AMLODIPINE-ODAN TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

AMLODIPINE (AMLODIPINE BESYLATE)

Saadav alates:

ODAN LABORATORIES LTD

ATC kood:

C08CA01

INN (Rahvusvaheline Nimetus):

AMLODIPINE

Annus:

5.0MG

Ravimvorm:

TABLET

Koostis:

AMLODIPINE (AMLODIPINE BESYLATE) 5.0MG

Manustamisviis:

ORAL

Ühikuid pakis:

100/250/500

Retsepti tüüp:

Prescription

Terapeutiline ala:

DIHYDROPYRIDINES

Toote kokkuvõte:

Active ingredient group (AIG) number: 0131437002; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2014-11-12

Toote omadused

_Amlodipine-Odan Product Monograph _
_ _
_Page 1 of 32 _
PRODUCT MONOGRAPH
PR
AMLODIPINE-ODAN
TABLETS
2.5MG, 5MG AND 10 MG AMLODIPINE
(AS AMLODIPINE BESYLATE)
ANTIHYPERTENSIVE-ANTIANGINAL AGENT
ODAN LABORATORIES LTD.
DATE OF PREPARATION:
325 STILLVIEW AVENUE
JANUARY 20, 2012
POINTE-CLAIRE, QC
CANADA H9R 2Y6
CONTROL # 152800
_Amlodipine-Odan Product Monograph _
_ _
_Page 2 of 32 _
PRODUCT MONOGRAPH
PR
AMLODIPINE-ODAN TABLETS
2.5mg, 5mg and 10 mg amlodipine (as amlodipine besylate)
Antihypertensive-Antianginal Agent
ACTION AND CLINICAL PHARMACOLOGY
Amlodipine-Odan (amlodipine besylate) is a calcium ion influx
inhibitor (calcium entry blocker
or calcium ion antagonist). Amlodipine is a member of the
dihydropyridine class of calcium
antagonists.
MECHANISM OF ACTION:
The therapeutic effect of this group of drugs is believed to be
related to their specific cellular
action of selectively inhibiting transmembrane influx of calcium ions
into vascular smooth muscle
and cardiac muscle. The contractile processes of these tissues are
dependent upon the movement
of extracellular calcium ions into these cells through specific ion
channels. Amlodipine inhibits
calcium ion influx across cell membranes selectively, with a greater
effect on vascular smooth
muscle cells than on cardiac muscle cells. Serum calcium concentration
is not affected by
amlodipine. Within the physiologic pH range, amlodipine is an ionized
compound and its kinetic
interaction with the calcium channel receptor is characterized by the
gradual association and
dissociation with the receptor binding site. Experimental data suggest
that amlodipine binds to
both dihydropyridine and nondihydropyridine binding sites.
A. HYPERTENSION The mechanism by which amlodipine reduces arterial
blood pressure involves
direct peripheral arterial vasodilation and reduction in peripheral
vascular resistance.
B. ANGINA The precise mechanism by which amlodipine relieves angina
has not been fully
delineated. Amlodipine is a dilator of peripheral arteries and
arterioles which reduces t