METHADOSE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHADONE HYDROCHLORIDE

Available from:

MALLINCKRODT CANADA ULC

ATC code:

N07BC02

INN (International Name):

METHADONE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

METHADONE HYDROCHLORIDE 10MG

Administration route:

ORAL

Units in package:

1L

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0144621001; AHFS:

Authorization status:

MARKETED

Authorization date:

2013-01-03

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
METHADOSE™
Methadone Hydrochloride Oral Concentrate, Cherry Flavoured
Solution, 10 mg/mL, Oral
USP
Methadone Hydrochloride Oral Concentrate, Dye-Free, Sugar-Free,
Unflavored
Solution, 10 mg/mL, Oral
USP
Treatment of Opioid Dependence
Mallinckrodt Canada ULC
6500 Trans Canada, suite 400
Pointe-Claire, QC, H9R 0A5
Canada
TM Trade Mark of Mallinckrodt LLC
Date of Initial Authorization:
October 04, 2012
Date of Revision:
January 13, 2022
Submission Control Number: 255151
_METHADOSE Methadone Hydrochloride Oral Concentrate USP _
_Page 2 of 46_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
03/2021
TABLE OF CONTENTS
TABLE OF CONTENTS
..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................4
1
INDICATIONS
..................................................................................................................4
1.1
Pediatrics
..................................................................................................................4
1.2
Geriatrics
..................................................................................................................4
2
CONTRAINDICATIONS
.................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...................................................5
4
DOSAGE AND ADMINISTRATION
.............................................................................6
4.1
Dosing Considerations
.............................................................................................6
4.2
Recommended Dose and Dosage Adjustment
.........................................................7
4.4
Administration
.........................................................................................................8
4.5
Missed Dose
.......................................................