Skip to main content

FLECAINIDE MLabs, FLECAR, FLECAINIDE B&B, FLECAIN (Micro Labs Pty Ltd)

Product name
FLECAINIDE MLabs, FLECAR, FLECAINIDE B&B, FLECAIN
Date registered
Evaluation commenced
Decision date
Approval time
164 working days (255)
Active ingredients
Flecainide acetate
Registration type
New generic medicine
Indication

FLECAINIDE MLabs, FLECAR, FLECAINIDE B&B, FLECAIN (tablets) are indicated for:

  1. Supraventricular arrhythmias:
    1. due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown-Ganong-Levine syndromes
    2. due to dual AV nodal pathways in patients with debilitating symptoms
    3. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms
    4. Although flecainide acetate may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. In these patients, particularly in the presence of impaired left ventricular function, [TRADE NAME] should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.

      Use of flecainide acetate in chronic atrial fibrillation has not been adequately studied and is not recommended.

  • Life-threatening ventricular arrhythmias not controlled by other drugs.
  • Flecainide acetate tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means.

    Help us improve the Therapeutic Goods Administration site