FLECAR flecainide acetate 50 mg tablet blister pack

Pays: Australie

Langue: anglais

Source: Department of Health (Therapeutic Goods Administration)

Ingrédients actifs:

flecainide acetate, Quantity: 50 mg

Disponible depuis:

Micro Labs Pty Ltd

forme pharmaceutique:

Tablet

Composition:

Excipient Ingredients: maize starch; magnesium stearate; silicified microcrystalline cellulose; croscarmellose sodium

Mode d'administration:

Oral

Unités en paquet:

20, 30, 40, 50, 60, 90, 100, 120, and 180 tablets.

Type d'ordonnance:

(S4) Prescription Only Medicine

indications thérapeutiques:

FLECAR 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, FLECAR 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.,FLECAR 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.

Descriptif du produit:

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

Statut de autorisation:

Registered

Date de l'autorisation:

2018-06-19

Résumé des caractéristiques du produit

FLECAR
1
AUSTRALIAN PRODUCT INFORMATION –
FLECAR 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
FLECAR 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 FLECAR 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,
FLECAR 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