DOM-VENLAFAXINE XR CAPSULE (EXTENDED RELEASE)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE)

Available from:

DOMINION PHARMACAL

ATC code:

N06AX16

INN (International Name):

VENLAFAXINE

Dosage:

37.5MG

Pharmaceutical form:

CAPSULE (EXTENDED RELEASE)

Composition:

VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) 37.5MG

Administration route:

ORAL

Units in package:

500

Prescription type:

Prescription

Therapeutic area:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0131294002; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-05-17

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
DOM-VENLAFAXINE XR
VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES
37.5 MG, 75 MG AND 150 MG VENLAFAXINE, AS VENLAFAXINE HYDROCHLORIDE
Antidepressant
DOMINION PHARMACAL
6111 Royalmount Ave, Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
February 28, 2013
Submission Control No: 116569, 151422, 162398
_ _
_Dom-VENLAFAXINE XR Product Monograph _
_Page 2 of 54 _
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
..................................................................................................15
DRUG INTERACTIONS
..................................................................................................23
DOSAGE AND ADMINISTRATION
..............................................................................30
OVERDOSAGE
................................................................................................................33
ACTION AND CLINICAL PHARMACOLOGY
............................................................34
STORAGE AND STABILITY
..........................................................................................37
SPECIAL HANDLING INSTRUCTIONS
.......................................................................37
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................38
PART II: SCIENTIFIC INFORMATION
...............................................................................39
PHARMACEUTICAL INFORMATION
..........................................................................39
CLINI