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依佐加滨片Potiga(ezogabine,retigabine，瑞替加滨)(一)
Generic Name and Formulations:
Ezogabine 50mg, 200mg, 300mg, 400mg; tablets.
Company:
GlaxoSmithKline Pharmaceuticals
Indications for POTIGA:
Adjunctive treatment of partial-onset seizures in patients ≥18yrs old.
Adult Dose for POTIGA:
Swallow whole. Give in 3 equally divided doses daily. ≥18yrs: initially 300mg/day for 1 week; titrate at weekly intervals by no more than 150mg/day up to a maintenance dose of 600–1200mg/day. Elderly (>65yrs) or hepatic impairment (Child-Pugh 7–9): initially 150mg/day; max 750mg/day. Renal impairment (CrCl <50mL or ESRD on dialysis) or hepatic impairment (Child-Pugh >9): initially 150mg/day; max 600mg/day. See literature.
Children's Dose for POTIGA:
<18yrs: not established.
Pharmacological Class:
Potassium channel opener
Rems:
YES
Warnings/Precautions:
Increased risk of urinary retention; monitor closely in patients with BPH, cognitively impaired, or concomitant medications that may affect voiding (eg, anticholinergics). Monitor for neuropsychiatric symptoms (eg, confusional state, psychosis, hallucinations), dizziness, somnolence. Monitor QT interval in patients with known prolonged QT interval, CHF, ventricular hypertrophy, hypokalemia, or hypomagnesemia. Monitor for emergence or worsening of depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior. Avoid abrupt cessation; withdraw gradually over at least 3 weeks. Pregnancy (Cat. C). Nursing mothers: not recommended.
Interactions:
Caution with drugs known to increase the QT interval. Plasma levels reduced by concomitant phenytoin or carbamazepine; consider increasing ezogabine dose. May potentiate digoxin; monitor. Increased exposure with alcohol; caution. May interfere in clinical lab assays of serum and urine bilirubin.
Adverse Reactions:
Dizziness, somnolence, fatigue, confusional state, vertigo, tremor, abnormal coordination, diplopia, attention disturbance, memory impairment, asthenia, blurred vision, gait disturbance, aphasia, dysarthria, balance disorder.
How Supplied:
Tabs—90
美国FDA批准Potiga(ezogabine)片剂治疗成人癫痫部分发作
国FDA于2011年6月10日批准Potiga(ezogabine)片剂作为添加治疗药物(add-on medication)治疗成人癫痫发作。Potiga主要用于治疗癫痫的部分发作,这是癫痫患者最常见的一种发作方式。癫痫是一种脑部疾病,发病原因是大脑神经细胞活动不正常或活动过度。癫痫部分发作时一般只影响大脑的部分区域,但会扩散到其他脑区。癫痫发作会引发系列症状,包括痉挛、行为异常、意识丧失伴随抽搐等。FDA相关主管官员指出,大约有1/3的癫痫患者不能通过现用药物很好地控制发作,因此为他们提供更多的治疗选择非常重要。Potiga是第一种用于治疗癫痫的神经元钾通道开放剂(neuronal potassium channel opener)。Potiga可通过稳定开放神经元钾通道,降低神经细胞应激性而起到抗痉挛作用,但作用机制还不十分明确。在临床试验中,Potiga最常见的副作用包括:眩晕、疲倦、意识模糊、震颤、协调性障碍、复视、注意力不集中、乏力等。Potiga会引起尿潴留,一般在治疗的头6个月内出现。尿潴留是癫痫治疗药物的一种独特的副作用,应予密切留意。Potiga还会引起神经精神方
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use POTIGA safely and effectively. See full prescribing information for POTIGA.
POTIGA (ezogabine) Tablets, CV
Initial U.S. Approval: 2011
INDICATIONS AND USAGE
POTIGA is a potassium channel opener indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older. (1)
DOSAGE AND ADMINISTRATION
•Administer in 3 divided doses daily, with or without food. (2)
•The initial dosage should be 100 mg 3 times daily (300 mg per day) for 1 week. (2)
•Titrate to maintenance dosage by increasing the dosage at weekly intervals by no more than 150 mg per day. (2 |
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