AMOXICILLIN/CLAV TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM)

Available from:

SANIS HEALTH INC

ATC code:

J01CR02

INN (International Name):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dosage:

875MG; 125MG

Pharmaceutical form:

TABLET

Composition:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 875MG; CLAVULANIC ACID (CLAVULANATE POTASSIUM) 125MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0234720005; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-03-10

Summary of Product characteristics

_AMOXICILLIN/CLAV Product Monograph _
_ _
_Page 1 of 37_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR AMOXICILLIN/CLAV
Amoxicillin and Clavulanate Potassium Tablets
AMOXICILLIN/CLAV
– 500 mg tablets
500 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
AMOXICILLIN/CLAV
– 875 mg tablets
875 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as
clavulanate potassium), Oral
USP Standard
Combinations of penicillins, including beta-lactamase inhibitors
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of
Initial Authorization:
March 10, 2023
Date of Revision:
October 06,
2023
Submission
Control
Number:
279154
_AMOXICILLIN/CLAV Product Monograph _
_ _
_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Immune
10/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
.......................................................................................................
5
4
DOSAGE AND ADMINISTRATION
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5
4.2
Recommended Dose and Dosage Adjustment
..................................