APO-BUSPIRONE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

BUSPIRONE HYDROCHLORIDE

MAH:

APOTEX INC

ATC_code:

N05BE01

INN:

BUSPIRONE

dosage:

10MG

pharmaceutical_form:

TABLET

composition:

BUSPIRONE HYDROCHLORIDE 10MG

administration_route:

ORAL

units_in_package:

15G/50G

prescription_type:

Prescription

therapeutic_area:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

leaflet_short:

Active ingredient group (AIG) number: 0116263001; AHFS:

authorization_status:

APPROVED

authorization_date:

2022-06-03

SPC

_APO-BUSPIRONE tablets (Buspirone Hydrochloride) _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-BUSPIRONE
Buspirone Hydrochloride Tablets USP
Tablets, 10 mg, Oral
USP
Anxiolytic
APOTEX INC.
150 Signet Drive
Weston, Ontario
M9L 1T9
Date of Initial Authorization:
FEB 28, 1996
Date of Revision:
JUN 03, 2022
Submission Control Number: 259719
_ _
_APO-BUSPIRONE tablets (Buspirone Hydrochloride) _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.2 Geriatrics
06/2022
2 Contraindications
06/2022
3 Serious warnings and precautions box
06/2022
4 Dosage and administration, 4.1 Dosing Considerations
06/2022
7 Warnings and precautions, General
06/2022
7 Warnings and Precautions, Serotonin Toxicity/Serotonin
Syndrome
06/2022
7 Warnings and precautions, Dependence/Tolerance
06/2022
7 Warnings and precautions, Withdrawal
06/2022
7 Warnings and precautions, Falls and Fractures
06/2022
7 Warnings and precautions, 7.1.4 Geriatrics
06/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS................................................................................................................
4
1.1
Pediatrics
............................................................................................................
4
1.2
Geriatrics
............................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX.................................................