GABAPENTIN CAPSULES

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GABAPENTIN

Available from:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC code:

N02BF01

INN (International Name):

GABAPENTIN

Dosage:

400MG

Pharmaceutical form:

CAPSULE

Composition:

GABAPENTIN 400MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTICONVULSANTS

Product summary:

Active ingredient group (AIG) number: 0125929002; AHFS:

Authorization status:

CANCELLED PRE MARKET

Authorization date:

2023-07-24

Summary of Product characteristics

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_Page 1 of 28_
PRODUCT MONOGRAPH
PR
GABAPENTIN CAPSULES
Gabapentin Capsules USP
100 mg, 300 mg, and 400 mg
Antiepileptic Agent
Ranbaxy Pharmaceuticals Canada Inc., Date of Preparation: August 20,
2009.
2680 Matheson Blvd. E., Suite 200
Mississauga, Ontario
L4W 0A5
Submission Control No: 132106
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_Page 2 of 28_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
....…...........................................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................3
ADVERSE
REACTIONS....................................................................................................5
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND
ADMINISTRATION..............................................................................13
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND
STABILITY..........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
....................................................................20
PHARMACEUTICAL
INFORMATION..........................................................................20
CLINICAL
TRIALS..........................................................................................................21
DETAILED
PHARMACOLOGY..............................................................