MINT-NADOLOL TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

NADOLOL

可用日期:

MINT PHARMACEUTICALS INC

ATC代码:

C07AA12

INN（国际名称）:

NADOLOL

剂量:

40MG

药物剂型:

TABLET

组成:

NADOLOL 40MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

治疗领域:

BETA-ADRENERGIC BLOCKING AGENTS

產品總結:

Active ingredient group (AIG) number: 0113396003; AHFS:

授权状态:

APPROVED

授权日期:

2020-02-19

产品特点

Page 1 of 24
PRODUCT MONOGRAPH
PR
MINT-NADOLOL
NADOLOL TABLETS, USP
40 MG AND 80 MG
ANTI-ANGINAL AND ANTIHYPERTENSIVE AGENT
MINT PHARMACEUTICALS INC.
6575 DAVAND DRIVE
MISSISSAUGA, ONTARIO
L5T 2M3
CONTROL NO: 219225
DATE OF PREPARATION: February 18, 2020
Page 2 of 24
Pr
MINT-NADOLOL
Nadolol Tablets, USP
40 mg and 80 mg
THERAPEUTIC CLASSIFICATION
Anti-anginal and Antihypertensive Agent
ACTIONS
MINT-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.
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 d