Country: Canada
Language: English
Source: Health Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM)
JAMP PHARMA CORPORATION
J01CR02
AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
500MG; 125MG
TABLET
AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 500MG; CLAVULANIC ACID (CLAVULANATE POTASSIUM) 125MG
ORAL
15G/50G
Prescription
AMINOPENICILLINS
Active ingredient group (AIG) number: 0234720009; AHFS:
APPROVED
2020-11-20
JAMP Amoxi Clav (Amoxicillin and Clavulanate Potassium Tablets) Page 1 of 37 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR JAMP AMOXI CLAV Amoxicillin and Clavulanate Potassium Tablets JAMP Amoxi Clav -250 tablets 250 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as clavulanate potassium), Oral JAMP Amoxi Clav -500F tablets 500 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as clavulanate potassium), Oral JAMP Amoxi Clav -875 tablets 875 mg amoxicillin (as trihydrate) and 125 mg clavulanic acid (as clavulanate potassium), Oral House Standard COMBINATIONS OF PENICILLINS, INCLUDING BETA-LACTAMASE INHIBITORS ATC CODE: J01CR02 JAMP Pharma Corporation 1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada Date of Initial Authorization: November 20, 2020 Date of Revision: August 3, 2023 Submission Control Number: 272812 JAMP Amoxi Clav (Amoxicillin and Clavulanate Potassium Tablets) Page 2 of 37 RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Immune 08/2023 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 ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS ............................................................................................................ 4 1.1 Pediatrics .................................................................................................................. 4 1.2 Geriatrics .................................................................................................................. 4 2 CONTRAINDICATIONS ............................................................................................... 5 4 DOSAGE AND ADMINISTRATION ............................... Read the complete document