ZYTRAM XL TABLET (EXTENDED-RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRAMADOL HYDROCHLORIDE

Available from:

PURDUE PHARMA

ATC code:

N02AX02

INN (International Name):

TRAMADOL

Dosage:

75MG

Pharmaceutical form:

TABLET (EXTENDED-RELEASE)

Composition:

TRAMADOL HYDROCHLORIDE 75MG

Administration route:

ORAL

Units in package:

50/60

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0151694007; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-12-02

Summary of Product characteristics

_ _
_ZYTRAM XL_
_®_
_ (tramadol HCl controlled release tablets) _
_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
ZYTRAM XL®
Tramadol Hydrochloride
Controlled Release Tablets, 75, 100, 150, 200, 300 and 400 mg, Oral
Purdue Pharma Standard
Opioid Analgesic
ATC code: N02AX02
Purdue Pharma
3381 Steeles Avenue East, Suite 310
Toronto, Ontario
M2H 3S7
Date of Initial Approval:
Sept 28, 2006
Date of Revision:
December 01, 2023
Submission Control Number: 274793
_ _
_ZYTRAM XL_
_®_
_ (tramadol HCl controlled release tablets) _
_Page 2 of 46_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
12/2023
7 WARNING AND PRECAUTIONS
12/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
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6
4.2
Recommended