Țară: Canada
Limbă: engleză
Sursă: Health Canada
CEFPROZIL
BRISTOL-MYERS SQUIBB CANADA
J01DC10
CEFPROZIL
250MG
TABLET
CEFPROZIL 250MG
ORAL
100
Prescription
SECOND GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0127613003; AHFS:
CANCELLED POST MARKET
2017-08-02
PRODUCT MONOGRAPH PR CEFZIL * (CEFPROZIL) TABLETS, 250 AND 500 MG POWDER FOR ORAL SUSPENSION, 125 MG/5ML AND 250 MG/5ML, WHEN RECONSTITUTED ANTIBIOTIC Bristol-Myers Squibb Canada Date of Preparation: Montreal, Canada March 29, 1995 Date of Revision: 14 August 2012 * Trade Mark Authorized User Bristol-Myers Squibb Canada Inc. Control Number: 156520 2 PRODUCT MONOGRAPH NAME OF DRUG CEFZIL* (cefprozil) Tablets, 250 and 500 mg Powder for oral suspension, 125 mg/5mL and 250 mg/5mL THERAPEUTIC CLASSIFICATION ANTIBIOTIC ACTIONS AND CLINICAL PHARMACOLOGY CEFZIL (cefprozil) is a semi synthetic broad spectrum cephalosporin antibiotic intended for oral administration. It has _in vitro_ activity against a broad range of gram positive and gram negative bacteria. The bactericidal action of cefprozil results from inhibition of cell-wall synthesis. Pharmacokinetics Cefprozil is well absorbed following oral administration in both fasting and non-fasting subjects. The oral bioavailability of cefprozil is about 90%. The pharmacokinetics of cefprozil are not altered when administered with meals, or when co-administered with antacid. Average plasma concentrations after administration of cefprozil to fasting subjects are shown in the following table. Urinary recovery accounts for 60% of the administered dose. 3 DOSAGE MEAN PLASMA CEFPROZIL* CONCENTRATIONS (ΜG/ML) 8-HOUR URINARY EXCRETION Peak ∼ 1.5 hr 4 hr 8hr 250 mg 500 mg 1 g 6.1 10.5 18.3 1.7 3.2 8.4 0.2 0.4 1.0 60% 62% 54% * Data represent mean values from 12 healthy, young male volunteers. During the first four-hour period after drug administration, the average urine concentrations following the 250 mg, 500 mg, and 1 g doses were approximately 170 μg/mL, 450 μg/mL and 600 μg/mL, respectively. The average plasma half-life in normal subjects is 1.3 hours. Plasma protein binding is approximately 36% and is independent of concentration in the range of 2 μg/mL to 20 μg/mL. There is no evidence of accumulation of cefprozil in the plasma in individuals with normal renal function Citiți documentul complet