Propafenone (Propafenone Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

In patients without structural heart disease, 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 judgement 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 propafenone HCl 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 propafenone HCl should be increased more gradually during the initial phase of treatment.

HOW SUPPLIED

Propafenone HCl tablets are supplied as white, scored, round, film-coated tablets in three dosage strengths:

•  150 mg tablets embossed "5124" and "V" available in bottles of 10, 100, 300, 500, 1000 and in unit-dose packs of 100.
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•  225 mg tablets embossed "5125" and "V" available in bottles of 10, 100, 500, 1000 and in unit-dose packs of 100.
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•  300 mg tablets embossed "5126" and "V" available in bottles of 10, 100, 500, 1000 and in unit-dose packs of 100.

DISPENSE in a tight, light-resistant container as defined in the USP.

STORE at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured by:
VINTAGE PHARMACEUTICALS, LLC
Huntsville, AL 35811

8182244
R3/06-R0