Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
FLECAINIDE ACETATE (UNII: M8U465Q1WQ) (FLECAINIDE - UNII:K94FTS1806)
Ranbaxy Pharmaceuticals Inc.
FLECAINIDE ACETATE
FLECAINIDE ACETATE 50 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
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 Lire le document complet