Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
CEFUROXIME (CEFUROXIME AXETIL)
ORBUS PHARMA INC
J01DC02
CEFUROXIME
250MG
TABLET
CEFUROXIME (CEFUROXIME AXETIL) 250MG
ORAL
100
Prescription
SECOND GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0122448001; AHFS:
CANCELLED (UNRETURNED ANNUAL)
2018-04-04
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 Belgenin tamamını okuyun