Multaq
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Multaq
MULTAQ
(dronedarone) Tablets
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). MULTAQ is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure (See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS).
In patients with permanent atrial fibrillation, MULTAQ doubles the risk of death, stroke and hospitalization for heart failure. (See Clinical Studies). MULTAQ is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm (See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS).
DRUG 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 C31H44N2O5 S, HCl with a relative molecular mass of 593.2. Its structural formula is:
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MULTAQ is provided as tablets for oral administration.
Each tablet of MULTAQ contains 400 mg of dronedarone (expressed as base).
The inactive ingredients are:
Core of the tablets- hypromellose, starch, crospovidone, poloxamer 407, lactose monohydrate, colloidal silicon dioxide, magnesium stearate.
Coating / polishing of the tablets- hypromellose, polyethylene glycol 6000, titanium dioxide, carnauba wax.
What are the possible side effects of dronedarone (Multaq)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- severe dizziness, fainting, fast or pounding heartbeats;
- slow heart rate, feeling like you might pass out;
- a new or a worsening irregular heartbeat pattern;
- feeling short of breath, even with mild exertion, swelling in your ankles or feet, rapid weight gain;
- wheezing, cough, chest pain, trouble breathing, coughing...
Read All Potential Side Effects and See Pictures of Multaq »
What are the precautions when taking dronedarone tablets (Multaq)?
See also Warning section.
Before taking dronedarone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, certain types of irregular heartbeat (sick sinus syndrome, second- or third-degree atrioventricular block), serious side effects (such as liver/lung disease) from taking the medication amiodarone.
Dronedarone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat...
Last reviewed on RxList: 4/15/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Multaq Information
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