ORB-CEFUROXIME TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

CEFUROXIME (CEFUROXIME AXETIL)

Disponible desde:

ORBUS PHARMA INC

Código ATC:

J01DC02

Designación común internacional (DCI):

CEFUROXIME

Dosis:

500MG

formulario farmacéutico:

TABLET

Composición:

CEFUROXIME (CEFUROXIME AXETIL) 500MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

SECOND GENERATION CEPHALOSPORINS

Resumen del producto:

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

Estado de Autorización:

CANCELLED (UNRETURNED ANNUAL)

Fecha de autorización:

2018-04-04

Ficha técnica

1
PRODUCT MONOGRAPH
PR
ORB-CEFUROXIME
CEFUROXIME AXETIL TABLETS, USP
250 MG AND 500 MG CEFUROXIME/TABLET
ANTIBIOTIC
Orbus Pharma Inc.
Date of Preparation: February 25, 2009
20 Konrad Crescent
Markham, Ontario
Control #: 117041
L3R8T4
2
PRODUCT MONOGRAPH
PR
ORB-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 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.
Comparative Bioavailability Studies
A two-way crossover, randomized, blinded, single-dose bioequivalence
study was performed on
22 normal, healthy, non-smoking male subjects under fasting
conditions. The rate and extent of
absorption of cefuroxime axetil was measured and compared following a
single oral dose (1 x
500 mg tablet) of ORB-CEFUROXIME (cefuroxime axetil) or CEFTIN®
tablets. The results
from measured data are summarized in the table on the following page:
3
Cefuroxime axetil
(1 x 500 mg)
From measured data
Geometric Mean
Arithmetic Mean (CV %)
Parameter
Test
*
Reference
†
% Ratio of
Geometric Means
#
90% Confidence Interval
#
AUC
T
‡
(µg·hr/mL)
19.55
19.89 (17.67)
18.71
19.38 (25.33)
104.19%
96.24% to 112.80%
AUC
I
(µg·hr/mL)
20.20
20.56 (17.79)
18.97
19.60 (24.26)
105.04%
97.04% to