Land: Canada
Sprog: engelsk
Kilde: Health Canada
CEFACLOR
TEVA CANADA LIMITED
J01DC04
CEFACLOR
500MG
CAPSULE
CEFACLOR 500MG
ORAL
100
Prescription
SECOND GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0113428004; AHFS:
CANCELLED POST MARKET
2018-04-30
PRODUCT MONOGRAPH NOVO-CEFACLOR (cefaclor) 250 mg and 500 mg Capsules USP Antibiotic Teva Canada Limited Date of Revision: May 7, 2014 30 Novopharm Court Toronto, Ontario M1B 2K9 Control # 173960 PRODUCT MONOGRAPH NOVO-CEFACLOR (cefaclor) 250 mg and 500 mg Capsules USP THERAPEUTIC CLASSIFICATION Antibiotic ACTION -lactam antibiotics, cefaclor owes its antibacterial activity to its ability to bind to and inhibit the action of certain bacterial cell wall synthetic enzymes, the penicillin-binding proteins. CLINICAL PHARMACOLOGY Cefaclor is well absorbed after oral administration to fed and fasted subjects. Following doses of 250 mg, 500 mg and 1 g to fasted subjects, average peak serum levels of approximately 7, 13 and 23 mg/L respectively were obtained within 0.5 to 1.0 hour. Total absorption is the same whether the drug is given before or after meals. However, when it is taken after food, the peak concentration achieved is 50% to 75% of that observed when the drug is administered to fasted subjects and is delayed by 0.8 to 1 hour. Approximately 25% of cefaclor is bound to human plasma. Within 8 hours 60% to 85% of the drug is excreted unchanged in the urine, the greater portion being excreted within the first 2 hours. During this 8-hour period, peak urine concentrations following the 250 mg, 500 mg and 1 g doses were approximately 600, 900 and 1,900 mg/L respectively. The serum half-life in normal subjects is 0.6 to 0.9 hours. In patients with reduced renal function, the serum half-life of cefaclor is slightly prolonged. In those with complete absence of renal function, the plasma half-life of the intact molecule is 2.3 to 2.8 hours. Excretion pathways in patients with markedly impaired renal function have not been determined. Hemodialysis shortens the half-life by 25% to 30%. Probenecid administered with a 500 mg dose of cefaclor increased the peak serum concentration only slightly, from 12.4 to 13.9 mg/L, and urine levels were predictably diminished. The mean half-life among five fasted volunteers with normal re Læs hele dokumentet