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左乙拉西坦levetiracetam

[ 人气:102 | 日期: 2020-08-04 | 返回 | 打印 ]
左乙拉西坦levetiracetam
药品名称:左乙拉西坦levetiracetam
药品别名:
英 文 名:levetiracetam
药品价格:$ 美国市场售价 18.8 美元
研发公司:
适 用 症:抗癫痫药,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。
型号规格:100mg/mL
药品详情:

【左乙拉西坦levetiracetam 简述】
 
    左乙拉西坦(Levetiracetam Tablets)是抗癫痫药,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。


左乙拉西坦levetiracetam_香港济民药业
 
【左乙拉西坦levetiracetam 适应症】
 
    抗癫痫药,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。
 
【左乙拉西坦levetiracetam 规格】
 
    100mg/mL
 
【左乙拉西坦levetiracetam 使用方法】
 
    青少年和儿童推荐剂量:起始剂量10 mg/kg,每日2次,最大剂量30 mg/kg,每日2次。体重15 kg:起始剂量每次150 mg,每日2次,最大剂量每次450 mg,每日2次。体重20 kg:起始剂量每次200 mg,每日2次,最大剂量每次600 mg,每日2次。体重25 kg:起始剂量每次250 mg,每日2次,最大剂量每次750 mg,每日2次。体重50 kg或以上:起始剂量每次500 mg,每日2次,最大剂量每次1500 mg,每日2次。20 kg 以下的儿童,为精确调整剂量,起始治疗应使用口服溶液。
 
    成人(>18岁)和青少年(12-17岁)(体重≥ (greater than or equal to) 50 kg者) :起始治疗剂量为每次500 mg,每日2次。根据临床效果及耐受性,每日剂量可增加至每次1500 mg,每日2次。剂量的变化应每2-4周增加或减少500 mg/次,每日2次。
    
【左乙拉西坦levetiracetam 注意事项】
 
    根据当前的临床实践,如需停止服用本品,建议逐渐停药。(例如 :成人每隔2-4周,每次减少500 mg,每日2次 ;儿童应每隔2周,每次减少10 mg/kg,每日2次)。临床研究中,一些患者对加用左乙拉西坦治疗有效应,可以停止原合并应用的抗癫痫药物(研究中共有69位患者其中的36位成人患者)。
 
  临床研究中报告有14%服用左乙拉西坦的成人及儿童患者癫痫发作频率增加25%以上,但在服用安慰剂的成人及儿童患者中,也各有26%及21%患者癫痫发作频率增加。对于肝功能损害的病人,参照[用法与用量]。对于严重肝功能损害的病人,应先行检查肾功能,然后进行调整。
 
  对驾驶和应用机器影响 :目前没有研究关于服药后对机器驾驭能力和驾驶车辆能力的影响。
 
  由于个体敏感性差异,在治疗初始阶段或者剂量增加后,会产生嗜睡或者其他中枢神经症状。因而,对于这些需要服用药物的病人,不推荐操作需要技巧的机器,如驾驶汽车或者操纵机械。
 
【左乙拉西坦levetiracetam 不良反应】
 
成人临床研究汇总的安全性数据表明, 药物组和安慰剂组不良反应的发生率相似,分别为46.4%和42.2%。 其中,严重不良反应分别为2.4%和2.0%。最常见的不良反应有嗜睡,乏力和头晕,常发生在治疗的开始阶段。随时间的推移, 中枢神经系统相关的不良反应发生率和严重程度会随之降低。左乙拉西坦不良反应没有明显的剂量相关性。
 
  儿童临床研究(4-16岁)表明药物组和安慰剂组产生不良反应的发生率相似,分别为55.4%和40.2%,药物组未发生严重不良反应(安慰剂组1.0%)。儿童最常见的不良反应有嗜睡、敌意、神经质、情绪不稳、易激动、食欲减退、乏力和头痛。除行为和精神方面不良反应发生率较成人高(儿童38.6%,成人 18.6%)外,总的安全性和成人相仿。成人和儿童不良反应的风险是具有可比性的。总结成人和儿童临床研究结果和上市后经验,评估了每个系统的不良反应和发生频率 :很常见>10% ;常见1-10% ;少见0.1-1% ;罕见:0.01-0.1% ;非常罕见<0.01%,包括单独的报告。上市后临床应用的数据,尚不足以估计治疗人群中不良反应的发生率。
 
  - 全身反应和给药部位不适 :很常见乏力。
 
  - 神经系统不适 :很常见嗜睡,常见健忘、共济失调、惊厥、头晕、头痛、运动过度、震颤。
 
  - 精神心理变化 :常见易激动、抑郁、情绪不稳、敌意、失眠、神经质、人格改变、思维异常。上市后不良事件报道 :行为异常、攻击性、易怒、焦虑、错乱、幻觉、易激动、精神异常、自杀、自杀性意念、自杀企图。但还没有足够数据,用于估计对它们的发生率或建立因果关系。
 
  -消化道不适 :常见腹泻、消化不良、恶心、呕吐。
 
  - 代谢和营养障碍 :常见食欲减退。当病人同时服用托吡酯时,食欲减退的危险性增加。
 
  - 耳及迷路系统不适 :常见眩晕。
 
  - 眼部不适 :常见复视。
 
  - 伤害、中毒和后续的并发症 :常见意外伤害。
 
  - 感染和传染 :常见感染。
 
  - 呼吸系统不适 :常见咳嗽增加。
 
  - 皮肤和皮下组织异常变化 :常见皮疹。上市后不良事件报道 - 脱发,某些病例中停药后自行恢复。
 
  - 血液系统和淋巴系统异常变化 :上市不良事件报道 - 白细胞减少、嗜中性细胞减少、全血细胞减少、血小板减少,但还没有足够数据,用于估计它们发生率或建立因果关系。

Keppra(levetiracetam)

 
Levetiracetam, marketed under the trade name Keppra among others, is a medication used to treat epilepsy.[1] It is used for partial onset, myoclonic, or tonic-clonic seizures.[1] It is taken by mouth as an immediate or extended release formulation or by injection into a vein.[1]
 
Common side effects include sleepiness, dizziness, feeling tired, and aggression.[1] Severe side effects may include psychosis, suicide, and allergic reactions such as Stevens-Johnson syndrome and anaphylaxis.[1] It is unclear if use is safe during pregnancy but it appear okay when breastfeeding.[2] It is the S-enantiomer of etiracetam.[3] How it works is not clear.[1]
 
Levetiracetam was approved for medical use in the United States in 1999.[1] It is avaliable as a generic medication.[4] A month supply in the United Kingdom costs the NHS about 19.31 £ per month as of 2019.[4] In the United States the wholesale cost of this amount is about 4.50 USD.[5] In 2016 it was the 89th most prescribed medication in the United States with more than 8 million prescriptions.[6]
 
Medical uses
Focal epilepsy
Levetiracetam is effective as single-drug treatment for newly-diagnosed focal epilepsy in adults.[7] It reduces focal seizures by 50% or more as an add-on medication.[8]
Partial-complex epilepsy
Levetiracetam is effective as add-on treatment for partial (focal) epilepsy.[9]
Generalized epilepsy
Levetiracetam is effective for treatment of generalized tonic-clonic epilepsy.[10] It has been approved in the United States as add-on treatment for myoclonic, and tonic-clonicseizures.[11] Levetiracetam has been approved in the European Union as a monotherapytreatment for epilepsy in the case of partial seizures, or as an adjunctive therapy for partial, myoclonic, and tonic-clonic seizures.[12]
Levetiracetam is sometimes used off-label to treat status epilepticus[13][14]
Prevention of seizures
Based on low-quality evidence, levetiracetam is about as effective as phenytoin for prevention of early seizures after traumatic brain injury.[15] It may be effective for prevention of seizures associated with subarachnoid hemorrhages.[16]
Other
Levetiracetam has not been found to be useful for treatment of neuropathic pain,[17] nor for treatment of essential tremors.[18] Levetiracetam has not been found to be useful for treating autism,[19][20] but is an effective treatment for partial, myoclonic, or tonic-clonic seizures associated with autism spectrum disorder.[21]
Special groups
Levetiracetam is a pregnancy category C drug. Studies in female pregnant rats have shown minor fetal skeletal abnormalities when given maximum recommended human doses of levetiracetam orally throughout pregnancy and lactation.[14]
Studies were conducted to look for increased adverse effects in the elderly population as compared to younger patients. One such study published in Epilepsy Research showed no significant increase in incidence of adverse symptoms experienced by young or elderly patients with central nervous system (CNS) disorders.[16]
Levetiracetam may be safely used with caution in children over the age of 4. However, it has not been determined whether it can be safely given to children under the age of 4.[22]
 
Adverse effects
 
The most common adverse effects of levetiracetam treatment include CNS effects such as somnolence, decreased energy, headache, dizziness, mood swings and coordination difficulties. These adverse effects are most pronounced in the first month of therapy. About 4% of patients dropped out of pre-approval clinical trials due to these side effects.[23]
About 13% of people taking levetiracetam experience adverse neuropsychiatric symptoms, which are usually mild. These include agitation, hostility, apathy, anxiety, emotional lability, and depression. Serious psychiatric adverse side effects that are reversed by drug discontinuation occur in about 1%. These include hallucinations, suicidal thoughts, or psychosis. These occurred mostly within the first month of therapy, but they could develop at any time during treatment.[24]
 
Although rare, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which appears as a painful spreading rash with redness and blistering and/or peeling skin, have been reported in patients treated with levetiracetam.[25] The incidence of SJS following exposure to anti-epileptics such as levetiracetam is about 1 in 3,000.[26]
 
Levetiracetam should not be used in people who have previously shown hypersensitivity to levetiracetam or any of the inactive ingredients in the tablet or oral solution. Such hypersensitivity reactions include, but are not limited to, unexplained rash with redness or blistered skin, difficulty breathing, and tightness in the chest or airways.[23]
 
In a study, the incidence of decreased bone mineral density of patients on levetiracetam was significantly higher than those for other epileptic medications.[27]
Suicide
Levetiracetam, along with other anti-epileptic drugs, can increase the risk of suicidal behavior or thoughts. People taking levetiracetam should be monitored closely for signs of worsening depression, suicidal thoughts or tendencies, or any altered emotional or behavioral states.[11]
Kidney and liver
Kidney impairment decreases the rate of elimination of levetiracetam from the body. Individuals with reduced kidney function may require dose adjustments. Kidney function can be estimated from the rate of creatinine clearance.[23]
Dose adjustment of levetiracetam is not necessary in liver impairment.[23]
Drug interactions
No significant pharmacokinetic interactions were observed between levetiracetam or its major metabolite and concomitant medications.[28] The pharmacokinetic profile of levetiracetam is not influenced by phenytoin, phenobarbital, primidone, carbamazepine, valproic acid, lamotrigine, gabapentin, digoxin, ethinylestradiol, or warfarin.[29]
 
Mechanism of action
The exact mechanism by which levetiracetam acts to treat epilepsy is unknown. Levetiracetam does not exhibit pharmacologic actions similar to that of classical anticonvulsants. It does not inhbit voltage-dependent Na+ channels, does not affect GABAergic transmission, and does not bind to GABAergic or glutamatergic receptors.[30] However, the drug binds to SV2A,[31] a synaptic vesicle glycoprotein, and inhibits presynapticcalcium channels,[32] reducing neurotransmitter release and acting as a neuromodulator. This is believed to impede impulse conduction across synapses.[33]
 




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