制造商：
Lundbeck公司，公司
药理分类：
抗癫痫
活性成分（补）：
Vigabatrin 500毫克;标签。
另外：
SABRIL口服溶液
Vigabatrin 500mg/packet;密码口服溶液。
指示（补）：
标签：在成人患者辅助治疗难治性复杂部分性发作（郊野公园段）谁也回答了一些不足，为谁替代疗法的潜在利益大于视力丧失的危险。不是CPS的第一行的代理人。
溶液：单药治疗的患者年龄1个月的2年，当婴儿痉挛症的潜在利益要大于视力丧失的危险。
药理作用：
氨基丁酸转氨酶不可逆抑制Vigabatrin，其中催化这一抑制性神经递质代谢的影响。这将导致在中枢神经系统氨基丁酸水平的提高，但其在治疗癫痫发作的确切机制仍是未知数。
临床试验：
进行了两项研究，以评估准则为成人的vigabatrin辅助治疗效果。效能是衡量检查CPS的中位数在二次加研究结束广义偏每月发作频率降低，与基线相比。在实现任何的癫痫发作频率降低患者的比例是一贯水平较高的vigabatrin比安慰剂; vigabatrin治疗被证明是减少发作次数显着优于安慰剂。
两个研究是在<2岁婴幼儿患者，以评估痉挛的vigabatrin疗效。在第一项研究中，主要疗效终点是婴儿谁是连续7天痉挛内免费治疗的前14天的比例。七是与痉挛的vigabatrin无低剂量治疗的患者的百分之114，而15.9％为高剂量组。在第二项研究中，在减少整体百分比在痉挛显着差异被发现之间的给予与那些服用安慰剂vigabatrin组。
法律分类：
接收
成人：
“18岁：使用标签。最初500毫克，每天两次;滴定如果需要，每星期1.5克500毫克，每天两次。肌酐清除率> 50-80mL/min：减少25％剂量，肌酐清除率> 30-50mL/min：减少50％剂量; CrCl为“10 - <30mL/min：减少75％的剂量。定期重新评估。逐步撤出（减少每周间隔1g/day）。
儿童：
“1月：不推荐。一个月- 2年：使用液剂。最初50mg/kg/day，每天两次;由25-50mg/kg/day滴定在为期3天的间隔最大150mg/kg/day。肾功能不全：降低剂量（见文献）。逐步撤出（减少25-50mg/kg，每3-4天）。
警告/注意事项：
监视器愿景，包括视力和扩张间接检眼镜，和视野，在基线（在4周），每3个月，停药后的3-6个月，视力减退为剂量的增加和累积暴露的风险增加。如果没有停止3个月后（成人）或2-4周（婴儿）治疗重大利益;如果明显的治疗越早失败。监控抑郁，自杀意念，情绪/行为的改变。老人。妊娠（Cat.C）。哺乳母亲：不推荐。
互动（补）：
可对抗苯妥英钠。避免其他可能导致眼视觉或功能障碍。可能会干扰肝功能测试（如，谷丙转氨酶），其他（见文献）。
不良反应（补）：
视力下降（可能是严重的，永久性的），其他视力改变（模糊，复视，视疲劳，眼痛），头痛，眼球震颤，贫血，嗜睡，疲劳，周围神经病变，体重增加，水肿，关节痛，头晕，震颤，中枢神经系统/神经系统的影响，皮疹，MRI在婴幼儿异常信号的变化。
注释：
仅通过限制销售计划。登记电话：（888）45股。鼓励孕妇患者暴露于vigabatrin致电（888）233-2334。要报告药物不良反应：（800）455-1141。
如何提供：
制表- 100
密码包- 50
最后更新：
09年11月6日
SABRIL TABLETS
Manufacturer:
Lundbeck, Inc.
Pharmacological Class:
Antiepileptic
Active Ingredient(s):
Vigabatrin 500mg; tabs.
Also:
SABRIL for ORAL SOLUTION
Vigabatrin 500mg/packet; pwd for oral soln.
Indication(s):
Tabs: Adjunctive therapy in adult patients with refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Not a first line agent for CPS.
Soln: Monotherapy for infantile spasms in patients ages 1 month–2 years, when the potential benefits outweigh the risk of vision loss.
Pharmacology:
Vigabatrin irreversibly inhibits GABA transaminase, which catalyses the metabolism of this inhibitory neurotransmitter. This causes an increase in GABA levels in the CNS, but its exact mechanism in treating seizures is still unknown.
Clinical Trials:
Two studies were conducted to assess the effectiveness of vigabatrin as adjunctive therapy for CPS in adults. Efficacy was measured by examining the reduction in median monthly frequency of CPS plus partial seizures secondarily generalized at the end of study, compared to baseline. The proportion of patients achieving any level of reduction in seizure frequency was consistently higher for vigabatrin compared to placebo; vigabatrin treatment was shown to be significantly superior to placebo in reducing seizure frequency.
Two studies were conducted in patients <2 years of age to assess the efficacy of vigabatrin for infantile spasms. In the first study, the primary efficacy endpoint was the proportion of infants who were spasm-free for 7 consecutive days within the first 14 days of therapy. Seven percent of the 114 patients treated with a low dose of vigabatrin were spasm-free, compared to 15.9% for the high-dose group. In a second study, a statistically significant difference in overall percentage of reduction in spasms was found between the group given vigabatrin versus those given placebo.
Legal Classification:
Rx
Adults:
>18 years: Use tabs. Initially 500mg twice daily; titrate if needed by 500mg per week to 1.5g twice daily. CrCl >50–80mL/min: reduce dose by 25%; CrCl >30–50mL/min: reduce dose by 50%; CrCl >10–<30mL/min: reduce dose by 75%. Reevaluate periodically. Withdraw gradually (reduce by 1g/day at weekly intervals).
Children:
<1 month: not recommended. 1month–2 years: use soln. Initially 50mg/kg/day twice daily; titrate by 25–50mg/kg/day at 3-day intervals to max 150mg/kg/day. Renal dysfunction: reduce dose (see literature). Withdraw gradually (reduce by 25–50mg/kg every 3–4 days).
Warnings/Precautions:
Monitor vision, including visual acuity and dilated indirect ophthalmoscopy, and visual fields, at baseline (within 4 weeks) and every 3 months, and for 3–6 months after discontinuing; risk of vision loss increases as dose and cumulative exposure increased. Discontinue if no substantial benefit after treating for 3 months (in adults) or 2–4 weeks (in infants); sooner if obvious treatment failure. Monitor for depression, suicidal ideation, changes in mood/behavior. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interaction(s):
May antagonize phenytoin. Avoid others that can cause visual or ophthalmic dysfunction. May interfere with liver function tests (eg, ALT), others (see literature).
Adverse Reaction(s):
Vision loss (may be severe and permanent), other visual changes (blurring, diplopia, asthenopia, eye pain), headache, nystagmus, anemia, somnolence, fatigue, peripheral neuropathy, weight gain, edema, arthralgia, dizziness, tremor, CNS/neurological effects, rash; abnormal MRI signal changes in infants.
Notes:
Available only through restricted distribution program. To register call (888) 45-SHARE. Encourage pregnant patients exposed to vigabatrin to call (888) 233-2334. To report ADRs: (800) 455-1141.
How Supplied:
Tabs—100
Pwd packets—50