APO-ISMN TABLET (EXTENDED-RELEASE)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ISOSORBIDE-5-MONONITRATE

Dostupné z:

APOTEX INC

ATC kód:

C01DA14

INN (Medzinárodný Name):

ISOSORBIDE MONONITRATE

Dávkovanie:

60MG

Forma lieku:

TABLET (EXTENDED-RELEASE)

Zloženie:

ISOSORBIDE-5-MONONITRATE 60MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Ethical

Terapeutické oblasti:

NITRATES AND NITRITES

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2005-11-07

Súhrn charakteristických

PRODUCT MONOGRAPH
P
R
APO-ISMN
ISOSORBIDE-5-MONONITRATE EXTENDED RELEASE TABLETS
APOTEX STANDARD
60 MG
ANTIANGINAL AGENT
APOTEX INC. DATE OF REVISION:
150 SIGNET DRIVE
December 15, 2010
WESTON, ONTARIO
M9L 1T9
CONTROL NO. 121829
1
PRODUCT
MONOGRAPH
P
R
APO-ISMN
Isosorbide-5-mononitrate Extended Release Tablets
Apotex Standard
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
acutely, have consistently failed. Only after nitrates have been
absent from the