METADOL-D TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-02-2021
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Active ingredient:
METHADONE HYDROCHLORIDE
Available from:
PALADIN LABS INC.
ATC code:
N07BC02
INN (International Name):
METHADONE
Dosage:
1MG
Pharmaceutical form:
TABLET
Composition:
METHADONE HYDROCHLORIDE 1MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE AGONISTS
Product summary:
Active ingredient group (AIG) number: 0144621002; AHFS:
Authorization status:
CANCELLED PRE MARKET
Authorization date:
2021-07-28
Summary of Product characteristics
_Product Monograph: Metadol-D_
®
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_Page 1 of 46 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
METADOL-D ®
Methadone Hydrochloride Tablets USP
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
Treatment of Opioid Dependence
Paladin Labs Inc.
100 Alexis Nihon Blvd., Suite 600
St-Laurent, Quebec
H4M 2P2
Date of Revision:
February 25, 2021
Version 6.0
Submission Control No: 241773
®
Registered trademark of Paladin Labs Inc.
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_Product Monograph: Metadol-D_
®
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_Page 2 of 46 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
.....................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS
.................................................................................................4
WARNINGS AND PRECAUTIONS
...............................................................................4
ADVERSE REACTIONS
................................................................................................16
DRUG INTERACTIONS
19
DOSAGE AND ADMINISTRATION
...........................................................................22
OVERDOSAGE
...............................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
........................................................26
STORAGE AND
STABILITY........................................................................................29
SPECIAL HANDLING INSTRUCTIONS
....................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................30
PART II: SCIENTIFIC INFORMATION
...............................................................................32
PHARMACEUTICAL INFORMATION
....................
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