Tablet

400mg

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use exactly as directed by your healthcare provider.

Dronedarone comes as a 400mg tablet to take by mouth twice a day.

Dronedarone works best if taken around the same time each day; with your morning meal and an evening meal.

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.

Check your own pulse often, and call your doctor right away if you notice an irregular rhythm.

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.

If you forget to take a dose, skip the missed dose and take the next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Store at room temperature away from moisture, heat, and light.

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

• you have severe liver or kidney disease;
• you have 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;
• you are pregnant or breast-feeding; or
• you used a medicine called amiodarone and then had lung problems or liver problems.

Do not use dronedarone if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and tell your doctor if you become pregnant.

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.

Grapefruit and grapefruit juice may interact with dronedarone and lead to unwanted side effects. Avoid the use of grapefruit products while 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, and death. Dronedarone can double your risk of death if you have certain heart conditions. You should not use this medicine 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).
  
  To make sure dronedarone is safe for you, tell your doctor if you have ever had:
• other heart problems;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
• liver or kidney disease.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue.
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;
• kidney problems–little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• liver problems–nausea, upper stomach pain, itching, unusual tiredness, 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.

Some medicines can cause unwanted or dangerous effects when used with dronedarone. Your doctor may need to change your treatment plan if you use any of the following drugs:

• cyclosporine;
• ritonavir;
• beta-blockers such as Corgard (nadolol), Inderal (propranolol), Lopressor and Toprol XL (metoprolol), Normodyne (labetalol), and Tenormin (atenolol);
• blood thinners such as Coumadin (warfarin) and Pradaxa (dabigatran);
• calcium channel blockers such as Adalat and Procardia (nifedipine), Calan, Covera, Isoptin, and Verelan (verapamil), or Cardizem, Dilacor, and Tiazac (diltiazem);
• diuretics (water pills);
• other heart rhythm medicines;
• an antibiotic–azithromycin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, pentamidine, telithromycin;
• antifungal medicine–ketoconazole, itraconazole, voriconazole;
• an antidepressant–amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, maprotiline, mirtazapine, nefazodone, nortriptyline, protriptyline, trimipramine; or
• antipsychotic medicine–chlorpromazine, fluphenazine, perphenazine, prochlorperazine, promethazine, thioridazine, trifluoperazine.

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.

Seek emergency medical attention

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