TIAZAC XC TABLET (EXTENDED-RELEASE)

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DILTIAZEM HYDROCHLORIDE

Tilgængelig fra:

BAUSCH HEALTH, CANADA INC.

ATC-kode:

C08DB01

INN (International Name):

DILTIAZEM

Dosering:

360MG

Lægemiddelform:

TABLET (EXTENDED-RELEASE)

Sammensætning:

DILTIAZEM HYDROCHLORIDE 360MG

Indgivelsesvej:

ORAL

Enheder i pakken:

90

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS CALCIUM-CHANNEL BLOCKING AGENTS

Produkt oversigt:

Active ingredient group (AIG) number: 0115863009; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2021-06-04

Produktets egenskaber

_Product Monograph _
_ _
_1 of 43 _
_Tiazac XC, Diltiazem Hydrochloride Extended-Release Tablets_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TIAZAC
® XC
Diltiazem Hydrochloride
Extended-Release Tablets 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg
oral
ANTIHYPERTENSIVE AGENT
ANTIANGINAL AGENT
BAUSCH HEALTH, CANADA INC.
DATE OF INITIAL AUTHORIZATION:
2150 St-Elzear Blvd. West
August 13, 2004
Laval, Quebec
H7L 4A8
DATE OF REVISION:
February 15, 2023
Control #: 266470
_ _
_Product Monograph Page 2 of 42 _
_Tiazac XC, Diltiazem Hydrochloride Extended-Release Tablets _
RECENT MAJOR LABEL CHANGES
2. CONTRAINDICATIONS
02/2023
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
…………………………………………………………………………...6
4.5
Missed
Dose......................................................................................................
6
5
OVERDOSAGE
...........