AURO-ONDANSETRON ODT TABLET (ORALLY DISINTEGRATING)

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ONDANSETRON

Available from:

AURO PHARMA INC

ATC code:

A04AA01

INN (International Name):

ONDANSETRON

Dosage:

8MG

Pharmaceutical form:

TABLET (ORALLY DISINTEGRATING)

Composition:

ONDANSETRON 8MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

5-HT3 RECEPTOR ANTAGONISTS

Product summary:

Active ingredient group (AIG) number: 0131120001; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-01-20

Summary of Product characteristics

Page 1 of 35
_PRODUCT MONOGRAPH _
_AURO-ONDANSETRON ODT_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-ONDANSETRON ODT
Ondansetron Orally Disintegrating Tablets
Orally Disintegrating Tablets, 4 mg and 8 mg, Oral
House Standard
Antiemetic
5-HT
3
receptor antagonist
ATC code A04AA01
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8, Canada.
Date of Initial Authorization:
January 20, 2021
Date of Revision:
September 08, 2022
Submission Control Number: 261680
Page 2 of 35
_PRODUCT MONOGRAPH _
_AURO-ONDANSETRON ODT_
_ _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, Adults (18-64 years of age)
09/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dose Adjustment
09/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular, Myocardial Ischemia and
Coronary Artery Spasm
09/2022
7 WARNINGS AND PRECAUTIONS, Special Populations, 7.1.1 Pregnant Women
01/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1 INDICATIONS
....................................................................................................................
4
1.1 Pediatrics (<18 years of age)
.......................................................................................
4
1.2 Geriatrics (≥65 years of age)
.......................................................................................
4
2 CONTRAINDICATIONS
.......................................................................................................
4
4 DOSAGE AND ADMINISTRATION
.......................................................................................
5
4.1 Dosing Considerations
................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment