MULTAQ- dronedarone tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Dronedarone (UNII: JQZ1L091Y2) (Dronedarone - UNII:JQZ1L091Y2)

Available from:

sanofi-aventis U.S. LLC

INN (International Name):

Dronedarone

Composition:

Dronedarone 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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-degree atrioventricular (AV) block, or sick sinus syndrome (except when used in conjunction with a functioning pacemaker) - Bradycardia <50 bpm - Concomitant use of strong CYP3A inhibitors, such as ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir [see Drug Interactions (7.2)] - Concomitant use of erythromycin [see Clinical Pharmacology (12.3)] - Concomitant use of drugs or

Product summary:

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: 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] .

Authorization status:

New Drug Application

Patient Information leaflet

sanofi-aventis U.S. LLC
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration.
Revised: October 2023
MEDICATION GUIDE
MULTAQ® (MUL-tak)
(dronedarone)
tablets
What is the most important information I should know about MULTAQ?
MULTAQ may cause serious side effects, including:
•
Increased risk of death, stroke, and heart failure in people with:
•
A certain type of heart failure called decompensated heart failure.
Heart failure is when
your heart does not pump blood through your body as well as it should.
MULTAQ can
cause new or worsening heart failure.
Do not take MULTAQ if you have symptoms of heart failure that recently
worsened and
you were hospitalized, or if you have severe heart failure.
Call your healthcare provider right away if you develop any of the
following signs or
symptoms of heart failure during treatment with MULTAQ:
•
shortness of breath or wheezing at rest
•
wheezing, chest tightness or coughing up frothy sputum at rest,
nighttime or after
minor exercise
•
trouble sleeping or waking up at night because of breathing problems
•
using more pillows to prop yourself up at night so you can breathe
more easily
•
gaining more than 5 pounds quickly
•
increasing swelling of feet or legs
•
A certain type of irregular heartbeat (rhythm) called permanent atrial
fibrillation (AF).
Permanent AF is when you and your healthcare provider decide not to
try to change your
heart rhythm back to a normal heart rhythm or your heart rhythm cannot
be changed back
to a normal rhythm.
Do not take MULTAQ if you have permanent AF. Your healthcare provider
should check
your heart rhythm regularly to make sure your heart keeps a normal
rhythm.
Call your healthcare provider right away if you develop any of the
following signs or
symptoms of AF during treatment with MULTAQ such as:
•
fast or irregular heartbeat or pulse
•
chest pain
•
dizziness or lightheadedness
•
tiredness or weakness
•
reduced ability to exercise
•
shortness of breath
MULTAQ doubles your risk o

Summary of Product characteristics

MULTAQ- DRONEDARONE TABLET, FILM COATED
SANOFI-AVENTIS U.S. LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MULTAQ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MULTAQ.
MULTAQ® (DRONEDARONE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS
WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
MULTAQ IS CONTRAINDICATED IN PATIENTS WITH SYMPTOMATIC HEART FAILURE
WITH RECENT
DECOMPENSATION REQUIRING HOSPITALIZATION OR NYHA CLASS IV HEART
FAILURE. MULTAQ
DOUBLES THE RISK OF DEATH IN THESE PATIENTS. (4, 5.1, 14.3)
MULTAQ IS CONTRAINDICATED IN PATIENTS IN ATRIAL FIBRILLATION (AF) WHO
WILL NOT OR CANNOT
BE CARDIOVERTED INTO NORMAL SINUS RHYTHM. IN PATIENTS WITH PERMANENT
AF, MULTAQ
DOUBLES THE RISK OF DEATH, STROKE, AND HOSPITALIZATION FOR HEART
FAILURE. (4, 5.2, 14.4)
RECENT MAJOR CHANGES
Dosage and Administration (2)
10/2023
Warnings and Precautions (5.8)
10/2023
INDICATIONS AND USAGE
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 AND ADMINISTRATION
One tablet of 400 mg twice a day with morning and evening meals (2)
DOSAGE FORMS AND STRENGTHS
400 mg film-coated tablets (3)
CONTRAINDICATIONS
Permanent AF (patients in whom normal sinus rhythm will not or cannot
be restored) (Boxed Warning,
4)
Recently decompensated heart failure requiring hospitalization or
Class IV heart failure (Boxed Warning,
4)
Second or third-degree atrioventricular (AV) block or sick sinus
syndrome (except when used in
conjunction with a functioning pacemaker) (4)
Bradycardia <50 bpm (4)
Concomitant use of a strong CYP3A inhibitor (4)
Concomitant use of erythromycin (4)
Concomitant use of drugs or herbal products that prolong the QT
interval and may induce torsade de