The extent of flecainide binding to human plasma proteins is about 40% and is independent of plasma drug level over the range of 0.015 to about 3.4 mcg/mL. Thus, clinically significant drug interactions based on protein binding effects would not be expected.

Hemodialysis removes only about 1% of an oral dose as unchanged flecainide.

Small increases in plasma digoxin levels are seen during coadministration of flecainide with digoxin. Small increases in both flecainide and propranolol plasma levels are seen during coadministration of these two drugs. (See PRECAUTIONS, Drug Interactions.)

Clinical Trials
In two randomized, crossover, placebo-controlled clinical trials of 16 weeks double-blind duration, 79% of patients with paroxysmal supraventricular tachycardia (PSVT) receiving flecainide were attack free, whereas 15% of patients receiving placebo remained attack free. The median time-before-recurrence of PSVT in patients receiving placebo was 11 to 12 days, whereas over 85% of patients receiving flecainide had no recurrence at 60 days.

In two randomized, crossover, placebo-controlled clinical trials of 16 weeks double-blind duration, 31% of patients with paroxysmal atrial fibrillation/flutter (PAF) receiving flecainide were attack free, whereas 8% receiving placebo remained attack free. The median time-before-recurrence of PAF in patients receiving placebo was about 2 to 3 days, whereas for those receiving flecainide the median time-before-recurrence was 15 days.

INDICATIONS AND USAGE
In patients without structural heart disease, Flecainide Acetate Tablets, USP are indicated for the prevention of:

•paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms

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

Flecainide Acetate Tablets, USP are also indicated for the prevention of:

•documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician are life-threatening.

Use of Flecainide Acetate Tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.

Because of the proarrhythmic effects of Flecainide Acetate Tablets, USP, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.

Flecainide Acetate Tablets, USP should not be used in patients with recent myocardial infarction. (See Boxed WARNINGS.)

Use of Flecainide Acetate Tablets, USP in chronic atrial fibrillation has not been adequately studied and is not recommended. (See Boxed WARNINGS.)

As is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate favorably affects survival or the incidence of sudden death.

CONTRAINDICATIONS
Flec