CARDIZEM CD CAPSULE (EXTENDED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DILTIAZEM HYDROCHLORIDE

Available from:

BAUSCH HEALTH, CANADA INC.

ATC code:

C08DB01

INN (International Name):

DILTIAZEM

Dosage:

180MG

Pharmaceutical form:

CAPSULE (EXTENDED RELEASE)

Composition:

DILTIAZEM HYDROCHLORIDE 180MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0115863007; AHFS:

Authorization status:

APPROVED

Authorization date:

2001-11-02

Summary of Product characteristics

_Product Monograph _
_ _
_Pr_
_CARDIZEM CD, Diltiazem Hydrochloride, USP _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CARDIZEM
® CD
Diltiazem Hydrochloride Controlled Delivery Capsules
Controlled Delivery Capsules, 120 mg, 180 mg, 240 mg and 300 mg, Oral
USP
ANTIHYPERTENSIVE AGENT
ANTIANGINAL AGENT
BAUSCH HEALTH, CANADA INC.
2150 St-Elzear Blvd. West
Laval, QC, H7L 4A8
Date of Initial Authorization:
November 2, 2011
Date of Revision:
June 16, 2022
Submission Control Number: 257201
_ _
_Product Monograph _
_ _
_Pr_
_CARDIZEM CD, Diltiazem Hydrochloride, USP _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
2. CONTRAINDICATIONS
6/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.1
Dosing Considerations
.........................................................................................5
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.4
Administration………………………………………………�