Questions about Atrial Fibrillation? Get answers from our expert.

Generic Name: dronedarone (droe NE da rone)
Brand Name: Multaq

What is dronedarone?

Dronedarone is an antiarrhythmic medication that affects the rhythm of heartbeats.

Dronedarone helps keep the heart beating normally in people with life-threatening heart rhythm disorders of the atrium (the upper chambers of the heart that allow blood to flow into the heart) and risk factors such as diabetes, high blood pressure, a history of stroke, or being over 70 years old.

Dronedarone is used to treat certain heart rhythm disorders called atrial fibrillation or atrial flutter. Dronedarone is given to reduce the need for hospitalization due to these heart conditions.

Dronedarone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about dronedarone?

You should not use dronedarone if you were recently hospitalized for heart failure, or if you now have symptoms of heart failure (shortness of breath, swelling, rapid weight gain). You also should not use dronedarone if you have a "permanent" heart rhythm disorder called atrial fibrillation. Dronedarone can double your risk of death if you have any of these heart conditions.

Slideshow: Atrial Fibrillation - Stroke Prevention Guidelines & Treatment Options

Dronedarone can harm an unborn baby or cause birth defects. Do not use dronedarone if you are pregnant.

You should not breast-feed while using this medicine.

You should not use dronedarone if you have severe liver disease or certain serious heart conditions such as "AV block" or sick sinus syndrome (unless you have a pacemaker). You should not use dronedarone if you have a history of very slow heart beats, or if you have ever used amiodarone and it caused you to have lung problems or liver problems.

There are many other medicines that can cause serious medical problems if you take them together with dronedarone. You may need to stop taking certain drugs while you are taking dronedarone. Tell your doctor about all other medicines you use.

What should I discuss with my healthcare provider before taking dronedarone?

Dronedarone is used to treat intermittent or "temporary" heart rhythm disorders. In some people with "permanent" atrial fibrillation, dronedarone increased the risk of stroke, hospitalization due to heart failure, and death. Dronedarone can double your risk of death if you have any of these heart conditions:

  • if you were recently hospitalized for heart failure;

  • if you now have symptoms of heart failure (shortness of breath, swelling, rapid weight gain); or

  • you have a "permanent" atrial fibrillation that cannot be changed back to a normal rhythm.

You also should not use dronedarone if you are allergic to it, or if you have:

  • severe liver disease;

  • certain serious heart conditions, especially severe heart failure, "AV block" or sick sinus syndrome (unless you have a pacemaker);

  • a history of slow heart beats that have caused you to faint;

  • if you are pregnant or breast-feeding; or

  • if you have ever used amiodarone and it caused you to have lung problems or liver problems.

Some medicines can cause unwanted or dangerous effects when used with dronedarone. You may need to stop taking certain drugs while you are taking dronedarone. Tell your doctor about all other medicines you use, especially:

  • cyclosporine;

  • ritonavir;

  • antifungal medicine--ketoconazole, itraconazole, voriconazole;

  • an antibiotic--clarithromycin, telithromycin;

  • an antidepressant;

  • medicine to treat a psychiatric disorder; or

  • other heart rhythm medicines.

To make sure dronedarone is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • a history of heart failure;

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or

  • if you have a pacemaker or defibrillator implanted in your chest.

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not use dronedarone if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine.

It is not known whether dronedarone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking dronedarone.

How should I take dronedarone?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Dronedarone works best if you take it with your morning and evening meals.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG) every 3 months. This will help your doctor determine how long to treat you with dronedarone. Your liver and kidney function may also need to be checked.

Use dronedarone regularly even if you feel fine or have no symptoms. Get your prescription refilled before you run out of medicine completely.

You should not stop using dronedarone suddenly. Stopping suddenly may make your condition worse.

Store at room temperature away from heat and moisture.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking dronedarone?

Grapefruit and grapefruit juice may interact with dronedarone and lead to unwanted side effects. Avoid the use of grapefruit products while taking dronedarone.

Dronedarone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • chest pain, wheezing, trouble breathing, dry cough, or coughing up mucus;

  • breathing problems while lying down trying to sleep;

  • severe dizziness, fainting, fast or pounding heartbeats;

  • slow heart rate, feeling like you might pass out;

  • a new or a worsening irregular heartbeat pattern;

  • signs of a kidney problem--little or no urinating, painful or difficult urination, blood in your urine, swelling in your feet or ankles, feeling tired; or

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • stomach pain, indigestion, nausea, vomiting, diarrhea;

  • feeling weak or tired; or

  • skin rash, itching, or redness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect dronedarone?

Many drugs can interact with dronedarone. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with dronedarone, especially:

  • digoxin;

  • St. John's wort;

  • a blood thinner (warfarin, Coumadin, Jantoven);

  • heart or blood pressure medication;

  • medicines to treat tuberculosis;

  • seizure medicine; or

  • "statin" cholesterol medication (Lipitor, Zocor, Vytorin, and others).

This list is not complete and many other drugs can interact with dronedarone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about dronedarone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 11.01. Revision Date: 2014-07-04, 10:38:15 AM.

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