|Drug Name:||Flecainide Acetate|
|Manufacturer:||Ranbaxy Pharmaceuticals Inc.|
The large majority of patients successfully treated with flecainide were found to have trough plasma levels between 0.2 and 1 mcg/mL.
The probability of adverse experiences, especially cardiac, may increase with higher trough plasma levels, especially when these exceed 1 mcg/mL.
Periodic monitoring of trough plasma levels may be useful in patient management.
Plasma level monitoring is required in patients with severe renal failure or severe hepatic disease, since elimination of flecainide from plasma may be markedly slower.Monitoring of plasma levels is strongly recommended in patients on concurrent amiodarone therapy and may also be helpful in patients with CHF and in patients with moderate renal disease.
In patients without structural heart disease, flecainide is 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 symptomsFlecainide is 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 for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital.
The use of flecainide is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic.Because of the proarrhythmic effects of flecainide, its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks.Flecainide should not be used in patients with recent myocardial infarction.
(See Boxed WARNINGS.)Use of flecainide 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 favorably affects survival or the incidence of sudden death.
Flecainide is contraindicated in patients with pre-existing second- or third-degree AV block, or with right bundle branch block when associated with a left hemiblock (bifascicular block), unless a pacemaker is present to sustain the cardiac rhythm should complete heart block occur.Flecainide is also contraindicated in the presence of cardiogenic shock or known hypersensitivity to the drug.
Mortality–Flecainide was included in the National Heart Lung and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long term, multicenter, 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 excessive mortality or non-fatal cardiac arrest rate was seen in patients treated with flecainide compared with that seen in patients assigned to a carefully matched placebo-treated group.
This rate was 16/315 (5.1%) for flecainide and 7/309 (2.3%) for the matched placebo.
The average duration of treatment with flecainide in this study was ten months.The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain, but at present, it is prudent to consider the risks of Class IC agents (including flecainide), coupled with the lack of any evidence of improved survival, generally unacceptable in patients without life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.Ventricular Pro-arrhythmic Effects in Patients with Atrial Fibrillation/Flutter.
A review of the world literature revealed reports of 568 patients treated with oral flecainide for paroxysmal atrial fibrillation/flutter (PAF).
Ventricular tachycardia was experienced in 0.4% (2/568) of these patients.
Of 19 patients in the literature with chronic atrial fibrillation (CAF), 10.5% (2) experienced VT or VF.
FLECAINIDE IS NOT RECOMMENDED FOR USE IN PATIENTS WITH CHRONIC ATRIAL FIBRILLATION.
Case reports of ventricular proarrhythmic effects in patients treated with flecainide for atrial fibrillation/flutter have included increased PVCs, VT, ventricular fibrillation (VF), and death.As with other Class I agents, patients treated with flecainide for atrial flutter have been reported with 1:1 atrioventricular conduction due to slowing the atrial rate.
A paradoxical increase in the ventricular rate also may occur in patients with atrial fibrillation who receive flecainide.Concomitant negative chronotropic therapy such as digoxin or beta-blockers may lower the risk of this complication.