DULOXETINE CAPSULE (DELAYED RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
06-02-2023
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Active ingredient:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Available from:
ALTAMED PHARMA
ATC code:
N06AX21
INN (International Name):
DULOXETINE
Dosage:
60MG
Pharmaceutical form:
CAPSULE (DELAYED RELEASE)
Composition:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG
Administration route:
ORAL
Units in package:
30/100/1000
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0152350002; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-02-06
Summary of Product characteristics
______________________________________________________________________________
_Duloxetine Product Monograph_
_ Page 1 of 82_
PRODUCT MONOGRAPH
PR DULOXETINE
Duloxetine Delayed-Release Capsules
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
Manufacturer’s standard
ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC
Altamed Pharma
1565, boul. Lionel-Boulet
Varennes, Quebec
J3X 1P7
Submission Control No.: 271223
DATE OF REVISION:
FEB
06,
2023
______________________________________________________________________________
_Duloxetine Product Monograph_
_ Page 2 of 82_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT
INFORMATION......................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
................................................................................................
5
WARNINGS AND PRECAUTIONS
...............................................................................
6
ADVERSE REACTIONS
................................................................................................
18
DRUG INTERACTIONS
................................................................................................
37
DOSAGE AND ADMINISTRATION
............................................................................
40
OVERDOSAGE
..............................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 44
STORAGE AND STABILITY
........................................................................................
47
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 47
PART II: SCIENTIFIC INFORMATION
..............................................................................
49
PHARMACEUTICAL INFORMATION
..............................
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