MINT-AMOXI/CLAV TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

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

Tilgjengelig fra:

MINT PHARMACEUTICALS INC

ATC-kode:

J01CR02

INN (International Name):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dosering :

875MG; 125MG

Legemiddelform:

TABLET

Sammensetning:

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

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

AMINOPENICILLINS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2021-03-04

Preparatomtale

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-AMOXI/CLAV
Amoxicillin
and Clavulanate Potassium Tablets
250 mg/125 mg, 500 mg/125 mg & 875 mg/125 mg Amoxicillin
and Clavulanate Potassium
Amoxicillin
(as amoxicillin
trihydrate) and Clavulanic acid (as clavulanate potassium)
Mfr. Standard
COMBINATIONS OF PENICILLINS, INCLUDING BETA-LACTAMASE INHIBITORS
ATC CODE: J01CR02
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Submission
Control No.: 252134
Date of Revision:
January 13, 2022
_. _
Page 2 of 40
PRODUCT MONOGRAPH
PR
MINT-AMOXI/CLAV
Amoxicillin
and Clavulanate Potassium Tablets
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
MINT-AMOXI/CLAV (Amoxicillin
and Clavulanate Potassium Tablets) is indicated for the
treatment of the following
infections when caused by MINT-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 MINT-AMOXI/CLAV is indicated only for the conditions listed
above, infections caused
by ampicillin (amoxicillin) susceptib