NOVO-CEFUROXIME TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

CEFUROXIME (CEFUROXIME AXETIL)

可用日期:

NOVOPHARM LIMITED

ATC代码:

J01DC02

INN（国际名称）:

CEFUROXIME

剂量:

125MG

药物剂型:

TABLET

组成:

CEFUROXIME (CEFUROXIME AXETIL) 125MG

给药途径:

ORAL

每包单位数:

100

处方类型:

Prescription

治疗领域:

SECOND GENERATION CEPHALOSPORINS

產品總結:

Active ingredient group (AIG) number: 0122448006; AHFS:

授权状态:

CANCELLED PRE MARKET

授权日期:

2015-10-16

产品特点

PRODUCT MONOGRAPH
PR
NOVO–CEFUROXIME
(Cefuroxime Axetil Tablets, USP)
125 mg, 250 mg and 500 mg cefuroxime/tablet
Antibiotic
Control Number: 031000
Novopharm Limited
Date of Preparation:
Toronto, Canada
April 03, 2008
PR
NOVO–CEFUROXIME
(Cefuroxime Axetil Tablets, USP)
125 mg, 250 mg and 500 mg cefuroxime/tablet
Antibiotic
ACTIONS AND CLINICAL PHARMACOLOGY
Cefuroxime axetil is an orally active prodrug of cefuroxime. After
oral administration, NOVO-
CEFUROXIME (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._
A comparative, two-way, single-dose, fasting bioavailability study was
performed on two 250
mg cefuroxime axetil products, NOVO-CEFUROXIME 250 mg tablets and
Ceftin
®
250 mg
tablets. The pharmacokinetic data calculated for cefuroxime axetil in
the NOVO-
CEFUROXIME and Ceftin
®
tablet formulations is tabulated in Table 1.
Table 1
Geometric Mean
Arithmetic Mean (C.V.)
Novo-Cefuroxime
(2 x 250 mg)
Ceftin
®**
(2 x 250 mg)
Percentage of Ceftin
®
AUC
T
(ng•hr/mL)
15.65
16.33 (28)
16.44
17.48 (36)
95
AUC
I
(ng•hr/mL)
16.36
16.97 (27)
17.12
18.16 (35)
96
C
max
(ng/mL)
5.39
5.63 (28)
5.50
5.76 (32)
98
T
max
*
(hr)
1.33 (0.25)
1.74 (0.97)
---
T
1/2
*
(hr)
1.26 (0.20)
1.32 (0.19)
---
*For the
T
max
and
T
1/2
parameters these are the arithmetic means (standard deviation).
**Ceftin® manufactured by Glaxo C