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MULTAQ is a brand name for Dronedarone, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MULTAQ (dronedarone hydrochloride) is indicated for: • the treatment of patients with paroxysmal or persistent atrial fibrillation (AF) who are in sinus rhythm or who are intended to be cardioverted, to reduce the risk of cardiovascular hospitalization due to atrial fibrillation (see 14 CLINICAL TRIALS). MULTAQ should…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing considerations MULTAQ (dronedarone tablets) Page 5 of 44 There is limited information on the optimal timing to switch from amiodarone to MULTAQ. It should be considered that amiodarone may have a long duration of action after discontinuation due to its long half-life.
If a switch is considered, this should be done with caution under the supervision of a specialist. Treatment with class I or III antiarrhythmics (such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) must be stopped before starting MULTAQ.
2 Recommended Dose and Dosage Adjustment • The recommended dosage is 400 mg twice daily in adults. MULTAQ should be taken as one tablet with the morning meal and one tablet with the evening meal. • Treatment with MULTAQ can be initiated in an outpatient setting.
3 Pharmacokinetics). Severe Hepatic impairment • MULTAQ is contraindicated in patients with severe hepatic impairment (see 2 CONTRAINDICATIONS). 5 Missed Dose If a dose of this medication has been missed, the missed dose should be skipped and the patient should go back to the regular dosing schedule.
The dose should not be doubled. 5 OVERDOSE In the event of overdosage, the patient’s cardiac rhythm and blood pressure should be monitored in addition to general supportive measures. Treatment should be supportive and based on symptoms.
It is not known whether dronedarone and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis or hemofiltration). There is no specific antidote available. For management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669).
1 Adverse Reaction Overview The safety profile of dronedarone 400mg twice daily in patients with AF or AFL is based on 5 placebo controlled studies, ATHENA, EURIDIS, ADONIS, ERATO and DAFNE. In these studies, a total of 6285 patients were randomized and treated.
Of these, 3282 patients were treated with dronedarone 400 mg twice daily, and 2875 received placebo. The mean exposure across studies was 12 months. In ATHENA, the maximum follow-up was 30 months. Assessment of intrinsic factors such as race, gender or age on the incidence of any treatment emergent adverse events did not suggest any excess of adverse events in a particular sub-group.
7% in the placebo-treated group. 8% in the placebo group). The most frequent adverse reactions observed with dronedarone 400 mg twice daily in the 5 studies were diarrhea, nausea and vomiting, fatigue and asthenia. 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions.
Therefore, the frequencies of adverse reactions observed in the clinical trials may not reflect frequencies observed in clinical practice and should not be compared to frequencies reported in clinical trials of another drug. Table 1 displays adverse reactions ≥ 1% associated with dronedarone 400 mg twice daily in AF or AFL patients, presented by system organ class and by decreasing order of frequency.
Adverse reactions included in the system organ class “Investigation” are presented separately in Table 2. 3 Less Common Clinical Trial Adverse Reactions (<1%) Nervous system disorders: Ageusia and dysgeusia.
Skin and subcutaneous tissue disorders:
Dermatitis, dermatitis allergic, eczema, erythemas (including erythema and rash erythematous and photosensitivity reaction. 4 Abnormal laboratory findings: hematologic, clinical chemistry and other quantitative data Clinical Trial Findings In addition, the following laboratory data/ECG parameters were reported with dronedarone 400 mg twice daily.
1 Pregnant Women 2024-10 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorisation are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSE ..................................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 6 7 WARNINGS AND PRECAUTIONS .................................................................................. 10 8 ADVERSE REACTIONS ................................................................................................
12 9 DRUG INTERACTIONS ................................................................................................ 19 10 CLINICAL PHARMACOLOGY .......................................................................................
22 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 27 PART II: SCIENTIFIC INFORMATION .......................................................................................
28 13 PHARMACEUTICAL INFORMATION ............................................................................ 28 14 CLINICAL TRIALS ........................................................................................................
). 5 Missed Dose If a dose of this medication has been missed, the missed dose should be skipped and the patient should go back to the regular dosing schedule. The dose should not be doubled. 5 OVERDOSE In the event of overdosage, the patient’s cardiac rhythm and blood pressure should be monitored in addition to general supportive measures.
Treatment should be supportive and based on symptoms. It is not known whether dronedarone and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis or hemofiltration). There is no specific antidote available.
For management of a suspected drug overdose, contact your regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669). 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths and Composition Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral tablet 400 mg carnauba wax, colloidal anhydrous silica, crospovidone, hypromellose, lactose monohydrate, macrogol 6000, magnesium stearate, maize starch, poloxamer 407, titanium MULTAQ (dronedarone tablets) Page 6 of 44 Description MULTAQ is provided as tablets for oral administration.
Each tablet of MULTAQ contains dronedarone hydrochloride equivalent to 400 mg dronedarone”.
The inactive ingredients are:
Core of the tablets: colloidal anhydrous silica, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, maize starch, poloxamer 407. Coating / Polishing of the tablets: carnauba wax, hypromellose, macrogol 6000, titanium dioxide.
1 Physical Characteristics MULTAQ 400 mg tablets are provided as white film-coated tablets for oral administration, oblong- shaped, engraved with a double wave marking on one side and “4142” code on the other side in: bottles of 60 tablets, 180 tablets, 500 tablets, and in boxes of 4 blisters (15 tablets per blister).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dronedarone in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
5 Post-Market Adverse Reactions The following adverse reactions have been identified during post-approval use of MULTAQ. Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiac disorders:
Congestive heart failure A few cases of atrial flutter with 1:1 atrioventricular conduction have been reported.
Hepatic:
Serum hepatic enzymes and serum bilirubin increase: Hepatocellular liver injury, including acute liver failure requiring transplant, has been reported in a few patients (see 7 WARNINGS AND PRECAUTIONS).
Immune system disorders:
Anaphylactic reactions including angioedema Renal: Marked increase in serum creatinine, pre-renal azotemia and acute renal failure, often in the setting of heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular) or hypovolemia, have been reported in patients taking MULTAQ.
In most cases, these effects appear to be reversible upon drug discontinuation and with appropriate medical treatment. However, rare cases of acute renal failure resulting in death have been reported postmarketing. Although all such cases were complex and confounded by multiple illnesses and concomitant medications, a contributive role of dronedarone in the development of renal failure could not be excluded.
Renal function should be monitored periodically (see 7 WARNINGS AND PRECAUTIONS, Renal).
Respiratory disorders:
Interstitial lung disease including pneumonitis and pulmonary fibrosis (a number of patients had been previously exposed to amiodarone).
Vascular disorders:
Vasculitis, including leukocytoclastic vasculitis (Schönlein-Henoch purpura) MULTAQ (dronedarone tablets) Page 13 of 44
28 15 MICROBIOLOGY ........................................................................................................ 32 16 NON-CLINICAL TOXICOLOGY .....................................................................................
32 PATIENT MEDICATION INFORMATION .................................................................................. 38 MULTAQ (dronedarone tablets) Page 4 of 44 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS MULTAQ (dronedarone hydrochloride) is indicated for: • the treatment of patients with paroxysmal or persistent atrial fibrillation (AF) who are in sinus rhythm or who are intended to be cardioverted, to reduce the risk of cardiovascular hospitalization due to atrial fibrillation (see 14 CLINICAL TRIALS).
MULTAQ should only be prescribed after alternative treatment options have been considered. 1 Pediatrics • Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics 2 EFFICACY AND SAFETY WERE COMPARABLE IN BOTH ELDERLY AND YOUNGER PATIENTS. CAUTION IS NEEDED IN ELDERLY […]
7 WARNINGS AND PRECAUTIONS General Anticoagulation Therapy Patients should be appropriately anticoagulated. Where applicable, International Normalized Ratio (INR) should be closely monitored after initiating dronedarone in patients taking vitamin K antagonists as per their label.
Dronedarone should not be used concomitantly with either dabigatran or rivaroxaban since it may increase exposure of dabigatran through P-gp inhibition or rivaroxaban through P-gp and CYP3A4 inhibition (see 9 DRUG INTERACTIONS). Cardiovascular Congestive Heart Failure (CHF) or Left Ventricular Systolic Dysfunction Dronedarone is contraindicated for use in patients in unstable hemodynamic conditions, history of, or current heart failure or left ventricular systolic dysfunction.
(see 2 CONTRAINDICATIONS). Patients with new or worsening heart failure during treatment Patients should be advised to consult a physician if they develop signs or symptoms of heart failure, such as weight gain, dependent edema, or increasing shortness of breath.
If heart failure develops treatment with MULTAQ should be discontinued (see 2 CONTRAINDICATIONS). Patients should be followed for the development of left ventricular systolic dysfunction during treatment. If left ventricular systolic dysfunction develops, treatment with MULTAQ should be discontinued.
Patients Developing Permanent AF During Treatment A clinical study in patients with permanent AF (AF duration for at least 6 months) and cardiovascular risk factors was stopped early due to an excess of cardiovascular death, stroke and unplanned dioxide.
MULTAQ (dronedarone tablets) Page 7 of 44 cardiovascular hospitalization. It is recommended to perform an ECG at least every 6 months while patients are receiving MULTAQ. If patients treated with MULTAQ develop permanent AF, treatment with MULTAQ should be discontinued.
Patients with Coronary Artery Disease Caution is needed in patients with coronary artery disease. QT prolongation The pharmacological action of dronedarone may induce a moderate (about 10 msec) QTc Bazett prolongation, related to prolonged repolarization.
These changes are linked to the therapeutic effect of dronedarone and do not reflect toxicity. Follow up, including ECG, is recommended during treatment. If QTc Bazett interval is ≥ 500 msec, dronedarone should be stopped (see 2 CONTRAINDICATIONS).
Based on clinical experience, dronedarone has a low pro-arrhythmic effect. However, proarrhythmic effects may occur in particular situations such as concomitant use with drugs favoring arrhythmia and/or electrolytic disorders (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS).
Endocrine and Metabolism Electrolyte imbalance Since antiarrhythmic drugs may be ineffective or may be arrhythmogenic in patients with hypokalemia or hypomagnesemia , any potassium or magnesium deficiency should be corrected before initiation and during dronedarone therapy.
Hepatic/Biliary/Pancreatic Liver Injury Hepatocellular liver injury, including acute liver failure requiring transplant, has been reported in patients treated with MULTAQ in the post-marketing setting. Healthcare professionals should advise patients treated with MULTAQ to immediately report symptoms suggesting hepatic injury (such as anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching).
It is not known whether routine periodic monitoring of serum enzymes will detect the development of severe liver injury. However, healthcare professionals should consider obtaining periodic hepatic serum enzymes, especially during the first 6 months of treatment.
If hepatic injury is suspected, MULTAQ should be discontinued immediately followed by appropriate blood tests. If liver injury is found, appropriate treatment should be instituted, and investigations should be performed to establish the cause.
The safety of restarting MULTAQ in patients who have sustained liver injury from any cause is unknown; accordingly, its use in such patients is not recommended. Monitoring and Laboratory Tests It is recommended to […]