Dronedarone hydrochloride

Details

Stereochemistry	ACHIRAL
Molecular Formula	C31H44N2O5S.ClH
Molecular Weight	593.217
Optical Activity	NONE
Defined Stereocenters	0 / 0
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

Cl.CCCCN(CCCC)CCCOC1=CC=C(C=C1)C(=O)C2=C(CCCC)OC3=C2C=C(NS(C)(=O)=O)C=C3

InChI

InChIKey=DWKVCQXJYURSIQ-UHFFFAOYSA-N

InChI=1S/C31H44N2O5S.ClH/c1-5-8-12-29-30(27-23-25(32-39(4,35)36)15-18-28(27)38-29)31(34)24-13-16-26(17-14-24)37-22-11-21-33(19-9-6-2)20-10-7-3;/h13-18,23,32H,5-12,19-22H2,1-4H3;1H

HIDE SMILES / InChI

Molecular Formula	C31H44N2O5S
Molecular Weight	556.756
Charge	0
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

Molecular Formula	ClH
Molecular Weight	36.461
Charge	0
Count

Stereochemistry	ACHIRAL
Additional Stereochemistry	No
Defined Stereocenters	0 / 0
E/Z Centers	0
Optical Activity	NONE

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
Curator's Comment: description was created based on several sources, including: https://www.drugs.com/ppa/dronedarone.html | https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=7fa41601-7fb5-4155-8e50-2ae903f0d2d6 | http://www.rxlist.com/multaq-drug.htm

Dronedarone is an antiarrhythmic that is FDA approved for the treatment of atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF). Dronedarone is multichannel blocker. Common adverse reactions include abdominal pain, diarrhea, indigestion, nausea, vomiting, asthenia and raised serum creatinine. Dronedarone has potentially important pharmacodynamics interactions: 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.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Potency
Inward rectifier potassium channel 2 5 Target ID: CHEMBL1914276 Sources: https://www.ncbi.nlm.nih.gov/pubmed/25182566	Blocker 555
Potassium/sodium hyperpolarization-activated cyclic nucleotide-gated channel 4 14 Target ID: CHEMBL1250417 Sources: https://www.ncbi.nlm.nih.gov/pubmed/21279331	Blocker 555	1.0 µM [IC50]
Cytochrome P450 3A4 127 Target ID: CHEMBL340 Sources: https://www.ncbi.nlm.nih.gov/pubmed/17389667 \| http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	Substrate 661

Conditions

Condition	Modality	Targets	Highest Phase	Product
Atrial fibrillation 131 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	Primary		Approved 8583	MULTAQ Approved Use MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14) Launch Date 2009
Atrial flutter 6 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	Primary		Approved 8583	MULTAQ Approved Use MULTAQ® is indicated to reduce the risk of hospitalization for atrial fibrillation in patients in sinus rhythm with a history of paroxysmal or persistent atrial fibrillation (AF) [see Clinical Studies (14) Launch Date 2009

C_max

Value	Dose	Co-administered	Analyte	Population
96.2 ng/mL EXPERIMENT https://onlinelibrary.wiley.com/doi/full/10.1046/j.1472-8206.2003.00216.x	1600 mg single, oral dose: 1600 mg route of administration: Oral experiment type: SINGLE co-administered: METOPROLOL	METOPROLOL	DRONEDARONE plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

AUC

Value	Dose	Co-administered	Analyte	Population
1386 ng × h/mL EXPERIMENT https://onlinelibrary.wiley.com/doi/full/10.1046/j.1472-8206.2003.00216.x	1600 mg single, oral dose: 1600 mg route of administration: Oral experiment type: SINGLE co-administered: METOPROLOL	METOPROLOL	DRONEDARONE plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

T_1/2

Value	Dose	Co-administered	Analyte	Population
12 h EXPERIMENT https://onlinelibrary.wiley.com/doi/full/10.1046/j.1472-8206.2003.00216.x	1600 mg single, oral dose: 1600 mg route of administration: Oral experiment type: SINGLE co-administered: METOPROLOL	METOPROLOL	DRONEDARONE plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN

Doses

Dose	Population	Adverse events
400 mg 2 times / day steady, oral Recommended Dose: 400 mg, 2 times / day Route: oral Route: steady Dose: 400 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	unhealthy, 20-97 years Health Status: unhealthy Age Group: 20-97 years Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	Disc. AE: Gastrointestinal disorders, QT interval prolonged... AEs leading to discontinuation/dose reduction: Gastrointestinal disorders (3.2%) QT interval prolonged (1.5%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
1600 mg 2 times / day multiple, oral Highest studied dose Dose: 1600 mg, 2 times / day Route: oral Route: multiple Dose: 1600 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf https://pubmed.ncbi.nlm.nih.gov/17056831	healthy, 21-40 years Health Status: healthy Age Group: 21-40 years Sex: M Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf https://pubmed.ncbi.nlm.nih.gov/17056831	Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf https://pubmed.ncbi.nlm.nih.gov/17056831
400 mg 2 times / day steady, oral Recommended Dose: 400 mg, 2 times / day Route: oral Route: steady Dose: 400 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf	unhealthy, adult Health Status: unhealthy Age Group: adult Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf	Disc. AE: Diarrhea, Nausea... AEs leading to discontinuation/dose reduction: Diarrhea (6.7%) Nausea (3.9%) Abdominal pain upper (2%) Abdominal pain (1.9%) Vomiting (1.7%) Dyspepsia (1.3%) Nasopharyngitis (3.7%) Upper respiratory tract infection (2.9%) Dizziness (3.4%) Blood creatinine increased (2.5%) Hepatic enzyme increased (1.2%) Blood urea increased (0.4%) Bradycardia (2.6%) Palpitations (1.1%) Cardiac failure congestive (1.3%) Cardiac failure (0.8%) Fatigue (2.7%) Oedema peripheral (4.2%) Back pain (3.3%) Arthralgia (3.1%) Pain in extremity (2.1%) Cough (2.2%) Dyspnoea (2.3%) Vertigo (1.3%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
400 mg 2 times / day steady, oral Dose: 400 mg, 2 times / day Route: oral Route: steady Dose: 400 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	unhealthy, adult Health Status: unhealthy Age Group: adult Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf	Other AEs: Heart failure... Other AEs: Heart failure (grade 5) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022425lbl.pdf
600 mg 2 times / day multiple, oral Dose: 600 mg, 2 times / day Route: oral Route: multiple Dose: 600 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf	unhealthy, adult Health Status: unhealthy Age Group: adult Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf	Disc. AE: Diarrhea, Vomiting... AEs leading to discontinuation/dose reduction: Diarrhea (7.6%) Vomiting (1.5%) Dyspepsia (3%) Abdominal pain (1.5%) Nasopharyngitis (4.5%) Electrocardiogram QT prolonged (1.5%) Blood creatinine increased (1.5%) Hepatic enzyme increased (4.5%) Blood urea increased (3%) Bradycardia (1.5%) Palpitations (6.1%) Cardiac failure congestive (4.5%) Cardiac failure (4.5%) Fatigue (4.5%) Cough (1.5%) Hypokalemia (3%) Vertigo (4.5%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf
800 mg 2 times / day multiple, oral Dose: 800 mg, 2 times / day Route: oral Route: multiple Dose: 800 mg, 2 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf	unhealthy, adult Health Status: unhealthy Age Group: adult Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf	Disc. AE: Diarrhea, Nausea... AEs leading to discontinuation/dose reduction: Diarrhea (29%) Nausea (8.1%) Vomiting (3.2%) Abdominal pain (3.2%) Influenza (3.2%) Upper respiratory tract infection (1.6%) Dizziness (4.8%) Electrocardiogram QT prolonged (3.2%) Hepatic enzyme increased (1.6%) Blood urea increased (3.2%) Bradycardia (6.5%) Palpitations (4.8%) Cardiac failure congestive (1.6%) Cardiac failure (1.6%) Fatigue (3.2%) Atrial tachycardia (4.8%) Cough (4.8%) Vertigo (3.2%) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_MedR_P2.pdf

AEs

Overview

CYP3A4	CYP2C9	CYP2D6	hERG
inhibitor 2252	inducer 440 inhibitor 2438	substrate 1388 inhibitor 2507	inhibitor 2217

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
CYP1A2 2153 CYP2C19 2057 CYP2E1 1060 P-gp 1741 OAT1 725 OAT3 747 OCT1 620 OATP1B1 1079 OATP1B3 961	CYP3A 220 CYP1A2 1197 P-gp 2052	CYP1A2 832 CYP2A6 86 CYP3A 142 CYP2C8 198 CYP2C19 329

Drug as perpetrator

Target	Modality	Activity	Clinical evidence
OATP1B1 1095	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=13 Page: 13.0	likely
OATP1B3 970	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=13 Page: 13.0	likely
CYP3A4 2633	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89,194	moderate [Ki 8.12 uM]	yes (co-administration study) Comment: dronedarone increased verapamil exposure by 1.4- fold, and nisoldipine exposure by 1.5- fold; dronedarone increased simvastatin, a sensitive CYP3A substrate, and simvastatin acid exposure by 4- fold and 2- fold, respectively; Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89,194
CYP1A2 2333	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP2A6 911	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP2C19 2141	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP2C8 1117	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP2C9 2497	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP3A 317	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP1A2 2333	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	not significant
CYP2C19 2141	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	not significant
CYP2E1 1146	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	not significant
OAT1 730	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=13 Page: 13.0	not significant
OAT3 749	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=13 Page: 13.0	not significant
OCT1 656	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf#page=13 Page: 13.0	not significant
CYP2C9 2497	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	not significant	weak (co-administration study) Comment: dronedarone increased S-warfarin exposure by 1.2- fold Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0
P-gp 1932	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,90	strong [IC50 0.97 uM]	yes (co-administration study) Comment: IC50 value obtained using vincristine as substrate; increased S-warfarin exposure by 1.2- fold Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,90
CYP2D6 2546	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89,194	weak [Ki 4.37 uM]	yes (co-administration study) Comment: dronedarone increased metoprolol exposure by 1.6- and 2.3- fold, respectively; increased propranolol exposure by 1.3- fold; Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89,194

Drug as victim

Target	Modality	Activity	Clinical evidence
CYP3A 220	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89	major	yes (co-administration study) Comment: administration of ketoconazole resulted in a 17- to 25- fold increase in dronedarone exposure; administration with rifampicin decreased dronedarone exposure by 80% Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76,89
CYP1A2 1197	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
CYP2D6 1388	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	no
P-gp 2052	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_ClinPharm_P1.pdf#page=76 Page: 76.0	unlikely

Tox targets

Target	Modality	Activity	Metabolite	Clinical evidence
hERG 2263	inhibitor 2237 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022425s000_Pharm_P1.pdf#page=59 Page: 59.0

Sourcing

Vendor/Aggregator	ID	URL
ChEBI	CHEBI:50659	https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:50659
ChemicalBook	CB11117179	https://www.chemicalbook.com/ChemicalProductProperty_EN_CB11117179
eMolecules	30152747	https://www.emolecules.com/cgi-bin/more?vid=30152747
MolPort	MolPort-006-170-000	https://www.molport.com/shop/molecule-link/MolPort-006-170-000
ZINC	ZINC000049933061	http://zinc15.docking.org/substances/ZINC000049933061

PubMed

Title	Date	PubMed
The role of thyroid hormone nuclear receptors in the heart: evidence from pharmacological approaches.	2010-03	19096930
New pharmacological options for patients with atrial fibrillation: the ATHENA trial.	2009-05	19406061
Dronedarone for atrial fibrillation--an odyssey.	2009-04-30	19403901
Trial watch: novel antiarrhythmic agent shows promise in Phase III trial.	2009-04	19337265
Alternatives to amiodarone: search for the Holy Grail.	2009-04	19223364
A preliminary assessment of the effects of ATI-2042 in subjects with paroxysmal atrial fibrillation using implanted pacemaker methodology.	2009-04	19174378
Major recent trials in cardiovascular diseases.	2009-03	19332959
Effect of dronedarone on cardiovascular events in atrial fibrillation.	2009-02-12	19213680
Clinical trials update from the Heart Failure Society of America and the American Heart Association meetings in 2008: SADHART-CHF, COMPARE, MOMENTUM, thyroid hormone analogue study, HF-ACTION, I-PRESERVE, beta-interferon study, BACH, and ATHENA.	2009-02	19168521
Atrial-selective pharmacological therapy for atrial fibrillation: hype or hope?	2009-01	19077816
Benzofuran derivatives and the thyroid.	2009-01	18727707
[Amiodaron for treatment of perioperative cardiac arrythmia: a broad spectrum antiarrythmetic agent?].	2008-12	18704341
Dronedarone: a new treatment for atrial fibrillation.	2008-11	18702618
Amiodarone as paradigm for developing new drugs for atrial fibrillation.	2008-10	18841075
New antiarrhythmic drugs for atrial fibrillation: focus on dronedarone and vernakalant.	2008-10	18523740
New horizons in antiarrhythmic therapy: will novel agents overcome current deficits?	2008-09-22	18790110
[Current pharmacological management of atrial fibrillation management by practice cardiologists - news from congress in Munich].	2008-09	19004121
Dronedarone for the control of ventricular rate in permanent atrial fibrillation: the Efficacy and safety of dRonedArone for the cOntrol of ventricular rate during atrial fibrillation (ERATO) study.	2008-09	18760136
Clinical trials update from Heart Rhythm 2008 and Heart Failure 2008: ATHENA, URGENT, INH study, HEART and CK-1827452.	2008-09	18678526
Increased mortality after dronedarone therapy for severe heart failure.	2008-06-19	18565860
Concurrent Chagas' disease and borderline disseminated cutaneous leishmaniasis: The role of amiodarone as an antitrypanosomatidae drug.	2008-06	18827865
Anti-arrhythmic drug therapy for atrial fibrillation: current anti-arrhythmic drugs, investigational agents, and innovative approaches.	2008-06	18515286
Pharmacotherapy for atrial arrhythmias: present and future.	2008-06	18456197
Acute inhibitory effect of dronedarone, a noniodinated benzofuran analogue of amiodarone, on Na+/Ca2+ exchange current in guinea pig cardiac ventricular myocytes.	2008-06	18392809
Update on atrial fibrillation: part II.	2008-03	18383050
Is dronedarone effective for the prevention of recurrent atrial fibrillation?	2008-03	18087298
Rationale and design of ATHENA: A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter.	2008-01	18031520
[Efficacy of dronedarone in cardiac failure due to severe left ventricular systolic dysfunction. Results of the ANDROMEDA].	2008	19076098
Atrial fibrillation after cardiac surgery: where are we now?	2008	18982137
[Efficacy of dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. Results of the EURIDIS and ADONIS].	2008	18789030
Relationship among amiodarone, new class III antiarrhythmics, miscellaneous agents and acquired long QT syndrome.	2008	18651412
Dronedarone in atrial fibrillation.	2007-12-06	18069129
Dronedarone in atrial fibrillation.	2007-12-06	18057346
In vitro effects of acute amiodarone and dronedarone on epicardial, endocardial, and M cells of the canine ventricle.	2007-12	18172226
Effect of dronedarone on renal function in healthy subjects.	2007-12	17662087
New antiarrhythmic drugs for establishing sinus rhythm in atrial fibrillation: what are our therapies likely to be by 2010 and beyond?	2007-11	17967585
Antiarrhythmics for maintaining sinus rhythm after cardioversion of atrial fibrillation.	2007-10-17	17943835
Maintaining sinus rhythm--making treatment better than the disease.	2007-09-06	17804851
Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter.	2007-09-06	17804843
Na+/Ca2+ exchange inhibitors: a new class of calcium regulators.	2007-09	17896959
Acute in vitro effects of dronedarone, an iodine-free derivative, and amiodarone, on the rabbit sinoatrial node automaticity: a comparative study.	2007-09	17875953
Inhibition of the HERG potassium channel by the tricyclic antidepressant doxepin.	2007-08-01	17560554
New antiarrhythmic treatment of atrial fibrillation.	2007-07	17605649
Comparative antiarrhythmic efficacy of amiodarone and dronedarone during acute myocardial infarction in rats.	2007-06-14	17391666
Effect of amiodarone and dronedarone administration in rats on thyroid hormone-dependent gene expression in different cardiac components.	2007-06	17535870
Dronedarone: an amiodarone analog for the treatment of atrial fibrillation and atrial flutter.	2007-04	17389667
A review of the investigational antiarrhythmic agent dronedarone.	2007-03	17495254
Dronedarone: in quest of the ideal antiarrhythmic drug.	2007	18059201
Dronedarone: drondarone, SR 33589, SR 33589B.	2007	17472412
Do we need pharmacological therapy for atrial fibrillation in the ablation era?	2006-12	17340189

Patents

Sample Use Guides

In Vivo Use Guide

One tablet of 400 mg twice a day with morning and evening meals.

Route of Administration: Oral

In Vitro Use Guide

In isolated ventricular myocytes, dronedarone inhibited rapidly activating delayed-rectifier K+ current (I(Kr)) (median inhibitory concentration [IC50] /= 30 uM).

Substance Class	Chemical Created by `admin` on `Mon Mar 31 18:05:38 GMT 2025` Edited by `admin` on `Mon Mar 31 18:05:38 GMT 2025`
Record UNII	FA36DV299Q
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

MULTAQ

Preferred Name

English

Dronedarone hydrochloride

Official Name

English

SR33598B

Code

English

Dronedarone HCL

Common Name

English

Methanesulfonamide, N-[2-butyl-3-[4-[3-(dibutylamino)propoxy]benzoyl]-5-benzofuranyl]-, monohydrochloride

Systematic Name

English

Dronedarone hydrochloride [EP MONOGRAPH]

Common Name

English

Dronedarone hydrochloride [MI]

Common Name

English

Dronedarone hydrochloride [USP-RS]

Common Name

English

Dronedarone hydrochloride [USP MONOGRAPH]

Common Name

English

Dronedarone hydrochloride [WHO-DD]

Common Name

English

Dronedarone hydrochloride [MART.]

Common Name

English

SR-33598B

Code

English

Dronedarone hydrochloride [USAN]

Common Name

English

N-(2-BUTYL-3-(4-(3-(DIBUTYLAMINO)PROPROXY)BENZOYL)BENZOFURAN-5-YL) METHANESULFONAMIDE-, MONOHYDROCHLORIDE

Systematic Name

English

Dronedarone hydrochloride [ORANGE BOOK]

Common Name

English

Classification Tree Code System Code

EMA ASSESSMENT REPORTS

MULTAQ (AUTHORIZED ATRIAL FIBRILLATION)