FLECATAB (Alphapharm Pty Ltd)
Product name
FLECATAB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
141 (255 working days)
Active ingredients
flecainide acetate
Registration type
New generic medicine
Indication
FLECATAB (tablet) is indicated for:
- Supraventricular arrhythmias
- due to pre-excitation syndromes (e.g. Wolff-Parkinson-White and Lown-Ganong-Levine syndromes)
- due to dual atrioventricular (AV) nodal pathways in patients with debilitating symptoms
- paroxysmal atrial flutter/fibrillation (PAF) associated with disabling symptoms
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, FLECATAB 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.
- An intravenous form of flecainide acetate is indicated when rapid control or short-term prophylaxis of the above arrhythmias is the main clinical requirement. All use of the injection (available in other brands) should be in hospitals only.