DOM-GABAPENTIN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
23-08-2017
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Active ingredient:
GABAPENTIN
Available from:
DOMINION PHARMACAL
ATC code:
N02BF01
INN (International Name):
GABAPENTIN
Dosage:
100MG
Pharmaceutical form:
CAPSULE
Composition:
GABAPENTIN 100MG
Administration route:
ORAL
Units in package:
100/500
Prescription type:
Prescription
Therapeutic area:
MISCELLANEOUS ANTICONVULSANTS
Product summary:
Active ingredient group (AIG) number: 0125929001; AHFS:
Authorization status:
APPROVED
Authorization date:
2001-04-04
Summary of Product characteristics
PRODUCT MONOGRAPH
Pr DOM-GABAPENTIN
Gabapentin Capsules, House Standard
100 mg, 300 mg and 400 mg
Gabapentin Tablets, USP
600 mg and 800 mg
Antiepileptic Agent
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
August 11, 2017
Submission Control No.: 207318
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_Dom-GABAPENTIN Product Monograph _
_Page 2 of 30_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................16
ACTION AND CLINICAL PHARMACOLOGY
............................................................16
STORAGE AND STABILITY
..........................................................................................19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................19
PART II: SCIENTIFIC INFORMATION
...............................................................................21
PHARMACEUTICAL INFORMATION
..........................................................................21
CLINICAL TRIALS
..........................................................................................................22
DETAILED PHARMACOLOG
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