Country: Canada
Language: English
Source: Health Canada
BUSPIRONE HYDROCHLORIDE
APOTEX INC
N05BE01
BUSPIRONE
5MG
TABLET
BUSPIRONE HYDROCHLORIDE 5MG
ORAL
100
Prescription
MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS
Active ingredient group (AIG) number: 0116263002; AHFS:
APPROVED
2020-12-18
_BUSPIRONE _ _Page 1 of 40_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR BUSPIRONE Buspirone Hydrochloride Tablets, 5 mg and 10 mg, Oral USP Anxiolytic APOTEX INC. 150 Signet Drive Weston, Ontario M9L 1T9 Date of Initial Authorization: FEB 16, 1996 Date of Revision: OCT 18, 2021 Submission Control Number: 252361 _ _ _BUSPIRONE _ _Page 2 of 40_ RECENT MAJOR LABEL CHANGES 1 Indications, 1.2 Geriatrics 10/2021 2 Contraindications 12/2020 3 Serious warnings and precautions box 10/2021 4 Dosage and administration, 4.1 Dosing Considerations 10/2021 7 Warnings and precautions, General 10/2021 7 Warnings and Precautions, Serotonin Toxicity/Serotonin Syndrome 12/2020 7 Warnings and precautions, Dependence/Tolerance 10/2021 7 Warnings and precautions, Withdrawal 10/2021 7 Warnings and precautions, Falls and Fractures 10/2021 7 Warnings and precautions, 7.1.4 Geriatrics 10/2021 8 Adverse Reactions, 8.5 Post-Market Adverse Reactions 10/2021 9 Drug Interactions 12/2020 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......................................... Read the complete document