ISMN TABLET (EXTENDED-RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ISOSORBIDE-5-MONONITRATE

MAH:

SIVEM PHARMACEUTICALS ULC

ATC_code:

C01DA14

INN:

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

leaflet_short:

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

authorization_status:

CANCELLED POST MARKET

authorization_date:

2017-06-27

SPC

PRODUCT MONOGRAPH
Pr
ISMN
Isosorbide-5-mononitrate extended release tablets, BP
60 mg
Antianginal Agent
SIVEM PHARMACEUTICALS ULC
4705 Dobrin Street
Saint-Laurent, Quebec
H4R 2P7
www.sivem.ca
Date of Preparation:
September 21, 2015
Submission Control No.: 187095
Sivem
TM
is a trademark of Sivem Pharmaceuticals ULC
PRODUCT MONOGRAPH
NAME OF DRUG
ISMN
isosorbide-5-mononitrate extended release tablets, BP
60 mg
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 acu