Flecainide Acetate Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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 tablets, USP are 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 tablets, USP favorably affects survival or the incidence of sudden death.
There is currently no drug history available for this drug.
Flecainide acetate is an antiarrhythmic drug available in tablets of 50 mg, 100 mg, or 150 mg for oral administration.
Flecainide acetate is benzamide, N-(2-piperidinyl-methyl)-2,5-bis (2,2,2-trifluoroethoxy)-monoacetate. The structural formula is given below.
Flecainide acetate USP is a white to slightly off-white, crystalline powder with a pKa of 9.3. It has an aqueous solubility of 48.4 mg/mL at 37°C.
Flecainide acetate tablets, USP also contain: croscarmellose sodium, hydrogenated vegetable oil type 1, magnesium stearate, microcrystalline cellulose, and pregelatinized starch.
Flecainide Acetate Manufacturers
Aurobindo Pharma Limited
Physicians Total Care, Inc.
Ranbaxy Pharmaceuticals Inc.
Roxane Laboratories, Inc.
Barr Laboratories Inc.
Amneal Pharmaceuticals Of New York, Llc
American Health Packaging
Carilion Materials Management
Citron Pharma Llc
Avera Mckennan Hospital
Login To Your Free Account