PRO-AMOXI CLAV TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

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

Disponibil de la:

PRO DOC LIMITEE

Codul ATC:

J01CR02

INN (nume internaţional):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dozare:

250MG; 125MG

Forma farmaceutică:

TABLET

Compoziție:

AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG; CLAVULANIC ACID (CLAVULANATE POTASSIUM) 125MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Rezumat produs:

Active ingredient group (AIG) number: 0234720008; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2023-03-22

Caracteristicilor produsului

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-