NU-METOPROLOL (TYPE L) TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METOPROLOL TARTRATE

Available from:

NU-PHARM INC

ATC code:

C07AB02

INN (International Name):

METOPROLOL

Dosage:

100MG

Pharmaceutical form:

TABLET

Composition:

METOPROLOL TARTRATE 100MG

Administration route:

ORAL

Units in package:

100/1000

Prescription type:

Prescription

Therapeutic area:

BETA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0111923003; AHFS:

Authorization status:

CANCELLED (UNRETURNED ANNUAL)

Authorization date:

2018-03-28

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PR
NU-METOPROLOL
METOPROLOL TARTRATE TABLETS USP
25, 50 & 100 MG
PR
NU-METOPROLOL (TYPE L)
METOPROLOL TARTRATE FILM-COATED TABLETS USP
50 & 100 MG
PR
NU-METOPROLOL SR
METOPROLOL TARTRATE SLOW-RELEASE TABLETS
100 & 200 MG
SS-ADRENERGIC RECEPTOR BLOCKING AGENT
NU-PHARM INC.
DATE OF PREPARATION:
50 MURAL ST., UNITS 1 & 2
NOVEMBER 6, 2009
RICHMOND HILL, ONTARIO
L4B 1E4
CONTROL#: 134115
2
PRODUCT MONOGRAPH
NAME OF DRUG
PR
NU-METOPROLOL
METOPROLOL TARTRATE TABLETS USP
NU-METOPROLOL (TYPE L)
METOPROLOL TARTRATE FILM-COATED TABLETS USP
NU-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 patients with heart
f