FLECAINIDE ACETATE- flecainide tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLECAINIDE ACETATE (UNII: M8U465Q1WQ) (FLECAINIDE - UNII:K94FTS1806)

Available from:

Ranbaxy Pharmaceuticals Inc.

INN (International Name):

FLECAINIDE ACETATE

Composition:

FLECAINIDE ACETATE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 symptoms Flecainide 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 th

Product summary:

Flecainide Acetate Tablets, USP 50 mg are white to off-white, round, convex faced tablets debossed with “RX794” on one side and plain on the other side. They are supplied as follows: NDC 63304-794-01 unit of use bottles of 100 Flecainide Acetate Tablets, USP 100 mg are white to off-white, round, convex faced tablets debossed with “RX795” on one side and bisected on the other side. They are supplied as follows: NDC 63304-795-01 unit of use bottles of 100 Flecainide Acetate Tablets, USP 150 mg are white to off-white, oval, convex faced tablets debossed with “RX796” on one side and bisected on the other side. They are supplied as follows: NDC 63304-796-01 unit of use bottles of 100 Store at 20° - 25° C (68° - 77° F) (See USP Controlled Room Temperature.) Dispense in a tight, light-resistant container. Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA by: Ohm Laboratories Inc. North Brunswick, NJ 08902 USA July 2003

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLECAINIDE ACETATE- FLECAINIDE TABLET
RANBAXY PHARMACEUTICALS INC.
----------
FLECAINIDE ACETATE TABLETS, USP
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
S IGNS .
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