳汁，浓度为母体血药浓度的1%～10%，哺乳期妇女应予以注意。 4.药物对检验值或诊断的影响： (1)因本药的酮性代谢产物随尿排出，尿酮试验可出现假阳性； (2)甲状腺功能试验可能受影响； (3)乳酸脱氢酶、丙氨酸氨基转移酶、门冬氨酸氨基转移酶可能轻度升高。并提示无症状性肝脏中毒； (4)血清胆红素可能升高，提示潜在的严重肝脏中毒。 5.用药前后及用药时应当检查或监测： (1)全血细胞(包括血小板)计数； (2)肝、肾功能检查，肝功能在最初半年内最好每1～2月复查1次，半年后复查间隔酌情延长； (3)监测血浆丙戊酸钠浓度。 不良反应 1.神经系统：可见共济失调、无力、异常运动、生理震颤增加、面部及肢体抽搐，偶见中枢过度兴奋症状，失眠。偶可引起继发性全身性抽搐发作。 2.消化系统：常见畏食、恶心、呕吐、胃痛及腹泻，但继续治疗则症状减轻。有发生急性胰腺炎、肝功能不全的报道。少数患者甚至出现肝衰竭而致死亡。 3.血液系统：偶见皮下出血、贫血，白细胞减少或全血细胞减少。 4.内分泌代谢：可见食欲亢进、体重增加。有发生高甘氨酸血症和高甘氨酸尿症的报道。个别患有急性间歇性卟啉症的患者服用本药后可导致急性卟啉症发作。偶见低血糖、Reye-liji综合征。 5.泌尿生殖系统：可见闭经或月经失调。 6.皮肤：少见过敏性皮疹，偶见暂时性脱发。 7.耳：偶可发生可逆或不可逆的听力丧失，但与本药的因果关系尚未明确。 用法用量 1.口服给药：每天按体重15mg/kg或每天600～1200mg，分次服。开始时按体重5～10mg/kg。1周后递增，直至发作得以控制为止。当每天用量超过250mg时，应分次服用，以减少胃肠道刺激。最大量一般为每天按体重30mg/kg，或每天1800～2400mg。 2.静脉注射：癫痫持续状态：每次400mg，每天2次。 バレリン錠100mg／バレリン錠200mg／バレリンシロップ5％ 治疗类别名称 抗癫痫药 躁狂症，躁狂状态治疗药物 偏头痛的治疗剂 商標名 VALERIN Tablets VALERIN Syrup 5% 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 分子量 166.19 構造式 性状 白色の結晶性の粉末である。水に極めて溶けやすく、エタノール(99.5)又は酢酸(100)に溶けやすい。吸湿性である。 取扱い上の注意 ○バレリン錠100mg、バレリン錠200mgは開封後吸湿に注意すること。 ○バレリンシロップ5％の使用後は瓶の口の周囲をよく拭いてからキャップをしめること。(瓶の口からシロップがたれて固まり、キャップがあかない原因となる。) ○安定性試験 バレリン錠100mg、バレリン錠200mg： 最終包装製品を用いた長期保存試験（室温、3年間）の結果、外観及び含量等は規格の範囲内であり、バレリン錠100mg、バレリン錠200mgは通常の市場流通下において3年間安定であることが確認された。 バレリンシロップ5％： 最終包装製品を用いた長期保存試験（室温、4年間）の結果、外観及び含量等は規格の範囲内であり、バレリンシロップ5％は通常の市場流通下において4年間安定であることが確認された。 包装规格 片 100毫克： 100片（10片×10），1000片（10片×100）[PTP]  500粒[瓶] 片 200毫克： 100片（10片×10），1000片（10片×100）[PTP] 500粒[瓶] 糖浆5％：120ML，500毫升 生产厂家 大日本住友制薬 http://www.info.pmda.go.jp/go/pack/1139004F1045_1_23/1139004F1045_1_23?view=body Brand name : VALERIN Tablets 100mg 　Active ingredient: Sodium valproate 　Dosage form: white tablet (φ: 8.1mm, thickness: 4.3mm) 　Print on wrapping: バレリン錠, 100mg, P721 ------------------------------------- Brand name : VALERIN Tablets 200mg 　Active ingredient: Sodium valproate 　Dosage form: white tablet (φ: 10.1mm, thickness: 5.2mm) 　Print on wrapping: バレリン錠, 200mg, P722 ------------------------------------- Brand name : VALERIN Syrup 5% 　Active ingredient: Sodium valproate 　Dosage form: colorless to faintly yellowish clear solution 　Print on wrapping: Effects of this medicine This medicine works on central nerve system and increases GABA concentration in the brain in order to control epilepsy seizure. It also improves unstable mood caused by epilepsy as well as suppresses uncontrollable excitation and behavior, and migraine attack. It is usually used to treat epilepsy of every kinds, character and behavior disorder (bad mood, irritability, etc.) accompanied by epilepsy, mania, and manic-state in bipolar disorder. It also used to suppress migraine attack, however, it should not be used to treat migraine attack 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 hepatopathy or urea cycle disorders. •If you are pregnant, breastfeeding or possibity pregnant. •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>> •For epilepsy, mania, and manic-state in bipolar disorder: In general, for adults, take 8-24mL (400-1,200mg of the active ingredient) in 2-3 divided doses a day. The dose may be adjusted according to your disease, age and symptoms. For suppression of migraine attack: In general, for adults, take 8-16mL (400-800mg of the active ingredient) in 2-3 divided doses a day. The dose may be adjusted according to your age and symptoms. The daily dosage is restricted to 20mL(1,000mg).Strictly follow the instructions in any case. •If you miss a dose, take the missed dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. You should never give two doses at one time. •If you accidentally took 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 •This medicine may cause sleepiness, diminished attention, loss of concentration, decreased reflex motor capacity, etc. Therefore do not drive a car or operate dangerous machinery while taking it. Possible adverse reactions to this medicine The most commonly reported adverse reactions include somnolence, nausea, vomiting 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. •generalized fatigability, loss of appetite, nausea [serious hepatopathy] •flapping tremor, faint consciousness, impaired mind [consciousness disorder accompanied by hyperammonemia] •anemic condition, generalized fatigability, top-heavy feeling [hemolytic anemia, pure red cell aplasia, pancytopenia, thrombocytopenia, granulocytopenia] •bad upper abdominal pain, lumbar backache, fever [acute pancreatitis] •fever, rash, joint pain [interstitial nephritis, Fanconi's 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 heat, moisture and direct sunlight. •Discard the remainder. Do not store them Sumitomo Dainippon Pharma Co.,Ltd.Internal Revised: 5/2012 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.