英文药名: Keppra (Levetiracetam Oral Solution)

中文药名: 左乙拉西坦口服液,开浦兰

生产品牌药厂家: UCB Pharma Inc

药品简介

UCB公司表示欧洲人用药委员会(CHMP)支持批准癫痫病药Keppra(左乙拉西坦)作为辅助药物用于治疗1个月到4岁的婴儿与儿童的癫痫部分性发作。支持此项批准的数据来自一项3期试验，116名儿科受试者参加了试验，服用左乙拉西坦口服液剂量为(20-50mg/kg/day)，考察该药的有效性与安全性。
试验表明左乙拉西坦显著降低43.1%患者的癫痫发作次数，而空白组此比例为19.6%，试验中患者对该药耐受性良好。左乙拉西坦在欧洲批准用于16岁以上患者癫痫部分性发作，在美国批准用于17岁以上癫痫部分性发作。2008美国批准KeppraXR（左乙拉西坦缓释片）与其它抗癫痫药物联用于治疗16岁以上患者的癫痫部分性发作。

【商品名】开浦兰
【通用名称】左乙拉西坦片
【成份】左乙拉西坦的化学名称为(S)-α-乙基-2-氧代-1-吡咯烷乙酰胺，分子式：C8H14N2O2，分子量：170.21。
【性状】本品为椭圆形薄膜包衣片（250mg为蓝色片，500mg为黄色片，1000mg为白色片），除去包衣后均显白色。

【适应症】用于成人及4岁以上儿童癫痫患者部分性发作的加用治疗。

【用法用量】
（1）给药途径：口服。需以适量的水吞服，服用不受进食影响。
（2）给药方法和剂量：
成人（>18岁）和青少年（12-17岁）（体重≥50kg者）：起始治疗剂量为每次500mg，每日2次。根据临床效果及耐受性，每日剂量可增加至每次1500mg，每日2次。剂量的变化应每2-4周增加或减少500mg/次，每日2次。

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原产地英文商品名:
KEPPRA SOLUTION 100MG/ML 473MLS/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 473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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原产地英文商品名:
LEVETIRACETAM(KEPPRA GENERIC) 500MG/5ML/VIAL 10VIALS/BOX
原产地英文药品名:
LEVETIRACETAM
中文参考商品译名:
左乙拉西坦(开浦兰仿制药) 500毫克/5毫升/瓶 10瓶/盒
中文参考药品译名:
左乙拉西坦
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原产地英文商品名:
LEVETIRACETAM SOLUTION(KEPPRA GENERIC) 100MG/ML 473MLS/BOTTLE
原产地英文药品名:
LEVETIRACETAM
中文参考商品译名:
左乙拉西坦溶液(开浦兰仿制药) 100毫克/毫升 473毫升/瓶
中文参考药品译名:
左乙拉西坦

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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].