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Dronedarone

Pronunciation

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

Dronedarone should not be used in patients with severe (class IV) heart failure. It should also not be used in patients with heart failure who have recently had worsening symptoms that required hospitalization. The risk of death may be increased in these patients.

Dronedarone should not be used in patients with a certain type of irregular heartbeat called permanent atrial fibrillation. The risk of death, stroke, and hospitalization for heart failure may be increased in these patients.


Dronedarone is used for:

Decreasing the risk of needing to go to the hospital for a certain type of irregular heartbeat called atrial fibrillation in certain patients with a history of this type of irregular heartbeat.

Dronedarone is an antiarrhythmic. Exactly how it works is not known.

Do NOT use dronedarone if:

  • you are allergic to any ingredient in dronedarone
  • you have permanent atrial fibrillation (atrial fibrillation that will not or cannot be changed back to a regular heartbeat)
  • you have severe (class IV) heart failure
  • you have heart failure and have recently had worsening symptoms that required hospitalization
  • you have second- or third-degree heart block or sick sinus syndrome, unless you have a pacemaker
  • you have a very slow heartbeat or certain other types of irregular heartbeat
  • you have severe liver problems
  • you have developed liver or lung problems after using another antiarrhythmic medicine called amiodarone
  • you are pregnant, may become pregnant, or are breast-feeding
  • you are taking another antiarrhythmic (eg, amiodarone, dofetilide, flecainide, sotalol), asenapine, certain azole antifungals (eg, itraconazole, ketoconazole, voriconazole), carbamazepine, citalopram, clozapine, cobicistat, cyclosporine, fingolimod, halofantrine, haloperidol, a hydantoin (eg, phenytoin), a macrolide antibiotic (eg, clarithromycin, erythromycin), maprotiline, nefazodone, nilotinib, ondansetron, paliperidone, phenobarbital, phenothiazines (eg, thioridazine), primidone, protease inhibitors (eg, boceprevir, ritonavir), quetiapine, rifamycins (eg, rifampin), St. John's wort, telithromycin, tetrabenazine, a tricyclic antidepressant (eg, amitriptyline), or vardenafil
  • you are taking any other medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Contact your doctor or health care provider right away if any of these apply to you.

Before using dronedarone:

Some medical conditions may interact with dronedarone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of other heart problems (eg, heart failure, irregular heartbeat other than atrial fibrillation), electrolyte problems (eg, low blood potassium or magnesium), liver problems, kidney problems, or lung or breathing problems

Some MEDICINES MAY INTERACT with dronedarone. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Many prescription and nonprescription medicines (eg, used for allergies, blood thinning, cancer, chest pain, depression or other mental or mood problems, drug or other substance abuse or dependence, heartburn, hepatitis C, high blood pressure, high cholesterol, HIV, immune system suppression, infections, irregular heartbeat or other heart problems, multiple sclerosis, nausea and vomiting, pain, seizures, swelling or fluid retention, Tourette syndrome), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) because they may interact with dronedarone. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with dronedarone

This may not be a complete list of all interactions that may occur. Ask your health care provider if dronedarone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use dronedarone:

Use dronedarone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Dronedarone comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get dronedarone refilled.
  • Take dronedarone by mouth with food, such as with the morning and evening meals, unless your doctor tells you otherwise.
  • Do not eat grapefruit or drink grapefruit juice while you take dronedarone.
  • Take dronedarone on a regular schedule to get the most benefit from it.
  • Continue to take dronedarone even if you feel well. Do not miss any doses.
  • If you miss a dose of dronedarone, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use dronedarone.

Important safety information:

  • Dronedarone may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to dronedarone. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Do NOT take more than the recommended dose or stop taking dronedarone without checking with your doctor.
  • Tell your doctor or dentist that you take dronedarone before you receive any medical or dental care, emergency care, or surgery.
  • Severe liver problems have been reported in some patients using dronedarone. Tell your doctor right away if you develop symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; nausea, vomiting, or loss of appetite; right-sided stomach pain; fever; fatigue; unexplained itching; general feeling of being unwell). Discuss any questions or concerns with your doctor.
  • Kidney problems (eg, kidney failure) have happened in people taking dronedarone. Most of the time, these effects have gone back to normal when dronedarone was stopped and with treatment. Call your doctor right away if you have a change in the amount of urine produced.
  • Women who may become pregnant must use an effective form of birth control while they take dronedarone. Talk with your doctor about the best birth control methods for you.
  • Lab tests, including electrocardiogram (ECG), blood electrolyte levels, kidney function, and liver function, may be performed while you use dronedarone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Dronedarone should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use dronedarone if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if dronedarone is found in breast milk. Do not breast-feed while taking dronedarone.

Possible side effects of dronedarone:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; indigestion; mild stomach pain; nausea; tiredness; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); chest pain; cough; new or worsening irregular heartbeat; slow heartbeat; symptoms of heart failure (eg, shortness of breath; swelling of the hands, ankles, legs, or feet; sudden, unexplained weight gain; wheezing; coughing up frothy mucus at rest, at night, or after minor exercise; trouble sleeping because of breathing problems); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; nausea, vomiting, or loss of appetite; right-sided stomach pain; fever; fatigue; unexplained itching; general feeling of being unwell).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; severe dizziness; slow or irregular heartbeat.

Proper storage of dronedarone:

Store dronedarone at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep dronedarone out of the reach of children and away from pets.

General information:

  • If you have any questions about dronedarone, please talk with your doctor, pharmacist, or other health care provider.
  • Dronedarone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take dronedarone or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about dronedarone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to dronedarone. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using dronedarone.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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