Dronedarone (Oral route)

Pronunciation:

droe-NE-da-rone

Brand Names:

Multaq

Dosage Forms:

Tablet

Warnings:

Oral route(Tablet)

In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure, dronedarone hydrochloride doubles the risk of death. Dronedarone hydrochloride is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure. In patients with permanent atrial fibrillation, dronedarone hydrochloride doubles the risk of death, stroke, and hospitalization for heart failure. Dronedarone hydrochloride is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm .

Classifications:

Therapeutic—

Antiarrhythmic

Chemical—

Benzofuran

Uses of This Medicine:

Dronedarone is used to lower the chance of going to the hospital for serious heart rhythm problems in patients with a history of paroxysmal or persistent atrial fibrillation. Dronedarone belongs to the group of medicines known as antiarrhythmics. It works directly on the heart tissue and will slow the nerve impulses in the heart. This helps keep the heart rhythm normal.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dronedarone in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dronedarone in the elderly.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Alfuzosin
Amiodarone
Amisulpride
Amitriptyline
Anagrelide
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Azithromycin
Bedaquiline
Bepridil
Boceprevir
Buprenorphine
Buserelin
Ceritinib
Chloroquine
Chlorpromazine
Ciprofloxacin
Cisapride
Citalopram
Clarithromycin
Clofazimine
Clomipramine
Clothiapine
Clozapine
Cobicistat
Colchicine
Conivaptan
Crizotinib
Cyclobenzaprine
Cyclosporine
Dabrafenib
Darunavir
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Deutetrabenazine
Dexmedetomidine
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Droperidol
Ebastine
Efavirenz
Eliglustat
Encorafenib
Entrectinib
Eribulin
Erythromycin
Escitalopram
Famotidine
Felbamate
Fexinidazole
Fingolimod
Flecainide
Flibanserin
Fluconazole
Fluoxetine
Fluphenazine
Formoterol
Foscarnet
Fosphenytoin
Fostemsavir
Galantamine
Gatifloxacin
Gemifloxacin
Gepirone
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibutilide
Idelalisib
Iloperidone
Imipramine
Indinavir
Inotuzumab Ozogamicin
Itraconazole
Ivabradine
Ivosidenib
Ketoconazole
Lapatinib
Lefamulin
Lenvatinib
Leuprolide
Levofloxacin
Levoketoconazole
Levomethadyl
Lidocaine
Lofexidine
Lomitapide
Lumefantrine
Macimorelin
Mefloquine
Mesoridazine
Methadone
Methotrimeprazine
Metronidazole
Mifepristone
Mirtazapine
Mizolastine
Moricizine
Moxifloxacin
Nafarelin
Nefazodone
Nelfinavir
Nilotinib
Nirmatrelvir
Norfloxacin
Nortriptyline
Octreotide
Ofloxacin
Olanzapine
Ondansetron
Osilodrostat
Osimertinib
Oxaliplatin
Pacritinib
Paliperidone
Panobinostat
Papaverine
Paroxetine
Pasireotide
Pazopanib
Pentamidine
Perphenazine
Pimavanserin
Pimozide
Pipamperone
Piperaquine
Pitolisant
Ponesimod
Posaconazole
Probucol
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Quinine
Ranolazine
Relugolix
Ribociclib
Risperidone
Ritonavir
Saquinavir
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
Sparfloxacin
Sulpiride
Sultopride
Sunitinib
Tacrolimus
Tamoxifen
Telaprevir
Telavancin
Telithromycin
Terfenadine
Tetrabenazine
Thioridazine
Tolterodine
Toremifene
Trazodone
Triclabendazole
Trimipramine
Triptorelin
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vilanterol
Vinflunine
Voclosporin
Voriconazole
Vorinostat
Ziprasidone
Zotepine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acalabrutinib
Acebutolol
Acecainide
Adagrasib
Afatinib
Alfentanil
Alprazolam
Apalutamide
Apixaban
Aprepitant
Atenolol
Avapritinib
Azimilide
Belzutifan
Benzhydrocodone
Berotralstat
Betaxolol
Betrixaban
Bisoprolol
Bosentan
Bosutinib
Bretylium
Brexpiprazole
Brigatinib
Carbamazepine
Carteolol
Carvedilol
Celiprolol
Chloral Hydrate
Cilostazol
Cobimetinib
Codeine
Dabigatran Etexilate
Daridorexant
Deflazacort
Dexamethasone
Digoxin
Dihydrocodeine
Diltiazem
Docetaxel
Doxorubicin
Doxorubicin Hydrochloride Liposome
Duvelisib
Elacestrant
Elexacaftor
Enflurane
Enzalutamide
Eplerenone
Esmolol
Etravirine
Everolimus
Fedratinib
Fentanyl
Finerenone
Fosaprepitant
Fosnetupitant
Halothane
Hydrocodone
Ibrutinib
Ifosfamide
Infigratinib
Isoflurane
Isradipine
Ivacaftor
Labetalol
Lacosamide
Larotrectinib
Lemborexant
Lenacapavir
Levobunolol
Lidoflazine
Lorlatinib
Lovastatin
Lumacaftor
Lumateperone
Lurbinectedin
Mavacamten
Meperidine
Methotrexate
Metipranolol
Metoprolol
Midazolam
Mitapivat
Mitotane
Mobocertinib
Modafinil
Morphine
Morphine Sulfate Liposome
Nadolol
Nafcillin
Naloxegol
Nebivolol
Neratinib
Netupitant
Nevirapine
Olaparib
Olutasidenib
Omaveloxolone
Oxcarbazepine
Oxprenolol
Oxycodone
Ozanimod
Palovarotene
Pemigatinib
Penbutolol
Pentazocine
Pexidartinib
Phenobarbital
Phenytoin
Pindolol
Pirtobrutinib
Pixantrone
Practolol
Pralsetinib
Prednisone
Prilocaine
Primidone
Propranolol
Quizartinib
Rifabutin
Rifampin
Rifapentine
Rimegepant
Ritlecitinib
Rivaroxaban
Selumetinib
Sematilide
Simeprevir
Simvastatin
Siponimod
Sirolimus
Sirolimus Protein-Bound
Sonidegib
Sparsentan
Spiramycin
St John's Wort
Sufentanil
Sulfamethoxazole
Tazemetostat
Tenofovir Alafenamide
Tezacaftor
Timolol
Tocilizumab
Tolvaptan
Topotecan
Tramadol
Trimethoprim
Trofinetide
Ubrogepant
Venetoclax
Verapamil
Vincristine
Vincristine Sulfate Liposome
Warfarin
Zanubrutinib
Zolmitriptan
Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amlodipine
Suvorexant

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

AV block (type of abnormal heart rhythm), with no pacemaker or
Bradycardia (slow heartbeat) or
Heart failure, recent or history of or
Heart rhythm problems (e.g., prolonged QT or PR interval) or
Liver disease, severe or
Lung disease caused by amiodarone (Cordarone®) or
Permanent atrial fibrillation (type of abnormal heart rhythm) or
Sick sinus syndrome (type of abnormal heart rhythm), with no pacemaker—Should not be used in patients with these conditions.

Hypokalemia (low potassium in the blood) or
Hypomagnesemia (low magnesium in the blood) or
Lung disease (e.g., interstitial lung disease)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

This medicine should be taken with food.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For heart rhythm problems:
  - Adults—400 milligrams (mg) two times per day, taken as one tablet in the morning and evening.
  - Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not use this medicine if you are also using cyclosporine (Gengraf®, Neoral®, Sandimmune®), ritonavir (Norvir®), medicine for depression (such as amitriptyline, nefazodone, nortriptyline, Elavil®, Serzone®), medicine for heart rhythm problems (such as amiodarone, disopyramide, dofetilide, flecainide, propafenone, quinidine, sotalol, Cardioquin®, Cordarone®, Norpace®, Tikosyn®), medicine for infections (such as clarithromycin, erythromycin, itraconazole, ketoconazole, telithromycin, voriconazole, Ery-tab®, Nizoral®, Vfend®), or a phenothiazine medicine (such as chlorpromazine, prochlorperazine, promethazine, thioridazine, Compazine®, Mellaril®, Phenergan®, Thorazine®, Trilafon®). Using these medicines together may cause serious side effects.

Check with your doctor right away if you develop any of the following: chest pain, shortness of breath, swelling of your hands, ankles, or feet, or weight gain. These may be symptoms of heart failure.

This medicine can cause changes in your heart rhythm, such as a condition called QT prolongation. It may cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

Check with your doctor right away if you have upper stomach pain, pale stools, dark urine, loss of appetite, nausea, unusual tiredness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Tell your doctor right away if you are having shortness of breath, chest tightness, or any type of breathing problem while being treated with this medicine.

This medicine may increase risk for heart attack, stroke, or other serious side effects. Talk to your doctor about whether you should continue to take this medicine for paroxysmal or persistent atrial fibrillation.

Do not stop taking this medicine without first checking with your doctor.

Grapefruits and grapefruit juice may increase the side effects from dronedarone by increasing the amount of this medicine in your body. You should not eat grapefruit or drink grapefruit juice while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common: Chest pain or discomfort; lightheadedness, dizziness, or fainting; shortness of breath; slow or irregular heartbeat; unusual tiredness

Incidence not known: Abdominal or stomach pain, severe; chills; cough; dark urine; fever; general feeling of discomfort or illness; loss of appetite; nausea or vomiting; thickening of bronchial secretions; unusual tiredness or weakness; yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common: Diarrhea; lack or loss of strength

Less common: Acid or sour stomach; belching; blistering, crusting, irritation, itching, or reddening of the skin; cracked, dry, or scaly skin; heartburn; indigestion; itching skin; rash; redness or discoloration of the skin; skin rash, encrusted, scaly, and oozing; skin rash, hives, itching, or redness; stomach discomfort, upset, or pain; swelling

Rare: Change in taste; increased sensitivity of the skin to sunlight; loss of taste; severe sunburn

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 11/16/2023

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