AXID CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-07-2021
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Active ingredient:
NIZATIDINE
Available from:
PENDOPHARM DIVISION OF PHARMASCIENCE INC
ATC code:
A02BA04
INN (International Name):
NIZATIDINE
Dosage:
300MG
Pharmaceutical form:
CAPSULE
Composition:
NIZATIDINE 300MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
HISTAMINE H2-ANTAGONISTS
Product summary:
Active ingredient group (AIG) number: 0120317002; AHFS:
Authorization status:
APPROVED
Authorization date:
2002-02-04
Summary of Product characteristics
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_AXID (nizatidine) _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AXID®
Nizatidine Capsules
Capsules 150 mg, 300 mg, Oral
USP
Histamine H
2
Receptor Antagonist
PENDOPHARM, Division of Pharmascience Inc.
6111 Royalmount Avenue, Suite 100
Montréal, QC, Canada
H4P 2T4
Date of Revision:
July 20, 2021
Submission Control Number: 247715
® Registered trademark of Pharmascience Inc.
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_AXID (nizatidine) _
_Page 2 of 27_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.2
Recommended Dose and Dosage
Adjustment.......................................................4
4.4
Administration.....................................................................................................5
4.5
Missed Dose
........................................................................................................5
5
OVERDOSAGE
...............................................................................................................5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
...................................6
7
WARNINGS AND PRECAUTIONS
...................................
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