Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
AMOXICILLIN (AMOXICILLIN TRIHYDRATE); CLAVULANIC ACID (CLAVULANATE POTASSIUM)
PRO DOC LIMITEE
J01CR02
AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
250MG; 125MG
TABLET
AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG; CLAVULANIC ACID (CLAVULANATE POTASSIUM) 125MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0234720008; AHFS:
APPROVED
2023-03-22
Page 1 of 31 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PRO-AMOXI CLAV Amoxicillin and Clavulanate Potassium Tablets, USP Amoxicillin (as amoxicillin trihydrate) and Clavulanic acid (as clavulanate potassium) 250 mg/125 mg, 500 mg/125 mg and 875 mg/125 mg COMBINATIONS OF PENICILLINS, INCLUDING BETA-LACTAMASE INHIBITORS ATC CODE: J01CR02 PRO DOC LTÉE 2925, boul. Industriel Laval, Quebec H7L 3W9 . SUBMISSION CONTROL NO.: 272455 DATE OF INITIAL APPROVAL: MAR 22, 2023 Page 2 of 31 PRODUCT MONOGRAPH PR PRO-AMOXI CLAV Amoxicillin and Clavulanate Potassium Tablets, USP 250/125 mg, 500/125 mg and 875/125 mg ANTIBIOTIC AND Β-LACTAMASE INHIBITOR ACTION Amoxicillin exerts a bactericidal action against sensitive organisms during the stage of active multiplication through the inhibition of the biosynthesis of bacterial cell wall mucopeptides. Clavulanic acid inhibits specific β-lactamases of some microorganisms and allows amoxicillin to inhibit amoxicillin (ampicillin) resistant organisms which produce clavulanic acid sensitive β- lactamases. INDICATIONS AND CLINICAL USE PRO-AMOXI CLAV (amoxicillin and clavulanate potassium) is indicated for the treatment of the following infections when caused by PRO-AMOXI CLAV -susceptible strains of the designated bacteria: Sinusitis when caused by β-lactamase producing strains of _H. influenzae _or _Moraxella (Branhamella) catarrhalis. _ Otitis Media when caused by β-lactamase producing strains of _H. influenzae _or _Moraxella (Branhamella) catarrhalis. _ Lower Respiratory Tract Infections when caused by β-lactamase producing strains of _H. _ _influenzae, K. pneumoniae, S. aureus _or _Moraxella (Branhamella) catarrhalis. _ Skin and Soft Tissue Infections when caused by β-lactamase producing strains of _S. aureus. _ Urinary Tract Infections when caused by β-lactamase producing strains of _E. coli. _ While PRO-AMOXI CLAV is indicated only for the conditions listed above, infections caused by ampicillin (amoxicillin) susceptible organisms are also amenable to PRO- Soma hati kamili