RATIO-CEFUROXIME TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFUROXIME (CEFUROXIME AXETIL)

Available from:

TEVA CANADA LIMITED

ATC code:

J01DC02

INN (International Name):

CEFUROXIME

Dosage:

500MG

Pharmaceutical form:

TABLET

Composition:

CEFUROXIME (CEFUROXIME AXETIL) 500MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

SECOND GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0122448002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-08-08

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
RATIO-CEFUROXIME
CEFUROXIME AXETIL TABLETS USP
250 MG AND 500 MG CEFUROXIME
ANTIBIOTIC
TEVA CANADA LIMITED
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Preparation:
September 19, 2017
CONTROL: 208784
2
PRODUCT MONOGRAPH
PR
RATIO-CEFUROXIME
CEFUROXIME AXETIL TABLETS USP
250 MG AND 500 MG CEFUROXIME/TABLET
ANTIBIOTIC
ACTIONS AND CLINICAL PHARMACOLOGY
Cefuroxime axetil is an orally active prodrug of cefuroxime. After
oral administration, cefuroxime
axetil, as RATIO-CEFUROXIME*, is absorbed from the gastrointestinal
tract and rapidly hydrolyzed
by nonspecific esterases in the intestinal mucosa and blood to release
cefuroxime into the blood
stream. Conversion to cefuroxime, the microbiologically active form,
occurs rapidly. The inherent
properties of cefuroxime are unaltered after its administration as
cefuroxime axetil. Cefuroxime
exerts its bactericidal effect by binding to an enzyme or enzymes
referred to as penicillin-binding
proteins (PBPs) involved in bacterial cell wall synthesis.
This binding results in inhibition of bacterial cell wall synthesis
and subsequent cell death.
Specifically, cefuroxime shows high affinity for PBP 3, a primary
target for cefuroxime in gram-
negative organisms such as _E. coli._
INDICATIONS AND CLINICAL USES
RATIO-CEFUROXIME (cefuroxime axetil) is indicated for the treatment of
patients with mild to
moderately severe infections caused by susceptible strains of the
designated organisms in the
following diseases:
UPPER RESPIRATORY TRACT INFECTIONS
Pharyngitis and tonsillitis caused by _Streptococcus pyogenes. _
_ _
Otitis Media caused by _Streptococcus pneumoniae_, _Streptococcus
pyogenes _(group A beta-hemolytic
streptococci), _Haemophilus influenzae_ (beta-lactamase negative and
beta-lactamase positive strains)
or _Moraxella catarrhalis_. Sinusitis caused by _Moraxella
catarrhalis_, _Streptococcus pneumoniae_ or
_Haemophilus influenzae_ (including ampicillin-resistant strains).
LOWER RESPIRATORY TRACT INFECTIONS
*
All dosages are expressed in terms of cefu