APO-FELODIPINE TABLET (EXTENDED-RELEASE)

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

FELODIPINE

Dostupné s:

APOTEX INC

ATC kód:

C08CA02

INN (Mezinárodní Name):

FELODIPINE

Dávkování:

2.5MG

Léková forma:

TABLET (EXTENDED-RELEASE)

Složení:

FELODIPINE 2.5MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

DIHYDROPYRIDINES

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2016-02-24

Charakteristika produktu

Page 1 of 34
PRODUCT MONOGRAPH
APO-FELODIPINE
Felodipine Extended-Release Tablets
Apotex Standard
2.5 mg, 5 mg and 10 mg
Antihypertensive Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Control Number: 179638
Date of Preparation:
February 22, 2016
Page 2 of 34
PRODUCT MONOGRAPH
APO-FELODIPINE
Felodipine Extended-Release Tablets
Apotex Standard
2.5 mg, 5 mg and 10 mg
THERAPEUTIC CLASSIFICATION
Antihypertensive Agent
ACTIONS 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 circulat