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RYTHMOL is an antiarrhythmic indicated to:
• prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. (1)
• prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients who do not have structural heart disease. (1)
• treat documented life-threatening ventricular arrhythmias. (1)
Usage Considerations:
• Use in patients with permanent atrial fibrillation or with atrial flutter or PSVT has not been evaluated. Do not use to control ventricular rate during atrial fibrillation. (1)
• In patients with atrial fibrillation and atrial flutter, use RYTHMOL with drugs that increase the atrioventricular nodal refractory period. (1)
• Because of proarrhythmic effects, use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic. (1) • The effect of propafenone on mortality has not been determined. (1)
The most commonly reported adverse events with propafenone (>5%) included: unusual taste, nausea and/or vomiting, dizziness, constipation, headache, fatigue, first degree AV block, and intraventricular conduction delay. (6.1)
• Inhibitors of CYP2D6, 1A2, and 3A4 increase propafenone exposure. (7.1)
• Propafenone may increase digoxin or warfarin levels. (7.2, 7.3)
• Orlistat may reduce propafenone exposure. Taper orlistat withdrawal. (7.4)
• Lidocaine may increase central nervous system side effects. (7.6)
May cause new or worsened arrhythmias. Evaluate patients via ECG prior to and during therapy. (5.1)
• RYTHMOL may unmask Brugada or Brugada-like Syndrome. (4, 5.2) • Avoid use with other drugs that prolong the QT interval. (5.3)
• Avoid simultaneous use of propafenone with both a cytochrome P450 2D6 inhibitor and a 3A4 inhibitor. (5.4)
• May provoke overt heart failure. (5.5) • May cause dose-related first degree AV block or other conduction disturbances. Only use in patients with conduction disorders who have pacemakers. (5.6)
• May affect artificial pacemakers.Monitor pacemaker function. (5.7)
• Agranulocytosis: Patients should report signs of infection. (5.8)
• May exacerbate myasthenia gravis. (5.11)
