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Basic Drug Info
Drug Name:Flecainide Acetate
Manufacturer:Ranbaxy Pharmaceuticals Inc.
Other Info:

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.



Clinical Trials:


Indications and Usage

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.
Heart Diseases -- Pathological conditions involving the HEART including its structural and functional abnormalities.

Paroxysmal supraventricular tachycardia -- An episodic form of supraventricular tachycardia, with abrupt onset and termination.

Atrioventricular Nodal Reentry Tachycardia -- Abnormally rapid heartbeats caused by reentry of atrial impulse into the dual (fast and slow) pathways of ATRIOVENTRICULAR NODE. The common type involves a blocked atrial impulse in the slow pathway which reenters the fast pathway in a retrograde direction and simultaneously conducts to the atria and the ventricles leading to rapid HEART RATE of 150-250 beats per minute.

Atrioventricular Reentrant Tachycardia -- A supraventricular tachycardia due to reentry along a circuit including a concealed AV nodal bypass tract. This tachycardia circuit proceeds in an antegrade fashion through the AV node and then is conducted retrograde through the bypass tract into the atria.

Supraventricular tachycardia -- A generic expression for any tachycardia that originates above the BUNDLE OF HIS.

Ventricular arrhythmia -- Irregular heart beat resulting from a pathologic process in the cardiac ventricles.--2004

Sustained Ventricular Tachycardia -- An electrocardiographic finding of ventricular tachycardia greater than 30 seconds in duration.

Sudden death -- The abrupt cessation of all vital bodily functions, manifested by the permanent loss of total cerebral, respiratory, and cardiovascular functions.

Contraindications

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.
Complete atrioventricular block -- Complete failure of atrial electrical impulse conduction through the AV node to the ventricles.

Right bundle branch block -- An impairment of transmission of the cardiac electrical impulse along the fibers of the right bundle branch. A " complete RBBB pattern" (with QRS duration > 0.11s) does not necessarily reflect the existence of a total conduction block in the right branch. This pattern only indicates that the entire or major parts of both ventricles are activated by the impulse emerging from the left branch. Thus, a significant degree of conduction delay ("high-grade" or "incomplete RBBB") can produce a similar pattern.

Bifascicular block -- An electrocardiographic finding comprising right bundle branch block and left anterior fasicular block, or right bundle branch block and left posterior fasicular block. Defects occuring in two of the three divisions of the conduction system of the heart are considered bifasicular blocks. Technically left bundle branch block may be considered a bifasicular block.

Cardiogenic shock -- Shock resulting from diminution of cardiac output in heart disease.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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.
Branded Drugs
The following US Branded drugs contain Flecainide Acetate


TAMBOCOR -- GRACEWAY PHARMACEUTICALS LLC


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