AXID CAPSULE

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

NIZATIDINE

MAH:

PENDOPHARM DIVISION OF PHARMASCIENCE INC

ATC_code:

A02BA04

INN:

NIZATIDINE

dosage:

300MG

pharmaceutical_form:

CAPSULE

composition:

NIZATIDINE 300MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

HISTAMINE H2-ANTAGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0120317002; AHFS:

authorization_status:

APPROVED

authorization_date:

2002-02-04

SPC

_ _
_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
...................................