MYLAN-PINDOLOL TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PINDOLOL

Mevcut itibaren:

MYLAN PHARMACEUTICALS ULC

ATC kodu:

C07AA03

INN (International Adı):

PINDOLOL

Doz:

10MG

Farmasötik formu:

TABLET

Kompozisyon:

PINDOLOL 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/500

Reçete türü:

Prescription

Terapötik alanı:

BETA-ADRENERGIC BLOCKING AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0112362003; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2012-10-19

Ürün özellikleri

1
PRODUCT MONOGRAPH
MYLAN-PINDOLOL
(Pindolol Tablets, USP)
5 AND 10 MG
Antihypertensive/Antianginal Agent
Mylan Pharmaceuticals ULC
Date of Preparation:
85 Advance Road
August 19, 2010
Etobicoke, Ontario
M8Z 2S6
Control#: 140702
2
PRODUCT MONOGRAPH
MYLAN-PINDOLOL
(Pindolol Tablets, USP)
5 AND 10 MG
THERAPEUTIC CLASSIFICATION
Antihypertensive/Antianginal Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Pindolol is a 13-adrenergic-receptor-blocking agent which possesses
partial agonist activity
(intrinsic sympathomimetic activity - I.S.A.). It is used in the
treatment of hypertension and/or
the prophylaxis of angina pectoris.
Hypertension
The mechanism of the antihypertensive effect of pindolol has not been
established. Among the
factors that may be involved are:
a)
competitive ability to antagonize catecholamine-induced tachycardia at
the 13-receptor
sites in the heart, thus decreasing cardiac output
b)
a reduction in total peripheral resistance
c)
inhibition of the vasomotor centres
d)
inhibition of renin release by the kidneys.
3
Angina pectoris
The mechanism of the antianginal effect of pindolol has not been
established. Pindolol may
reduce the oxygen requirement of the heart at any level of effort by
blocking catecholamine-
induced increases in the 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 effect is beneficial in patients with angina, it
manifests itself during exercise or
stress by delaying the onset of pain and reducing the incidence and
severity of anginal attacks.
In man, orally-administered pindolol is rapidly and almost completely
absorbed (95%). Because
of negligible hepatic first pass effect, the bioavailability of oral
pindolol is high and approaches
90% of the oral dose. Maximum plasma concentrations are reached one to
two hours after oral
administration and the plasma half-life is ap