PMS-DIVALPROEX (500MG) TABLET (ENTERIC-COATED)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-03-2017
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Active ingredient:
VALPROIC ACID (DIVALPROEX SODIUM)
Available from:
PHARMASCIENCE INC
ATC code:
N03AG01
INN (International Name):
VALPROIC ACID
Dosage:
500MG
Pharmaceutical form:
TABLET (ENTERIC-COATED)
Composition:
VALPROIC ACID (DIVALPROEX SODIUM) 500MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0112996003; AHFS:
Authorization status:
APPROVED
Authorization date:
2001-08-01
Summary of Product characteristics
PRODUCT MONOGRAPH
PR PMS-DIVALPROEX
Divalproex Sodium Delayed-Release Tablets, USP
125 mg, 250 mg, 500 mg
ANTIEPILEPTIC
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Date of Revision:
March 20, 2017
Submission Control No: 203418
_pms-DIVALPROEX Product Monograph _
_Page 2 of 60_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................22
DRUG INTERACTIONS
..................................................................................................29
DOSAGE AND ADMINISTRATION
..............................................................................36
OVERDOSAGE
................................................................................................................39
ACTION AND CLINICAL PHARMACOLOGY
............................................................40
STORAGE AND STABILITY
..........................................................................................43
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................43
PART II: SCIENTIFIC INFORMATION
...............................................................................45
PHARMACEUTICAL INFORMATION
..........................................................................45
CLINICAL TRIALS
..........................................................................................................46
DETAILED PHARMACOLOGY
.........................
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