AURO-AMOXICILLIN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
02-11-2023
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
Available from:
AURO PHARMA INC
ATC code:
J01CA04
INN (International Name):
AMOXICILLIN
Dosage:
500MG
Pharmaceutical form:
CAPSULE
Composition:
AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 500MG
Administration route:
ORAL
Units in package:
30/100/500
Prescription type:
Prescription
Therapeutic area:
AMINOPENICILLINS
Product summary:
Active ingredient group (AIG) number: 0131314006; AHFS:
Authorization status:
APPROVED
Authorization date:
2012-06-27
Summary of Product characteristics
Auro-Amoxicillin Product Monograph
Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
Auro-Amoxicillin
Amoxicillin Capsules
Capsules, 250 mg and 500 mg amoxicillin (as amoxicillin trihydrate),
Oral
BP
Antibiotic
AURO PHARMA INC.
3700 Steeles Avenue West, Suite #
402 Woodbridge, Ontario, L4L 8K8
Canada
Date of Initial Authorization:
JUN 27, 2012
Date of Revision:
NOV 02, 2023
Submission Control Number: 276668
Auro-Amoxicillin Product Monograph
Page 2 of 28
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
10/2023
7 WARNINGS AND PRECAUTIONS
10/2023
TABLE OF CONTENTS
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
.....................................................................
5
4 DOSAGE AND ADMINISTRATION
.........................................................................................
5
4.1 Dosing Considerations
...........................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment Usual Dosage
............................................... 5
4.4 Administration
.......................................................................................................................
7
4.5 Missed Dose
..........................................................................................................................
7
5 OVERDOSAGE
....
Read the complete document
