美国批准USB公司的左乙拉西坦控释片（levetiracetam，Keppra XR）上市，辅助其它抗癫痫药治疗16岁及以上患者的癫痫部分发作。本品剂量规格：左乙拉西坦500 mg/片（薄膜包衣片）。辅料：羟丙基甲基纤维素，聚乙二醇3350，聚乙二醇6000，无水微粉硅胶，部分氢化的聚乙烯醇、二氧化钛、硬脂酸镁和滑石粉。

　　抗癫痫药治疗的目标是避免患者癫痫发作和使不良反应降至最小程度。目前市售的抗癫痫药可治疗许多癫痫患者，但很大比例患者的症状仍难以控制或患者不能难受药物的不良反应。

　　一项7个国家参加的对癫痫部分反复发作或无全身性发作患者的多中心随机双盲安慰剂对照的临床研究结果证实了本品辅助治疗的有效性。研究纳入的患者在8周内至少癫痫部分发作8次。研究中158例患者一日1次随机接受安慰剂（N=78）或Keppra XR（500 mg 2片，N=79）治疗12周。主要疗效评判标准是本品较安慰剂每周平均减少部分发作次数的百分率。结果显示，本品组每周较基础值减少46.1%，安慰剂组为33.4%。治疗组较安慰剂组多减少12.7%。

　　本品初始剂量为一日1次1000 mg，可以1000 mg/日的增量每2周调节1次，推荐最大剂量为3000 mg/日。

KEPPRA XR

Indications for KEPPRA XR

Adjunct in partial onset seizures in patients ≥16yrs old.

Adult dose for KEPPRA XR

≥16yrs: Initially 1g once daily; may increase at 2-week intervals in increments of 1g/day; max 3g/day. Renal impairment: CrCl 50–80mL/min: 1–2g every 24 hours; CrCl 30–50mL/min: 500mg–1.5g every 24 hours; CrCl <30mL/min: 500mg–1g every 24 hours; ESRD patients on dialysis: use immediate-release levetiracetam.

Children's dosing for KEPPRA XR

<16yrs: not recommended.

Also:

Warnings/Precautions for KEPPRA XR

Renal impairment. Suicidal tendencies (monitor). Avoid abrupt cessation. Elderly (consider monitoring renal function). Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

Adverse Reactions for KEPPRA XR

Somnolence, asthenia, infection, dizziness, coordination difficulties (eg, ataxia, abnormal gait), mood and behavioral abnormalities (eg, irritability, anger, depression, anxiety, apathy), neck pain, pharyngitis, hematologic abnormalities; rare: psychotic symptoms. Children: also accidental injury, hostility, nervousness. XR: also nausea.

Notes for KEPPRA XR

Register pregnant patients exposed to levetiracetam by calling (888) 537-7734.

How is KEPPRA XR supplied?

Tabs 250mg, 500mg, 750mg—120
1000mg—60
XR—60
Soln—pt
Single-use vials (5mL)—10