AG-DULOXETINE CAPSULE (DELAYED RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-11-2021
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Active ingredient:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Available from:
ANGITA PHARMA INC.
ATC code:
N06AX21
INN (International Name):
DULOXETINE
Dosage:
30MG
Pharmaceutical form:
CAPSULE (DELAYED RELEASE)
Composition:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0152350001; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-05-04
Summary of Product characteristics
______________________________________________________________________
AG-Duloxetine Product Monograph
Page 1 of 82
PRODUCT MONOGRAPH
Pr
AG-Duloxetine
Duloxetine Delayed-Release Capsules
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
Manufacturer’s standard
Analgesic/Antidepressant/Anxiolytic
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control No: 257576
Date of Revision: November 22, 2021
______________________________________________________________________
AG-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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