SANDOZ FELODIPINE TABLET (EXTENDED-RELEASE)

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

FELODIPINE

Mevcut itibaren:

SANDOZ CANADA INCORPORATED

ATC kodu:

C08CA02

INN (International Adı):

FELODIPINE

Doz:

5MG

Farmasötik formu:

TABLET (EXTENDED-RELEASE)

Kompozisyon:

FELODIPINE 5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100

Reçete türü:

Prescription

Terapötik alanı:

DIHYDROPYRIDINES

Ürün özeti:

Active ingredient group (AIG) number: 0121733002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2006-08-04

Ürün özellikleri

PRODUCT MONOGRAPH
PR
SANDOZ FELODIPINE
(felodipine)
Extended Release Tablets
5 mg and 10 mg
Manufacturer’s Standard
Antihypertensive Agent
Sandoz Canada Inc. Date of Revision: March 4, 2015
145 Jules-Léger
Boucherville, Quebec
J4B 7K8
Control Number: 182441
_Sandoz Felodipine _
_ Page 2 of 35 _
PR
SANDOZ FELODIPINE
(felodipine)
Extended Release Tablets
5 mg and 10 mg
THERAPEUTIC CLASSIFICATION
Antihypertensive Agent
ACTION AND CLINICAL PHARMACOLOGY
Felodipine is a calcium ion influx inhibitor (calcium channel
blocker). Felodipine is a member of the
dihydropyridine class of calcium channel blockers.
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 cardiac muscle and
vascular smooth muscle. The contractile processes of these tissues are
dependent upon the
movement of extracellular calcium into the cells through specific ion
channels. Felodipine
blocks transmembrane influx of calcium through the slow channel
without affecting to any
significant degree the transmembrane influx of sodium through the fast
channel. This results
in a reduction of free calcium ions available within cells of the
above tissues.
Felodipine does not alter total serum calcium. In vitro studies show
that the effects of felodipine
on contractile mechanisms are selective, with greater effects on
vascular smooth muscle than on
cardiac muscle. Negative inotropic effects can be detected in vitro,
but such effects have not been
seen in intact animals.
The effect of felodipine on blood pressure in man is principally a
consequence of a dose-related
decrease in peripheral vascular resistance, with a modest reflex
increase in heart rate (see ACTION
AND CLINICAL PHARMACOLOGY - Pharmacodynamics).
PHARMACOKINETICS
Felodipine is completely absorbed from the gastrointestinal tract
after oral administration.
Due to rapid biotransformation of felodipine during its first pass
through the portal circulation the
system