JAMP-AMOXICILLIN CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
15-03-2024
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Active ingredient:
AMOXICILLIN (AMOXICILLIN TRIHYDRATE)
Available from:
JAMP PHARMA CORPORATION
ATC code:
J01CA04
INN (International Name):
AMOXICILLIN
Dosage:
250MG
Pharmaceutical form:
CAPSULE
Composition:
AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG
Administration route:
ORAL
Units in package:
20/100/1000
Prescription type:
Prescription
Therapeutic area:
AMINOPENICILLINS
Product summary:
Active ingredient group (AIG) number: 0131314001; AHFS:
Authorization status:
APPROVED
Authorization date:
2014-10-23
Summary of Product characteristics
JAMP-Amoxicillin Product Monograph Page 1 of 28
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-AMOXICILLIN
Amoxicillin Powder for Oral Suspension
Suspension, 250 mg / 5 mL amoxicillin (as amoxicillin trihydrate)
after reconstitution, Oral
House Standard
Antibiotic
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
March 10, 2023
Date of Revision:
MAR 15, 2024
Submission Control Number: 279419
JAMP-Amoxicillin Product Monograph Page 2 of 28
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2024
7 WARNINGS AND PRECAUTIONS, Cardiovascular
02/2024
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
02/2024
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
……………………………………………………………………………………….
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
................................................................ 5
4
DOSAGE AND ADMINISTRATION
....................................................................................
5
4.1
Dosing Considerations
.................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment Usual Dosage
……………………………….…. 7
4.3
Reconstitution
...................................................................................................
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