ORB-CEFUROXIME TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CEFUROXIME (CEFUROXIME AXETIL)

Sẵn có từ:

ORBUS PHARMA INC

Mã ATC:

J01DC02

INN (Tên quốc tế):

CEFUROXIME

Liều dùng:

500MG

Dạng dược phẩm:

TABLET

Thành phần:

CEFUROXIME (CEFUROXIME AXETIL) 500MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

SECOND GENERATION CEPHALOSPORINS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED (UNRETURNED ANNUAL)

Ngày ủy quyền:

2018-04-04

Đặc tính sản phẩm

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