Application Nr Approved Date Route Status External Links
ANDA075882 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage 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 Is 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.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Flecainide Acetate FLECAINIDE ACETATE ZINC896543

Comments