英文药名：HYDANTOL COMBINATION TABLETS（Phenytoin/Phenobarbital） 中文药名：苯妥英/苯巴比妥D.E.F组合片 生产厂家：第一三共公司制药 ヒダントールＤ配合錠／ヒダントールＥ配合錠／ヒダントールＦ配合錠 治疗类别名称 抗癫痫药 商標名 HYDANTOL D COMBINATION TABLETS HYDANTOL E COMBINATION TABLETS HYDANTOL F COMBINATION TABLETS 1. 苯妥英钠 一般名 フェニトイン（Phenytoin） 化学名 5,5-Diphenylimidazolidine-2,4-dione 分子式 C15H12N2O2 分子量 252.27 構造式 性状 白色结晶粉末或颗粒，没有气味和滋味。 乙醇（95）或微溶于丙酮，微溶于乙醚，和几乎不溶于水。 溶于氢氧化钠TS。 熔点 约296℃（分解） 2. 苯巴比妥 一般名 フェノバルビタール（Phenobarbital） 化学名 5-Ethyl-5-phenylpyrimidine-2,4,6(1H,3H,5H)-trione 分子式 C12H12N2O3 分子量 232.24 構造式 性状 它是一种白色晶体或结晶粉末。 N，N-二甲基甲酰胺以非常易溶，乙醇（95）或溶于丙酮，难溶于乙腈，在水中极微溶解。 溶于氢氧化钠TS。 饱和水溶液的pH值是从5.0至6.0。 熔点 175〜179℃ 药效药理 使用只ddY雄性小鼠，通过Hidantoruð组合片剂最大冲击抽搐方法中，E组合片剂，女组合片剂苯妥英钠这是一个组件，苯巴比妥和苯甲酸钠咖啡因的口服给药的抗惊厥作用，以及那些的配合作用它的影响。 药物悬浮于0.3％c.m.c.相对于口服给药，ED 50，LD 50和95％置信限是由里奇菲尔德-的Wilcoxon法算出。 苯妥英单独10.4mg/kg的ED 50，苯巴比妥为19.5mg /公斤，但苯甲酸钠咖啡因没有表现出抗惊厥作用。苯妥英，当与苯巴比妥混合，但在Hidantoru˚F结合的混合比计片剂ED 50是13.87mg/kg时，ED 50通过实验是11.5mg/kg时，也Hidantoruð组合片剂的配合比例虽然在ED 50而言是15.6mg/kg时，在12.8mg /kg时，它被接纳苯妥英钠，造成通过加入苯巴比妥的效果的增强ED 50试验。 适应病症 癫痫发作 强直 - 阵挛性发作（一般发作，大发作），焦点癫痫发作（包括Jackson型攻击） 植物神经性发作，精神运动性发作 用法用量 成人：每天6-12片分割口服。此外，增加或减少取决于患者的年龄和症状。 包装规格 Ｄ组合片：100片（PTP）1000粒（瓶） Ｅ组合片：100片（PTP）1000粒（瓶） F组合片：100片（PTP）1,000片（PTP·瓶） 制造厂商 第一三共有限公司 藤永制药有限公司 HYDANTOL COMBINATION TABLETS（Phenytoin/Phenobarbital） HYDANTOL D COMBINATION TABLETS（ヒダントールD配合錠）  Brand name : HYDANTOL D COMBINATION TABLETS 　Active ingredient: Phenytoin  Phenobarbital  Caffeine and sodium benzoate 　Dosage form: white tablet (φ: 9.1 mm, thickness: 3.8 mm) 　Print on wrapping: HYDANTOL D, ヒダントールD配合錠 HYDANTOL E COMBINATION TABLETS（ヒダントールE配合錠）  Brand name : HYDANTOL E COMBINATION TABLETS 　Active ingredient: Phenytoin  Phenobarbital  Caffeine and sodium benzoate 　Dosage form: white tablet (φ: 9.1 mm, thickness: 3.8 mm) 　Print on wrapping: HYDANTOL E, ヒダントールE HYDANTOL F COMBINATION TABLETS（ヒダントールF配合錠）  Brand name : HYDANTOL F COMBINATION TABLETS 　Active ingredient: Phenytoin  Phenobarbital  Caffeine and sodium benzoate 　Dosage form: white tablet (φ: 9.1 mm, thickness: 3.8 mm) 　Print on wrapping: HYDANTOL F, ヒダントールF Effects of this medicine This medicine contains phenytoin, antiepileptic agents; and phenobarbital, hypnotic sedatives and anticonvulsive as active ingredients; and combines caffeine and sodium benzoate to relieve and prevent drowsiness. It suppresses transmission of hyper-excitement of nerve and shows hypnotic, sedative and anticonvulsive effect. It is usually used in the treatment of convulsive seizure in epilepsy, autonomic seizure, and psychomotor seizure. Before using this medicine, be sure to tell your doctor and pharmacist •If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you are a patient with cardiac disorder, hepatic disorder, renal disorder, pulmonary disorder, or acute intermittent porphyria. •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>> •General dosage regimen: For adults, take 6 to 12 tablets daily, in several divided doses. The dosage may be adjusted according to the diseases, age or symptoms. Strictly follow the instructions of your doctor/pharmacist. •Take a dose as soon as possible when you remember that you missed a dose. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose. •If you took too much of the medicine (more than ordered), check with your doctor/pharmacist. •Do not stop taking the medicine without the instructions of your doctor. Precautions while taking this medicine •The medicine may cause drowsiness; or decline of ability to pay attention, to concentrate or reflex movement. Avoid driving a car or operating dangerous machinery after taking the medicine. •Please note that drinking alcohol may enhance the effect of the medicine. •Avoid foods containing Saint John's Wort as it may diminish the effect of the medicine. Possible adverse reactions to this medicine Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: scarlatiniform rash, measles-like rash, toxic eruption-like rash, etc. 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. •redness and swelling, rash, blisters in the skin or mucosa, fever, red blotches(butterfly shape) on face  [muco-cutaneo-ocular syndrome, toxic epidermal necrosis, exfoliative dermatitis, SLE-like symptoms] •rash, fever, swelling in lymph nodes  [hypersensitivity syndrome] •being unable to stop taking the medicine despite trying to stop it  [dependence] •anemia, nasal or gums bleeding, dizziness  [aplastic anemia, blood disorder such as pancytopenia] •general fatigue, nausea, yellowing in the skin/white of eyes  [fulminant hepatitis, hepatic dysfunction, jaundice] •muscle pain, feeling of weakness, red-brown urine [rhabdomyolysis] 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. •Do not store the remainder and ask your pharmacist how to discard it. Internal Published: 10/2009 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/1139103X1036_1_07/