PRO-BISOPROLOL - 5 TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

BISOPROLOL FUMARATE

Disponibil de la:

PRO DOC LIMITEE

Codul ATC:

C07AB07

INN (nume internaţional):

BISOPROLOL

Dozare:

5MG

Forma farmaceutică:

TABLET

Compoziție:

BISOPROLOL FUMARATE 5MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

BETA-ADRENERGIC BLOCKING AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0122418001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2008-04-03

Caracteristicilor produsului

1
PRODUCT MONOGRAPH
PR PRO-BISOPROLOL – 5
PR PRO-BISOPROLOL – 10
BISOPROLOL FUMARATE TABLETS USP
5 MG, 10 MG
Β-ADRENOCEPTOR BLOCKING AGENT
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
SUBMISSION CONTROL NUMBER:
233100
DATE OF REVISION:
November 18, 2019
Bisoprolol EN PM
Pg. 1
2
PRODUCT MONOGRAPH
PR PRO-BISOPROLOL – 5
PR PRO-BISOPROLOL – 10
BISOPROLOL FUMARATE TABLETS USP
5 AND 10 MG
PHARMACOLOGICAL CLASSIFICATION
Β-ADRENOCEPTOR BLOCKING AGENT
ACTION AND CLINICAL PHARMACOLOGY
Bisoprolol fumarate is a synthetic β
1
-selective (cardioselective) adrenoceptor blocking agent without
significant membrane stabilizing activity or intrinsic sympathomimetic
activity in its therapeutic dosage
range. This preferential effect is not absolute, however, and at
higher doses bisoprolol may also inhibit β
2
-
adrenoceptors, located chiefly in the bronchial and vascular
musculature.
PHARMACODYNAMICS
The most prominent effect of bisoprolol is the negative chronotropic
effect, resulting in a reduction in
resting and exercise heart rate. There is a fall in resting and
exercise cardiac output with little observed
change in stroke volume, and only a small increase in right atrial
pressure, or pulmonary capillary wedge
pressure at rest or during exercise.
The mechanism of action of its antihypertensive effects has not been
completely established. Factors which
may be involved include:
1) Antagonism of β-adrenoceptors to decreased cardiac output
2) Inhibition of renin release by the kidneys
3) Diminution of tonic sympathetic outflow from the vasomotor centers
in the brain
In normal
volunteers,
bisoprolol
therapy
resulted
in a reduction
of exercise
and isoproterenol-
inducted
tachycardia. The maximal effect occurred with 1 -4 hours post-dosing.
Effects persisted for 24 hours at
doses equal to or greater than 5 mg.
Electrophysiology studies in man have demonstrated that bisoprolol
significantly decreases heart rate,
increases sinus node recovery time, prolongs AV node refractory
periods, and with rapid atrial stimu