RENEDIL TABLET (EXTENDED-RELEASE)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

FELODIPINE

Dostupné z:

SANOFI-AVENTIS CANADA INC

ATC kód:

C08CA02

INN (Medzinárodný Name):

FELODIPINE

Dávkovanie:

2.5MG

Forma lieku:

TABLET (EXTENDED-RELEASE)

Zloženie:

FELODIPINE 2.5MG

Spôsob podávania:

ORAL

Počet v balení:

30

Typ predpisu:

Prescription

Terapeutické oblasti:

DIHYDROPYRIDINES

Prehľad produktov:

Active ingredient group (AIG) number: 0121733003; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2014-06-23

Súhrn charakteristických

PRODUCT MONOGRAPH
RENEDIL
®
(Felodipine)
Extended Release Tablets
2.5 mg, 5 mg, 10 mg
Antihypertensive Agent
sanofi-aventis Canada Inc.
Date of Preparation:
2150 St. Elzear Blvd. West
April 26, 2006
Laval, Quebec H7L 4A8
Submission Control No. 105393
s-a Version 1.0 dated
2
NAME OF DRUG
RENEDIL
®
(felodipine)
Extended Release Tablets
(2.5, 5 and 10 mg)
THERAPEUTIC CLASSIFICATION
Antihypertensive Agent
ACTION AND CLINICAL PHARMACOLOGY
RENEDIL (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.
3
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