英文药名: Mysoline(primidone tablets) 中文药名: 扑米酮片,扑癫酮片,去氧苯巴比妥片,麦苏林 药品名称 通用名: 扑米酮片 曾用名: 扑癫酮片、去氧苯巴比妥片、麦苏林、Mysoline 英文名: PRIMIDONE TABLETS 药品类别: 抗癫痫药 性状: 本品为白色片。 药理毒理 本品为抗癫癎药。在体内的主要代谢产物为苯巴比妥共同发挥作用。体外电生理实验见其使神经细胞的氯离子通道开放，细胞过极化，拟似γ-氨基丁酸(GABA) 的作用。在治疗浓度时可降低谷氨酸的兴奋作用、加强γ-氨基丁酸的抑制作用，抑制中枢神经系统单突触和多突触传递，导致整个神经细胞兴奋性降低，提高运动皮质电刺激阈。使发作阈值提高，还可以抑制致癎灶放电的传播。 药代动力学 口服胃肠道吸收较快，但慢于苯巴比妥。小儿的生物利用度约92%。口服3~4小时血药浓度达峰值（0.5~9小时），血浆蛋白率结合率较低，约为20%，分布广泛，体内分部广范，表观分布容积一般为0.6L/kg，T1/2约10~15小时。由肝脏代谢为活性产物苯乙基二酰胺（PEMA）和苯巴比妥，前者T1/2为24~48小时，后者成人T1/2为50~144 小时，小儿为40~70小时。成人被吸收的扑米酮15~25%转化为苯巴比妥，服药一周血药浓度达稳态，血浆有效浓度为10~20μg/ ml。给药后约20~40%以扑米酮、30%以PEMA、25% 以苯巴比妥的形式由肾排泄。可通过胎盘、可分泌入乳汁。 适应症 用于癫癎强直阵挛性发作（大发作），单纯部分性发作和复杂部分性发作的单药或联合用药治疗。也用于特发性震颤和老年性震颤的治疗。 用法用量 成人常用量：50mg开始，睡前服用，3日后改为每日2次，一周后改为每日3次，第10日开始改为250mg，每日3次，总量不超过每日1.5g；维持量一般为250mg，每日3次。 小儿常用量： 8岁以下，每日睡前服50mg；3日后增加为每次50mg，每日2次；一周后改为100mg，每日2次；10日后根据情况可以增加至125mg~250mg，每日3次；或每日按体重10~25mg/kg分次服用。8岁以上同成人。 任何疑问，请遵医嘱！ 不良反应 1.患者不能耐受或服用过量可产生视力改变，复视，眼球震颤，共济失调，认识迟钝，情感障碍，精神错乱，呼吸短促或障碍。 2.少见的有儿童和老人者为异常的兴奋或不安等反常反应。 3.偶见有过敏反应（呼吸困难，眼睑肿胀，喘鸣或胸部紧迫感），粒细胞减少，再障、红细胞发育不良，巨细胞性贫血。 4.发生手脚不灵活或引起行走不稳、关节孪缩，眩晕、嗜睡。少数患者出现性功能减退、头痛、食欲不振，疲劳感，恶心或呕吐，但继续服用往往会减轻或消失。可出现中毒性表皮坏死。 禁忌症 下列情况慎用： 1.肝肾功能不全者（可能引起本品在体内的积蓄）。 2.有卟啉病者（可引起新的发作） 3.哮喘、肺气肿或其他可能加重呼吸困难或气道不畅等呼吸系统疾患。 4.可引起轻微脑功能障碍的病情加重。 注意事项 1.对巴比妥类过敏者对本品也可能过敏。 2.对诊断的干扰：血清胆红素可能降低，酚妥拉明试验可出现假阳性，如需作此试验需停药至少24小时，最好48~72小时。 3.个体间血药浓度差异很大，用药需个体化。 4.停药时用量应递减，防止重新发作。 5. 治疗期间需按时服药，发现漏服应尽快补服，但距下次给药前1小时内则不必补服，勿一次服用双倍量。 6.用药期间应注意检查血细胞计数，定期测定扑米酮及其代谢产物苯巴比妥的血药浓度。 孕妇及哺乳期妇女用药 本品能通过胎盘，可能致畸，也有胎儿发生苯妥英综合征的报道（生长迟缓，颅面部及心脏异常，指甲及指节的发育不良）。通过胎儿肝酶诱导可导致维生素K缺乏，在妊娠最后一个月应补充维生素K，防止新生儿出血，患者怀孕后应尽量减少合并用药。本品分泌入乳汁可致婴儿中枢神经受到抑制或嗜睡。 儿童用药 少数可出现反应异常，如烦躁不安和兴奋，也易引起严重嗜睡应少用。 老年患者用药 少数可出现认知功能障碍，烦躁不安，兴奋或嗜睡。 药物相互作用 1. 饮酒、全麻药、具有中枢神经抑制作用的药、注射用硫酸镁与本品合用时可增加中枢神经活动或呼吸的抑制用量需调整。 2. 与抗凝药、皮质激素、洋地黄、地高辛、盐酸多西环素或三环类抗抑郁药合用时，由于苯巴比妥对肝酶的诱导作用，使这些药物代谢增快而疗效降低。 3. 与单胺氧化酶抑制药合用时，本品代谢抑制可能出现中毒。 4. 本品可减低维生素B12 的肠道吸收，增加维生素C由肾排出，由于肝酶的正诱导，可使维生素D代谢加快。 5. 与垂体后叶素合用，有增加心律失常或冠脉供血不足的危险。 6. 与卡马西平合用，由于两者相互的肝酶正诱导作用而疗效降低，应测定血药浓度。 7. 与其他抗癫痫药合用，由于代谢的变化引起癫癎发作的形式改变，需及时调整用量。 8. 与丙戊酸钠合用，本品血浓增加，同时丙戊酸半衰期缩短，应调整用量，避免引起中毒。不宜与苯巴比妥合用。与苯妥因钠合用时本品代谢加快。与避孕药合用时可致避孕失败。   包装规格： 250mg*100 片 125mg*100 片 250mg*100 片  Mysoline Generic Name: primidone Dosage Form: tablet Mysoline® (primidone, USP) Anticonvulsant Primidone  is used for treating and preventing seizures. It may be taken alone or with other medicines. How to take Take Primidone by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Taking Primidone at the same time each day will help you remember to take it. Continue to take Primidone even if you feel well. Do not miss any doses. Side effects Check with your doctor if any of these most common side effects persist or become bothersome: Dizziness, drowsiness, incoordination, lightheadedness, loss of appetite, nausea, vomiting. Seek medical attention right away if any of these severe side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased sexual ability; double vision or unusual eye movements; fever, mood or mental changes; unusual tiredness or weakness. Symptoms of overdose may include confusion, trouble breathing, uncontrolled eye movement. If you suspect an overdose of Primidone, seek medical attention immediately. Precaution Do NOT use Primidone if: you are allergic to any ingredient in Primidone or to phenobarbital; you have the blood disease porphyria; you are taking sodium oxybate (GHB). Contact your doctor or health care provider right away if any of these apply to you. Before using Primidone: Some medical conditions may interact with Primidone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you: if you have a history of drug abuse or dependence, depression, or suicidal thoughts or behaviors; if you have liver problems, lung problems, or breathing problems. Primidone may cause drowsiness, dizziness, lightheadedness, and vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Primidone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Primidone may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it. It may take several weeks for Primidone to work well. Do not stop taking Primidone without talking with your doctor. Hormonal birth control (eg, birth control pills) may not work as well while you are using Primidone. To prevent pregnancy, use an extra form of non-hormonal birth control (eg, condoms). Tell your doctor or dentist that you take Primidone before you receive any medical or dental care, emergency care, or surgery. Lab tests, including blood counts, may be performed while you use Primidone. These tests may be used to monitor your condition or check for side effects. Primidone may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Primidone while you are pregnant. Primidone is found in breast milk. Do not breast-feed while taking Primidone. Do not suddenly stop taking Primidone. If you need to stop Primidone or add a new medicine, your doctor will gradually lower your dose. If you suddenly stop taking Primidone, you may experience withdrawal symptoms, including anxiety, muscle twitching, trembling hands and fingers, weakness, dizziness, hallucinations, nausea, vomiting, sleeplessness, lightheadedness, or seizures. Drug interactions Tell your health care provider if you are taking any other medicines, especially any of the following: Sodium oxybate (GHB), stiripentol, or valproic acid because the risk of severe side effects such as severe drowsiness and incoordination may be increased; Anticoagulants (eg, warfarin), beta-blockers (eg, propranolol), clozapine, corticosteroids (eg, prednisone), doxycycline, estrogen, hydantoins (eg, phenytoin), metronidazole, oral contraceptives (eg, birth control pills), quinidine, or theophylline because their effectiveness may be decreased by Primidone. This may not be a complete list of all interactions that may occur. Ask your health care provider if Primidone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine. Missed dose If you miss a dose of Primidone, take it as soon as possible. If it is within 1 hour of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Storage Store Primidone at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, light, and moisture. Keep this medicine out of the reach of children and away from pets.