APO-NADOLOL TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

NADOLOL

Dostępny od:

APOTEX INC

Kod ATC:

C07AA12

INN (International Nazwa):

NADOLOL

Dawkowanie:

160MG

Forma farmaceutyczna:

TABLET

Skład:

NADOLOL 160MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

BETA-ADRENERGIC BLOCKING AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0113396002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2020-09-02

Charakterystyka produktu

Page 1 of 31
PRODUCT MONOGRAPH
Pr
APO-NADOLOL
Nadolol Tablets USP
40, 80 and 160 mg
Anti-anginal and Antihypertensive Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
August 27, 2020
Control No: 242230
Page 2 of 31
Pr
APO-NADOLOL
Nadolol Tablets USP
40, 80 and 160 mg
THERAPEUTIC CLASSIFICATION
Anti-anginal and Antihypertensive Agent
ACTIONS
APO-NADOLOL (nadolol) is a non-cardioselective beta-adrenergic
blocking agent.
The exact mechanism by which nadolol exercises its anti-anginal effect
is not certain, but it may
reduce the oxygen requirements of the heart by blocking
catecholamine-induced increases in heart
rate, systolic blood pressure, and the velocity and extent of
myocardial contraction. However, oxygen
requirements may be increased by such actions as increases in left
ventricular fibre length, end
diastolic pressure and the systolic ejection period. When the net
physiological effect is advantageous
in angina patients, it manifests itself during exercise or stress by
delaying the onset of pain and
reducing the incidence and severity of anginal attacks. Nadolol can
therefore increase the capacity
for work and exercise in such patients.
The mechanism of the antihypertensive effect of nadolol has not yet
been established. Among
the factors that may be involved are:
a)
Competitive ability to antagonize catecholamine-induced tachycardia at
the beta-receptor sites
in the heart, thus decreasing cardiac output.
b)
Inhibition of renin release by the kidneys.
c)
Inhibition of vasomotor centers.
Page 3 of 31
Pharmacokinetics:
In humans, approximately 34% of orally-administered nadolol is slowly
absorbed. Approximately
30% of the nadolol present in serum is reversibly bound to plasma
proteins and the drug is
extensively distributed to extravascular tissues. Maximum serum
concentrations are reached 2-4
hours after oral administration, while steady state serum
concentrations are reached after 6-9 days.
The serum half-life is 20-24 hours at therapeutic dose levels.
Nadolol is not detectably me