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Rythmol (Propafenone Hydrochloride) - Summary

 
 



WARNING: MORTALITY

  • In the National Heart, Lung, and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-center, randomized, double-blind trial in subjects with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than 6 days but less than 2 years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in subjects assigned to placebo (3.0%; 22/725). The average duration of treatment with encainide or flecainide in this trial was 10 months.
  • The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present, it is prudent to consider any IC antiarrhythmic to have a significant proarrhythmic risk in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.
 

RYTHMOL SUMMARY

RYTHMOL (propafenone hydrochloride) is an antiarrhythmic drug supplied in scored, film-coated tablets of 150 and 225 mg for oral administration. Propafenone has some structural similarities to beta-blocking agents.

RYTHMOL® is indicated to:

  • •prolong the time to recurrence of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms in patients without structural heart disease.
  • •prolong the time to recurrence of paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms in patients without structural heart disease.
  • •treat documented ventricular arrhythmias, such as sustained ventricular tachycardia that, in the judgment of the physician, are life-threatening. Initiate treatment in the hospital.

Usage Considerations:

  • •The use of RYTHMOL in patients with permanent atrial fibrillation (AF) or in patients exclusively with atrial flutter or PSVT has not been evaluated. Do not use RYTHMOL to control ventricular rate during AF.
  • •Some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional atrioventricular (AV) nodal refractory period is recommended.
  • •The use of RYTHMOL in patients with chronic atrial fibrillation has not been evaluated.
  • •Because of the proarrhythmic effects of RYTHMOL, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits outweigh the risks.
  • •The effect of propafenone on mortality has not been determined [see Boxed Warning].

See all Rythmol indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Rythmol (Propafenone)

Comparative bioavailability of propafenone after administration of a magistral suspension vs. commercial tablets in healthy volunteers. [2009]
Propafenone (CAS 34183-22-7) is an effective antiarrhythmic drug used in children, although in some countries no specific pediatric formulation is available.

Efficacy and tolerability of oral propafenone versus quinidine in the treatment of recent onset atrial fibrillation: A randomized, prospective study. [2009]
BACKGROUND: A prospective, randomized study was conducted to evaluate the efficacy and tolerability of oral propafenone and quinidine for the conversion of paroxysmal atrial fibrillation (AF)... CONCLUSIONS: Although both drugs revealed the same effectiveness, the conversion to sinus rhythm in the group treated with propafenone was observed more quickly despite the longer paroxysmal AF episode duration.

Propafenone for the prevention of atrial tachyarrhythmias after cardiac surgery: a randomized, double-blind placebo-controlled trial. [2008.07]
We studied the efficacy of propafenone in preventing atrial tachyarrhythmias after cardiac surgery, and the possible relationships between CYP2D6 polymorphism and the efficacy, pharmacokinetics, and tolerability of propafenone. One hundred and sixty patients were randomized (double blind) to receive propafenone (n= 78) or placebo (n= 82) for 1 week after cardiac surgery.

Propafenone for the Prevention of Atrial Tachyarrhythmias After Cardiac Surgery: A Randomized, Double-blind Placebo-controlled Trial. [2008.01.02]
We studied the efficacy of propafenone in preventing atrial tachyarrhythmias after cardiac surgery, and the possible relationships between CYP2D6 polymorphism and the efficacy, pharmacokinetics, and tolerability of propafenone. One hundred and sixty patients were randomized (double blind) to receive propafenone (n= 78) or placebo (n= 82) for 1 week after cardiac surgery.

Propafenone added to ibutilide increases conversion rates of persistent atrial fibrillation. [2006.05]
CONCLUSION: Concurrent administration of propafenone plus ibutilide for pharmacological cardioversion of persistent AF is safe and more effective than ibutilide alone.

more studies >>

Clinical Trials Related to Rythmol (Propafenone)

Bioequivalence of RYTHMOL SR� Manufactured at Two Different Sites [Completed]
Bioequivalence of propafenone hydrochloride capsules manufactured at two different sites

Efficacy of Propafenone Versus Dronedarone for the Maintenance of Sinus Rhythm in Patients With Atrial Fibrillation [Completed]

Antiarrhythmic Drugs Assessment in Preventing Atrial Fibrillation [Not yet recruiting]
The current evidences indicate that ~30% patients with sick sinus syndrome(SSS) would develop persistent atrial fibrillation (AF) after a long term pacing therapy. However, the accurate influence of antiarrhythmic drugs on the AF is still not well defined. The purpose of the study is to assess the therapeutic effects of various antiarrhythmic drugs (Amiodarone, Sotalol and Propafenone) on the long term management of AF in SSS patients with AF, including the reduced AF burden (duration and episodes) and persistent AF free survival rate. All patients will be followed up for 12 months.

A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation [Completed]
This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or sotalol) were randomized 2: 1 to cryoablation intervention (Experimental Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90 days after study therapy was initiated was considered a blanked period for all subjects.

Efficacy and Safety of Electrical Versus Pharmacological Cardioversion in Early Atrial Fibrillation [Completed]
The optimal strategy to restore sinus rhythm in patients with atrial fibrillation (AF) of less than 48 hours' duration is still controversial. The investigators performed a controlled single-center trial to compare electrical and pharmacological (propafenone) cardioversion to restore the sinus rhythm in selected patients with acute atrial fibrillation.

more trials >>

Reports of Suspected Rythmol (Propafenone) Side Effects

Asthenia (8)Nausea (7)Dysgeusia (7)Somnolence (6)Feeling Abnormal (6)Blood Bilirubin Increased (5)Weight Decreased (5)Eye Irritation (5)Haemorrhoidal Haemorrhage (5)Photophobia (5)more >>


Page last updated: 2010-10-05

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