Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
IMIPENEM; CILASTATIN (CILASTATIN SODIUM)
MERCK CANADA INC
J01DH51
IMIPENEM AND CILASTATIN
500MG; 500MG
POWDER FOR SOLUTION
IMIPENEM 500MG; CILASTATIN (CILASTATIN SODIUM) 500MG
INTRAVENOUS
25 VIALS
Prescription
CARBAPENEMS
Active ingredient group (AIG) number: 0218820001; AHFS:
CANCELLED POST MARKET
2009-05-13
PRODUCT MONOGRAPH PRIMAXIN ® (imipenem and cilastatin sodium for injection, USP) I.V. Infusion ANTIBIOTIC MERCK FROSST CANADA LTD. Kirkland, Quebec, Canada CONTROL: 118199 DATE OF REVISION: FEBRUARY 18, 2008 PRIMAXIN ® is a Registered Trademark of Merck & Co., Inc. Used under license 1 NAME OF DRUG PRIMAXIN ® (imipenem and cilastatin sodium for injection, USP) I.V. Infusion THERAPEUTIC CLASSIFICATION Antibiotic ACTION Imipenem exerts a bactericidal action by inhibiting cell wall synthesis in aerobic and anaerobic gram-positive and gram-negative bacteria. PRIMAXIN ® (imipenem and cilastatin sodium) consists of two components: (1) imipenem, a derivative of thienamycin, a carbapenem antibiotic; and (2) cilastatin sodium, a specific inhibitor of dehydropeptidase-I a renal enzyme which metabolizes and inactivates imipenem. Cilastatin blocks the metabolism of imipenem in the kidney, so that concomitant administration of imipenem and cilastatin allows antibacterial levels of imipenem to be attained in the urine. Inhibition of cell-wall synthesis is achieved in gram-negative bacteria by the binding of imipenem to penicillin binding proteins (PBPs). In the case of _Escherichia coli_ and selected strains of _Pseudomonas aeruginosa_, imipenem has been shown to have highest affinity for PBP-2, PBP-1a and PBP-1b, with lower activity against PBP-3. The preferential binding of imipenem on PBP-2 and PBP- 1b leads to direct conversion of the individual cell to a spheroplast resulting in rapid lysis and cell death without filament formation. When imipenem is removed prior to complete killing of gram-negative species, the remaining viable cells show a measurable lag, termed a "post-antibiotic effect" (PAE), prior to resumption of new growth. 2 INDICATIONS AND CLINICAL USE PRIMAXIN ® (imipenem and cilastatin sodium) may be indicated in the treatment of serious infections when caused by sensitive strains of bacteria. Where considered necessary, therapy may be initiated on the basis of clinical judgment before results of sensitiv Přečtěte si celý dokument