TIAZAC 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:

120MG

Pharmaceutical form:

CAPSULE (EXTENDED RELEASE)

Composition:

DILTIAZEM HYDROCHLORIDE 120MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2001-11-02

Summary of Product characteristics

_Product Monograph _
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_Page_
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_Pr_
_TIAZAC_
_®_
_, Diltiazem Hydrochloride Extended-Release Capsules, USP _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TIAZAC
®
Diltiazem Hydrochloride,
Extended-Release Capsules 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg,
oral
USP
ANTIHYPERTENSIVE AGENT
ANTIANGINAL AGENT
BAUSCH HEALTH, CANADA INC.
DATE OF INITIAL AUTHORIZATION:
2150 St-Elzear Blvd. West
May 26, 1997
Laval, Quebec
H7L 4A8
DATE OF REVISION:
December 21, 2022
Control #: 266363
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_Product Monograph Page 2 of 38 _
_Pr_
_TIAZAC_
_®_
_,_
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_Diltiazem Hydrochloride Extended-Release Capsules, USP _
RECENT MAJOR LABEL CHANGES
2. CONTRAINDICATIONS
12/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
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....................................................................................................
5
4.5
Missed
Dose....................................................