Dronedarone


Thông tin thuốc gốc
Chỉ định và Liều dùng
Oral
Atrial fibrillation
Adult: 400 mg bid (morning and evening).
Renal Impairment
Mild to Moderate: No dosage adjustment needed. Severe: Contraindicated.
Hepatic Impairment
Mild to Moderate: No dosage adjustment needed. Severe: Contraindicated.
Cách dùng
Should be taken with food. Avoid grapefruit juice.
Chống chỉ định
Permanent AF; symptomatic heart failure w/ recent decompensation requiring hospitalisation or NYHA Class IV symptoms; bradycardia <50 bpm; 2nd- or 3rd-degree AV block, or sick sinus syndrome; QTc Bazett interval ≥500 msec; hepatic and lung toxicity associated w/ previous amiodarone therapy; history of or current heart failure or left ventricular systolic dysfunction. Concomitant use w/ phenothiazines antipsychotics, tricyclic antidepressants, class I and III antiarrhythmics, some macrolides (e.g. erythromycin), bepridil, terfenadine, CPY3A4 inhibitor (e.g. ciclosporin, cimetidine, clarithromycin, ketoconazole, HIV-protease inhibitors, grapefruit juice, nefazodone) or inducers (e.g. phenytoin, phenobarbital, rifampicin, carbamazepine, St John's wort). Severe hepatic and renal impairment. Pregnancy and lactation.
Thận trọng
May increase risk of arrhythmia in patients w/ hypokalaemia and hypomagnesaemia. Correct K and Mg deficiency prior to initiation and during treatment.
Phản ứng phụ
Hypokalaemia, hypomagnesaemia, bradycardia, diarrhoea, nausea, vomiting, abdominal pain, and dyspepsia, rashes and asthenia, pneumonitis and pulmonary fibrosis.
Potentially Fatal: Stroke, new or worsening heart failure, hepatocellular liver injury and hepatic failure, QT prolongation.
MonitoringParameters
Monitor ECG at least every 3 mth renal function periodically, and hepatic function before and throughout therapy.
Tương tác
Increased risk of bradycardia w/ β-blockers, Ca channel blockers and other antiarrhythmics. May increase plasma concentrations of statins, sirolimus and tacrolimus, vit K antagonists, warfarin and digoxin.
Potentially Fatal: Increased risk of QT prolongation and torsade de pointes w/ phenothiazines antipsychotics, tricyclic antidepressants, class I and III antiarrhythmics, some macrolides (e.g. erythromycin), bepridil and terfenadine. Decreased plasma concentration w/ CYP3A4 inducers (e.g. phenytoin, phenobarbital, rifampicin, carbamazepine). Increased plasma concentration w/ CPY3A4 inhibitor (e.g. ciclosporin, cimetidine, clarithromycin, ketoconazole, HIV-protease inhibitors, nefazodone).
Food Interaction
Avoid grapefruit juice as this may increase the serum levels of dronedarone. Avoid St John's wort as this may decrease the serum levels of dronedarone.
Tác dụng
Description: Dronedarone is an antiarrhythmic agent structurally related to amiodarone but w/o the iodine moiety to reduce the risk of non-target organ adverse effects associated w/ amiodarone. It exhibits all the properties of the 4 antiarrhythmic classes. It prolongs cardiac action potential duration and refractory periods by inhibiting K channels, inhibits Na and Ca channels, and has noncompetitive antiadrenergic activity.
Pharmacokinetics:
Absorption: Absolute bioavailability: Approx 4% (w/o food) and approx 15% (w/ food). Time to peak plasma concentration: 3-6 hr.
Distribution: Volume of distribution: Approx 20 L/kg. Plasma protein binding: >98% (mainly albumin).
Metabolism: Hepatic metabolism mainly via CYP3A4 isoenzyme to N-butyl metabolite. Initial metabolic pathway includes N-debutylation, oxidative deamination and direct oxidation.
Excretion: Via faeces: Approx 84% (as metabolites and unchanged drug); urine: Approx 6% (as metabolites). Elimination half-life: 13-19 hr.
Bảo quản
Store at 25°C.
Phân loại MIMS
References
Anon. Dronedarone. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 29/08/2013.

Buckingham R (ed). Dronedarone. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/12/2012.

FDA Drug Safety Communication: Review Update of Multaq (Dronedarone) and Increased Risk of Death and Serious Cardiovascular Adverse Events. U.S. FDA. https://www.fda.gov/. Accessed 29/08/2013.

McEvoy GK, Snow EK, Miller J et al (eds). Dronedarone Hydrochloride. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 29/08/2013.

MULTAQ Film Coated [Sanofi-Aventis U.S. LLC]. DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 29/08/2013.

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