PMS-PANTOPRAZOLE TABLET (DELAYED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM)

Available from:

PHARMASCIENCE INC

ATC code:

A02BC02

INN (International Name):

PANTOPRAZOLE

Dosage:

20MG

Pharmaceutical form:

TABLET (DELAYED-RELEASE)

Composition:

PANTOPRAZOLE (PANTOPRAZOLE SODIUM) 20MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

PROTON-PUMP INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0133229002; AHFS:

Authorization status:

APPROVED

Authorization date:

2008-06-03

Summary of Product characteristics

_pms-PANTOPRAZOLE Product Monograph _
_Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-PANTOPRAZOLE
Pantoprazole Sodium Delayed-Release Tablets
Delayed-Release Tablets, 20 mg and 40 mg pantoprazole (as pantoprazole
sodium), Oral
House Standard (20 mg) & USP (40 mg)
Proton Pump Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 265478
Date of Initial Authorization:
FEB 7, 2007
Date of Revision:
DEC 6, 2022
_pms-PANTOPRAZOLE Product Monograph _
_Page 2 of 50_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
03/2021
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 (<18 years of age)
....................................................................................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................................