DILTIAZEM TZ CAPSULE (EXTENDED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DILTIAZEM HYDROCHLORIDE

Available from:

PRO DOC LIMITEE

ATC code:

C08DB01

INN (International Name):

DILTIAZEM

Dosage:

120MG

Pharmaceutical form:

CAPSULE (EXTENDED RELEASE)

Composition:

DILTIAZEM HYDROCHLORIDE 120MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0115863004; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-07-27

Summary of Product characteristics

_Diltiazem TZ _
_Page 1 of 30 _
PRODUCT MONOGRAPH
PR
DILTIAZEM TZ
Diltiazem Hydrochloride
Extended-Release Capsules
120 mg, 180 mg, 240 mg, 300 mg and 360 mg
Manufacturer’s Standard
Antihypertensive/Antianginal Agent
PRO DOC LTÉE
Date of Revision:
2925, boul. Industriel
April 06, 2021
Laval, Québec
H7L 3W9
Submission Control No. 249784
_Diltiazem TZ _
_Page 2 of 30 _
PR
DILTIAZEM TZ
Diltiazem Hydrochloride
Extended-Release Capsules
120 mg, 180 mg, 240 mg, 300 mg and 360 mg
Antihypertensive/Antianginal Agent
ACTION AND CLINICAL PHARMACOLOGY
DILTIAZEM TZ (diltiazem hydrochloride) is a calcium ion cellular
influx inhibitor (calcium
entry blocker or calcium ion antagonist).
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. 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.
HYPERTENSION: The antihypertensive effect of diltiazem is believed to
be brought about largely
by its vasodilatory action on peripheral blood vessels with resultant
decrease in peripheral
vascular resistance.
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
vasodilatory action.
In angina of effort it appears that the action of diltiazem is related
to the reduction of myocardial
oxygen demand. This is probably caused by a decrease in blood pressure
brought about by the
reduction of peripheral resistance and of heart rate.
HEMODYNAMIC AND ELECTROPHYSIOLOGIC