RATIO-DILTIAZEM CD CAPSULE (CONTROLLED-DELIVERY)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

DILTIAZEM HYDROCHLORIDE

Saatavilla:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

ATC-koodi:

C08DB01

INN (Kansainvälinen yleisnimi):

DILTIAZEM

Annos:

300MG

Lääkemuoto:

CAPSULE (CONTROLLED-DELIVERY)

Koostumus:

DILTIAZEM HYDROCHLORIDE 300MG

Antoreitti:

ORAL

Kpl paketissa:

100/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0115863008; AHFS:

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2014-09-19

Valmisteyhteenveto

PRODUCT MONOGRAPH
PR RATIO-DILTIAZEM
CD
DILTIAZEM HYDROCHLORIDE
ONCE-A-DAY CONTROLLED DELIVERY CAPSULES
MANUFACTURER’S STANDARD
120 MG, 180 MG, 240 MG AND 300 MG
ANTIHYPERTENSIVE AGENT
ANTIANGINAL AGENT
RATIOPHARM INC.
DATE OF PREPARATION:
17800 RUE LAPOINTE
NOVEMBER 26, 2008
MIRABEL PQ
CANADA J7J 1P3
D-1034
DATE OF REVISION:
CONTROL#: 126074
Page 2
PRODUCT MONOGRAPH
PR RATIO-DILTIAZEM
CD
DITIAZEM HYDROCHLORIDE
ONCE-A-DAY CONTROLLED DELIVERY CAPSULES
MANUFACTURER’S STANDARD
120 MG, 180 MG, 240 MG AND 300 MG
ANTIHYPERTENSIVE AGENT
ANTIANGINAL AGENT
ACTION AND CLINICAL PHARMACOLOGY
RATIO-DILTIAZEM CD capsules are a formulation of diltiazem
hydrochloride, which is a
calcium ion influx inhibitor (calcium entry blocker or calcium ion
antagonist).
MECHANISM OF ACTION:
The therapeutic effect of this drug is believed to be related to the
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. Diltiazem
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.
Diltiazem does not alter total serum calcium.
ANGINA: The precise mechanism by which diltiazem relieves angina has
not been fully
determined but it is believed to be brought about largely by its
vasodilator action.
In angina due to coronary spasm, diltiazem increases myocardial oxygen
delivery by
dilating both large and small coronary arteries and by inhibiting
coronary spasm at drug
Page 3
levels, which cause little negative inotropic effect. The resultant
increases in coronary
blood flow are accompanied by dose dependent decreases in systemic
blood pressure and
decreases in peripheral resistance.
In angina of effort it appears that the a