Dronedarone Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

Do not take this medication if you have severe heart failure that makes you short of breath during light activity or even while resting, or if you recently had to stay in a hospital because your heart failure got worse. Also, do not take this medication if you have a certain kind of irregular heartbeat (permanent atrial fibrillation) that will not or cannot be changed back to a normal heart rhythm. Dronedarone may increase your risk of death, stroke, or the need to be treated in the hospital for heart failure if you have any of these conditions. Consult your doctor for more details and to discuss the risks and benefits of dronedarone. Tell your doctor right away if you have new or worsening symptoms of heart failure such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain.

Warnings:

Do not take this medication if you have severe heart failure that makes you short of breath during light activity or even while resting, or if you recently had to stay in a hospital because your heart failure got worse. Also, do not take this medication if you have a certain kind of irregular heartbeat (permanent atrial fibrillation) that will not or cannot be changed back to a normal heart rhythm. Dronedarone may increase your risk of death, stroke, or the need to be treated in the hospital for heart failure if you have any of these conditions. Consult your doctor for more details and to discuss the risks and benefits of dronedarone. Tell your doctor right away if you have new or worsening symptoms of heart failure such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain.

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Uses

This medication is 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. See also Warning section.

How to use Dronedarone Tablet

Read the Medication Guide provided by your pharmacist before you start taking dronedarone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

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. Keep taking this medication 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.

Side Effects

See also Warning section.

Nausea or diarrhea may occur. If either of these effects lasts or gets worse, tell your doctor promptly.

Remember that this medication has been prescribed because your doctor 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 nausea/vomiting that doesn’t stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), symptoms of lung problems (such as dry cough that doesn’t go away, 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.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

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 (see above).

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.

Interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

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), rifampin, ritonavir, 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, elacestrant, flibanserin, among others.

Does Dronedarone Tablet interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as EKG, kidney/liver function, blood mineral levels including potassium) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, skip the missed dose and take your next dose at your regular scheduled time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Multaq – Uses, Side Effects, Interactions

How does this medication work? What will it do for me?

Dronedarone belongs to the class of medications called antiarrhythmics. It is used to help control an abnormal heart rate and rhythm called atrial fibrillation and can lower the risk of having to go the hospital for heart problems or the risk of death. It works by affecting how electrical impulses affect the heart muscle. Dronedarone should only be used after other treatment options have been considered.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each white film-coated tablet for oral administration, oblong-shaped, engraved with a double wave marking on one side and “4142” code on the other side contains dronedarone hydrochloride equivalent to dronedarone 400 mg. Nonmedicinal ingredients: colloidal anhydrous silica, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, maize starch, and poloxamer 407; coating: carnauba wax, hypromellose, macrogol 6000, and titanium dioxide.

How should I use this medication?

The usual recommended dose of this medication for adults is 400 mg twice daily with the morning and evening meal. People taking this medication should avoid drinking grapefruit juice or eating grapefruit, as this can increase the blood levels of this medication and lead to side effects and other problems.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature in its original package and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take dronedarone if you:

• are allergic to dronedarone or any ingredients of the medication
• are pregnant or breast-feeding
• are taking a medication such as ketoconazole, itraconazole, voriconazole, cyclosporin, telithromycin, clarithromycin,nefazodone, or ritonavir
• are taking a medication that can cause a change in heart rhythm called torsades de pointes (e.g., phenothiazines [promethazine, chlorpromazine], tricyclic antidepressants [amitriptyline, clomipramine, desipramine], flecainide, propafenone, quinidine, disopyramide, sotalol, amiodarone
• have a heart rate less than 50 beats per minute
• have a type of atrial fibrillation called permanent atrial fibrillation (where a decision has been made by the doctor not to try to change the heart rhythm back to normal)
• have an electrocardiogram (ECG) that shows a problem with the electrical activity of the heart called QT prolongation
• have second- or third-degree heart block or sick sinus syndrome (except if treated with a pacemaker)
• have severe congestive heart failure (CHF) or another condition associated with unstable heart function
• have severe left ventricular dysfunction
• have severely reduced liver function
• have liver or lung toxicity related to a prior use of the medication amiodarone

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• diarrhea
• heartburn
• nausea
• rash
• skin sensitivity to sunlight
• stomach pains
• taste changes
• tiredness
• vomiting
• weakness

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• chest pain
• dizziness
• inflammation of the skin
• itchy, red skin
• signs of liver problems (e.g., yellow skin or eyes, abdominal pain, dark urine, clay-coloured stools, loss of appetite, nausea and vomiting, or itching)
• slow heart rate
• shortness of breath when lying down or sleeping
• swelling of the feet or lower legs
• sudden weight gain

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of an allergic reaction (e.g., difficulty breathing, coughing, or wheezing; hives; itchy skin rash)
• signs of angioedema (e.g., swelling of the face, lips, mouth, tongue or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Congestive heart failure: If you have moderate congestive heart failure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. This medication should not be used for people with severe congestive heart failure. People with severe heart failure who take this medication have an increased chance of dying. If you develop heart failure symptoms or worsening symptoms (e.g., weight gain, increasing shortness of breath, difficulty breathing at night, swelling of the feet or legs) while taking this medication, contact your doctor immediately.

Lung problems: Dronedarone can cause lung problems (pulmonary fibrosis, inflammation of lung tissue). Tell your doctor immediately if you experience any difficulty breathing, shortness of breath, or dry cough while you are taking this medication.

Kidney function: The results of a blood test for kidney function, called creatinine, may be increased without a change in your kidney function. Your doctor will use the creatinine level as your new normal. Tell any other doctor you see about the new “normal” value of your blood creatinine.

Liver: There have been reports of liver injury in people who were taking dronedarone. Your doctor may regularly perform tests to monitor your liver function. If you experience symptoms of liver damage (e.g., yellowing of the skin or eyes, fatigue, abdominal pain, nausea, vomiting, dark urine, or itching), contact your doctor immediately.

Low potassium and magnesium levels: Before starting and while taking this medication, your doctor may want to check your blood levels of potassium and magnesium, especially if you are taking medications (e. g., hydrochlorothiazide, furosemide, indapamide) that may reduce these levels. If they are low, your doctor may recommend that you take supplements or may make changes to your medications.

QT prolongation: This medication can affect the electrical activity of the heart and cause QT prolongation. You doctor will monitor your heart rhythm regularly while you are taking this medication with a test called an electrocardiogram (ECG). You should not take this medication if your ECG already shows that you have QT prolongation or if you are taking a medication that can cause QT prolongation.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if dronedarone passes into breast milk. This medication should not be used while breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children under 18 years of age.

What other drugs could interact with this medication?

There may be an interaction between dronedarone and any of the following:

• alfuzosin
• aliskiren
• amantadine
• amiodarone
• antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• apixaban
• barbiturates (e.g., butalbital, pentobarbital phenobarbital)
• benzodiazepines (e.g., alprazolam, chlordiazepoxide, clonazepam, clorazepate, diazepam, flurazepam, midazolam)
• beta-blockers (e.g., atenolol, bisoprolol, metoprolol, propranolol)
• boceprevir
• bosentan
• buspirone
• bosutinib
• bromocriptine
• buprenorphine
• buserelin
• calcitriol
• calcium channel blockers (e.g., verapamil, diltiazem, nifedipine)
• cancer medications (e. g., busulfan, docetaxel, etoposide, imatinib, irinotecan, vinblastine, vincristine)
• captopril
• carbamazepine
• chloral hydrate
• chloroquine
• cinacalcet
• clonidine
• colchicine
•  inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
• oral corticosteroids (e.g., methylprednisolone, prednisone)
• crizotinib
• cyclosporine
• dabigatran
• darifenacin
• deferasirox
• degarelix
• disopyramide
• digoxin
• domperidone
• donepezil
• doxazosin
• enzalutamide
• ergot alkaloids (e.g., ergotamine, dihydroergotamine)
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• famotidine
• fesoterodine
• fingolimod
• flecainide
• galantamine
• grapefruit juice and grapefruit
• guanfacine
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e. g., delaviridine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• imatinib
• indacaterol
• indapamide
• ledipasvir
• leuprolide
• lidocaine
• lithium
• lomitapide
• loperamide
• macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin)
• maraviroc
• mefloquine
• methadone
• methamphetamine
• metoclopramide
• metronidazole
• mifepristone
• mirabegron
• mitotane
• naloxegol
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
• nateglinide
• nefazodone
• nilotinib
• nitrates (e.g., isosorbide dintrate)
• octreotide
• olodaterol
• pasireotide
• phenobarbital
• phenytoin
• phosphodiesterase 5 inhibitors (e. g., sildenafil, tadalafil, vardenafil)
• pimecrolimus
• primaquine
• primidone
• procainamide
• propafenone
• prucalopride
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
• ranitidine
• rifabutin
• rifampin
• riociguat
• rivaroxaban
• rivastigmine
• romidepsin
• salmeterol
• saxagliptin
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
• sirolimus
• sitagliptin
• St. John’s wort
• Solifenacin
• sofosbuvir
• “statin” medications (e.g., atorvastatin, lovastatin, simvastatin)
• sulfamethoxazole
• tacrolimus
• tamoxifen
• tamsulosin
• telaprevir
• theophylline
• tizanidine
• tolterodine
• tolvaptan
• tramadol
• trazodone
• tricyclic antidepressants (e. g., amitriptyline, clomipramine, imipramine, desipramine)
• trimethoprim
• ulipristal
• venlafaxine
• vilanterol
• warfarin
• zolpidem
• zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2023. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Multaq

Dronedarone – an antiarrhythmic drug that allows you to set new goals in the treatment of patients with atrial fibrillation | Gilyarov

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14. Patel C, Yan GX, Kowey PR. Dronedarone. Circulation 2009; 120:636-44.

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Atrial fibrillation (AF). Long-term control and maintenance of sinus rhythm.

Atrial fibrillation (AF) or atrial fibrillation. Long-term control and maintenance of sinus rhythm

When choosing a strategy for long-term control and maintenance of sinus rhythm in the treatment of AF, antiarrhythmic drugs are required. At an early stage in the development of AF, there is a “window of opportunity” when a stable restoration of sinus rhythm can be achieved.

The main argument in favor of a rhythm control strategy is the relief of symptoms of AF.

The following are the main principles of antiarrhythmic therapy in patients with AF:

1. The rationale for antiarrhythmic therapy is to reduce the symptoms of AF.

2. The effectiveness of antiarrhythmic drugs used to control sinus rhythm is modest.

3. Effective antiarrhythmic therapy usually results in a reduction rather than a complete cessation of AF relapses.

4. If an antiarrhythmic drug fails, the patient may respond to another drug.

5. Arrhythmogenic or extracardiac side effects are common.

6. The choice of antiarrhythmic drug should be primarily determined by safety, not efficacy.

Antiarrhythmic drugs used to maintain sinus rhythm.

Depending on the course of the disease, the initially chosen strategy may not be sufficient, so it can be replaced by combinations of antiarrhythmic drugs or by surgical intervention – radiofrequency catheter ablation of the heart (RFA of the left atrium), surgical ablation.