METADOL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METHADONE HYDROCHLORIDE

Available from:

PALADIN LABS INC.

ATC code:

N07BC02

INN (International Name):

METHADONE

Dosage:

1MG

Pharmaceutical form:

SOLUTION

Composition:

METHADONE HYDROCHLORIDE 1MG

Administration route:

ORAL

Units in package:

250 ML

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0144621002; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-03-06

Summary of Product characteristics

_METADOL_
_®_
_ Product Monograph _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
METADOL
®
Methadone Hydrochloride Tablets
1 mg, 5 mg, 10 mg and 25 mg
Methadone Hydrochloride Oral Solution USP
1 mg/mL
Methadone Hydrochloride Oral Concentrate USP
10 mg/mL
Opioid Analgesic
Paladin Labs Inc.
100 Blvd. Alexis Nihon, Suite 600
Saint-Laurent, Québec
H4M 2P2
Date of Revision:
February 25, 2021
Version: 14.0
Submission Control No: 241772
®
Registered trademark of Paladin Labs Inc.
_METADOL_
_®_
_ Product Monograph _
_Page 2 of 47_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS
.................................................................................................4
WARNINGS AND PRECAUTIONS
...............................................................................5
ADVERSE REACTIONS
................................................................................................15
DRUG INTERACTIONS
................................................................................................17
DOSAGE AND ADMINISTRATION
...........................................................................20
OVERDOSAGE
...............................................................................................................23
ACTION AND CLINICAL PHARMACOLOGY
........................................................24
STORAGE AND
STABILITY........................................................................................26
SPECIAL HANDLING INSTRUCTIONS
....................................................................26
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................31
PART II: SCIENTIFIC INFORMATION
.......................................................