Dronedarone

Dronedarone
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

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Black Box Warning

WARNING See full prescribing information for complete Boxed Warning. To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION. TIKOSYN is available only to hospitals and prescribers who have received appropriate TIKOSYN dosing and treatment initiation education; see DOSAGE AND ADMINISTRATION.

Overview

Dronedarone is {{{aOrAn}}} Antiarrhythmic that is FDA approved for the {{{indicationType}}} of maintenance of normal sinus rhythm (delay in AF/AFl recurrence), Conversion of arial fibrillation/flutter. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Abdominal pain, Diarrhea, Indigestion, Nausea, Vomiting, Asthenia , Serum creatinine raised.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

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• Dosing Information

(Dosage)

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Dronedarone FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

TIKOSYN is contraindicated in patients with congenital or acquired long QT syndromes. TIKOSYN should not be used in patients with a baseline QT interval or QTc >440 msec (500 msec in patients with ventricular conduction abnormalities). TIKOSYN is also contraindicated in patients with severe renal impairment (calculated creatinine clearance <20 mL/min). The concomitant use of verapamil or the cation transport system inhibitors cimetidine, trimethoprim (alone or in combination with sulfamethoxazole), or ketoconazole with TIKOSYN is contraindicated (see WARNINGS and PRECAUTIONS, Drug-Drug Interactions), as each of these drugs cause a substantial increase in dofetilide plasma concentrations. In addition, other known inhibitors of the renal cation transport system such as prochlorperazine, dolutegravir and megestrol should not be used in patients on TIKOSYN. The concomitant use of hydrochlorothiazide (alone or in combinations such as with triamterene) with TIKOSYN is contraindicated (see PRECAUTIONS, Drug-Drug Interactions) because this has been shown to significantly increase dofetilide plasma concentrations and QT interval prolongation. TIKOSYN is also contraindicated in patients with a known hypersensitivity to the drug.

Warnings

WARNING See full prescribing information for complete Boxed Warning. To minimize the risk of induced arrhythmia, patients initiated or re-initiated on TIKOSYN should be placed for a minimum of 3 days in a facility that can provide calculations of creatinine clearance, continuous electrocardiographic monitoring, and cardiac resuscitation. For detailed instructions regarding dose selection, see DOSAGE AND ADMINISTRATION. TIKOSYN is available only to hospitals and prescribers who have received appropriate TIKOSYN dosing and treatment initiation education; see DOSAGE AND ADMINISTRATION.

There is limited information regarding Dronedarone Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Dronedarone Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Dronedarone Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Dronedarone Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Dronedarone in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dronedarone in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dronedarone during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Dronedarone in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Dronedarone in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Dronedarone in geriatric settings.

Gender

There is no FDA guidance on the use of Dronedarone with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dronedarone with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dronedarone in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dronedarone in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dronedarone in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dronedarone in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Dronedarone Administration in the drug label.

Monitoring

There is limited information regarding Dronedarone Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Dronedarone and IV administrations.

Overdosage

There is limited information regarding Dronedarone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Mechanism of Action

There is limited information regarding Dronedarone Mechanism of Action in the drug label.

Structure

There is limited information regarding Dronedarone Structure in the drug label.

Pharmacodynamics

There is limited information regarding Dronedarone Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Dronedarone Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Dronedarone Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Dronedarone Clinical Studies in the drug label.

How Supplied

There is limited information regarding Dronedarone How Supplied in the drug label.

Storage

There is limited information regarding Dronedarone Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Dronedarone Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Dronedarone interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Dronedarone Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Dronedarone Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Dronedarone

File:Dronedarone.svg
Legal status
Legal status	Phase III
Identifiers
IUPAC name N-(2-Butyl-3-(p-(3-(dibutylamino)propoxy)benzoyl)- 5-benzofuranyl)methanesulfonamide
CAS Number	141626-36-0
PubChem CID	208898
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C31H44N2O5S
Molar mass	556.758

Dronedarone (also known as SR33589) is a drug under development by Sanofi-Aventis, mainly for the indication of cardiac arrhythmias (irregular heartbeat). It is currently in phase III trials for atrial fibrillation and in patients with an implantable cardioverter-defibrillator (ICD); a trial in heart failure was stopped as an interim analysis showed a possible increase in heart failure deaths.

Chemically it is a benzofuran derivative related to amiodarone, a popular antiarrhythmic the use of which is limited to toxicity due its high iodine content (pulmonary fibrosis, thyroid disease) as well as by liver disease. Dronedarone lacks the iodine, and is expected to have less toxicity, yet it displays amiodarone-like class III antiarrhytmic activity in vitro and in clinical trials.

In a 2007 trial in atrial fibrillation, dronedarone was significantly more effective than placebo in maintaining sinus rhythm, with no difference in lung and thyroid function in the short term.