País: Canadá
Idioma: inglés
Fuente: Health Canada
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE)
PHARMACEUTICAL PARTNERS OF CANADA INC
J01XA01
VANCOMYCIN
1G
POWDER FOR SOLUTION
VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE) 1G
INTRAVENOUS
1GM
Prescription
GLYCOPEPTIDES
Active ingredient group (AIG) number: 0131315001; AHFS:
CANCELLED POST MARKET
2008-02-15
PRODUCT MONOGRAPH Pr Sterile Vancomycin Hydrochloride, USP Pr Vancomycin Hydrochloride for Injection, USP Antibiotic Pharmaceutical Partners of Canada Inc. Date of Preparation: 45 Vogell Road, Suite 200 January 17, 2008 Richmond Hill, ON L4B 3P6 Control No.: 119199 1 NAME OF DRUG Sterile Vancomycin Hydrochloride, USP Vancomycin Hydrochloride for Injection, USP THERAPEUTIC CLASSIFICATION ANTIBIOTIC ACTION _In vitro_ studies indicate that the bactericidal action of vancomycin hydrochloride against many gram-positive bacteria results from the inhibition of cell-wall synthesis. There is also evidence that vancomycin alters the permeability of the cell membrane and selectively inhibits RNA synthesis. INDICATIONS AND CLINICAL USES VANCOMYCIN HYDROCHLORIDE IV may be indicated in the therapy of severe or life- threatening staphylococcal infections in patients who cannot receive or who have failed to respond to the penicillins and cephalosporins or who have infections with staphylococci resistant to other antibiotics, including methicillin. VANCOMYCIN HYDROCHLORIDE IV has been used successfully alone in the treatment of staphylococcal endocarditis. VANCOMYCIN HYDROCHLORIDE IV has been reported to be effective alone or in combination with an aminoglycoside for endocarditis caused by _Streptococcus viridans_ or _S. bovis._ For endocarditis caused by enterococci (e.g. _E. faecalis_), VANCOMYCIN HYDROCHLORIDE IV has been reported to be effective only in combination with an aminoglycoside. VANCOMYCIN HYDROCHLORIDE IV has been reported to be effective for the treatment of diphtheroid endocarditis. VANCOMYCIN HYDROCHLORIDE IV has been used successfully in combination with either rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by _S. epidermidis_ or diphtheroids. Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to VANCOMYCIN HYDROCHLORIDE IV. 2 Its effectiveness has been documented in other Leer el documento completo