APO-PROPRANOLOL TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Preparatomtale Preparatomtale (SPC)
29-01-2021

Aktiv ingrediens:

PROPRANOLOL HYDROCHLORIDE

Tilgjengelig fra:

APOTEX INC

ATC-kode:

C07AA05

INN (International Name):

PROPRANOLOL

Dosering :

20MG

Legemiddelform:

TABLET

Sammensetning:

PROPRANOLOL HYDROCHLORIDE 20MG

Administreringsrute:

ORAL

Enheter i pakken:

100/1000

Resept typen:

Prescription

Terapeutisk område:

BETA-ADRENERGIC BLOCKING AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0101831005; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2021-01-29

Preparatomtale

                                Page 1 of 26
PRODUCT MONOGRAPH
Pr
APO-PROPRANOLOL
(Propranolol Hydrochloride)
(10, 20, 40, 80 and 120 mg Tablets)
USP
Beta-Adrenergic Receptor Blocking Agent
APO TEX INC.,
Toronto, Ontario
M9L 1T9
DATE OF REVISION:
29 January 2021
Control Number: 242932
Page 2 of 26
NAME OF DRUG
Pr
APO-PROPRANOLOL
(Propranolol Hydrochloride)
(10, 20, 40, 80 and 120 mg Tablets)
USP
PHARMACOLOGIC CLASSIFICATION
Beta-adrenergic receptor blocking agent
ACTIONS
APO-PROPRANOLOL (propranolol hydrochloride) is a beta-adrenergic
receptor blocking
agent. It has no other autonomic nervous system activity. Propranolol
hydrochloride is a
competitive antagonist which specifically competes with
beta-adrenergic receptor stimulating
agents for available beta receptor sites.
When access to beta-adrenergic receptor sites is blocked by
propranolol hydrochloride, the
chronotropic, inotropic, and vasodilator responses to beta-adrenergic
stimulation are
decreased proportionately.
Beta-adrenergic blockade is useful in some clinical conditions in
which sympathetic activity
is excessive or inappropriate, and therefore detrimental to the
patient. Sympathetic
stimulation is however, vital in some situations, (e.g. in patients
with A-V block or with a
severely damaged: heart) and should, be preserved. The basic objective
of beta-adrenergic
blockade is to decrease adverse sympathetic stimulation but not to the
degree that impairs
necessary sympathetic support. Beta-blockade results in bronchial
constriction by interfering
with endogenously or exogenously induced bronchodilation. (See
CONTRAINDICATIONS
and WARNINGS).
The mechanism of the antihypertensive effects of propranolol
hydrochloride has not been
established. Among the factors that may be involved are (1) decreased
cardiac output, (2)
inhibition of renin release by the kidneys, and (3) diminution of
tonic sympathetic nerve
outflow from vasomotor centers in the brain. It has been suggested,
but not established, that
propranolol hydrochloride may achieve a better antihypertensive effect
in patients with
n
                                
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Preparatomtale Preparatomtale fransk 29-01-2021

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