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Dronedarone

Genric name: Dronedarone [Droe-NEda-rone]
Brand names: Multaq
Dosage form: Oral tablet, 400 mg

What is Dronedarone?

Dronedarone helps reduce your chances of being hospitalized due to a heartrhythm disorder known as atrial fibrillation. Dronedarone can be used by adults with this condition who now have a normal heartbeat. This medication guide does not list all possible uses for Dronedarone.

Side effects of Dronedarone

If you experience any of the following symptoms of an allergy: difficulty breathing, hives, swelling in your lips, face, throat, or tongue

Dronedarone can cause severe side effects. If you experience:

  • Shortness of breath, dry cough
  • Little or no urine;
  • Heartbeats that are fluttering, rapid or even pounding, and dizziness, as if you were about to pass out.
  • Heart issues: swelling, rapid weight gain and shortness of breath
  • Liver problems: fatigue, nausea, stomach pain, dark urine, and jaundice.
  • Low magnesium or potassium levels can cause dizziness, numbness, or tingling. You may also experience irregular heartbeats and fluttering, as well as increased thirst, urine, or muscle cramps.

Side effects common to dronedarone include:

  • Stomach pain, indigestion, nausea, vomiting, and diarrhea;
  • Feeling tired or weak
  • Itching or skin rash

There may be other side effects. Call your doctor if experiencing side effects; for reporting purposes call the FDA directly at 1-800-FDA-1088.

Similar/related drugs

Diltiazem, Xarelto, digoxin, rivaroxaban, flecainide, sotalol, and propafenone

Warns

Dronedarone doubles your death risk if certain heart conditions are present. Contact your doctor immediately if your pulse is irregular, you experience chest pain, have a foamy cough, rapid weight gain or swelling, or have trouble breathing, especially at night. Inform your doctor of all new or discontinued medications. Some drugs may interact with each other, while others should never be taken together. Dronedarone may also lead to liver issues. If you experience symptoms like vomiting, nausea, upper right stomach pains, dark urine, or yellowing skin and eyes, call your doctor.

Before you take this drug

Dronedarone should be avoided if:

  • Severe liver disease
  • A serious condition of the heart, such as "sick-sinus syndrome" or "AV block" (unless you are wearing a pacemaker), or very low heartbeats that have made you faint
  • If you're pregnant or nursing,
  • If you have lung or liver issues after taking amiodarone,

Dronedarone may double the risk of your death if certain heart conditions are present. Dronedarone should be avoided if

  • You have severe cardiac failure.
  • You were hospitalized recently for heart failure symptoms that worsened (shortness of breath, tightness in the chest, difficulty breathing at night, swelling, or rapid weight gain);
  • You have "permanent atrial fibrillation" that can't be reversed (this is determined by your physician).

Many drugs interact with each other and can cause harmful effects. Dronedarone should never be taken with certain drugs. If you are also taking:

  • Other heart rhythm medications
  • Cyclosporine;
  • Ritonavir, or another antiviral medication;
  • An antibiotic, such as Clarithromycin and Telithromycin.
  • Antidepressants such as amitriptyline, clomipramine, and other antidepressants;
  • Antifungal medicines such as ketoconazole or itraconazole.
  • Antipsychotic medicines such as chlorpromazine, fluphenazine, Promethazine, and others

If you suffer from other heart conditions, tell your doctor.Dronedarone can harm an unborn child. Prevent pregnancy with effective contraception, and inform your doctor immediately if you fall pregnant. Dronedarone should not be used while breastfeeding.

How to take Dronedarone?

Read all the instructions or guides that come with your medication and follow all the directions. Follow the directions on your prescription label. Dronedarone can be taken in the morning or evening. You may have to check your heart function every three months in order to determine whether you need dronedarone. Don't stop dronedarone treatment without consulting your doctor. If you see an irregular pulse rhythm, call your physician. Keep away from moisture and heat.

Details on dosage

Adult dose for atrial fibrillation:

Take 400mg orally twice a day, with meals.
Use: Reduce the risk of hospitalization for cardiovascular disease in patients who have paroxysmal atrial fibrillation or persistent atrial flutter or who also suffer from cardiovascular risk factors such as hypertension, diabetes, or a prior cerebral accident.

Adult dose for atrial flutter:

Take 400mg orally twice a day, with meals.
Usage: Reduce the risk of hospitalization for cardiovascular disease in patients who have paroxysmal atrial fibrillation or atrial Flutter, recent episodes of atrial fibrillation or AFL, and cardiovascular risk factors associated with them (i.e., age > 70, hypertension or diabetes, previous cerebrovascular accidents, left atrial diameter 50mm or greater, or left-ventricular ejection factor [LVEF] 40%), are in sinus rhythm, or will be cardioverted.

What happens if I miss the dose?

Do not take the dose you missed. Use your next dose as usual. Use only one dose at a time.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Grapefruit can interact with dronedarone, causing side effects. While taking dronedarone, avoid consuming grapefruit.

Interaction with other drug

Dronedarone may cause serious heart problems. You are at greater risk if you use other medications for heart disease, high blood pressure and HIV.

Inform your physician of all medications you are currently taking.Dronedarone can be affected by many drugs, including:

  • Digoxin;
  • John's wort;
  • A blood thinner, such as warfarin (coumadin), jantoven, or coumadin;
  • A diuretic, or "water pills."
  • Medicines to treat tuberculosis
  • Medicine to prevent organ transplant rejection;
  • Seizure medicine;
  • Lipitor, zocor, and other "statin" cholesterol medications

The list of dronedarone-interacting drugs is not exhaustive. Many other medications may also be affected by this drug. These include prescription, over-the-counter, herbal, and vitamins. This list does not include all interactions with drugs.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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