决奈达隆（Dronedarone）是一种新的抗心律失常药物，它由法国赛诺菲一安万特公司开发，在美国和欧盟上市，该药具有与胺碘酮（amiodarone）类似的电生理作用，为后者的替代更新药物。
Multaq为一种抗心率失常药物用于降低发生突发性与持久性心房颤动与心房扑动患者因心血管病住院的风险，这些患者近期发生过心房颤动或心房扑动并有心血管病危险因素。Multaq为首个证明可降低患者心血管病住院风险的心房颤动药物，心房扑动可发展为心房颤动。400mg的Multaq每天服用两次。
批准日期：[美国FDA]，2009年7月1日，[欧盟EMEA] 2009年12月16日。公司：赛诺菲-安万特
MULTAQ(盐酸多罗达隆[dronedarone])片，供口服使用
首次美国批准：2009
警告：
失代偿性心力衰竭或永久性心房颤动患者死亡、中风和心力衰竭风险增加
MULTAQ禁用于有症状心力衰竭、近期失代偿需要住院或NYHA IV类心力衰竭的患者。Multq在这些患者中死亡的风险增加了两倍。
MULTAQ禁用于房颤（AF）患者不能或不能复律为正常窦性心律。在永久性房颤患者中，MultAQ增加了死亡、中风和心力衰竭的住院风险。
近期重大变化
警告和注意事项，肝损伤：02／2011
警告和预防措施，Creatinine治疗开始后的增加：08／2011
适应证和用法、禁忌证、警告和注意事项：XX／2011
作用机理
强的松的作用机制尚不清楚。Dronedarone具有抗心律失常的特性，属于所有四个Vaughan-Williams类，但是这些活性中的每一个对于临床效果的贡献尚不清楚。
适应症及用法
MULTAQ是一种抗心律失常药物，用于降低有阵发性或持续性房颤病史的窦性心律患者的房颤住院风险。
剂量与给药
一片400毫克，每日两次，早晚各餐一次。
剂型和强度
400毫克薄膜包衣片。
禁忌症
永久性房颤（正常窦性心律不能恢复或不能恢复的患者）（装箱警告）
最近失代偿性心力衰竭需要住院治疗或Ⅳ级心力衰竭。（装箱警告）
二度或三度房室传导阻滞或病态窦房结综合征（除非与功能起搏器联合使用）。Bradycardia＜50 BPM。
同时使用强CYP3A抑制剂。
同时使用药物或草药产品，延长QT间期，并可能诱发尖端扭转。
与先前使用胺碘酮有关的肝毒性。
严重肝损害。
QTc Bazett区间大于500毫秒。
孕期和哺乳期母亲。
警告和注意事项
每3个月至少测一次心律。如果检测到AF，停止MultAQ或心脏复律。
肝损伤：如果怀疑肝损伤，停止MultAQ。
在使用MultAQ之前和整个过程中确保适当的抗血栓治疗。
低钾血症和低镁血症：维持钾和镁在正常范围内。
肌酐升高：定期监测血清肌酐。
致畸因素：育龄妇女在使用Multq时应采取有效的避孕措施。
不良反应
最常见的不良反应（2%）是腹泻、恶心、腹痛、呕吐和乏力。
为了报告可能的不良反应，请与赛诺菲-安万特美国有限责任公司（Sanofi-aventis U.S.LLC）在1-800-633-1610或FDA 1-800-FDA-1088或www.fda.gov/medwatch联系
药物相互作用
龙舌兰酮是由CYP3A代谢的，是中度抑制剂。
CYP 3A和CYP 2D6具有潜在的重要药效学相互作用
抗心律失常药：避免同时使用。
Digoxin：在治疗前考虑停用或减半地高辛剂量，并监测地高辛水平。
钙通道阻滞剂（CCB）：在低剂量下启动CCB，并在ECG耐受性验证后增加。
β受体阻滞剂：可诱发过度心动过缓，低剂量启动，心电图检查后耐受性增加。
CYP3A诱导剂：避免伴随使用。
柚子汁：避免伴随使用。
他汀类药物：遵循标签建议同时使用某些他汀类药物与CYP 3A和P-gp抑制剂，如龙奈达酮。具有窄治疗指数的CYP 3A底物（例如，西罗莫司和他克莫司）：当与MULTAQ一起使用时，根据需要监测和调整伴随药物的剂量。
华法林：在服用华法林后，开始服用强的松，监测INR。
如何供应/储存和搬运
MULTAQ 400mg片剂作为白色薄膜包衣片提供，用于口服给药，长方形，一侧刻有双波标记，另一侧刻有“4142”代码：
瓶60片，NDC 548 68 3086 0
存储在25°C（77°F）：允许15至30°C（59至86°F）的漂移（参见USP控制的室温）。
完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=236d4549-f44b-4677-b857-acedd10b9920
MULTAQ(DRONEDARONE)TABLET
WARNINGS 
WARNING:
HEART FAILURE
MULTAQ is contraindicated in patients with NYHA Class IV heart failure, or NYHA Class II–III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic[see Contraindications].
In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA Study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone.
Initial U.S. Approval: 2009
DESCRIPTION
Dronedarone HCl is a benzofuran derivative with the following chemical name:
N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride.
Dronedarone HCl is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol.
MULTAQ is provided as tablets for oral administration.
Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base).
The inactive ingredients are:
Core of the tablets- hypromellose, starch, crospovidone, poloxamer 407, lactose monohydrate, colloidal silicon dioxide, magnesium stearate.
Coating/polishing of the tablets- hypromellose, polyethylene glycol 6000, titanium dioxide, carnauba wax.
CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY
Mechanism of Action
The mechanism of action of dronedarone is unknown. Dronedarone has antiarrhythmic properties belonging to all four Vaughan-Williams classes, but the contribution of each of these activities to the clinical effect is unknown.
INDICATIONS AND USAGE 
INDICATIONS AND USAGE
MULTAQ® is indicated to reduce the 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 associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter  geq50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted
CONTRAINDICATIONS
Class IV heart failure or symptomatic heart failure with a recent decompensation
Second- or third- degree atrioventicular (AV) block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)
Bradycardia <50 bpm
Concomitant use of a strong CYP3A inhibitor
Concomitant use of drugs or herbal products that prolong the QT interval and may induce Torsade de Pointes
Severe hepatic impairment
QTc Bazett interval  geq500 ms
Pregnancy
Nursing mothers
PRECAUTIONS
WARNINGS AND PRECAUTIONS
Heart failure: If heart failure develops or worsens, consider the suspension or discontinuation of MULTAQ
Liver injury: if hepatic injury is suspected, discontinue MULTAQ
Hypokalemia and hypomagnesemia: Maintain potassium and magnesium levels within the normal range
QT prolongation: Stop MULTAQ if QTc Bazett  geq500ms
Increase in creatinine: Monitor serum creatinine periodically
Teratogen: Women of childbearing potential should use effective contraception while using MULTAQ
DRUG INTERACTIONS
Dronedarone is metabolized by CYP 3A and is a moderate inhibitor of
CYP 3A and CYP 2D6 and has potentially important pharmacodynamic interactions.
Antiarrhythmics: Avoid concomitant use
Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor
Calcium channel blockers (CCB): Initiate CCB with low dose and increase after ECG verification of tolerability
Beta-blockers: May provoke excessive bradycardia, Initiate with low dose and increase after ECG verification of tolerability
CYP 3A inducers: Avoid concomitant use
Grapefruit juice: Avoid concomitant use
Statins: Follow label recommendations for concomitant use of certain statins with a CYP 3A and P-gP inhibitor like dronedarone
CYP 3A substrates with a narrow therapeutic index (e.g., sirolimus and tacrolimus): Monitor and adjust dosage of concomitant drug as needed when used with MULTAQ
Warfarin: Monitor INR after initiating dronedarone in patients taking warfarin.
ADVERSE REACTIONS
Most common adverse reactions (=2%) are diarrhea, nausea, abdominal pain, vomiting, and asthenia
DOSAGE AND ADMINISTRATION 
DOSAGE AND ADMINISTRATION
The only recommended dosage of MULTAQ is 400 mg twice daily in adults. MULTAQ should be taken as one tablet with the morning meal and one tablet with the evening meal.
Treatment with Class I or III antiarrhythmics (e.g., amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol) or drugs that are strong inhibitors of CYP3A (e.g., ketoconazole) must be stopped before starting MULTAQ
HOW SUPPLIED
HOW SUPPLIED/STORAGE AND HANDLING
MULTAQ 400-mg tablets are provided as white film-coated tablets for oral administration, oblong-shaped, engraved with a double wave marking on one side and “4142” code on the other side in:
Bottles of 60 tablets, NDC 0024-4142-60
Bottles of 180 tablets, NDC 0024-4142-18
Bottles of 500 tablets NDC 0024-4142-50
Box of 10 blisters (10 tablets per blister) NDC 0024-4142-10
Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F), [see USP controlled room temperature].