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Rythmol SR (Propafenone Hydrochloride) - Summary

 
 



BOX WARNING

Mortality:

In the National Heart, Lung and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-center, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with encainide of flecainide (Class 1C antiarrhythmics) compared with that seen in patients assigned to placebo (3.0%; 22/725). The average duration of treatment with encainide or flecainide in this study was ten 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 1C antiarrhythmic to have a significant 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 SR SUMMARY

RYTHMOL SR (propafenone hydrochloride) is an antiarrhythmic drug supplied in extended-release capsules of 225, 325 and 425 mg for oral administration.

RYTHMOL SR is indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease.

The use of RYTHMOL SR in patients with permanent atrial fibrillation or in patients exclusively with atrial flutter or PSVT has not been evaluated. RYTHMOL SR should not be used to control ventricular rate during atrial fibrillation.

The effect of RYTHMOL SR on mortality has not been determined (see black box WARNINGS).


See all Rythmol SR indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Rythmol SR (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 SR (Propafenone)

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 [Recruiting]
PS-023 is a randomized controlled clinical study. The purpose of this study is to determine whether this new catheter system (Arctic Front CryoAblation Catheters, FlexCath Steerable Sheath) is safe and effective for the treatment of paroxysmal atrial fibrillation, as well as to see if this treatment is better compared to a medication. This catheter system uses freezing energy, cryoablation, to ablate (destroy) abnormal tissue in or near the pulmonary veins. A refrigerant (cooling material) is delivered within the catheter to cool the catheter tip. This freezes and destroys the cells at the entrance to the pulmonary veins. If the atrial fibrillation comes from somewhere else in the heart, another catheter, the Freezor MAX, will be used to freeze that area. This experimental catheter also uses freezing to ablate abnormal tissue. Many atrial fibrillation patients also have another arrhythmia called atrial flutter. In order to treat or to prevent atrial flutter after the procedure, the Freezor MAX catheter may be used to freeze the cells in the area of the heart where atrial flutter starts.

Efficacy of Pilsicainide After Radiofrequency Ablation of Paroxysmal Atrial Fibrillation [Recruiting]
Investigators hypothesized that the use of Pilsicainide after radiofrequency ablation of AF could reduce the incidence of recurrence of atrial arrhythmia during follow up compared with other class IC antiarrhythmic drugs.

Catheter Ablation Versus Antiarrhythmic Drugs for Outflow Tract Ventricular ARrhythmias [Recruiting]
A randomized, parallel, open study comparing catheter ablation versus antiarrhythmic drugs for outflow tract ventricular arrhythmias

Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) [Completed]
To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.

more trials >>

Reports of Suspected Rythmol SR (Propafenone) Side Effects

Drug Ineffective (8)Asthenia (6)Fall (5)Product Quality Issue (5)Headache (4)Balance Disorder (4)Cerebrovascular Accident (4)Sensory Loss (3)Fatigue (3)Dizziness (3)more >>


Page last updated: 2010-10-05

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