NU-PROPAFENONE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

PROPAFENONE HYDROCHLORIDE

Tilgjengelig fra:

NU-PHARM INC

ATC-kode:

C01BC03

INN (International Name):

PROPAFENONE

Dosering :

150MG

Legemiddelform:

TABLET

Sammensetning:

PROPAFENONE HYDROCHLORIDE 150MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

CLASS IC ANTIARRYTHMICS

Produkt oppsummering:

Active ingredient group (AIG) number: 0116258001; AHFS:

Autorisasjon status:

CANCELLED (UNRETURNED ANNUAL)

Autorisasjon dato:

2018-03-28

Preparatomtale

PRODUCT MONOGRAPH
NU-PROPAFENONE
PROPAFENONE HYDROCHLORIDE TABLETS
150 MG
ANTIARRHYTHMIC AGENT
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL STREET, UNITS 1&2
February 11, 2003
RICHMOND HILL, ONTARIO
L4B 1E4
_Control # 089683_
1
PRODUCT MONOGRAPH
NU-PROPAFENONE
Propafenone Hydrochloride Tablets
150 mg
THERAPEUTIC CLASSIFICATION
Antiarrhythmic Agent
A
CTIONS AND CLINICAL PHARMACOLOGY
Mechanism of Action
Propafenone is an antiarrhythmic agent which possesses class Ic
properties in the modified
electrophysiological classification of Vaughan-Williams. It has a
direct stabilizing action on
myocardial cell membranes. The electrophysiological effect of
propafenone manifests itself as a
reduction of the upstroke velocity (Phase 0) of the monophasic action
potential, while phase 4
spontaneous automaticity is depressed. Diastolic excitability
threshold is increased and effective
refractory period prolonged. In Purkinje fibers, and to a lesser
extent myocardial fibers,
propafenone reduces the fast inward sodium current.
In addition to a local anesthetic effect, approximately equal to
procaine, propafenone has weak
beta-blocking activity. Clinical trials employing isoproterenol
challenge and exercise testing
suggest that the affinity of propafenone for beta-adrenergic
receptors, as calculated from dose
ratios and drug concentrations, is about 1/40 that of propranolol.
Propafenone also inhibits the
slow calcium influx at high concentrations; however, this action is
weak (approximately 1/100 of
verapamil) and does not contribute to its antiarrhythmic effect.
2
Electrophysiology
Electrophysiology studies have shown that propafenone prolongs
atrioventricular conduction and
in some instances significantly lengthens sinus nodal recovery times
with a non-significant effect
on sinus cycle length. AV nodal conduction time (AH interval) as well
as His-Purkinje conduction
time (HV interval) are prolonged. Propafenone increases atrial, AV
nodal and ventricular
effective refractory periods. Propafenone causes a dose-dependent
increase in t