UCB癫痫症治疗药Keppra静脉注射剂获得了FDA的批准，它是近期在美国获准的唯一一种含口服剂和注射剂的抗痫药。 Keppra用作局部发作性癫痫症成人患者的辅助治疗药。之前，它已具备片剂和口服液两种剂型，刚获准的注射剂将在癫痫症急性发作时使用。 Keppra已成为UCB最热销的药物，而它的注射剂将进一步推动其销量。 部分中文Keppra处方资料（仅供参考） 通用名称为Keppra，Enbrel 左乙拉西坦500毫克，750mg; EXT - REL选项卡。 法律分类： 接收 制造商的Keppra，Enbrel 联合银行公司 主治为Keppra，Enbrel ≥16yrs岁的患者部分性发作的附属物。 成人剂量为Keppra，Enbrel ≥16yrs：最初1克每日一次，可能会增加每隔2周1g/day递增;最大3g/day。肾损害：肌酐清除率50-80mL/min：每24小时1 - 2G，肌酐清除率30-50mL/min：1.5克500毫克，每24小时肌酐清除率<30mL/min：500毫克，1G每24小时;对透析的ESRD患者：使用左乙拉西坦立即释放。 儿童剂量为Keppra，Enbrel <16yrs：不推荐。 另外： Keppra，Enbrel作者 Keppra，Enbrel作者注射 Keppra，Enbrel作者口头解决方案 为Keppra，Enbrel警告/注意事项 肾功能受损。自杀倾向（监视器）。避免突然停止。长者（考虑监测肾功能）。劳动和交付。怀孕（Cat.C）。哺乳的母亲：不推荐。 Keppra，Enbrel的不良反应 嗜睡，乏力，感染，头晕，协调困难（例如，共济失调，步态异常），情绪和行为异常（例如，烦躁，愤怒，抑郁，焦虑，冷漠），颈部疼痛，咽炎，血液学异常;罕见的精神病症状。儿童：还意外伤害，敌意，紧张。 ：还恶心。 为Keppra，Enbrel的注意事项 注册暴露致电（888）537-7734左乙拉西坦怀孕的患者。 Keppra，Enbrel的是如何提供的？ 750mg-120标签250毫克，500毫克，1000毫克，60 XR- 60; Soln- PT;单用小瓶（5毫升）-10 --------------------------------------------------------------- 原产地英文商品名: KEPPRA 250mg/tab 120tabs/bottle 原产地英文药品名: LEVETIRACETAM 中文参考商品译名: 开浦兰 250毫克/片 120片/瓶 中文参考药品译名: 左乙拉西坦 生产厂家中文参考译名: UCB INC 生产厂家英文名: UCB INC --------------------------------------------------------------- 原产地英文商品名: KEPPRA 500mg/tab 120tabs/bottle 原产地英文药品名: LEVETIRACETAM 中文参考商品译名: 开浦兰 500毫克/片 120片/瓶 中文参考药品译名: 左乙拉西坦 生产厂家中文参考译名: UCB INC 生产厂家英文名: UCB INC --------------------------------------------------------------- 原产地英文商品名: KEPPRA 750mg/tab 120tabs/bottle 原产地英文药品名: LEVETIRACETAM 中文参考商品译名: 开浦兰 750毫克/片 120片/瓶 中文参考药品译名: 左乙拉西坦 生产厂家中文参考译名: UCB INC 生产厂家英文名: UCB INC --------------------------------------------------------------- 原产地英文商品名: KEPPRA 1000mg/tab 60tabs/bottle 原产地英文药品名: LEVETIRACETAM 中文参考商品译名: 开浦兰 1000毫克/片 60片/瓶 中文参考药品译名: 左乙拉西坦 生产厂家中文参考译名: UCB INC 生产厂家英文名: UCB INC --------------------------------------------------------------- KEPPRA is an antiepileptic drug available as 250 mg (blue), 500 mg (yellow), 750 mg (orange), and 1000 mg (white) tablets and as a clear, colorless, grape-flavored liquid (100 mg/mL) for oral administration. The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Levetiracetam is chemically unrelated to existing antiepileptic drugs (AEDs). Levetiracetam is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104.0 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL) and practically insoluble in n-hexane. (Solubility limits are expressed as g/100 mL solvent.) KEPPRA tablets contain the labeled amount of levetiracetam. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, talc, titanium dioxide, and additional agents listed below: 250 mg tablets: FD&C Blue #2/indigo carmine aluminum lake 500 mg tablets: iron oxide yellow 750 mg tablets: FD&C yellow #6/sunset yellow FCF aluminum lake, iron oxide red KEPPRA oral solution contains 100 mg of levetiracetam per mL. Inactive ingredients: ammonium glycyrrhizinate, citric acid monohydrate, glycerin, maltitol solution, methylparaben, potassium acesulfame, propylparaben, purified water, sodium citrate dihydrate and natural and artificial flavor. INDICATIONS KEPPRA is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. DOSAGE AND ADMINISTRATION KEPPRA is indicated a s adjunctive treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. KEPPRA is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Partial Onset Seizures Adults 16 Years And Older In clinical trials, daily doses of 1000 mg, 2000 mg, and 3000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose (see Clinical Studies), a consistent increase in response with increased dose has not been shown. Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg BID). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Doses greater than 3000 mg/day have been used in open-label studies for periods of 6 months and longer. There is no evidence that doses greater than 3000 mg/day confer additional benefit. Pediatric Patients Ages 4 To < 16 Years Treatment should be initiated with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg BID). The daily dose should be increased every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg BID). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 52 mg/kg. Patients with body weight ≤ 20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution. Table 15 below provides a guideline for tablet dosing based on weight during titration to 60 mg/kg/day. Only whole tablets should be administered. KEPPRA is given orally with or without food. HOW SUPPLIED KEPPRA 250 mg tablets are blue, oblong-shaped, scored, film-coated tablets debossed with "ucb 250" on one side. They are supplied in white HDPE bottles containing 120 tablets (NDC 50474- 594-40). KEPPRA 500 mg tablets are yellow, oblong-shaped, scored, film-coated tablets debossed with "ucb 500" on one side. They are supplied in white HDPE bottles containing 120 tablets (NDC 50474-595-40). KEPPRA 750 mg tablets are orange, oblong-shaped, scored, film-coated tablets debossed with "ucb 750" on one side. They are supplied in white HDPE bottles containing 120 tablets (NDC 50474-596-40). KEPPRA 1000 mg tablets are white, oblong-shaped, scored, film-coated tablets debossed with “ucb 1000” on one side. They are supplied in white HDPE bottles containing 60 tablets (NDC 50474-597-66). KEPPRA 100 mg/mL oral solution is a clear, colorless, grape-flavored liquid. It is supplied in 16 fl. oz. white HDPE bottles (NDC 50474-001-48). Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].