APO-AMOXI CLAV 250MG/62.5MG PER 5ML POWDER FOR SUSPENSION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

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

Disponible des:

APOTEX INC

Codi ATC:

J01CR02

Designació comuna internacional (DCI):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dosis:

62.5MG; 250MG

formulario farmacéutico:

POWDER FOR SUSPENSION

Composición:

CLAVULANIC ACID (POTASSIUM CLAVULANATE) 62.5MG; AMOXICILLIN (AMOXICILLIN TRIHYDRATE) 250MG

Vía de administración:

ORAL

Unidades en paquete:

100/150 ML

tipo de receta:

Prescription

Área terapéutica:

AMINOPENICILLINS

Resumen del producto:

Active ingredient group (AIG) number: 0234720001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2001-06-07

Fitxa tècnica

Page 1 of 37
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-AMOXI CLAV
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, USP
powder for oral suspension
250 MG AMOXICILLIN AND 62.5 MG CLAVULANIC ACID / 5 ML
400 MG AMOXICILLIN AND 57 MG CLAVULANIC ACID / 5 ML
(AS AMOXICILLIN TRIHYDRATE AND CLAVULANATE POTASSIUM)
COMBINATIONS OF PENICILLINS, INCLUDING BETA-LACTAMASE INHIBITORS
ATC CODE: J01CR02
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JUNE 8, 2021
TORONTO, ONTARIO
M9L 1T9
CONTROL NO: 250793
Page 2 of 37
PRODUCT MONOGRAPH
PR
APO-AMOXI CLAV
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
powder for oral suspension
250 mg Amoxicillin and 62.5 mg Clavulanic Acid / 5 mL
400 mg Amoxicillin and 57 mg Clavulanic Acid / 5 mL
(as Amoxicillin Trihydrate and Clavulanate Potassium)
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
APO-AMOXI CLAV (amoxicillin
and clavulanate potassium) is indicated for the treatment of
the following
infections when caused by APO-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
-l