制造商：
Avanir制药
药理分类：
缺乏竞争力的NMDA受体拮抗剂和sigma - 1受体激动剂+ CYP2D6抑制剂。
活性成分（补）：
氢溴酸右美沙芬20毫克，10毫克硫酸奎尼丁;胶囊。
指示（补）：
治疗假性影响（PBA的）。
药理作用：
右美沙芬（DM）是一个Σ- 1受体激动剂和没有竞争力的NMDA受体拮抗剂。奎尼丁抑制CYP2D6的提高竞争力，催化转化为糖尿病的主要途径糖尿病的血浆水平。这一机制的马克在PBA的发挥其影响是未知的。
临床试验：
对Nuedexta疗效显示于一体，在PBA的患者的研究与基础肌萎缩侧索硬化症，多发性硬化症。患者随机接受Nuedexta，糖尿病氢溴酸30mg/quinidine硫酸10毫克或安慰剂。主要结果测量，笑或哭发作，有统计学显着每一部/奎尼丁比安慰剂组低。次要终点是不稳规模为神经学中心（中枢神经系统- LS）的，7项自我评估报告，三笑哭和4项评估问卷。中枢神经系统- ls在分析了平均分之间的84天与基线差异为基础，并有统计学显着每一部/奎尼丁比安慰剂组低。
使用更高的剂量进行组合（马克氢溴酸30mg/quinidine硫酸30毫克）的两项研究提供了Nuedexta疗效的证据。
法律分类：
接收
成人：
≥18岁：7天1粒，每日则（第8天开始），每12小时1粒。定期重新评估。
儿童：
<18年：不推荐。
禁忌（补）：
奎尼丁，奎宁，或甲氟喹。历史的奎宁，甲氟喹，或奎尼丁引起的血小板减少症，肝炎，骨髓抑制，狼疮样综合征。单胺氧化抑制剂后14天。 QT间期延长。先天性长QT综合征。德pointes的历史扭转性室速。心力衰竭。 QT间期延长的药物，是CYP2D6的底物（如甲硫达嗪，匹莫齐特）。完全性房室传导阻滞W / O型心脏起搏器，或完全房室传导阻滞的危险。
警告/注意事项：
如果停止奎尼丁相关的血小板减少症发生时（续使用可能导致致命的出血），不要重新启动。风险QT间期延长和扭转性室速德pointes的（例如，伴随药物延长QT间隔或强或中等的CYP3A4抑制剂，左心室肥厚，LVD）的：做心电图在基线和第一剂量后3-4小时心电图，如果重新评估风险心律失常的因素（如电解质异常，心动过缓，QT间期异常家庭史）在治疗过程中的变化。正确的开始之前低血钾，低血镁。如果停止心律失常发生。重症肌无力。考虑对CYP2D6的弱代谢基因分型。严重肾或肝损害。妊娠（目录三）。哺乳的母亲。
互动（补）：
见禁忌。伴随SSRIs类药物可能会导致（如氟西汀）或抗抑郁药（如氯丙咪嗪，丙咪嗪），血清素综合症。家长药物和/或代谢物的形成失败可能会降低安全性和/或效能伴随CYP2D6的底物积累，调整剂量CYP2D6的底物或使用替代疗法。伴随西帕明，帕罗西汀：减少这些药物的剂量，响应的调整。监测地高辛;可能需要减少剂量。添加剂中枢神经系统的影响与酒精。
不良反应（补）：
胃肠不适，头晕，咳嗽，乏力，周边水肿，尿路感染，流感，增加γ-谷氨酰转移，胀气，血小板减少，过敏，抗胆碱作用，肝炎（停止如果发生）。
如何提供：
帽- 60
最后更新：
2011年2月24日
NUEDEXTA
Manufacturer:
Avanir Pharmaceuticals
Pharmacological Class:
Uncompetitive NMDA receptor antagonist and sigma-1 agonist + CYP2D6 inhibitor.
Active Ingredient(s):
Dextromethorphan HBr 20mg, quinidine sulfate 10mg; capsules.
Indication(s):
To treat pseudobulbar affect (PBA).
Pharmacology:
Dextromethorphan (DM) is a sigma-1 receptor agonist and an uncompetitive NMDA receptor antagonist. Quinidine increases plasma levels of DM by competitively inhibiting CYP2D6, which catalyzes a major biotransformation pathway for DM. The mechanism by which DM exerts its effects in PBA is unknown.
Clinical Trials:
The efficacy of Nuedexta was shown in one study in PBA patients with underlying amyotrophic lateral sclerosis or multiple sclerosis. Patients were randomized to receive Nuedexta, DM HBr 30mg/quinidine sulfate 10mg, or placebo. The primary outcome measure, laughing or crying episodes, was statistically significantly lower in each DM/quinidine arm compared to placebo. The secondary endpoint was the Center for Neurologic Studies Lability Scale (CNS-LS), a 7-item self-report questionnaire with 3 items assessing crying and 4 assessing laughter. The CNS-LS was analyzed based on the difference between the mean scores on day 84 and baseline, and was also statistically significantly lower in each DM/quinidine arm compared to placebo.
Two studies conducted using a higher dose combination (DM HBr 30mg/quinidine sulfate 30mg) provided evidence of Nuedexta efficacy.
Legal Classification:
Rx
Adults:
≥18 years: 1 capsule daily for 7 days, then (starting on Day 8) 1 capsule every 12 hours. Reevaluate periodically.
Children:
<18 years: not recommended.
Contraindication(s):
Concomitant quinidine, quinine, or mefloquine. History of quinine, mefloquine, or quinidine-induced thrombocytopenia, hepatitis, bone marrow depression, lupus-like syndrome. Within 14 days of MAOIs. Prolonged QT interval. Congenital long QT syndrome. History of torsades de pointes. Heart failure. Drugs that prolong QT interval and are CYP2D6 substrates (eg, thioridazine, pimozide). Complete AV block w/o pacemaker, or risk of complete AV block.
Warnings/Precautions:
Discontinue if quinidine-related thrombocytopenia occurs (continued use may cause fatal hemorrhage); do not restart. Risk of QT prolongation and torsades de pointes (eg, concomitant drugs that prolong QT interval or that are strong or moderate CYP3A4 inhibitors, left ventricular hypertrophy, LVD): do ECG at baseline and 3–4 hours after 1st dose; reevaluate ECG if risk factors for arrhythmia (eg, electrolyte abnormality, bradycardia, family history of QT abnormality) change during treatment. Correct hypokalemia, hypomagnesemia before starting. Discontinue if arrhythmias occur. Myasthenia gravis. Consider genotyping for poor metabolizers of CYP2D6. Severe renal or hepatic impairment. Pregnancy (Cat. C). Nursing mothers.
Interaction(s):
See Contraindications. May cause serotonin syndrome with concomitant SSRIs (eg, fluoxetine) or TCAs (eg, clomipramine, imipramine). Accumulation of parent drug and/or failure of metabolite formation may decrease safety and/or efficacy of concomitant CYP2D6 substrates; adjust dose of CYP2D6 substrate or use alternative treatment. Concomitant desipramine, paroxetine: reduce dose of these drugs, adjust based on response. Monitor digoxin; may need to reduce dose. Additive CNS effects with alcohol.
Adverse Reaction(s):
GI upset, dizziness, cough, asthenia, peripheral edema, UTI, flu, increased gamma-glutamyltransferase, flatulence; thrombocytopenia, hypersensitivity, anticholinergic effects, hepatitis (discontinue if occurs).
How Supplied:
Caps—60