Label: FLECAINIDE ACETATE tablet

  • NDC Code(s): 65162-641-10, 65162-641-11, 65162-642-10, 65162-642-11, view more
  • Packager: Amneal Pharmaceuticals LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 25, 2024

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  • DESCRIPTION
    Flecainide acetate is an antiarrhythmic drug available in tablets of 50, 100, or 150 mg for oral administration. Flecainide acetate is benzamide ...
  • CLINICAL PHARMACOLOGY
    Flecainide has local anesthetic activity and belongs to the membrane stabilizing (Class 1) group of antiarrhythmic agents; it has electrophysiologic effects characteristic of the IC class of ...
  • INDICATIONS AND USAGE
    In patients without structural heart disease, flecainide is indicated for the prevention of - - paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant ...
  • CONTRAINDICATIONS
    Flecainide is contraindicated in patients with preexisting second- or third degree AV block, or with right bundle branch block when associated with a left hemiblock (bifascicular block), unless a ...
  • WARNINGS
    Mortality - Flecainide was included in the National Heart Lung and Blood Institute’s Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi center, randomized, double-blind study in ...
  • PRECAUTIONS
    Drug Interactions - Flecainide has been administered to patients receiving digitalis preparations or beta-adrenergic blocking agents without adverse effects. During administration of multiple ...
  • ADVERSE REACTIONS
    In post-myocardial infarction patients with asymptomatic PVCs and nonsustained ventricular tachycardia, flecainide therapy was found to be associated with a 5.1% rate of death and non-fatal ...
  • OVERDOSAGE
    No specific antidote has been identified for the treatment of flecainide overdosage. Overdoses ranging up to 8000 mg have been survived, with peak plasma flecainide concentrations as high as 5.3 ...
  • DOSAGE AND ADMINISTRATION
    For patients with sustained VT, no matter what their cardiac status, flecainide, like other antiarrhythmics, should be initiated in hospital with rhythm monitoring. Flecainide has a long ...
  • HOW SUPPLIED
    Flecainide acetate tablets, USP are available as follows: 50 mg: White, round tablets debossed with “AN” above “641” on one side and plain on other side. Bottles of 100 ...
  • PRINCIPAL DISPLAY PANEL
    641
  • PRONCIPAL DISPLAY PANEL
    642
  • PRONCIPAL DISPLAY PANEL
    643
  • INGREDIENTS AND APPEARANCE
    Product Information