Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
flecainide acetate, Quantity: 50 mg
Micro Labs Pty Ltd
Tablet
Excipient Ingredients: silicified microcrystalline cellulose; maize starch; croscarmellose sodium; magnesium stearate
Oral
20, 30, 40, 50, 60, 90, 100, 120, and 180 tablets.
(S4) Prescription Only Medicine
Flecainide MLabs is indicated for:,1. Supraventricular arrhythmias:,a) due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown-Ganong-Levine syndromes,b) due to dual AV nodal pathways in patients with debilitating symptoms,c) paroxysmal atrial fibrillation/flutter (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, Flecainide MLabs 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.,2. Life threatening ventricular arrhythmias not controlled by other drugs.,Flecainide MLabs tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means.,Prescribers should also consult the "Precautions" section of this Product Information.
Visual Identification: White to off white, circular, biconvex, tablets debossed with F1 on one side and plain on other side with an approximate diameter of 6.5 mm.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2018-06-19
FLECAINIDE MLABS 1 AUSTRALIAN PRODUCT INFORMATION – FLECAINIDE MLABS TABLETS (FLECAINIDE ACETATE) 1. NAME OF THE MEDICINE Flecainide acetate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Flecainide acetate; N-(2-piperidinylmethyl)-2, 5-bis (2,2,2-trifluoroethoxy) benzamide acetate, belongs to the benzamide class of antiarrhythmic drugs and is structurally related to lignocaine and procainamide. It is chemically distinguished from these agents by the presence of trifluoroethoxy- substituents in the aromatic portion of the molecule and a piperidine ring in the amide side chain instead of the diethylaminoethyl group of the procainamide side chain. The compound is a racemic mixture. EXCIPIENTS: Silicified microcrystalline cellulose, croscarmellose sodium, maize starch and magnesium stearate. 3. PHARMACEUTICAL FORM 50 MG TABLETS: White to off white, circular, biconvex, tablets debossed with F1 on one side and plain on other side with an approximate diameter of 6.5 mm. 100 MG TABLETS: White to off white, circular, biconvex, tablets debossed with F & 2 separated by scoreline on one side and plain on other side with an approximate diameter of 8.8 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS FLECAINIDE MLabs is indicated for: 1. Supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown-Ganong-Levine syndromes b) due to dual AV nodal pathways in patients with debilitating symptoms c) paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Although FLECAINIDE MLabs 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, FLECAINIDE MLabs 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 Baca dokumen lengkap