Dronedarone

Dronedarone is a prescription medication used for treating atrial fibrillation/flutter. 

• Dronedarone is available under the following different brand names: Multaq

Adult dosage

Tablet

• 400mg

Atrial Fibrillation/Flutter

Adult dosage

• 400 mg orally twice daily with meals

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Dronedarone include:

• stomach pain,
• indigestion,
• nausea,
• vomiting,
• diarrhea,
• feeling weak or tired,
• skin rash,
• itching, and
• redness

Serious side effects of Dronedarone include:

• shortness of breath,
• swelling,
• rapid weight gain,
• chest pain,
• wheezing,
• trouble breathing,
• dry cough,
• coughing up mucus,
• breathing problems while lying down trying to sleep,
• severe dizziness,
• fainting,
• fast or pounding heartbeats,
• slow heart rate,
• light-headedness,
• new or worsening irregular heartbeat pattern,
• little or no urination,
• swelling in your feet or ankles,
• feeling tired,
• nausea,
• upper stomach pain,
• itching,
• unusual tiredness,
• loss of appetite,
• dark urine,
• clay-colored stools, and
• yellowing of the skin or eyes (jaundice)

Rare side effects of Dronedarone include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Dronedarone has severe interactions with at least 63 other drugs
• Dronedarone has serious interactions with at least 176 other drugs
• Dronedarone has moderate interactions with at least 240 other drugs
• Dronedarone has serious interactions with at least 68 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Permanent AF in patients in whom normal sinus rhythm cannot be restored
• Symptomatic HF with recent decompensation requiring hospitalization, or symptoms of NYHA class IV HF due to doubled risk of death
• Concomitant strong CYP3A4 inhibitors (e.g., grapefruit juice, itraconazole, clarithromycin, erythromycin)
• Symptomatic HF with recent decompensation requiring hospitalization
• NYHA class IV HF
• Referral to HF program
• 2nd or 3rd-degree heart block or sick sinus syndrome (unless used with a functioning pacemaker)
• Bradycardia below 50 bpm
• QTc interval above 500 milliseconds or PR interval above 280 milliseconds
• Coadministration with drugs that prolong QT interval may cause torsade de Pointes-type ventricular tachycardia (e.g, phenothiazine, TCAs, macrolide antibiotics, class I and III antiarrhythmic agents [amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol])
• Liver toxicity related to previous use of amiodarone
• Severe hepatic impairment (i.e., Child-Pugh Class C)
• Pregnancy (category X)
• Breastfeeding women

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Dronedarone?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Dronedarone?”

Cautions

• Increased risk of stroke, particularly in the first two weeks of therapy; should only be initiated in patients with sinus rhythm who are receiving appropriate antithrombotic therapy
• Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis reported; onset of dyspnea or non-productive cough may be related to pulmonary toxicity; carefully evaluate patients clinically; if pulmonary toxicity is confirmed, discontinue therapy
• Post-marketing cases of increased INR with or without bleeding events have been reported in warfarin-treated patients initiated on dronedarone; monitor INR after initiating in patients taking warfarin
• Potassium levels should be within the normal range before administration of therapy and maintained in the normal range during administration; increased risk of hypomagnesemia/hypokalemia with potassium-depleting diuretics
• Dronedarone induces moderate prolongation of the QT interval; monitor; if QTc Bazett interval is above500 millisecond, discontinue therapy
• A marked increase in serum creatinine, prerenal azotemia, and acute renal failure, often in the setting of heart failure or hypovolemia, was reported; typically reversible when the drug is discontinued; monitor renal function
• A small increase in SCr following initiation; elevation has a rapid onset, reaches a plateau after 7 days, and is reversible upon discontinuation
• Women of childbearing potential must exercise caution while in therapy and must be counseled on appropriate contraceptive choices
• Heart failure
  • New onset or worsening of heart failure has been reported during treatment in a post-marketing setting; in a placebo-controlled study in patients with permanent AF increased rates of heart failure were observed in patients with normal left ventricular function and no history of symptomatic heart failure, as well as those with a history of heart failure or left ventricular dysfunction; discontinue if new or worsening HF develops
  • Not approved for permanent atrial fibrillation (phase III PALLAS trial halted because preliminary analysis showed a 2-fold increase in death, as well as 2-fold increases in stroke and hospitalization for HF)
• Hepatotoxicity
  • Hepatocellular liver injury, including acute liver failure requiring transplant, reported in the post-marketing setting; advise patients to report immediately symptoms suggesting hepatic injury (such as anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching)
  • Consider obtaining periodic hepatic serum enzymes, especially during the first 6 months of treatment; not known whether routine periodic monitoring of serum enzymes will prevent the development of severe liver injury; if hepatic injury is suspected, promptly discontinue therapy and test serum enzymes, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase, as well as serum bilirubin, to establish whether there is liver injury
  • If liver injury is found, institute appropriate treatment and investigate the probable cause; do not restart therapy in patients without another explanation for observed liver injury

Pregnancy & Lactation

• Do not use it during pregnancy
• Lactation
  • Unknown if distributed in breast milk; contraindicated