Dronedarone

By Medically reviewed by hellodoktor

Generic Name: Dronedarone Brand Name(s): Generics only. No brands available.

Uses

What is Dronedarone used for?

Dronedarone is commonly used if you have had certain types of irregular heartbeat (paroxysmal or persistent atrial fibrillation) in the past but now have a normal heart rhythm. It helps you keep a normal heart rhythm and lowers your chance of having to go to the hospital for atrial fibrillation. Dronedarone is known as an antiarrhythmic drug.

This medication should not be used if you have permanent atrial fibrillation because of the increased risk of very serious side effects.

How should I take Dronedarone?

Take this medication by mouth with food as directed by your doctor, usually twice daily (once with your morning meal and once with your evening meal).

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop taking dronedarone without asking your doctor first, even if you feel well. Your doctor may direct you to also take another medication (“blood thinner”/anticoagulant) to lower the risk of getting serious blood clots. Follow your doctor’s instructions carefully.

Get medical help right away if your heartbeat or pulse becomes fast or irregular.

How do I store Dronedarone?

Dronedarone is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Dronedarone in the bathroom or the freezer. There may be different brands of Dronedarone that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Dronedarone down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Dronedarone?

Before taking dronedarone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, certain types of irregular heartbeat (second- or third-degree atrioventricular block or sick sinus syndrome, unless you have a heart pacemaker), serious side effects (such as liver/lung disease) from taking the medication amiodarone.

Dronedarone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using dronedarone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using dronedarone safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation.

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Dronedarone during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking this Dronedarone. This Dronedarone is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Dronedarone?

Nausea or diarrhea may occur. If either of these effects persists or worsens, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: symptoms of liver disease (such as persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), symptoms of lung problems (such as persistent dry cough, shortness of breath), signs of kidney problems (such as change in the amount of urine).

Get medical help right away if you have any very serious side effects, including: slow/fast/irregular heartbeat, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Dronedarone?

A product that may interact with this drug is: fingolimod.

Many drugs besides dronedarone may affect the heart rhythm (QT prolongation). Examples include amiodarone, disopyramide, dofetilide, flecainide, pimozide, procainamide, propafenone, quinidine, sotalol, among others.

Other medications can affect the removal of dronedarone from your body, which may affect how dronedarone works. Examples include azole antifungals (such as ketoconazole, itraconazole, voriconazole), cyclosporine, macrolide antibiotics (such as clarithromycin, erythromycin), nefazodone, HIV protease inhibitors (such as lopinavir, ritonavir), rifampin, St. John’s wort, drugs used to treat seizures (such as carbamazepine, phenobarbital, phenytoin), telithromycin, among others.

Dronedarone can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include dabigatran, digoxin, among others.

Dronedarone may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Dronedarone?

Dronedarone may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Dronedarone?

Dronedarone may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Dronedarone.

What is the dose of Dronedarone for an adult?

Usual Adult Dose for Atrial Fibrillation

400 mg orally 2 times a day with a meal

Use: To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age greater than 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter 50 mm or more, or left ventricular ejection fraction [LVEF] less than 40%), who are in sinus rhythm or who will be cardioverted.

Usual Adult Dose for Atrial Flutter

400 mg orally 2 times a day with a meal

Use: To reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors (i.e., age greater than 70 years, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter 50 mm or more, or left ventricular ejection fraction [LVEF] less than 40%), who are in sinus rhythm or who will be cardioverted.

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Mild to moderate liver dysfunction: No adjustment recommended

Severe liver dysfunction: Contraindicated

Other Comments

Administration advice:

-Administer with food.

-Grapefruit juice should be avoided.

Monitoring:

Cardiovascular: Periodic assessment of heart failure risks or worsening of preexisting NYHA Class I heart failure.

Hepatic: Liver function tests should be performed at baseline and periodically during treatment.

Metabolic: Potassium or magnesium deficiency should be corrected prior to starting treatment.

Renal: Serum creatinine should be monitored prior to and 7 days after treatment initiation.

General: Doses greater than 400 mg daily are not considered more effective and are less well tolerated.

What is the dose of Dronedarone for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Dronedarone available?

Dronedarone is available in the following dosage forms and strengths:

  • Tablet

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Dronedarone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: January 25, 2018 | Last Modified: September 12, 2019

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