PMS-ISMN TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ISOSORBIDE-5-MONONITRATE

Available from:

PHARMASCIENCE INC

ATC code:

C01DA14

INN (International Name):

ISOSORBIDE MONONITRATE

Dosage:

60MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

ISOSORBIDE-5-MONONITRATE 60MG

Administration route:

ORAL

Units in package:

30/100

Prescription type:

Ethical

Therapeutic area:

NITRATES AND NITRITES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2007-10-25

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
PMS-ISMN
(isosorbide-5-mononitrate)
60 mg extended release tablets
Antianginal Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Date of Revision:
October 26, 2010
Submission Control No.: 141495
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PRODUCT MONOGRAPH
NAME OF DRUG
pms-ISMN
(isosorbide-5-mononitrate)
60 mg extended release tablets
THERAPEUTIC CLASSIFICATION
Antianginal agent
ACTIONS AND CLINICAL PHARMACOLOGY
As with other organic nitrates, the principal pharmacological action
of 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 acutely, have consistently