APO-DILTIAZ SR CAPSULE (SUSTAINED-RELEASE)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

DILTIAZEM HYDROCHLORIDE

Disponibbli minn:

APOTEX INC

Kodiċi ATC:

C08DB01

INN (Isem Internazzjonali):

DILTIAZEM

Dożaġġ:

60MG

Għamla farmaċewtika:

CAPSULE (SUSTAINED-RELEASE)

Kompożizzjoni:

DILTIAZEM HYDROCHLORIDE 60MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

BOTTLES PF 100/250/500, U/D OF 100/620/700

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0115863002; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2019-01-16

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
PR
APO-DILTIAZ
DILTIAZEM HYDROCHLORIDE TABLETS USP
30 MG AND 60 MG
ANTIANGINAL AGENT
PR
APO-DILTIAZ SR
DILTIAZEM HYDROCHLORIDE SUSTAINED RELEASE (TWICE-A-DAY) CAPSULES APOTEX STANDARD
60 MG, 90 MG AND 120 MG
ANTIHYPERTENSIVE AGENT _/ _ANTIANGINAL AGENT
PR
APO-DILTIAZ CD
DILTIAZEM HYDROCHLORIDE CONTROLLED DELIVERY (ONCE-A-DAY) CAPSULES
APOTEX STANDARD
120 MG, 180 MG, 240 MG AND 300 MG
ANTIHYPERTENSIVE AGENT _/ _ANTIANGINAL AGENT
APOTEX INC
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
CONTROL NO: 232840
DATE OF REVISION:
DECEMBER 19, 2019
_Page 2 of 59 _
PRODUCT MONOGRAPH
PR
APO-DILTIAZ
Diltiazem Hydrochloride Tablets USP
30 mg and 60 mg
PR
APO-DILTIAZ SR
Diltiazem Hyhrochloride Sustained Release (Twice-a-day) Capsules
Apotex Standard
60 mg, 90 mg and 120 mg
PR
APO-DILTIAZ CD
Diltiazem Hydrochloride Controlled Delivery (Once-a-day) Capsules
Apotex Standard
120 mg, 180 mg, 240 mg and 300 mg
ACTION AND CLINICAL PHARMACOLOGY
APO-DILTIAZ
(diltiazem)
tablets,
APO-DILTIAZ
SR
capsules
and
APO-DILTIAZ
CD
capsules are formulations 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 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.
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 angin