Страна: Канада
мова: англійська
Джерело: Health Canada
CEFACLOR
APOTEX INC
J01DC04
CEFACLOR
375MG
POWDER
CEFACLOR 375MG
ORAL
70/100ML
Prescription
SECOND GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0113428002; AHFS:
CANCELLED POST MARKET
2019-01-16
0 PRODUCT MONOGRAPH APO-CEFACLOR CEFACLOR CAPSULES USP 250 AND 500 MG CEFACLOR FOR ORAL SUSPENSION USP 125, 250 AND 375 MG/5 ML ANTIBIOTIC APOTEX INC. 150 SIGNET DRIVE TORONTO, ONTARIO DATE OF REVISION: M9L 1T9 November 21, 2018 _NC Control No: 214441_ _ _ 1 PRODUCT MONOGRAPH APO-CEFACLOR Cefaclor Capsules USP 250 and 500 mg Cefaclor for Oral Suspension USP 125, 250 and 375 mg/5 mL THERAPEUTIC CLASSIFICATION Antibiotic ACTIONS AND CLINICAL PHARMACOLOGY Like other β‐ 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. 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 percent 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 1900 mg/L respectively. 2 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 concentratio Прочитайте повний документ