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Dronedarone Initiation and Titration Pathway
Document Purpose: Standardized recommendations for initiation of dronedarone and ongoing monitoring/patient management
Clinical Indication:
• Symptomatic AF in the absence of significant heart failure or liver abnormalities
Absolute Contraindications:
• Permanent AF
• Heart failure with recent decompensation requiring hospitalization
• Left ventricular systolic dysfunction (LVEF 440 msec (men) or >460 msec (women) in the absence of a pre-existing bundle branch block
• Severe hepatic impairment
Relative Contraindications (caution for use):
• Sinus bradycardia (25% increase from baseline QTc (>500ms) |
| |Every 6-12 months if stable |Heart rate 150ms |
| | |Heart rate 150ms |
| | |Heart rate 440 msec (men) or >460 msec (women) in the absence of a pre-existing bundle branch block
• Sinus bradycardia (75 years of age)
• Reactive airway disease
• Systolic heart failure (use cautiously if LVEF 1.4 cm on echocardiogram
• Hypokalemia or hypomagnesemia (correct imbalances prior to use and throughout therapy)
• Should be avoided in patients at high risk of Torsades de Pointes VT
o i.e. women aged >65 y taking diuretics or those with renal insufficiency
Baseline Investigations:
• Blood pressure
• ECG (within 1 week)
• Echocardiogram (or other assessment of LV function; within 1 year)
• Laboratory investigations (within 1 month) - Serum electrolytes, and Serum Creatinine/eGFR
Dosing:
• Starting Dose
o 40 mg BID (optional) or 80 mg BID (usual starting dose)
• Renal Dosing
o CrCl 40-60 ml/min: adjust dose to once daily
o CrCl < 40 ml/min: contraindicated
• Titration: See table below
|Current Dose |Increase Dose to |Decrease Dose to |
|40 mg BID |80 mg BID |----- |
|80 mg BID |120 mg BID |40 mg BID |
|120 mg BID |160 mg BID |80 mg BID |
|160 mg BID |-------- |120 mg BID |
If the patient’s dosing does not fall into one of the intervals, contact the EP/cardiologist or consult clinical pharmacist for closest equivalent dosing.
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Monitoring:
|Parameter |Frequency |Considerations |
|ECG |Within 7 days of a dose change |Notify prescriber if any of the following develop: |
| |Every 6-12 months if stable |>25% increase from baseline QTc (>500ms) |
| | |Heart rate 440 msec (men) or >460 msec (women) in the absence of a pre-existing bundle branch block
• Hypersensitivity to the drug components, including iodine
Relative Contraindications (caution for use):
• Sinus bradycardia (6 months) - Chest X-ray, PFT with DLCO
Dosing:
• Loading Dose
o 600 to 800 mg daily, in divided doses until 10 g total or
o 400 mg twice daily x 1 week then 400 mg once daily x 2 weeks or
o 400 mg daily x 1 month
• Maintenance Dose:
o 200 mg daily (lower maintenance doses can be considered)
Monitoring - Routine Surveillance for chronic amiodarone use
• ECG - every 6-12 months if stable
• Liver Panel & Thyroid Function Tests - every 6 months
• Chest-RAY – every 12 months
• Eye Exam – as needed for symptoms
• Pulmonary Function Test – as needed if symptoms arise
|Parameter |Frequency |Considerations |
|ECG |Within 7 days of a dose change,|QTc increases >25% of baseline or to ≥500 ms |
| |at the end of the loading |Notify MD/NP |
| |phase, and every 6-12 months |Given the risk of torsades is low for amiodarone it may be acceptable to continue despite QTc ≥550|
| | |ms |
| | |Look for reversible causes of QTc prolongation such as hypokalemia, hypomagnesemia, drug |
| | |interactions etc |
| | |Heart rate ................
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