AURO-CEFUROXIME TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CEFUROXIME (CEFUROXIME AXETIL)

Доступно од:

AURO PHARMA INC

АТЦ код:

J01DC02

INN (Међународно име):

CEFUROXIME

Дозирање:

250MG

Фармацеутски облик:

TABLET

Састав:

CEFUROXIME (CEFUROXIME AXETIL) 250MG

Пут администрације:

ORAL

Јединице у пакету:

60

Тип рецептора:

Prescription

Терапеутска област:

SECOND GENERATION CEPHALOSPORINS

Резиме производа:

Active ingredient group (AIG) number: 0122448001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2021-01-11

Карактеристике производа

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_Page 1 of 26_
PRODUCT MONOGRAPH
PR
AURO-CEFUROXIME
CEFUROXIME AXETIL TABLETS BP
250 MG AND 500 MG CEFUROXIME
ANTIBIOTIC
Auro Pharma Inc.
Date of Preparation:
3700 Steeles Avenue West, Suite # 402 January 8, 2021
Woodbridge, Ontario, L4L 8K8, Canada.
Control Number: 243113
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_Page 2 of 26_
PRODUCT MONOGRAPH
PR
AURO-CEFUROXIME
Cefuroxime Axetil Tablets BP
250 mg and 500 mg Cefuroxime
ANTIBIOTIC
ACTIONS AND CLINICAL PHARMACOLOGY
Cefuroxime axetil is an orally active prodrug of cefuroxime. After
oral administration,
cefuroxime axetil 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
AURO-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 Infection