APO-NADOLOL TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

NADOLOL

から入手可能:

APOTEX INC

ATCコード:

C07AA12

INN（国際名）:

NADOLOL

投薬量:

160MG

医薬品形態:

TABLET

構図:

NADOLOL 160MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

BETA-ADRENERGIC BLOCKING AGENTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2020-09-02

製品の特徴

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