Dronedarone

Dronedarone is a prescription medication used to lower the chance of hospitalization caused by atrial fibrillation (irregular heart rhythms). Dronedarone belongs to a group of drugs called antiarrhythmics, which help the heart beat normally.

This medication comes in tablet form and is taken twice a day, with food.

Common side effects of dronedarone include stomach problems, nausea, and tiredness. 

Dronedarone is a prescription medication used to lower the chance of hospitalization from an atrial fibrillation (irregular heart rhythm).  This medication is used in adults who have had atrial fibrillation in the past but now have a normal heart rhythm.

This medication may be prescribed for other uses.  Ask your doctor or pharmacist for more information.

Dronedarone may be found in some form under the following brand names:

• Multaq

Dronedarone may cause serious side effects, including:

• See "Drug Precautions".
• Slowed heartbeat (bradycardia)

The most common side effects of dronedarone include:

• Stomach problems such as
  • diarrhea
  • nausea
  • vomiting
  • stomach area (abdominal) pain
  • indigestion
• feeling tired and weak
• skin problems such as redness, rash, and itching

Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of dronedarone. For more information ask your doctor or pharmacist.

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• certain medicines that can change the amount of dronedarone that gets into your body. Do not use these medicines with dronedarone:
  • Nefazodone for depression
  • Norvir (ritonavir) for HIV infection
  • Nizoral (ketoconazole), and Sporanox (itraconazole), and Vfend (voriconazole) for fungal infections
  • Ketek (telithromycin), Biaxin (clarithromycin) for bacterial infections
  • Cyclosporine for organ transplant
• You take certain medicines that can lead to a dangerous abnormal heart rhythm:
  • Some medicines for mental illness called phenothiazines
  • Some medicines for depression called tricyclic antidepressants
  • Some medicines for abnormal heart rhythm or fast heartbeat
  • Some medicines for bacterial infection
  Ask your doctor if you are not sure if your medicine is one that is listed above.

1. Dronedarone is not for people with heart failure with symptoms which recently worsened or for people with severe heart failure. People with these conditions who take dronedarone have an increased chance of dying. Heart failure means your heart does not pump blood through your body as well as it should.

Do not take dronedarone if you have symptoms of heart failure which recently worsened or if you have severe heart failure.

Call your doctor right away if you have any signs and symptoms of heart failure:

• 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

2.  Dronedarone is not for people with a type of atrial fibrillation (irregular heart rhythm) called permanent atrial fibrillation (AF). In permanent AF, your heartbeat stays in atrial fibrillation and will not or cannot be changed back to a normal rhythm. Your doctor will monitor your heart rhythm regularly to make sure your heartbeat keeps a normal rhythm.

Do not take dronedarone if you have permanent AF.

Call your doctor right away if you notice that your pulse is irregular. This is a sign that you are in atrial fibrillation.

3.  Dronedarone may cause liver problems, including life-threatening liver failure. Your doctor may order blood tests to check your liver before you start taking dronedarone and during treatment. In some cases dronedarone treatment may need to be stopped. Tell your doctor right away if you develop any of these signs and symptoms of liver problems:

• loss of appetite, nausea, vomiting
• fever, feeling unwell, unusual tiredness
• itching
• yellowing of the skin or the whites of the eyes (jaundice)
• unusual darkening of the urine
• right upper stomach area pain or discomfort

Do not take dronedarone if:

• You are in atrial fibrillation and your doctor is not planning to change you back into normal rhythm
• You have symptoms of heart failure which recently worsened or you have severe heart failure
• You have severe liver problems or had liver problems after using amiodarone (a medicine for abnormal heart rhythm)
• You take certain medicines that can change the amount of dronedarone that gets into your body. See "Drug Interactions".

Do not drink grapefruit juice while you take dronedarone. Grapefruit juice can increase the amount of dronedarone in your blood and increase the likelihood that you will have a side effect of dronedarone.

Before starting dronedarone, tell your doctor:

• If you have any other heart problems
• If you are pregnant or breastfeeding
• Tell your doctor about all the medicines you take, including any new medicines. Include all prescription and non-prescription medicines, vitamins and herbal remedies. Dronedarone and certain other medicines can react with each other, causing serious side effects. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. See "Drug Interactions".

Be sure to tell your doctor and pharmacist if you take:

• medicine for high blood pressure, chest pain, or other heart conditions
• statin medicine to lower blood cholesterol
• medicine for TB (tuberculosis)
• medicine for seizures
• medicine for organ transplant
• herbal supplement called St. John's wort

Some of these medicines could keep dronedarone from working well or make it more likely for you to have side effects.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category X. It is not known if dronedarone will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Women who may become pregnant should use effective birth control (contraception) while taking dronedarone. Talk to your doctor about the best birth control methods for you.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if dronedarone passes into your breast milk. You and your doctor should decide if you will take dronedarone or breastfeed. You should not do both.

• Take dronedarone exactly as your doctor tells you.
• Take dronedarone two times a day with food, once with your morning meal and once with your evening meal.
• Do not stop taking dronedarone even if you are feeling well for a long time. The medicine may be working.
• If you miss a dose, wait and take your next dose at your regular time. Do not take 2 doses at the same time. Do not try to make up for a missed dose.

Take dronedarone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dosage of dronedarone is 400 mg twice daily in adults.

If you take too much of this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store dronedarone at room temperature (59–86°F or 15–30°C).
• Keep dronedarone and all medicines out of the reach of children.

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; dronedarone doubles the risk of death. Dronedarone is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure. 

In patients with permanent atrial fibrillation, dronedarone doubles the risk of death, stroke and hospitalization for heart failure. Dronedarone is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm.