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Multaq

How does the heart work?

The heart is a two stage electric pump whose job it is to circulate blood through the body. There is a group of cells that serve as an automatic pacemaker located in the atrium that generates an electrical current that spreads to the heart muscle cells to generate a coordinated squeeze, so that the pump can function.

The heart has four chambers, the right and left atria (singular= atrium) and the right and left ventricles. The right side of the heart pumps blood to the lungs while the left side pumps it to the rest of the body.

Blood from the body is collected in the right atrium and is pushed into the right ventricle with a small beat of the upper chamber of the heart. The right ventricle then pumps the blood to the lungs to pick up oxygen. They oxygen-rich blood returns to the left atrium where the small atrial beat pushes it to the left ventricle. The left ventricle is much thicker than the right because it needs t...

Multaq

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MULTAQ®
(dronedarone) Tablets

WARNING: HEART FAILURE

MULTAQ (dronedarone tablets) is contraindicated in patients with NYHA Class IV heart failure, or NYHA Class II - III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic [see CONTRAINDICATIONS].

In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA Study), patients given dronedarone had a greater than two-fold increase in mortality. Such patients should not be given dronedarone [see Clinical Studies].

DRUG DESCRIPTION

Dronedarone HC1 is a benzofuran derivative with the following chemical name: N-{2-butyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl} methanesulfonamide, hydrochloride.

Dronedarone HC1 is a white fine powder that is practically insoluble in water and freely soluble in methylene chloride and methanol.

Its empirical formula is C31H44N2O5S, with a relative molecular mass of 593.2. Its structural formula is:

MULTAQ
  (dronedarone) Structural Formula Illustration

MULTAQ (dronedarone tablets) 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 any of these serious side effects:

  • slow heart rate, fast or pounding heartbeats, 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,...

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).

Dronedarone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical...

Read All Potential Precautions of Multaq »

Last reviewed on RxList: 5/10/2011
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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