FLECAINIDE ACETATE tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

FLECAINIDE ACETATE (UNII: M8U465Q1WQ) (FLECAINIDE - UNII:K94FTS1806)

Sẵn có từ:

AvKARE, Inc.

INN (Tên quốc tế):

FLECAINIDE ACETATE

Thành phần:

FLECAINIDE ACETATE 50 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

In patients without structural heart disease, flecainide is indicated for the prevention of - paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms - paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide is also indicated for the prevention of - documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained VT), that in the judgment of the physician, are lifethreatening. Use of flecainide for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital. The use of flecainide is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. Because of the proarrhythmic effects of flecainide, its use should be reserved for patients in whom, in the opinion

Tóm tắt sản phẩm:

Flecainide acetate tablets 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 NDC 42291-293-01 100 mg White, round tablets debossed with “AN” above “642” with a single-line bisect separating them on one side and plain on other side. Bottles of 100 NDC 42291-294-01 150 mg White, oval tablets debossed with “AN” above “643” with a single-line bisect separating them on one side and plain on other side. Bottles of 100 NDC 42291-295-01 Store at 20° to 25°C (68° to 77°F)(see USP controlled room temperature).

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

FLECAINIDE ACETATE- FLECAINIDE ACETATE TABLET
AVKARE, INC.
----------
FLECAINIDE ACETATE TABLETS, USP
RX ONLY
DESCRIPTION
Flecainide acetate is an antiarrhythmic drug available in tablets of
50, 100, or 150 mg for oral
administration.
Flecainide acetate is benzamide,
N-(2-piperidinylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)-, monoacetate.
The structural formula is given below.
Molecular formula: C
H
F
N
O
•C
H
O
Molecular weight: 474.40
Flecainide acetate is a white crystalline substance with a pK
of 9.3. It has an aqueous solubility of
48.4 mg/mL at 37°C.
Flecainide acetate tablets also contain the following inactive
ingredients:
croscarmellose sodium, microcrystalline cellulose and magnesium
stearate.
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 antiarrhythmics.
ELECTROPHYS IOLOGY
In man, flecainide produces a dose-related decrease in intracardiac
conduction in all parts of the heart
with the greatest effect on the His-Purkinje system (H-V conduction).
Effects upon atrioventricular
(AV) nodal conduction time and intra-atrial conduction times, although
present, are less pronounced than
those on ventricular conduction velocity. Significant effects on
refractory periods were observed only
in the ventricle. Sinus node recovery times (corrected) following
pacing and spontaneous cycle lengths
are somewhat increased. This latter effect may become significant in
patients with sinus node
dysfunction. (See WARNINGS.)
Flecainide causes a dose-related and plasma-level related decrease in
single and multiple PVCs and can
suppress recurrence of ventricular tachycardia. In limited studies of
patients with a history of
ventricular tachycardia, flecainide has been successful 30-40% of the
time in fully suppressing the
inducibility of arrhythmias by programmed electrical
17
20
6
2
3
2
4
2
a
stimulation. Based on PVC suppression, it appears that plasma levels
of 0.