APO-DEXLANSOPRAZOLE CAPSULE (DELAYED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DEXLANSOPRAZOLE

Available from:

APOTEX INC

ATC code:

A02BC06

INN (International Name):

DEXLANSOPRAZOLE

Dosage:

60MG

Pharmaceutical form:

CAPSULE (DELAYED RELEASE)

Composition:

DEXLANSOPRAZOLE 60MG

Administration route:

NASOGASTRIC

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0152766002; AHFS:

Authorization status:

APPROVED

Authorization date:

2024-01-25

Summary of Product characteristics

_APO-DEXLANSOPRAZOLE (Dexlansoprazole Delayed-Release Capsules)_
_Page 1 of 48 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DEXLANSOPRAZOLE
Dexlansoprazole Delayed-Release Capsules
Capsule (delayed release), 30 mg and 60 mg, Nasogastric and Oral
Proton Pump Inhibitor
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Submission Control Number: 268660
Date of Initial Authorization:
JUL 12, 2022
Date of Revision:
JUN 07, 2023
_APO-DEXLANSOPRAZOLE (Dexlansoprazole Delayed-Release Capsules)_
_Page 2 of 48 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Immune
06/2023
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
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4
1.2
Geriatrics
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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
......................................................