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dronedarone (cont.)

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

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. Talk with your doctor about your individual risk. Do not stop taking this medication without first talking to your doctor. Stopping suddenly may make your condition worse.

You should not use this medication if you are allergic to dronedarone, 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 were hospitalized with severe heart failure within the past 30 days; or
  • if you are pregnant or breast-feeding.

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 medications you use, especially:

  • heart rhythm medication;
  • an antibiotic or antifungal medication;
  • an antidepressant;
  • medicine to treat HIV or AIDS;
  • medicine to treat or prevent malaria;
  • medicine to treat a psychiatric disorder;
  • migraine headache medication;
  • narcotic pain medicine;
  • medicine to prevent or treat nausea and vomiting; or
  • medicine used to prevent organ transplant rejection.

To make sure you can safely take dronedarone, tell your doctor if you have any of these other conditions:

  • 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 medication 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 medication.

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 (Multaq)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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

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

To be sure this medication is not causing harmful effects, your heart function will need to be checked every 3 months using an electrocardiograph or ECG (sometimes called an EKG). An ECG measures electrical activity of the heart. This will help your doctor determine how long to treat you with dronedarone. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

Do not stop taking this medication without first talking to your doctor.

Store at room temperature away from heat and moisture.

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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