Multaq (Dronedarone)
Multaq
Dronedarone Hydrochloride
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Prescription Required.

Product of Canada.

Shipped from Canada.

Prescription Required.Product of Canada.Shipped from Canada.

Pentasa (Mesalamine)

What is Pentasa (Mesalamine)?

What is Multaq (Dronedarone Hydrochloride)?

Multaq, also known as dronedarone, is an antiarrhythmic drug used to reduce hospitalizations for atrial fibrillation (AF) in patients in sinus rhythm that have a history of paroxysmal or persistent AF.

How does Multaq work?

The exact mechanism of Multaq is not clearly defined. Multaq exhibits antiarrhythmic properties from all four Vaughan-Williams classifications, but the contributions of each activity are unknown. Multaq regulates heart rhythm through a combination of inhibiting sodium channels (Class I), beta-1 receptors (Class II), potassium channels (Class III), and calcium channels (Class IV).

Dosage and How to Use

Multaq is only available in 400 mg tablets.

It is recommended to take Multaq (400 mg) twice daily, one tablet with the morning meal and one tablet with the evening meal.

Treatment with Class I or III antiarrhythmics or medications that are strong CYP3A inhibitors must be stopped before taking Multaq.

Storage

Store at 25°C (77°F); Temperature excursions between 15°C to 30°C (59°F to 86°F) are permitted.

Overdose

If an overdose of Multaq is ingested, seek medical attention immediately. Overdosage treatment should be supportive and focused on relieving the patient’s symptoms. There is no antidote available for Multaq overdosage, and it is not known if Multaq or its metabolites are removed through dialysis.

Side Effects

The most common side effects of Multaq are:

  • Diarrhea
  • Nausea
  • Vomiting
  • Abdominal pain
  • Indigestion
  • Weakness or tiredness
  • Skin redness or itching

Rare but serious side effects of Multaq include:

  • Slowed heartbeat
  • Inflammation, scarring, or thickening of the lungs
    • Contact your doctor immediately if you experience shortness of breath or a dry cough.
  • Low potassium or magnesium levels
    • Low potassium or magnesium levels can happen if taking diuretics during treatment with Multaq.
  • Changes in kidney function blood tests
  • Liver problems, including life-threatening liver failure
    • Contact your doctor immediately if you notice one of the following signs of liver failure:
      • Nausea, vomiting, or loss of appetite
      • Fever or feeling unwell
      • Unusual tiredness
      • Yellowing of the skin or eyes
      • Dark urine
      • Pain in the upper right area of the stomach

This is not a complete list of all possible side effects. Please contact your doctor or pharmacist for more information.

Warnings & Precautions

Boxed Warnings

Cardiovascular Death in NYHA Class IV or Decompensated Heart Failure

  • Multaq is contraindicated and doubles the risk of death in patients with NYHA Class IV heart failure or symptomatic heart failure with recent decompensation requiring hospitalization.

Cardiovascular Death, Hospitalization for Heart Failure, and Stroke in Patients with Permanent Atrial Fibrillation

  • Multaq increases the risk of cardiovascular death, heart failure events, and stroke in patients with permanent atrial fibrillation. Patients taking Multaq need monitoring of cardiac rhythm every three months at a minimum. If indicated, cardiovert the patient to a normal sinus rhythm or discontinue Multaq. Multaq is contraindicated if not in normal sinus rhythm.

Other Warnings & Precautions

New Onset or Worsening Heart Failure

  • New onset or worsening heart failure in patients taking Multaq has been reported. Patients should immediately contact their doctor if they develop any of the following signs of heart failure: weight gain, edema, or shortness of breath. If heart failure develops or worsens, Multaq should be discontinued.

Liver injury

  • Hepatocellular liver injury, including liver failure requiring transplant, has been reported in patients taking Multaq. Patients should contact their doctor immediately if they experience any of the following signs of liver dysfunction: anorexia, nausea, vomiting, fever, fatigue, pain in the upper right area of the stomach, yellowing of the skin or eyes, itchy skin, or dark urine. If liver injury is suspected, Multaq should be discontinued, and liver function tests should be collected.

Pulmonary toxicity

  • Interstitial lung disease, including pneumonitis and pulmonary fibrosis, has been reported in patients taking Multaq. Patients must contact their doctor if they experience shortness of breath or a dry cough. Multaq should be discontinued if pulmonary damage is confirmed.

Hypokalemia and Hypomagnesemia with Potassium-Depleting Diuretics

  • Hypokalemia and hypomagnesemia may occur in patients taking diuretics during treatment with Multaq. Potassium and magnesium levels should be monitored in these patients.

QT Interval Prolongation

  • Multaq induces a moderate (average of 10 ms) QTc prolongation. If the QTc Bazett interval exceeds 500 ms, Multaq should be discontinued.

Renal impairment and Failure

  • Increased serum creatinine, pre-renal azotemia, and acute renal failure have been reported in patients taking Multaq. The effects are often reversible, but renal function should be monitored periodically.

Women of Childbearing Potential

  • Women of childbearing potential must use effective contraception while taking Multaq due to the risk of fetal harm.

Drug Interactions and Other Interactions

Pharmacodynamic Interactions

  • Drugs prolonging the QT interval (leading to Torsades de Pointes)
    • Coadministration with other QT-prolonging drugs (certain phenothiazines, tricyclic antidepressants, macrolide antibiotics, Class I or III antiarrhythmics) is contraindicated due to the risk of Torsades de Pointes.
  • Digoxin
    • Patients taking digoxin during treatment with Multaq have shown an increased risk of arrhythmic or sudden cardiac death. Digoxin can exacerbate the bradycardiac effects of Multaq. Multaq also increases the patient’s exposure to digoxin. Consider stopping digoxin, but if continued, reduce the digoxin dose by 50%.
  • Calcium channel blockers
    • Calcium channel blockers that slow sinus and AV node conduction may be additive to the effects of Multaq. Start with a low-dose calcium channel blocker and only increase after an ECG showing favorable tolerability.
  • Beta-blockers
    • Bradycardia is more common when patients are taking beta-blockers during treatment with Multaq. Start with a low-dose beta-blocker and only increase after an ECG showing favorable tolerability.

Pharmacokinetic Interactions

  • Ketoconazole and other strong CYP3A inhibitors
    • Ketoconazole and other strong CYP3A inhibitors such as itraconazole, voriconazole, ritonavir, clarithromycin, and nefazodone are contraindicated because they significantly increase exposure to Multaq.
  • Grapefruit juice
    • Patients should avoid grapefruit juice due to increased exposure to Multaq.
  • Rifampin and other CYP3A inducers
    • Patients should avoid rifampin and other CYP3A inducers (phenobarbital, carbamazepine, phenytoin, and St. John’s wort) because they significantly reduce exposure to Multaq.
  • Calcium channel blockers
    • Verapamil and Diltiazem are moderate inhibitors of CYP3A and increase exposure to Multaq. Start with a low-dose calcium channel blocker and only increase after an ECG showing favorable tolerability.

Effect of Multaq on Other Drugs

  • Simvastatin
    • Multaq increases simvastatin exposure. The maximum simvastatin dosage is 10 mg when a patient is on Multaq treatment.
  • Other statins
    • There are multiple mechanisms of interaction between statins and Multaq. Please follow statin label recommendations for use with CYP3A and P-gp inhibitors like Multaq.
  • Calcium channel blockers
    • Multaq increases exposure to calcium channel blockers. Start with a low-dose calcium channel blocker and only increase after an ECG showing favorable tolerability.
  • Sirolimus, tacrolimus, and other CYP3A substrates with a narrow therapeutic window
    • Multaq can increase exposure to sirolimus, tacrolimus, and other CYP3A substrates with a narrow therapeutic window. Monitor plasma concentrations and adjust the dosage if needed.
  • Beta-blockers and other CYP2D6 substrates
    • Multaq increases exposure to beta-blockers. Start with a low-dose beta-blocker and only increase after an ECG showing favorable tolerability. Other CYP2D6 substrates may have increased exposure when coadministered with Multaq.
  • P-glycoprotein (P-gp) substrates
    • Digoxin
    • Multaq increases digoxin exposure by inhibiting the P-gp transporter. Consider discontinuing digoxin, but if digoxin is continued, decrease the dose by 50%.
    • Dabigatran
      • Multaq increases dabigatran exposure by inhibiting the P-gp transporter. Patients taking dabigatran concomitantly with Multaq should be dosed based on creatine clearance (CrCL): CrCL 30-50 mL/min should receive 75 mg of dabigatran twice daily; CrCL 15-30 mL/min should not use dabigatran.
  • Warfarin
    • When warfarin was administered during Multaq treatment, there was slightly increased exposure to S-warfarin. There have been cases of increased INR with or without bleeding.

Contraindications

Multaq is contraindicated in the following scenarios:

  • Permanent atrial fibrillation (when normal sinus rhythm cannot be restored)
  • Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms
  • Second or third-degree AV block or sick sinus syndrome (except when used in combination with a functioning pacemaker)
  • Heart rate < 50 bpm
  • Concomitant use of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir)
  • Liver or lung toxicity experienced with prior use of amiodarone
  • QTc Bazett interval of ?500 ms or PR interval >280 ms
  • Severe hepatic impairment
  • Pregnancy
  • Nursing mothers
  • Hypersensitivity to dronedarone or any excipient in the formulation

Frequently Asked Questions

Multaq is a prescription medication that reduces the risk of hospitalization caused by atrial fibrillation.

The most important thing is to know about the severe side effects that Multaq can cause.

  • Do not take Multaq if you have severe or recently worsened heart failure. Multaq can double your risk of death if you have these conditions.
    • Contact your doctor immediately if you have any of the following signs of heart failure:
      • Shortness of breath
      • Chest tightness or wheezing
      • Trouble sleeping because of breathing problems
      • Swelling in the legs or feet
      • Gaining more than 5 pounds quickly
  • Do not take Multaq if you have permanent atrial fibrillation
    • If you notice an irregular pulse while taking Multaq, contact your doctor right awa
  • Multaq can cause liver problems, including liver failure. Contact your doctor if you have any of the following signs of liver problems:
    • Loss of appetite, nausea, vomiting
    • Unusual tiredness, feeling unwell
    • Yellowing of the skin or eyes
    • Dark urine
    • Pain in the upper right area of your stomach
    • Itchy skin

Multaq helps regulate heart rhythm by inhibiting sodium channels, beta-1 receptors, potassium channels, and calcium channels.

You should not take Multaq if you have any of the following:

  • Permanent atrial fibrillation
  • Symptomatic heart failure leading to hospitalization or Class IV heart failure
  • A heart problem called a heart block, and you do not have an implanted pacemaker
  • Severe liver problems
  • Liver or lung problems after taking amiodarone
  • Heart rate < 50 beats per minute
  • Are taking certain medications that can change the levels of Multaq in your body, or are taking certain medications that can lead to an abnormal heart rhythm. Make sure to inform your doctor of all the medications or supplements you are taking. Please reach out to your doctor or pharmacist for more information.
  • Pregnant or plan on becoming pregnant
  • Breastfeeding or plan to breastfeed
  • Allergy to dronedarone or any other ingredients in Multaq

Multaq should be taken as a 400 mg tablet twice a day. One tablet with the morning meal and one tablet with the evening meal.

You should avoid grapefruit and grapefruit juice. Grapefruit juice will increase the levels of Multaq in your body.

The most common side effects are diarrhea, nausea, vomiting, abdominal pain, indigestion, tiredness, and itchy skin.

Although rare, serious side effects can occur with Multaq treatment, such as:

  • Slowed heartbeat
  • Inflammation, scarring, or thickening of the lungs
    • Contact your doctor immediately if you experience shortness of breath or a dry cough
  • Low potassium or magnesium levels can happen if you are taking diuretics during treatment with Multaq
  • Changes in kidney function blood tests
  • Liver problems, including life-threatening liver failure
    • Contact your doctor immediately if you notice one of the following:
      • Nausea, vomiting, or loss of appetite
      • Feeling unwell or tired
      • Yellowing of the skin or eyes
      • Dark urine
      • Pain in the upper right area of the stomach

Multaq is used when your heart is in normal sinus rhythm to prevent your heart from going into atrial fibrillation. However, Multaq is not used to stop atrial fibrillation that is already occurring.

Store at room temperature between 15°C to 30°C (59°F to 86°F).

If you miss a dose, take the next dose at the next scheduled time. Do not double up on the next dose in an attempt to make up for the missed dose.

If overdosage occurs, seek medical attention immediately. Be prepared to tell or show what was taken, how much, and when it was taken. The medical team will need to monitor your heart rhythm and blood pressure to assess the right course of action.

It is not known if Multaq is safe during pregnancy, and it should not be used if you are pregnant. Contact your doctor immediately if you are pregnant or plan on becoming pregnant. Women of childbearing potential should use effective contraception while taking Multaq.

It is not known if Multaq passes into breast milk, and it should not be used if you are breastfeeding or plan on breastfeeding.

There is currently no generic version of Multaq available.