Country: Canada
Language: English
Source: Health Canada
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)
STERIMAX INC
J01XA01
VANCOMYCIN
10G
POWDER FOR SOLUTION
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 10G
INTRAVENOUS
100ML
Prescription
GLYCOPEPTIDES
Active ingredient group (AIG) number: 0131315008; AHFS:
APPROVED
2013-08-21
PRODUCT MONOGRAPH PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION (Vancomycin Hydrochloride USP) 500 mg/vial, 1 g/vial, and 10 g/vial Vancomycin ANTIBIOTIC SteriMax Inc. Date of Preparation: 1-2735 Matheson Blvd E August 20, 2013 Mississauga, ON L4W 4M8 Control No. 167324 Page 2 of 23 PRODUCT MONOGRAPH NAME OF DRUG PR VANCOMYCIN HYDROCHLORIDE FOR INJECTION (Vancomycin Hydrochloride USP) 500 mg/vial, 1 g/vial and 10 g/vial Vancomycin THERAPEUTIC CLASSIFICATION ANTIBIOTIC ACTIONS AND CLINICAL PHARMACOLOGY The bactericidal action of vancomycin against most gram-positive bacteria results from the inhibition of the biosynthesis of peptidoglycan polymers during the second stage of cell wall synthesis in dividing organisms. This effect occurs at a site different from that of penicillins and cephalosporins. The cytoplasmic membrane composition may also be affected and membrane permeability altered. There is also evidence that vancomycin selectively inhibits RNA synthesis. Vancomycin is a tricyclic glycopeptide antibiotic derived from _Amycolatopsis orientalis_ (formerly _Nocardia orientalis_). It is primarily active against gram-positive organisms including staphylococci and streptococci. It is active against methicillin-resistant strains of _Staphylococcus _ _aureus_ and _Staphylococcus epidermidis._ Vancomycin is poorly absorbed from the GI tract. It is given intravenously for therapy of systemic infections. Following i.v. administration, vancomycin is widely distributed and inhibitory concentrations of vancomycin can be documented in the pericardial, pleural, ascetic and synovial fluids. Low concentrations of the drug may appear in CSF if meninges are inflamed. The volume of distribution for vancomycin ranges from 0.43 to 1.25 L/kg. At a concentration of 10 to 100 μ g/mL _in vitro_, vancomycin is reportedly 52 to 60% bound to serum proteins. PHARMACOKINETICS In subjects with normal kidney function, multiple intravenous dosing of 1 g vancomycin (15 mg/kg), infused over 60 minutes, produces mean plasma concentrations of appr Read the complete document