Kraj: Kanada
Język: angielski
Źródło: Health Canada
CEFEPIME (CEFEPIME HYDROCHLORIDE)
BRISTOL-MYERS SQUIBB CANADA
J01DE01
CEFEPIME
1G
POWDER FOR SOLUTION
CEFEPIME (CEFEPIME HYDROCHLORIDE) 1G
INTRAMUSCULAR
1.0G
Prescription
FOURTH GENERATION CEPHALOSPORINS
Active ingredient group (AIG) number: 0150504001; AHFS:
CANCELLED POST MARKET
2015-01-28
PRODUCT MONOGRAPH PR MAXIPIME * (CEFEPIME HYDROCHLORIDE) FOR INJECTION 500 MG, 1 G AND 2 G CEFEPIME ANTIBIOTIC Bristol-Myers Squibb Canada Date of Preparation: Montréal, Canada May 23, 1995 Date of Revision: September 23 rd , 2008 * TM of Bristol-Myers Squibb Company used under licence by Bristol-Myers Squibb Canada Control no.:122780 L4 version 1.1 dated: 11 November 2013 1 PRODUCT MONOGRAPH MAXIPIME (CEFEPIME HYDROCHLORIDE) for Injection 500 mg, 1 g and 2 g Cefepime THERAPEUTIC CLASSIFICATION Antibiotic ACTIONS AND CLINICAL PHARMACOLOGY MAXIPIME (cefepime hydrochloride) is a semi-synthetic broad spectrum cephalosporin antibiotic intended for intramuscular or intravenous administration. Cefepime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. It has a broad spectrum of activity against a wide range of Gram-positive and Gram-negative bacteria. PHARMACOKINETICS The average plasma concentrations of cefepime in normal adult males at various times following single 30-minute infusions and single intramuscular injections of 500 mg, 1 g and 2 g are summarized below. MEAN PLASMA CONCENTRATIONS OF CEFEPIME (ΜG/ML) CEFEPIME DOSE 0.5 HR 1.0 HR 2.0 HR 4.0 HR 8.0 HR 12.0 HR IV 500 mg 38.2 21.6 11.6 5.0 1.4 0.2 1 g 78.7 44.5 24.3 10.5 2.4 0.6 2 g 163.1 85.8 44.8 19.2 3.9 1.1 IM 500 mg 8.2 12.5 12.0 6.9 1.9 0.7 1 g 14.8 25.9 26.3 16.0 4.5 1.4 2 g 36.1 49.9 51.3 31.5 8.7 2.3 2 MEAN PLASMA CONCENTRATION - TIME PROFILES AFTER SINGLE INTRAVENOUS INFUSIONS COMPARED TO MIC 90 OF TARGET PATHOGENS MEAN PLASMA CONCENTRATION - TIME PROFILES AFTER SINGLE INTRAMUSCULAR INJECTIONS COMPARED TO MIC 90 OF TARGET PATHOGENS 3 See MICROBIOLOGY for susceptibility break points. Average elimination half-life of cefepime is approximately 2 hours, and does not vary with respect to dose over the range of 250 mg to 2 g. There was no accumulation in healthy subjects receiving doses up to 2 g intravenously every 8 hours for a period of 9 days. Total body clearance averages 120 mL/min. Average renal clearance of cefepime Przeczytaj cały dokument