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Dronedarone oral

Updated 2 Feb 2023 | Supraventricular arrhythmias


Oral formulations of dronedarone.

Drugs List

  • dronedarone 400mg tablets
  • MULTAQ 400mg film coated tablets
  • Therapeutic Indications


    Prevention of recurrence of non-permanent atrial fibrillation

    Maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation.

    Dronedarone should only be prescribed after alternative treatment options have been considered.



    400mg twice daily.

    The first tablet should be taken with the morning meal and the second tablet should be taken with the evening meal.

    Additional Dosage Information

    Missed doses
    If a dose is missed then the patient should take the next dose at the regular scheduled time and should not double the dose.


    Children under 18 years
    Sinus node dysfunction
    Bradycardia with pulse rate at rest < 50 beats per minute
    Bundle branch block
    Cardiac failure
    Haemodynamic instability
    History of cardiac failure
    History of hepatotoxicity secondary to amiodarone
    History of pulmonary toxicity secondary to amiodarone
    Left ventricular dysfunction
    Long QT syndrome
    Non paced atrial conduction defects
    Non paced second/third degree AV block
    Non-paced sinus node dysfunction
    QTc interval greater than or equal to 500 msec
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe hepatic impairment
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Females of childbearing potential
    Patients over 75 years
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    History of torsade de pointes
    Ischaemic heart disease
    Lactose intolerance

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Treatment to be initiated by specialist
    Contains lactose
    Monitor creatinine prior to & after 7 days & then use as baseline value
    Perform ECG before and during treatment
    Perform liver function tests before commencing therapy
    If serum creatinine is raised at day 7, recheck at day 14
    Monitor renal function regularly
    Monitor serum electrolytes
    Perform LFTs 1 week and 1 month after initiation then monthly for 6 months
    Perform LFTs at months 9 and 12 and periodically thereafter
    Advise patient to report new or worsening signs of cardiac failure
    Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
    Predisposition QT prolongation: Counsel patient on symptoms of arrhythmias
    Consider discontinuation if serum creatinine continues to rise
    Discontinue at the first signs of cardiac failure
    Discontinue if ALT level exceeds 3 times the upper limit of normal
    Discontinue if jaundice or other evidence of hepatic impairment occurs
    Discontinue if left ventricular systolic dysfunction develops
    Discontinue if permanent atrial fibrillation occurs
    Discontinue if pulmonary toxicity occurs
    Discontinue treatment if QTc exceeds 500msec
    Advise patient not to take simvastatin unless advised by clinician
    Advise patient not to take St John's wort concurrently
    Grapefruit juice should not be taken simultaneously
    Female: Ensure adequate contraception during treatment

    Perform ECGs serially, at least every 6 months.

    If alanine transaminase (ALT) levels are elevated to greater than or equal to 3 times the upper limit of normal (ULN), levels should be remeasured within 48 to 72 hours. If ALT levels are confirmed to be greater than or equal to 3 times ULN, after remeasurement, dronedarone should be withdrawn. Appropriate investigation and close observation of patients should continue until normalisation of ALT. Advise patients to immediately report symptoms of hepatic injury (such as sustained new onset abdominal pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine or itching).

    Increases in plasma creatinine levels have been observed in healthy subjects and in patients taking dronedarone 400mg twice daily. This increase occurs early after treatment initiation and reaches a plateau after 7 days. Patients should have their plasma creatinine levels measured prior to and 7 days after initiation. If an increase in creatinine is observed, serum creatinine should be re-measured after a further 7 days. If no further increase is observed, this value should be used as the new reference baseline. Renal function should be monitored periodically thereafter. If serum creatinine continues to rise then consideration should be given to further investigation and discontinuing treatment.

    An increase in creatinine should not necessarily lead to the discontinuation of treatment with angiotensin converting enzyme inhibitors or angiotensin II receptor antagonists.

    Dronedarone may induce moderate QTc prolongation (about 10msec), related to prolonged repolarisation. These changes are linked to the therapeutic effect of dronedarone and do not reflect toxicity. Follow up, including ECG is recommended during treatment. If the QTc interval is greater than or equal to 500milliseconds then treatment with dronedarone should be stopped.

    Interstitial lung disease including pneumonitis and pulmonary fibrosis have been reported. Onset of dyspnoea or non productive cough may be related to pulmonary toxicity and patients should be carefully evaluated. If pulmonary toxicity is confirmed treatment should be discontinued.

    Patients should be appropriately anticoagulated in accordance with current clinical guidelines. The INR should be closely monitored after initiation of dronedarone in patients taking vitamin K antagonists, see specific product literature.

    Pregnancy and Lactation


    Dronedarone is contraindicated during pregnancy.

    The manufacturer does not recommend using dronedarone during pregnancy or in women of childbearing potential not using contraception. Animal studies have shown teratogenic effects. Human data is limited and as such a potential risk cannot be ruled out.


    Dronedarone is contraindicated for use during breastfeeding.

    The manufacturer advises that the patient either discontinues dronedarone or discontinues breastfeeding. Animal data reports dronedarone is excreted in the breast milk, however presence in human breast milk and the effects on exposed infants are unknown.

    Side Effects

    Abdominal pain
    Abnormal liver function tests
    Allergic dermatitis
    Congestive cardiac failure
    Gastro-intestinal disturbances
    Hepatic failure
    Hepatocellular damage
    Interstitial lung disease
    Leukocytoclastic vasculitis
    Prolongation of QT interval
    Pulmonary fibrosis
    Serum creatinine increased


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: October 2019

    Reference Sources

    Summary of Products Characteristics: Multaq 400mg film coated tablets. Sanofi Aventis. Revised September 2019.

    NICE Evidence Services Available at: Last accessed: 14 October 2019

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