制造商：
赛诺菲安万特
药理分类：
抗心律失常
活性成分（补）：
接受dronedarone 400毫克;标签。
指示（补）：
为了减少心血管住院风险与阵发性或持续性心房纤维颤动（AF）或心房扑动与房颤/ AFL和心血管危险因素（年龄最近的事件（AFL）的病人> 70yrs，HTN型，糖尿病，脑血管意外之前，左心房直径≥50mm或左室射血分数<40％，谁是谁窦性心律或将cardioverted。
药理作用：
决奈达隆是一个具有抗心律失常药物的抗心律失常属于物业代理的所有四种类型（类别一至四）。
临床试验：
在雅典娜的研究，4628带有AF / AFL和窦性心律患者接受治疗长达30个月，无论是研究药物或安慰剂，除了常规治疗。主要终点为心血管原因或为任何原因死亡首次住院时间。相较于安慰剂组，dronedarone降低24.2％，从任何导致心血管疾病住院或死亡的复合终点。
在其他两个研究，EURIDIS和阿多尼斯，1237年门诊与房颤/ AFL的前一集，谁在为窦性心律或接受dronedarone或给予安慰剂，与常规疗法相结合，并为12个月之后。决奈达隆推迟了对自动对焦/ AFL的首次复发时间，降低约25％的第一对焦/ AFL的复发风险，在复发率约11％在12个月的绝对差异。
在仙女座研究中，患者住院最近有症状性心力衰竭（HF）和严重左室收缩功能障碍给予要么接受dronedarone或安慰剂。主要复合终点是所有原因的死亡率或住院治疗的心衰。这项研究被提前终止，因为增加死亡率在接受dronedarone集团，主要是由于心衰恶化。
法律分类：
接收
成人：
≥18yrs：400毫克，每日两次随餐（上午及下午）。
儿童：
“18yrs：不推荐。
禁忌（补）：
心功能IV级心衰。 NYHA分级Ⅱ〜Ⅲ高频近期需要住院治疗或转诊到专门的诊所失代偿心力衰竭。第二或第三度房室传导阻滞或病窦综合征，除非节奏。心动过缓“（<50bpm）。伴随强CYP3A的抑制剂（如酮康唑，伊曲康唑，伏立康唑，环孢素，泰利霉素，克拉霉素，奈法唑酮，利托那韦）。伴随剂，可引起QT间期延长（如噻嗪，三环，某些口服大环内酯类抗生素，第一和第三类抗心律失常药）。 QT间期≥500ms的时间间隔Bazett。 PR间期> 280ms。严重肝损害。妊娠（Cat.X）（使用有效的避孕）。哺乳的母亲。
警告/注意事项：
如果考虑暂停或中止心衰恶化发展。维持正常的血清钾离子和镁离子浓度。
互动（补）：
见禁忌。避免随之而来的抗心律失常药，CYP3A的诱导剂（如苯巴比妥，卡马西平，苯妥英，圣约翰草），西柚汁。减少1 / 2地高辛剂量，重新评估和监测。降低剂量和钙离子通道阻滞剂监测，β-阻断剂（心动过缓），其他CYP2D6的底物。维拉帕米，地尔硫增加决奈达隆水平。决奈达隆增加维拉帕米，地尔硫卓，硝苯地平水平。他汀类药物，会增强一些，西罗莫司，他克莫司，其他狭窄的治疗范围CYP3A的底物：调整剂量和监视器。监视其他CYP3A的或CYP2D6的底物（如SSRI类药物）。
不良反应（补）：
胃肠不适，乏力，皮疹，血清肌酐上升。
如何提供：
制表- 60，180，500
最后更新：
2009年7月29日
【原产地英文商品名】MULTAQ 400mg/tablet 100tablets/bottle
【原产地英文药品名】DRONEDARONE HYDROCHLORIDE
【中文参考商品译名】
注：以下产品不同的规格和不同价格，购买时请以电话咨询为准！
·MULTAQ 400毫克/片 100片/瓶
·MULTAQ 400毫克/片 15片/板 4板/盒
【中文参考药品译名】盐酸决奈达隆
【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
MULTAQ
Manufacturer:
Sanofi-aventis
Pharmacological Class:
Antiarrhythmic
Active Ingredient(s):
Dronedarone 400mg; tabs.
Indication(s):
To reduce risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL) with a recent episode of AF/AFL and cardiovascular risk factors (age >70yrs, HTN, diabetes, prior cerebrovascular accident, left atrial diameter ≥50mm or LVEF <40%, who are in sinus rhythm or who will be cardioverted.
Pharmacology:
Dronedarone is an antiarrhythmic drug that has properties belonging to all four types of antiarrhythmic agents (Classes I–IV).
Clinical Trials:
In the ATHENA study, 4628 patients with AF/AFL and sinus rhythm were treated for up to 30 months with either the study drug or placebo, in addition to conventional therapy. The primary endpoint was the time to first hospitalization for cardiovascular reasons or death from any cause. Compared to placebo, dronedarone reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24.2%.
In two other studies, EURIDIS and ADONIS, 1237 outpatients with a prior episode of AF/AFL and who were in sinus rhythm were given either dronedarone or placebo, in combination with conventional therapy, and were followed for 12 months. Dronedarone delayed the time to first recurrence of AF/AFL, lowering the risk of first AF/AFL recurrence by about 25%, with an absolute difference in recurrence rate of about 11% at 12 months.
In the ANDROMEDA study, patients recently hospitalized with symptomatic heart failure (HF) and severe left ventricular systolic dysfunction were given either dronedarone or placebo. The primary composite endpoint was all-cause mortality or hospitalization for HF. This study was terminated early because of increased mortality in the dronedarone group, mostly due to worsening HF.
Legal Classification:
Rx
Adults:
≥18yrs: 400mg twice daily (AM & PM) with meals.
Children:
<18yrs: not recommended.
Contraindication(s):
NYHA Class IV HF. NYHA Class II–III HF with recent decompensation requiring hospitalization or referral to a specialized HF clinic. 2nd- or 3rd-degree AV block or sick sinus syndrome, unless paced. Bradycardia (<50bpm). Concomitant strong CYP3A inhibitors (eg, ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, ritonavir). Concomitant agents that can cause QTc prolongation (eg, phenothiazines, tricyclics, certain oral macrolide antibiotics, Class I and III antiarrhythmics). QTc Bazett interval ≥500ms. PR interval >280ms. Severe hepatic impairment. Pregnancy (Cat.X) (use effective contraception). Nursing mothers.
Warnings/Precautions:
Consider suspending or discontinuing if worsening HF develops. Maintain normal serum K+ and Mg+ levels.
Interaction(s):
See Contraindications. Avoid concomitant antiarrhythmics, CYP3A inducers (eg phenobarbital, carbamazepine, phenytoin, St. John's wort), grapefruit juice. Reduce digoxin dose by 1/2, reevaluate and monitor. Reduce dose and monitor Ca+ channel blockers, β-blockers (bradycardia), other CYP2D6 substrates. Verapamil, diltiazem increase dronedarone levels. Dronedarone increases verapamil, diltiazem, nifedipine levels. May potentiate some statins, sirolimus, tacrolimus, other narrow-therapeutic range CYP3A substrates: adjust dose and monitor. Monitor other CYP3A or CYP2D6 substrates (eg, SSRIs).
Adverse Reaction(s):
GI upset, asthenia, rash, increased serum creatinine.
How Supplied:
Tabs—60, 180, 500