MEDROL 4 MG TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHYLPREDNISOLONE

Available from:

PFIZER CANADA ULC

ATC code:

H02AB04

INN (International Name):

METHYLPREDNISOLONE

Dosage:

4MG

Pharmaceutical form:

TABLET

Composition:

METHYLPREDNISOLONE 4MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ADRENALS

Product summary:

Active ingredient group (AIG) number: 0106290007; AHFS:

Authorization status:

APPROVED

Authorization date:

2003-09-19

Summary of Product characteristics

_MEDROL (methylprednisolone) – Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MEDROL*
methylprednisolone
4mg & 16mg tablets, for oral use
USP
Glucocorticoid
Pfizer Canada ULC
17 300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
Date of Initial Authorization:
May 30, 2001
Date of Revision:
MAR 12, 2024
Submission Control Number: 280540
* TM Pharmacia Enterprises S.A.
Pfizer Canada ULC, licensee
© Pfizer Canada ULC, 2023
_MEDROL (methylprednisolone) – Product Monograph _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General, Endocrine and
Metabolism
07/2023
8 ADVERSE REACTIONS
03/2024
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
................................................................................................................
5
1.2
Geriatrics
................................................................................................................
5
2.
CONTRAINDICATIONS
.................................................................................................
5
4.
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing Considerations
............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
....................................................... 6
4.5
Missed Dose
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