Sabril(通用名：氨己烯酸) 药品英文名 Vigabatrin 药品别名 喜保宁、Sabril 药物剂型 片剂：500mg。 药理作用 本品为γ-氨基丁酸(GABA)的类似物，能特异性地与GABA氨基转移酶结合，且不可逆转，导致脑内GABA浓度增高，从而发挥抗癫痫作用。本品作为辅助治疗，用于治疗对其他抗癫痫药无效的患者，特别是部分性发作(主要用于控制复杂的部分性发作)患者。本品可加重失神发作或肌阵挛性发作。本品还可用于韦斯特(West)综合征(婴儿痉挛症)的婴儿，此症对常规抗癫痫药通常无效。作为辅助治疗药物，本品可获得较好疗效。单独应用时，对新诊断出的患者治疗有效。 药动学 口服吸收迅速，服后2h可达血药峰值。t1/2为5～7h。主要随尿排出，给药量的65%左右在头24h内以原药随尿排出。血浆蛋白结合不明显。 适应证 1.治疗其他抗癫痫药无效的癫痫，特别是部分性发作。 2.还可治疗婴儿痉挛症(韦斯特综合征、West综合征)。 禁忌证 对本品过敏者、孕妇、哺乳者禁用。 注意事项 老年和肾损害患者慎用。 不良反应 1.常见的有疲劳、嗜睡、头痛、头晕、精神错乱和抑郁。 2.偶有攻击行为和精神病(多见于有精神病史和行为问题的患者)、记忆减退、复视、体重增加、胃肠障碍、水肿和脱发。 3.还可能发生眼球震颤、神经过敏、易激动、共济失调、感觉异常和震颤。 4.有些患者发生不可逆的视野缺损、视网膜病变如视网膜周围萎缩，更少见者有视神经炎和萎缩。 5.精神方面可能发生激动、攻击性行为、妄想狂，有或无精神病史者均可出现。 6.还极少发生躁狂症或精神失常。 7.血红蛋白和转氨酶值可能降低。 用法用量 1.成人开始剂量为每天2g，分2次或单次服。必要时增加0.5～1g，最大剂量每天4g。 2.儿童开始口服每天40mg/kg，2次分服，必要时逐渐增加到每天80～100mg/kg。体重大于50kg者可给予成人剂量。 药物相应作用 抗癫痫药物之间有着复杂的相互作用，毒性可能增加，而抗癫痫的作用却并非相应的增加。这类相互作用变化很多，不可预测，在合用中必须严密监测血药浓度，谨防中毒。 专家点评 临床上该药主要用于治疗部分性发作，也可用于婴儿痉挛或作为继发性全身发作的加用药。但对于失神发作，肌阵挛性发作无效。 Important Safety Information SABRIL® (vigabatrin) Tablets SABRIL® (vigabatrin) for Oral Solution Indication SABRIL is indicated as adjunctive therapy for 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. SABRIL is not indicated as a first line agent for complex partial seizures. SABRIL is indicated as monotherapy for pediatric patients 1 month to 2 years of age with infantile spasms (IS) for whom the potential benefits outweigh the potential risk of vision loss. Important Safety Information WARNING: VISION LOSS See full Prescribing Information for complete boxed warning •SABRIL causes progressive and permanent bilateral concentric visual field constriction in a high percentage of patients. In some cases, SABRIL may also reduce visual acuity •Risk increases with total dose and duration of use, but no exposure to SABRIL is known that is free of risk of vision loss •Risk of new and worsening vision loss continues as long as SABRIL is used, and possibly after discontinuing SABRIL •Unless a patient is formally exempted, periodic vision assessment is required for patients on SABRIL. However, this assessment cannot always prevent vision damage •Because of the risk of permanent vision loss, SABRIL is available only through a special restricted distribution program SABRIL causes permanent vision loss in infants, children, and adults. Because assessing vision loss is difficult in children, the frequency and extent of vision loss in infants and children is poorly characterized. In adults, SABRIL causes permanent bilateral concentric visual field constriction in 30% or more of patients that ranges in severity from mild to severe, including tunnel vision to within 10° of visual fixation, and can result in disability. In some cases, SABRIL also can damage the central retina and may decrease visual acuity. The onset of vision loss from SABRIL is unpredictable and can occur within weeks of starting treatment or sooner, or at any time during treatment, even after months or years. The lowest dose and shortest exposure to SABRIL should be used that is consistent with clinical objectives. Because of the risk of permanent vision loss, SABRIL should be withdrawn from patients with IS who fail to show substantial clinical benefit within 2 to 4 weeks of initiation, or sooner if treatment failure becomes obvious, or adult patients treated for refractory CPS as adjunctive therapy who fail to show substantial clinical benefit within 3 months of initiation, or sooner if treatment failure becomes obvious. Patient response to and continued need for SABRIL should be periodically reassessed. Unless a patient is formally exempted from periodic ophthalmologic assessment as documented in the SHARE program, vision assessment is required at baseline (no later than 4 weeks after starting SABRIL), at least every 3 months while on therapy and about 3-6 months after the discontinuation of SABRIL therapy. Once detected, vision loss is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss. Drug discontinuation should be considered, balancing benefit and risk, if visual loss is documented. Symptoms of vision loss from SABRIL are unlikely to be recognized by the patient, parent or caregiver before vision loss is severe. Vision loss of milder severity, although unrecognized by the patient, parent or caregiver may still adversely affect function. The possibility that vision loss from SABRIL may be more common, more severe, or have more severe functional consequences in infants and children than in adults, cannot be excluded. SABRIL should not be used in patients with, or at high risk of, other types of irreversible vision loss or with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks. The interaction of other types of irreversible vision damage with vision damage from SABRIL has not been well characterized, but is likely adverse. In adult patients treated for CPS, dose adjustment is necessary in patients with renal impairment. Abnormal MRI signal changes have been observed in some infants treated for IS with SABRIL. These changes generally resolved with discontinuation of treatment and in a few patients the lesion resolved despite continued use. Antiepileptic drugs (AEDs), including SABRIL, increase the risk of suicidal thoughts or behavior. Adult patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior and/or any unusual changes in mood or behavior. As with all AEDs, SABRIL should be discontinued gradually to avoid withdrawal seizures. Vigabatrin is excreted in human milk and may cause serious adverse events in nursing infants. SABRIL should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Pregnancy Registry: To provide information regarding the effects of in utero exposure to SABRIL, physicians are advised to recommend that pregnant patients taking SABRIL enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. SABRIL has been shown to cause neurotoxicity, anemia, somnolence and fatigue, peripheral neuropathy, weight gain and edema. The most commonly observed adverse reactions reported in 2 add-on clinical studies of adults with refractory CPS treated with SABRIL as adjunctive therapy with the recommended dose of 3 g/day (≥10% and at least 5% greater than placebo, respectively) were dizziness (24% vs 17%), fatigue (23% vs 16%), somnolence (22% vs 13%), tremor (15% vs 8%), blurred vision (13% vs 5%), and arthralgia (10% vs 3%). A 6 g/day dose has not been shown to confer additional benefit compared to the 3 g/day dose and is associated with an increased incidence of adverse events. The most common adverse events reported by >5% of infants taking SABRIL for IS occurring more frequently than placebo, respectively, in a randomized, placebo-controlled IS study with a 5-day double-blind treatment phase (n=40) were somnolence (45% vs 30%), bronchitis (30% vs 15%), ear infection (10% vs 5%), and acute otitis media (10% vs 0%). http://www.oneyao.net/article/2010/0404/18672.html ----------------------------------------------------------------- 注：以下产品不同规格和不同价格，购买以咨询为准！ ----------------------------------------------------------------- 产地国家: 欧洲共同体国家 原产地英文商品名: Sabril 500mg 50bags 原产地英文药品名: Vigabatrin 中文参考商品译名: 氨己烯酸片 500毫克 50袋 中文参考药品译名: 氨己烯酸 生产厂家中文参考译名: 赛诺菲-安万特 生产厂家英文名: SANOFI-AVENTIS AEBE ------------------------------------------------------------------ 产地国家: 希腊 原产地英文商品名: Sabril 500mg/Tab 30 Tablets 原产地英文药品名: Vigabatrin 中文参考商品译名: 氨己烯酸片 500毫克／片 30片 中文参考药品译名: 氨己烯酸 生产厂家中文参考译名: 赛诺菲-安万特 生产厂家英文名: SANOFI-AVENTIS AEBE ------------------------------------------------------------------ 产地国家: 德国 原产地英文商品名: Sabril 500mg/Tab 50 Tablets 原产地英文药品名: Vigabatrin 中文参考商品译名: 氨己烯酸片 500毫克／片 50片 中文参考药品译名: 氨己烯酸 生产厂家中文参考译名: 赛诺菲-安万特 生产厂家英文名: SANOFI-AVENTIS AEBE ------------------------------------------------------------------ 产地国家: 德国 原产地英文商品名: Sabril 500mg/Tab 100 Tablets 原产地英文药品名: Vigabatrin 中文参考商品译名: 氨己烯酸片 500毫克／片 100片 中文参考药品译名: 氨己烯酸 生产厂家中文参考译名: 赛诺菲-安万特 生产厂家英文名: SANOFI-AVENTIS AEBE 该药品相关信息网址1: http://www.sabril.net 该药品相关信息网址2: http://www.drugs.com/sabril.html