Dronedarone
Generic Name: dronedarone
Brand Names:
Multaq
11 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. Its empirical formula is C 31 H 44 N 2 O 5 S, HCl with a relative molecular mass of 593.2. Its structural formula is: MULTAQ is provided as tablets for oral administration.
Overview
11 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. Its empirical formula is C 31 H 44 N 2 O 5 S, HCl with a relative molecular mass of 593.2. Its structural formula is: MULTAQ is provided as tablets for oral administration.
Uses
1 INDICATIONS AND USAGE 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) ] . MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF ( 1 , 14 ).
Dosage
2 DOSAGE AND ADMINISTRATION The 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 [see Contraindications (4) ] . Verify that females of reproductive potential are not pregnant prior to initiating MULTAQ [see Warnings and Precautions (5.10) , Use in Specific Populations (8.1 , 8.3) ]. One tablet of 400 mg twice a day with morning and evening meals ( 2 )
Side Effects
6 ADVERSE REACTIONS The following safety concerns are described elsewhere in the label: • New or worsening heart failure [see Warnings and Precautions (5.4) ] • Liver Injury [see Warnings and Precautions (5.5) ] • Pulmonary toxicity [see Warnings and Precautions (5.6) ] • Hypokalemia and hypomagnesemia with potassium-depleting diuretics [see Warnings and Precautions (5.7) ] • QT prolongation [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥2%) are diarrhea, nausea, abdominal pain, vomiting, dyspepsia, bradycardia, skin issues (rashes, pruritus, eczema, dermatitis, dermatitis allergic), and asthenia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Dronedarone is metabolized by CYP3A and is a moderate inhibitor of CYP3A and CYP2D6 and has potentially important pharmacodynamic interactions ( 7 ) • Class I or III antiarrhythmics: Contraindicated. ( 4 , 7.1 ) • Digoxin: Consider discontinuation or halve dose of digoxin before treatment and monitor digoxin levels. ( 7.1 , 7.3 ) • Calcium channel blockers (CCB): Initiate CCB with low dose and increase after ECG verification of tolerability. ( 7.1 , 7.2 , 7.3 ) • Beta-blockers: May provoke excessive bradycardia. Initiate with low dose and increase after ECG verification of tolerability. ( 7.1 , 7.3 ) • CYP3A inducers: Avoid concomitant use. ( 7.2 ) • Grapefruit juice: Avoid concomitant use. ( 7.2 ) • Statins: Avoid simvastatin doses greater than 10 mg daily.
Warnings
WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure, MULTAQ doubles the risk of death [see Clinical Studies (14.3) ] . 5 WARNINGS AND PRECAUTIONS • Determine cardiac rhythm at least once every 3 months. If AF is detected discontinue MULTAQ or cardiovert. ( 5.2 ) • Ensure appropriate antithrombotic therapy prior to and throughout MULTAQ use. ( 5.3 ) • Liver injury: If hepatic injury is suspected, discontinue MULTAQ. ( 5.5 ) • If pulmonary toxicity is confirmed, discontinue treatment. ( 5.6 ) • Hypokalemia and hypomagnesemia: Maintain potassium and magnesium levels within the normal range. ( 5.7 ) • Renal impairment: Monitor renal function periodically. ( 5.9 ) • Embryofetal Toxicity: Based on animal data, MULTAQ may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception while using MULTAQ. 4 CONTRAINDICATIONS MULTAQ is contraindicated in patients with: • Permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored) [see Boxed Warning , Warnings and Precautions (5.2) ] • Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms [see Boxed Warning , Warnings and Precautions (5.1) ] • Second or third-d...
Pregnancy
8.1 Pregnancy Risk Summary MULTAQ may cause fetal harm when administered to a pregnant woman. In animal studies, dronedarone administered to pregnant rats and rabbits during the period of organogenesis caused multiple visceral (rats) and skeletal malformations (rats and rabbits) when administered at doses equivalent to or lower than the maximum recommended human dose (MRHD) (see Data ). There are no available data on dronedarone use in pregnant women to evaluate for a drug-associated risk of major birth defects or miscarriage or other adverse maternal or fetal outcomes.
Storage
Store at room temperature between 68°F to 77°F (20°C to 25°C): excursions permitted to 59°F–86°F (15°C–30°C), [see USP controlled room temperature] .
Frequently Asked Questions
What is Dronedarone used for?▼
1 INDICATIONS AND USAGE 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) ] . MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with a history of paroxysmal or persistent AF ( 1 , 14 ).
What are the side effects of Dronedarone?▼
6 ADVERSE REACTIONS The following safety concerns are described elsewhere in the label: • New or worsening heart failure [see Warnings and Precautions (5.4) ] • Liver Injury [see Warnings and Precautions (5.5) ] • Pulmonary toxicity [see Warnings and Precautions (5.6) ] • Hypokalemia and hypomagnesemia with potassium-depleting diuretics [see Warnings and Precautions (5.7) ] • QT prolongation [see Warnings and Precautions (5.8) ] Most common adverse reactions (≥2%) are diarrhea, nausea, abdominal pain, vomiting, dyspepsia, bradycardia, skin issues (rashes, pruritus, eczema, dermatitis, dermatitis allergic), and asthenia ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Dronedarone during pregnancy?▼
8.1 Pregnancy Risk Summary MULTAQ may cause fetal harm when administered to a pregnant woman. In animal studies, dronedarone administered to pregnant rats and rabbits during the period of organogenesis caused multiple visceral (rats) and skeletal malformations (rats and rabbits) when administered at doses equivalent to or lower than the maximum recommended human dose (MRHD) (see Data ). There are no available data on dronedarone use in pregnant women to evaluate for a drug-associated risk of major birth defects or miscarriage or other adverse maternal or fetal outcomes.
What are the important warnings for Dronedarone?▼
WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure, MULTAQ doubles the risk of death [see Clinical Studies (14.3) ] . 5 WARNINGS AND PRECAUTIONS • Determine cardiac rhythm at least once every 3 months. If AF is detected discontinue MULTAQ or cardiovert. ( 5.2 ) • Ensure appropriate antithrombotic therapy prior to and throughout MULTAQ use. ( 5.3 ) • Liver injury: If hepatic injury is suspected, discontinue MULTAQ. ( 5.5 ) • If pulmonary toxicity is confirmed, discontinue treatment. ( 5.6 ) • Hypokalemia and hypomagnesemia: Maintain potassium and magnesium levels within the normal range. ( 5.7 ) • Renal impairment: Monitor renal function periodically. ( 5.9 ) • Embryofetal Toxicity: Based on animal data, MULTAQ may cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception while using MULTAQ. 4 CONTRAINDICATIONS MULTAQ is contraindicated in patients with: • Permanent atrial fibrillation (patients in whom normal sinus rhythm will not or cannot be restored) [see Boxed Warning , Warnings and Precautions (5.2) ] • Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms [see Boxed Warning , Warnings and Precautions (5.1) ] • Second or third-d...
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.