PHL-ISMN TABLET (EXTENDED-RELEASE)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ISOSORBIDE-5-MONONITRATE

Tilgængelig fra:

PHARMEL INC

ATC-kode:

C01DA14

INN (International Name):

ISOSORBIDE MONONITRATE

Dosering:

60MG

Lægemiddelform:

TABLET (EXTENDED-RELEASE)

Sammensætning:

ISOSORBIDE-5-MONONITRATE 60MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30/100

Recept type:

Ethical

Terapeutisk område:

NITRATES AND NITRITES

Produkt oversigt:

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

Autorisation status:

CANCELLED PRE MARKET

Autorisation dato:

2017-09-13

Produktets egenskaber

PRODUCT MONOGRAPH
Pr
PHL-ISMN
(isosorbide-5-mononitrate)
60 mg extended release tablets
Antianginal Agent
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Revision:
April 12, 2011
Submission Control No.: 145488
_ _
_Page 2 of 24 _
PRODUCT MONOGRAPH
NAME OF DRUG
phl-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 failed. Only after
nitrates ha