METOPROLOL SR TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METOPROLOL TARTRATE

Available from:

PRO DOC LIMITEE

ATC code:

C07AB02

INN (International Name):

METOPROLOL

Dosage:

200MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

METOPROLOL TARTRATE 200MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0111923001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2017-07-28

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
METOPROLOL - 25
METOPROLOL TARTRATE TABLETS USP
25 MG
PR
METOPROLOL – 50
PR
METOPROLOL – 100
METOPROLOL TARTRATE FILM-COATED TABLETS USP
50 & 100 MG
PR
METOPROLOL SR
METOPROLOL TARTRATE SLOW-RELEASE TABLETS
100 & 200 MG
SS-ADRENERGIC RECEPTOR BLOCKING AGENT
PRO DOC LTÉE
DATE OF REVISION:
2925, BOUL. INDUSTRIEL
JUNE 14, 2010
LAVAL, QUÉBEC
H7L 3W9
Control # 138219
Page 2 of 34
PRODUCT MONOGRAPH
NAME OF DRUG
PR
METOPROLOL - 25
METOPROLOL TARTRATE TABLETS USP
PR
METOPROLOL -50
PR
METOPROLOL - 100
METOPROLOL TARTRATE FILM-COATED TABLETS USP
PR
METOPROLOL SR
METOPROLOL TARTRATE SLOW-RELEASE TABLETS
THERAPEUTIC CLASSIFICATION
ß-Adrenergic Receptor Blocking Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Metoprolol tartrate is a ß-adrenergic receptor-blocking agent.
_In vitro _
and
_in vivo _
animal studies
have shown that it has a preferential effect on the b
1
-adrenoreceptors, chiefly located in cardiac
muscle. This preferential effect is not absolute, however, and at
higher doses, metoprolol tartrate
also inhibits b
2
-adrenoreceptors, chiefly located in the bronchial and vascular
musculature.
Metoprolol tartrate has no membrane-stabilizing or partial agonism
(intrinsic sympathomimetic)
activities. It is used in the treatment of hypertension, angina
pectoris and to reduce mortality in
patients with myocardial infarction.
The mechanism of the antihypertensive effect has not been established.
Among the factors that
may be involved are:
a) competitive ability to antagonize catecholamine-induced tachycardia
at the b-receptor sites in
the heart, thus decreasing heart rate, cardiac contractility and
cardiac output;
b) inhibition of renin release by the kidneys;
c) inhibition of the vasomotor centres.
By blocking catecholamine-induced increases in heart rate, in velocity
and extent of myocardial
contraction, and in blood pressure, metoprolol reduces the oxygen
requirements of the heart at
any given level of effort, thus making it useful in the long-term
management of angina pectoris.
However, in patient