Rythmol (Propafenone Hydrochloride) - Indications and Dosage

Indications and Usage

In patients without structural heart disease, RYTHMOL (propafenone HCl) is indicated to prolong the time to recurrence of

• paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.

• paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms.

As with other agents, 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 AV refractory period is recommended.

The use of propafenone HCl in patients with chronic atrial fibrillation has not been evaluated. Propafenone HCl should not be used to control ventricular rate during atrial fibrillation.

Propafenone HCl is also indicated for the treatment of

• documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of propafenone HCl, 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.

Initiation of propafenone HCl treatment, as with other antiarrhythmics used to treat life-threatening ventricular arrhythmias, should be carried out in the hospital.

Propafenone HCl, like other antiarrhythmic drugs, has not been shown to enhance survival in patients with ventricular or atrial arrhythmias.

Dosage and Administration

The dose of RYTHMOL (propafenone HCI) must be individually titrated on the basis of response and tolerance. It is recommended that therapy be initiated with 150 mg propafenone given every eight hours (450 mg/day). Dosage may be increased at a minimum of 3 to 4 day intervals to 225 mg every 8 hours (675 mg/day) and, if necessary, to 300 mg every 8 hours (900 mg/day). The usefulness and safety of dosages exceeding 900 mg per day have not been established. In those patients in whom significant widening of the QRS complex or second or third degree AV block occurs, dose reduction should be considered.

As with other antiarrhythmic agents, in the elderly or in ventricular arrhythmia patients with marked previous myocardial damage, the dose of RYTHMOL should be increased more gradually during the initial phase of treatment.

How Supplied

RYTHMOL^® (propafenone HCI) tablets are supplied as scored, round, film-coated tablets containing either 150 mg, 225 mg, or 300 mg of propafenone hydrochloride and embossed (on the same side) with ^® and a two-letter code designation, JC for the 150 mg tablet, JI for the 225 mg tablet and JN for the 300 mg tablet, in the following package sizes:

	NDC #65726-xxx-yy
	Unit Dose	Bottle of 100
150 mg	265 – 90	265 – 25
225 mg	266 – 90	266 – 25
300 mg	267 – 90	267 – 25

Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)[see USP controlled room temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Rx only

September 2004

Distributed by:

Reliant Pharmaceuticals, Inc.

Liberty Corner, New Jersey 07938, USA

Address Medial Inquiries to:

Reliant Pharmaceuticals, Inc.

Medical Affairs

110 Allen Road

Liberty Corner, NJ 07938, USA

RYTHMOL is a registered trademark of G. Petrik used under license by Abbott Laboratories.

© 2004 Reliant Pharmaceuticals, Inc.

03-5340-R1

326F500

Printed in U.S.A.