部分中文Keppra处方资料（仅供参考）
7月17日，FDA批准葡萄味，不含染料的Keppra(R)(左乙拉西坦)口服液（100mg/ml）用于那些不喜欢或无法吞咽片剂的癫痫病患者。
FDA于1999年11月已批准keppra片剂用于辅助治疗成人患者癫痫的局限性发作。预计今秋keppra口服液可在在美国店购。
对健康受试者进行的一项比较Keppra口服液与片剂的交叉试验结果显示，10%的Keppra口服液与片剂具有生物等效性。此次试验中报告的药动学参数与以前用片剂对健康受试者进行的临床试验结果类似。两种剂型在AUC，AUC（0-t）及Cmax等参数之间的差异的90%置信区间在80%-125%之间，这一界限说明两者具有生物等效性。
Keppra的常见不良反应多发生在中枢神经系统，如嗜睡，疲劳，协调困难，行为异常，轻度但统计学有显著意义的血液学异常。用药剂量要根据肾功能状态因人而宜。临床对照试验中，与其他抗癫痫药合并用药时，最常出现的不良反应为感染，头晕，无力。
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 3000mg/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].
新型抗癫痫药开浦兰(keppra)左乙拉西坦可以减少脑瘤引起的癫痫发作
一项回顾性研究的结果表明，使用新型抗癫痫药开浦兰左乙拉西坦(keppra)替代传统药物可以减少大脑恶性肿瘤引起的癫痫。
因为左乙拉西坦不经过肝脏代谢，医生称使用此药来控制肿瘤引起的癫痫也可能减少药物相互作用的风险。“脑癌病人常见癫痫，因为病变影响了这一敏感位置”，第一作者、美国克立夫兰医院的斯迪文斯（glen h. j. stevens）说，“脑瘤病人通常在使用多种药物，药物之间的交互作用可能引起一些重要问题”。他在美国神经病学会第57届年会上提交了此研究。
“3年来，我们已给需要抗惊厥治疗的脑瘤病人都换用了左乙拉西坦，它不会诱导肝酶，病人能很好耐受，而且有效”，他说。278人中70%仍只用此药治疗，60%的病人癫痫发作频率减少了50%。
在另一项研究中，俄亥俄州大学的纽顿（herbert newton）发现了相似结果，表明脑瘤病人通过预防癫痫发作生活品质有较大改善。在他的这项回顾性研究中，病人的癫痫发作从每月1次至每天20多次不等，平均每天3次。“我们发现总的癫痫发作减少了87%”，合作者乔尔德拉斯特（samuel goldlust）说，“用左乙拉西坦的病人约59%没有复发”。此药导致37%的病人嗜睡，但病人没因此停药。此研究中的41名病人包括原发性脑癌病人或转移的脑瘤病人.
附件:
20118722492339.PDF
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产地国家:意大利
原产地英文商品名:
KEPPRA SOLUTION 100MG/ML 150MLS/BOTTLE
原产地英文药品名:
LEVETIRACETAM
中文参考商品译名:
开浦兰溶液剂 100毫克/毫升 150毫升/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
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产地国家: 意大利
原产地英文商品名:
KEPPRA SOLUTION 100MG/ML 300MLS/BOTTLE
原产地英文药品名:
LEVETIRACETAM
中文参考商品译名:
开浦兰溶液剂 100毫克/毫升 300毫升/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
该药品相关信息网址1:
http://www.keppra.com/
该药品相关信息网址2:
http://www.chemdrug.com/databases/7_8_uusqriixuwuykhca.html