IMDUR TABLET (EXTENDED-RELEASE)

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

ISOSORBIDE-5-MONONITRATE

Disponible depuis:

JUNO PHARMACEUTICALS CORP.

Code ATC:

C01DA14

DCI (Dénomination commune internationale):

ISOSORBIDE MONONITRATE

Dosage:

60MG

forme pharmaceutique:

TABLET (EXTENDED-RELEASE)

Composition:

ISOSORBIDE-5-MONONITRATE 60MG

Mode d'administration:

ORAL

Unités en paquet:

30/100

Type d'ordonnance:

Ethical

Domaine thérapeutique:

NITRATES AND NITRITES

Descriptif du produit:

Active ingredient group (AIG) number: 0120456002; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2018-08-03

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
IMDUR
®
(isosorbide-5-mononitrate extended release tablets)
60 mg extended release tablets
Antianginal Agent
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Date of Revision:
September 11, 2020
Submission Control Number: 242735
- 1 -
PRODUCT MONOGRAPH
NAME OF DRUG
IMDUR
®
(isosorbide-5-mononitrate extended release tablets)
60 mg extended release tablets
THERAPEUTIC CLASSIFICATION
Antianginal agent
ACTIONS AND CLINICAL PHARMACOLOGY
As with other organic nitrates, the principal pharmacological action
of IMDUR (isosorbide-5-
mononitrate), the major active metabolite of isosorbide dinitrate
(ISDN), is relaxation of
vascular smooth muscle and consequent dilation of peripheral arteries
and veins, especially
the latter. Dilation of the veins promotes peripheral pooling of blood
and decreases venous
return to the heart, thereby reducing left ventricular end-diastolic
pressure and pulmonary
capillary wedge pressure (pre-load). Arteriolar relaxation reduces
systemic vascular
resistance, systolic arterial pressure, and mean arterial pressure
(after-load). Dilation of the
coronary arteries also occurs. The hemodynamic responses to
isosorbide-5-mononitrate are
similar to those produced by other nitrates.
PHARMACODYNAMICS
Dosage regimens for most chronically used drugs are designed to
provide plasma
concentrations that are continuously greater than a minimally
effective concentration. This
strategy is inappropriate for organic nitrates. Prolonged
administration of nitrate drugs
according to traditionally recommended dosage regimens has been shown
to produce
tolerance. Tolerance results in a loss of efficacy. Several
well-controlled clinical trials have
used exercise testing to assess the antianginal efficacy of
continuously delivered nitrates. In
the large majority of these trials, nitrate effectiveness was
indistinguishable from placebo after
24 hours (or less) of continuous therapy. Attempts to overcome
tolerance by dose escalation,
even to doses far in excess of those used