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Multaq
dronedarone
Black Box Warnings .
Risk of Death, Stroke, and Heart Failure Increased if Decompensated Heart Failure or Permanent AFib
contraindicated in patients with symptomatic heart failure and recent decompensation requiring hospitalization, NYHA Class IV heart failure, or permanent atrial fibrillation; risk of death doubled in patients with decompensated heart failure or NYHA Class IV heart failure; risk of death, stroke, and hospitalization for heart failure doubled in patients with permanent atrial fibrillation
Adult Dosing .
Dosage forms: TAB: 400 mg
atrial fibrillation/flutter
- [400 mg PO bid]
- Info: for maintenance rhythm control in patients with paroxysmal or persistent atrial fibrillation history; give with meals
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- severe impairment: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- heart failure, NYHA Class IV
- symptomatic CHF with recent decompensation requiring hospitalization
- atrial fibrillation, permanent
- AV block, 2nd-3rd degree (patients without pacemaker)
- sick sinus syndrome (patients without pacemaker)
- HR <50 bpm
- QTc >500 msec
- PR interval >280 msec
- hypokalemia
- hypomagnesemia
- hepatic impairment, severe
- hepatotoxicity, amiodarone-associated
- pulmonary toxicity, amiodarone-associated
- pregnancy
- avoid: breastfeeding during tx and x5 days after D/C
- caution: patients of childbearing potential
- caution: elderly patients
Drug Interactions .
Overview
dronedarone
antiarrhythmic
- CYP3A4 substrate
- CYP2D6 inhibitor, weak
- CYP3A4 inhibitor, moderate
- P-gp inhibitor, strong
- bradycardia
- cardiotoxic effects
- delays atrioventricular conduction
- prolongs QT interval (known)
Contraindicated
- adagrasib
- amiodarone
- anagrelide
- apalutamide
- apomorphine
- arsenic trioxide
- artemether/lumefantrine
- asenapine
- atazanavir
- azithromycin
- bedaquiline
- cabozantinib
- ceritinib
- chloramphenicol
- chloroquine
- cisapride
- citalopram
- clarithromycin
- clofazimine
- cobicistat
- colchicine
- crizotinib
- cyclosporine
- darunavir
- degarelix
- desflurane
- desipramine
- dexmedetomidine injection
- disopyramide
- dofetilide
- domperidone
- donepezil
- dordaviprone
- droperidol
- encorafenib
- ephedra
- epirubicin
- eribulin
- erythromycin
- fexinidazole
- flecainide
- flibanserin
- fluconazole
- fluorouracil
- fosfomycin injection
- gilteritinib
- glasdegib
- goserelin
- haloperidol
- histrelin
- hydroxychloroquine
- hydroxyzine
- ibutilide
- idelalisib
- inotuzumab ozogamicin
- isoflurane
- itraconazole
- ivosidenib
- ketoconazole
- lefamulin
- leuprolide
- levofloxacin
- levoketoconazole
- lofexidine
- lomitapide
- lonafarnib
- lopinavir/ritonavir
- macimorelin
- methadone
- mifepristone
- mobocertinib
- moxifloxacin
- nefazodone
- nelfinavir
- nilotinib
- oliceridine
- ondansetron
- osimertinib
- pacritinib
- paliperidone
- palonosetron
- pasireotide
- pentamidine
- pimozide
- posaconazole
- procainamide
- propafenone
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- quizartinib
- revumenib
- ribociclib
- ritonavir
- romidepsin
- rucaparib
- selpercatinib
- sevoflurane
- sotalol
- taletrectinib
- telavancin
- tetrabenazine
- thioridazine
- tipranavir
- toremifene
- tramadol
- triclabendazole
- trifluridine
- triptorelin
- tucatinib
- vandetanib
- vemurafenib
- voriconazole
- ziftomenib
- ziprasidone
Avoid/Use Alternative
- albuterol
- albuterol inhaled
- alfentanil
- alfuzosin
- alprazolam
- amisulpride
- amitriptyline
- aprepitant
- arformoterol inhaled
- asciminib
- avapritinib
- berotralstat
- bosentan
- bosutinib
- brigatinib
- buprenorphine
- buspirone
- butalbital
- carbamazepine
- cariprazine
- cenobamate
- chlorpromazine
- ciprofloxacin
- clomipramine
- clonidine
- clozapine
- cobimetinib
- codeine
- conivaptan
- dabigatran
- dabrafenib
- dasatinib
- defactinib
- deutetrabenazine
- dexmedetomidine
- digoxin
- dihydrocodeine
- dihydroergotamine
- doxorubicin
- efavirenz
- elacestrant
- eliglustat
- ensartinib
- entrectinib
- enzalutamide
- ergotamine
- escitalopram
- etrasimod
- etravirine
- fentanyl
- fingolimod
- fluoxetine
- formoterol inhaled
- fosaprepitant
- foscarnet
- fosphenytoin
- fostemsavir
- gemtuzumab ozogamicin
- gepirone
- gepotidacin
- givinostat
- granisetron
- grapefruit
- hydrocodone
- idarubicin
- iloperidone
- ivabradine
- ivacaftor
- ixabepilone
- landiolol
- lapatinib
- lemborexant
- lenacapavir
- lenvatinib
- levalbuterol inhaled
- loperamide
- lorlatinib
- lovastatin
- lumacaftor/ivacaftor
- lurasidone
- lurbinectedin
- macitentan
- mavacamten
- mavorixafor
- mefloquine
- meperidine
- methylergonovine
- metronidazole
- midazolam
- midostaurin
- milsaperidone
- mirtazapine
- mitapivat
- mitotane
- modafinil
- nafcillin
- naloxegol
- neratinib
- netupitant
- nirogacestat
- nisoldipine
- ofloxacin
- olaparib
- olodaterol inhaled
- omaveloxolone
- osilodrostat
- oxaliplatin
- oxycodone
- ozanimod
- palovarotene
- pazopanib
- pemigatinib
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- pimavanserin
- pitolisant
- ponesimod
- pralsetinib
- primaquine
- primidone
- promethazine
- quetiapine
- ranolazine
- relugolix
- remibrutinib
- repotrectinib
- rifabutin
- rifampin
- rifapentine
- rilpivirine
- rilzabrutinib
- rivaroxaban
- sacituzumab govitecan
- sebetralstat
- selumetinib
- sertraline
- silodosin
- simvastatin
- siponimod
- sirolimus
- sirolimus albumin-bound
- solifenacin
- sonidegib
- sorafenib
- sotorasib
- St. John's wort
- sufentanil
- sunitinib
- tacrolimus
- tazemetostat
- terbutaline
- tolterodine
- tolvaptan
- topotecan
- trazodone
- valbenazine
- vardenafil
- venetoclax
- venlafaxine
- vilanterol inhaled
- voclosporin
Monitor/Modify Tx
- abemaciclib
- acalabrutinib
- acebutolol
- adalimumab
- adenosine
- ado-trastuzumab emtansine
- afatinib
- aficamten
- aldesleukin
- alectinib
- amlodipine
- apixaban
- apraclonidine ophthalmic
- aripiprazole oral
- articaine
- atenolol
- atorvastatin
- avacopan
- avanafil
- avatrombopag
- avelumab
- axitinib
- betaxolol
- betaxolol ophthalmic
- bevacizumab
- bezlotoxumab
- binimetinib
- bisoprolol
- bortezomib
- brexpiprazole
- bromocriptine
- budesonide
- bupivacaine
- bupivacaine liposomal
- butorphanol
- capecitabine
- capivasertib
- carfilzomib
- carteolol ophthalmic
- carvedilol
- certolizumab pegol
- chloroprocaine
- cilostazol
- clonazepam
- copanlisib
- cyclophosphamide
- danazol
- daridorexant
- daunorubicin
- deflazacort
- diltiazem
- docetaxel
- dulaglutide
- duvelisib
- edoxaban
- elexacaftor/tezacaftor/ivacaftor
- elinzanetant
- enfortumab vedotin
- epinephrine
- eplerenone
- erdafitinib
- esmolol
- estazolam
- estradiol (contraceptive)
- ethinyl estradiol (contraceptive)
- etoposide
- etripamil nasal
- everolimus
- fam-trastuzumab deruxtecan
- fedratinib
- felodipine
- finerenone
- fosamprenavir
- futibatinib
- gadobenate dimeglumine
- galantamine
- guanfacine
- hydrocortisone
- ibrutinib
- ifosfamide
- imatinib
- infliximab
- interferon beta 1a
- interferon beta 1b
- interferon gamma 1b
- irinotecan
- isavuconazonium
- isradipine
- labetalol
- lacosamide
- lamotrigine
- larotrectinib
- letermovir
- levobunolol ophthalmic
- lidocaine
- linagliptin
- lumateperone
- margetuximab
- mepivacaine
- metoprolol
- midodrine
- mirdametinib
- mitoxantrone
- morphine
- nadolol
- nebivolol
- neostigmine
- nifedipine
- nimodipine
- nintedanib
- nortriptyline
- octreotide
- paclitaxel
- palbociclib
- paltusotine
- peginterferon beta 1a
- pertuzumab
- pindolol
- pirtobrutinib
- pitavastatin
- ponatinib
- pravastatin
- praziquantel
- propofol
- propranolol
- pyridostigmine
- red yeast rice
- remimazolam
- repaglinide
- rimegepant
- riociguat
- ripretinib
- rivastigmine
- ropeginterferon alfa-2b
- ropivacaine
- ruxolitinib
- ruxolitinib topical
- salmeterol inhaled
- saxagliptin
- sildenafil
- sitagliptin
- sparsentan
- sugammadex
- suvorexant
- suzetrigine
- tadalafil
- talazoparib
- tamsulosin
- temsirolimus
- tenofovir alafenamide
- tenofovir disoproxil
- tezacaftor/ivacaftor
- thalidomide
- ticagrelor
- timolol
- timolol ophthalmic
- tivozanib
- tofacitinib
- trabectedin
- trastuzumab
- triazolam
- ubrogepant
- vanzacaftor/tezacaftor/deutivacaftor
- verapamil
- vinblastine
- vincristine
- vinorelbine
- warfarin
- zanidatamab
- zanubrutinib
- zenocutuzumab
- zongertinib
Caution Advised
- aliskiren
- armodafinil
- belzutifan
- bexarotene
- budesonide rectal
- clobazam
- danshen
- darifenacin
- darolutamide
- dexamethasone
- dicloxacillin
- echinacea
- elafibranor
- elagolix
- eletriptan
- enasidenib
- erlotinib
- eslicarbazepine acetate
- felbamate
- garlic
- ginkgo
- ginseng, Asian
- glecaprevir
- glycerol phenylbutyrate
- grazoprevir
- griseofulvin
- imlunestrant
- istradefylline
- maraviroc
- meropenem
- methylprednisolone
- naldemedine
- nevirapine
- odevixibat
- olutasidenib
- ospemifene
- oxcarbazepine
- perampanel
- perphenazine
- pibrentasvir
- pioglitazone
- prednisone
- rifaximin
- roflumilast
- roflumilast topical
- rufinamide
- sarilumab
- seladelpar
- sevabertinib
- sirolimus topical
- stiripentol
- sunvozertinib
- tecovirimat
- telotristat ethyl
- tocilizumab
- topiramate
- tovorafenib
- tretinoin
- upadacitinib
- vaborbactam
- vamorolone
- vilazodone
- vorasidenib
Adverse Reactions .
Serious Reactions
- CHF, new or exacerbation
- QT prolongation
- torsades de pointes
- bradycardia
- hepatotoxicity
- acute renal failure
- interstitial lung disease
- hypersensitivity reaction
- anaphylaxis
- photosensitivity
Common Reactions
- Cr elevated
- QT prolongation
- diarrhea
- asthenia
- nausea
- pruritus
- rash
- abdominal pain
- bradycardia
- vomiting
- dyspepsia
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline; electrolytes including Mg at baseline, then periodically; BUN/Cr; ECG q3mo; consider LFTs, especially during 1st 6mo of tx
Pregnancy/Lactation .
Pregnancy
Clinical Summary
avoid use during pregnancy; no human data available; risk of teratogenicity based on animal data at 0.5x and 1x MRHD
Individuals of Reproductive Potential
avoid pregnancy by using effective contraception during tx and x5 days after D/C in patients of childbearing potential
Lactation
Clinical Summary
avoid breastfeeding during tx and x5 days after D/C; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for dronedarone: liver; CYP450: 3A substrate
Excretion: for dronedarone: urine 6%, feces 84%; Half-life: 13-19h
Subclass: Antiarrhythmics, Oral
Mechanism of Action
for dronedarone: exact mechanism of action unknown; exhibits antiarrhythmic properties of all four Vaughn-Williams classes
Formulary .
No Formulary Selected
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