DULOXETINE CAPSULE (DELAYED RELEASE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Boleh didapati daripada:

ALTAMED PHARMA

Kod ATC:

N06AX21

INN (Nama Antarabangsa):

DULOXETINE

Dos:

60MG

Borang farmaseutikal:

CAPSULE (DELAYED RELEASE)

Komposisi:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100/1000

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0152350002; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2023-02-06

Ciri produk

______________________________________________________________________________
_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
..............................