APO-PINDOL TAB 5MG TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

PINDOLOL

Disponible depuis:

APOTEX INC

Code ATC:

C07AA03

DCI (Dénomination commune internationale):

PINDOLOL

Dosage:

5MG

forme pharmaceutique:

TABLET

Composition:

PINDOLOL 5MG

Mode d'administration:

ORAL

Unités en paquet:

100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

BETA-ADRENERGIC BLOCKING AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0112362001; AHFS:

Statut de autorisation:

MARKETED

Date de l'autorisation:

1988-12-31

Résumé des caractéristiques du produit

Page 1 of 28
PRODUCT MONOGRAPH
PR
APO-PINDOL
(Pindolol tablets U.S.P.)
Tablets 5, 10 and 15 mg
Antihypertensive/Antianginal Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Control No: 219137
DATE OF REVISION:
October 12, 2018
Page 2 of 28
NAME OF DRUG
PR
APO-PINDOL
(Pindolol tablets U.S.P.)
Tablets 5, 10 and 15 mg
THERAPEUTIC CLASSIFICATION
Antihypertensive/Antianginal Agent
ACTIONS
APO-PINDOL (pindolol) is a β-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 β-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
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%)
from the gastrointestinal tract. The mean absolute bioavailability
after oral administration is
about 87 to 92%. Plasma levels of 10 to 30 nanogram/mL are associated
with its
therapeutic efficacy. Following single dose administra