MINT-NADOLOL TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

NADOLOL

Mevcut itibaren:

MINT PHARMACEUTICALS INC

ATC kodu:

C07AA12

INN (International Adı):

NADOLOL

Doz:

80MG

Farmasötik formu:

TABLET

Kompozisyon:

NADOLOL 80MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

BETA-ADRENERGIC BLOCKING AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0113396001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2020-02-19

Ürün özellikleri

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