PRO-BISOPROLOL - 10 TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

BISOPROLOL FUMARATE

Available from:

PRO DOC LIMITEE

ATC code:

C07AB07

INN (International Name):

BISOPROLOL

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

BISOPROLOL FUMARATE 10MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0122418002; AHFS:

Authorization status:

APPROVED

Authorization date:

2008-04-03

Summary of Product characteristics

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