英文药名: Keppra(Levetiracetam Oral Solution and Injection)

中文药名: 左乙拉西坦口服液,开浦兰

品牌药生产厂家: 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。
规格：
100mg/ml*300ml  
100mg/ml*100ml

Generic name: Levetiracetam

Why is Keppra prescribed?

Keppra helps reduce the frequency of partial epileptic seizures, a form of epilepsy in which neural disturbances are limited to a specific region of the brain and the victim remains conscious throughout the attack. The drug is used along with other epilepsy medications, never by itself.

Most important fact about Keppra

Keppra can cause dizziness and drowsiness. Do not drive, operate machinery, or engage in other hazardous activities until you're sure the drug won't interfere.

How should you take Keppra?

Keppra may be taken with or without food.

Do not stop taking this drug on your own. If the doctor decides to discontinue Keppra, he will tell you how to taper off slowly. Abrupt discontinuation of Keppra can increase the frequency of seizures.

If you miss a dose.
Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.
Storage instructions...
Store this prescription at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Keppra.

Side effects may include:
Depression, dizziness, drowsiness, headache, infection, loss of muscle coordination, nervousness, pain, runny nose, sore throat, weakness

Why should Keppra not be prescribed?

You will not be able to use Keppra if it gives you an allergic reaction.

Special warnings about Keppra

Especially during the first few weeks of treatment, Keppra sometimes triggers psychological problems, including psychosis, hallucinations, aggression, agitation, anger, hostility, irritability, anxiety, apathy, emotional instability, depression, and attempted suicide. These problems usually pass, but be sure to alert your doctor if you feel one developing; your doctor may have to discontinue the drug or change your dosage.

At the start of treatment, Keppra also can cause extreme drowsiness, unusual weakness, and coordination difficulties. Bring such symptoms to your doctor's attention. In a few patients, therapy must be stopped or reduced.

This drug has not been tested in children under age 16.

Possible food and drug interactions when taking Keppra

No unwanted interactions have been identified to date.

Special information if you are pregnant or breastfeeding

In animal tests, Keppra has produced fetal abnormalities. Accordingly, Keppra is recommended for pregnant women only if its potential benefits outweigh the potential risk to the baby. Notify your physician immediately if you are pregnant or plan to become pregnant.

Keppra makes its way into breast milk and could cause serious reactions in a nursing infant. Do not take this drug while nursing.

Recommended dosage for Keppra

ADULTS

For adults and children over 16, the usual starting dosage of Keppra is 500 milligrams twice a day. The dose may be increased every 2 weeks up to a maximum dose of 1,500 milligrams twice a day. If you have kidney disease, your dosage will be lower.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

Symptoms of Keppra overdose may include:
Aggression, agitation, coma, drowsiness, reduced consciousness, slowed breathing