APO-AMOXICILLIN-CLAVULANATE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

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

Available from:

APOTEX INC

ATC code:

J01CR02

INN (International Name):

AMOXICILLIN AND BETA-LACTAMASE INHIBITOR

Dosage:

250MG; 125MG

Pharmaceutical form:

TABLET

Composition:

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

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

AMINOPENICILLINS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2021-05-04

Summary of Product characteristics

Page 1 of 35
PRODUCT MONOGRAPH,
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-AMOXICILLIN-CLAVULANATE
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP
250 MG AMOXICILLIN AND 125 MG CLAVULANIC ACID / TABLET
500 MG AMOXICILLIN AND 125 MG CLAVULANIC ACID / TABLET
875 MG AMOXICILLIN AND 125 MG CLAVULANIC ACID / TABLET
(AS AMOXICILLIN TRIHYDRATE AND CLAVULANATE POTASSIUM)
COMBINATIONS OF PENICILLINS, INCLUDING BETA-LACTAMASE INHIBITORS
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
APRIL 30, 2021
TORONTO, ONTARIO
M9L 1T9
CONTROL NO: 247608
Page 2 of 35
PRODUCT MONOGRAPH
PR
APO-AMOXICILLIN-CLAVULANATE
Amoxicillin
and Clavulanate Potassium Tablets USP
250 mg Amoxicillin and 125 mg Clavulanic Acid / Tablet
500 mg Amoxicillin and 125 mg Clavulanic Acid / Tablet
875 mg Amoxicillin and 125 mg Clavulanic Acid / Tablet
(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-AMOXICILLIN-CLAVULANATE (amoxicillin and clavulanate potassium) is
indicated
for the treatment of the following
infections when caused by APO-AMOXICILLIN-
CLAVULANATE -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 prod