托吡酯片（Topiramate Tablets）

托吡酯片（Topiramate Tablets） 托吡酯片(Topiramate Tablets) 托吡酯片 (topiramate tablets) (妥泰) 本品主要成分为托吡酯, 其化学名称为2,3: 4.5 - 双 - o - (1 - 甲基亚乙基) -. beta. - d吡喃果糖氨基硫酸酯. 【性状】 【药理毒理】 【药代动力学】 【适应症】 本品用于初诊为癫痫的患者的单药治疗或曾经合并用药现转为单药治疗的癫痫患者. 本品用于成人及2 - 16岁儿童部分性癫痫发作的加用治疗. 【用法用量】 对成人和儿童皆推荐从低剂量开始治疗, 然后逐渐增加剂量, 调整至有效剂量. 本品治疗成人和儿童部分性癫痫发作有效.在对照的加用治疗试验中, 已正实托吡酯血浆浓度与临床疗效无相关性, 尚无证据证明托吡酯在人类中有耐受性, 在承认部分性癫痫发作患者中进行的剂量范围研究得出, 剂量大于400mg / 日 (600、800和1000mg / 日) 并不增加疗效. 应用本品治疗时, 不必监测血浆托吡酯浓度以达到最佳疗效.本品加用苯妥英治疗时, 仅有极少数病例需调整苯妥英的用量以达到最佳临床疗效.在本品加用治疗期间, 加用或停用苯妥英和卡马西平可能需要调整本品的剂量. 进食与否皆可服用本品 加用治疗 成人 (17岁以上) 剂量调整应从每晚25mg开始, 服用1周后, 每间隔1 - 2周递增 0.5-1mg / kg / 日 (分2次服用), 如果儿童不耐受, 应调整剂量, 或降低剂量增加, 或延长和剂量调整时间间隔, 剂量应根据临床疗效进行调整. 成人托吡酯单药治疗, 推荐日总量为100mg, 最高为500mg, 部分难治型癫痫患者可以耐受每日1000mg剂量, 上述推荐的剂量适用于所有成人包括老年人和无肾脏疾患的患者. 2 - 16岁儿童患者 剂量调整应从每晚 0.5-1mg / kg给药开始, 服用1周后, 每间隔1 - 2周递增 0.5-1mg / kg / 日 (分2次服用), 如果儿童不耐受, 应调整剂量法案, 或降低剂量增加量, 或延长剂量调整时间间隔, 剂量应根据临床疗效进行调整. 本品单药治疗, 推荐每日总量为3 - 6mg / kg / 日, 近期诊断为部分性癫痫发作的儿童患者, 日剂量曾达到过500mg. 肾功能受损患者: 推荐肾功能受损的患者 (肌酐清楚率,70ml / my / 1.73?,服用通常成人剂量的一半, 这些患者可能需要稍长的时间达到每个剂量的稳态. 进行血液透析的患者: 托吡酯以正常人4 - 6倍的速度经血液透析清楚, 因此, 延长透析时间可能会导致托吡酯浓度降至维持其抗癫痫疗效所需的浓度以下, 为避免血液透析时托吡酯血浆浓度迅速下降, 可能需补充托吡酯剂量.实际上, 剂量调整应考虑 (1) 透析时间 (2) 透析系统的清除速度, 以及 (3) 透析患者肾脏对托吡酯有效的清除率. 肝病患者 托吡酯在肝受损患者体内的清楚可能降低, 此类患者应慎用本品. 【不良反应】 依据who - art词典对报告的不良事件进行了分类. 加用治疗临床研究 由于托吡酯通常与其他抗癫痫药合用, 因此不可能确定是哪种药物或是哪几种药物与不良事件有关. 成人 几个双盲临床试验, 其中一些采用快速剂量调整, 结果发现事件的发生率大于或等于5%, And the treatment group than the placebo group the incidence of adverse events: drowsiness, dizziness, fatigue, nervousness, ataxia, dysarthria, psychomotor retardation, abnormal vision, memory difficulties and confusion, paresthesia, diplopia, nystagmus, nausea, anorexia, weight loss, language barriers, concentration / attention difficulties, depression abdominal pain, weakness, and emotional disorder. In addition some of the bad time although the incidence is not high, but it might and drug related: dysgeusia, agitation, cognitive impairment, emotional instability, abnormal gait, coordination, apathy, mental illness or mental disorder, or attack response behavior, leukopenia and kidney stones. Although individual cases of thromboembolic events have been reported, the relationship between these drugs and drugs remains unclear. Pediatric patients: Several double-blind clinical trials, some of them with fast dose adjustment, and the treatment group adverse events rate is greater than the placebo composition: lethargy, anorexia, fatigue, nervousness, injury, personality disorder, attention / attention difficulties, attack reaction or behavior, weight loss, abnormal gait, emotional disorder, ataxia, increased saliva, nausea, memory disorders, hyperactivity, dizziness, language and related disorders and abnormal sensation. In addition some adverse events, although the incidence is not high, but it might and drug related: emotional instability, apathy, agitation, cognitive impairment, mental retardation, sports consciousness disorders, hallucinations, depression and leukopenia. Clinical study of single drug therapy The incidence and type of adverse events in monotherapy were similar to those with additional therapy, and only the incidence of paresthesia and fatigue was lower or similar to that of additional therapy. Adult Several double-blind clinical trials showed that the incidence of adverse events in the treatment group was greater than or equal to 10%. Adverse events included paresthesia, headache, fatigue, dizziness, drowsiness, weight loss, nausea and anorexia. children Several double-blind clinical trials showed that the incidence of children in the treatment group was greater than or equal to 10%. Adverse events were headache, fatigue, anorexia, and extreme sleepiness. Post marketing adverse events report There were several reports of liver enzyme elevation in patients treated with topiramate alone or in combination with other drugs. Several cases of hepatitis and liver failure were reported in patients who had been treated with topiramate. Had bullous skin and mucous membrane reactions (including erythema multiforme, pemphigus, Stevens Johnson syndrome and toxic epidermalnecrolysis) the individual reports, most of the patients in these reports are taking bullous skin and mucous membrane reaction and other related drugs. Rare reports of sweating, mainly in children. A rare report of suicidal ideation, attempted or suicide. Report of rare metabolic acidosis. [taboo] It is forbidden to be allergic to this product. [notes] Including this product, anti epileptic drugs gradually stopped to make the possibility of seizure frequency increase to a minimum, in adult trials, weekly reduction 100mg/, in some patients without complications may accelerate the process of withdrawal. The main excretory route of topiramate, the most metabolite, is renal clearance. The renal clearance capacity and renal function, and has nothing to do with age, with moderate or severe renal impairment of the patients reached steady state plasma concentration time may take 10-15 days, and the patients with normal renal function only 4-8 days. The dose adjustment in all cases should be based on clinical efficacy (such as seizures to avoid side effects), and need to know for the known kidney damage in patients reached steady state plasma concentration at each dose time were longer. Adequate water intake should be maintained when taking topiramate, adequate drinking water can reduce the risk of kidney stones. Maintaining adequate water intake before or during exercise or in a higher temperature environment can reduce fever related adverse events. [medication for pregnant and lactating women] [medication for children] [medication for elderly patients] [drug interactions] [drug overdose] [Specification] [TBZP, TT] The front page, the last page, the front page