Dronedarone

Generic name: Dronedarone
Brand names: Multaq
Dosage form: oral tablet (400 mg)
Drug class: Group III antiarrhythmics

Usage of Dronedarone

Dronedarone is a heart rhythm medicine that helps lower your risk of needing to be hospitalized for a heart rhythm disorder called atrial fibrillation. Dronedarone is for adults who have had this disorder in the past, but now have normal heart rhythm.

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

Dronedarone side effects

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

Dronedarone may cause serious side effects. Call your doctor at once if you have:

dry cough, shortness of breath;

little or no urination;

fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

heart problems--swelling, rapid weight gain, feeling short of breath;

liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes); or

low magnesium or potassium levels--dizziness, numbness or tingling, irregular heartbeats, fluttering in your chest, increased thirst or urination, muscle cramps or limp feeling.

Common side effects of dronedarone 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.

Before taking Dronedarone

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

severe liver disease;

a serious heart condition such as "sick sinus syndrome," "AV block" (unless you have a pacemaker), or very slow heartbeats that have caused you to faint;

if you are pregnant or breastfeeding; or

if you used a medicine called amiodarone and then had lung problems or liver problems.

Dronedarone can double your risk of death if you have certain heart conditions. You should not use dronedarone if:

you have severe heart failure;

you were recently hospitalized for worsening heart failure symptoms (shortness of breath, chest tightness, night-time breathing problems, swelling, rapid weight gain); or

you have a "permanent" atrial fibrillation that cannot be changed back to a normal rhythm (this will be determined by your doctor).

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with dronedarone. Your doctor may change your treatment plan if you also use:

other heart rhythm medicines;

cyclosporine;

ritonavir or other antiviral medicine;

an antibiotic such as clarithromycin or telithromycin;

an antidepressant such as amitriptyline, clomipramine, doxepin, imipramine, nefazodone, and others;

antifungal medicine such as itraconazole, ketoconazole, or voriconazole; or

antipsychotic medicine such as chlorpromazine, fluphenazine, promethazine, thioridazine, and others.

Tell your doctor if you have other heart problems.

Dronedarone may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

You should not breastfeed while using dronedarone.

Relate drugs

How to use Dronedarone

Usual Adult Dose for Atrial Fibrillation:

400 mg orally 2 times a day with a mealUse: To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age greater than 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter 50 mm or more, or left ventricular ejection fraction [LVEF] less than 40%), who are in sinus rhythm or who will be cardioverted.

Usual Adult Dose for Atrial Flutter:

Warnings

Dronedarone can double your risk of death if you have certain heart conditions. Call your doctor at once if you have an irregular pulse, chest tightness, wheezing, a cough with foamy mucus, swelling or rapid weight gain, or trouble breathing (especially at night).

Tell your doctor about all other medicines you start or stop using. Many drugs can interact, and some drugs should not be used together.

Dronedarone can also cause liver problems. Call your doctor if you have symptoms such as vomiting, loss of appetite, right-sided upper stomach pain, dark urine, and yellowing of your skin or eyes.

What other drugs will affect Dronedarone

Dronedarone can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your current medicines. Many drugs can affect dronedarone, especially:

digoxin;

St. John's wort;

a blood thinner (warfarin, Coumadin, Jantoven);

a diuretic or "water pill";

medicines to treat tuberculosis;

medicine to prevent organ transplant rejection;

seizure medicine; or

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

This list is not complete and many other drugs may affect dronedarone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Disclaimer

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