DOM-BUPROPION SR TABLET (EXTENDED-RELEASE)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
13-02-2014
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Active ingredient:
BUPROPION HYDROCHLORIDE
Available from:
DOMINION PHARMACAL
ATC code:
N06AX12
INN (International Name):
BUPROPION
Dosage:
100MG
Pharmaceutical form:
TABLET (EXTENDED-RELEASE)
Composition:
BUPROPION HYDROCHLORIDE 100MG
Administration route:
ORAL
Units in package:
60
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTIDEPRESSANTS
Product summary:
Active ingredient group (AIG) number: 0131140002; AHFS:
Authorization status:
APPROVED
Authorization date:
2009-11-30
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
DOM-BUPROPION SR
Bupropion Hydrochloride Sustained Release Tablets, House Standard
100 mg and 150 mg
Antidepressant
DOMINION PHARMACAL
Date of Revision:
6111 Royalmount Ave, Suite 100
February 13, 2014
Montréal, Québec
H4P 2T4
Control number: 171397
_Product Monograph Dom-BUPROPION SR _
_Page 2 of 37 _
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
.....................................................................................................
10
DRUG INTERACTIONS
.....................................................................................................
15
DOSAGE AND ADMINISTRATION
.................................................................................
17
OVERDOSAGE
...................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 20
STORAGE AND STABILITY
.............................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 24
PART II: SCIENTIFIC INFORMATION
...........................................................................
25
PHARMACEUTICAL INFORMATION
.............................................................................
25
CLINICAL TRIALS
.............................................................................................................
26
DETAIL
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