Country: United States
Language: English
Source: NLM (National Library of Medicine)
VANCOMYCIN HYDROCHLORIDE (UNII: 71WO621TJD) (VANCOMYCIN - UNII:6Q205EH1VU)
Sandoz Inc
VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN 500 mg in 10 mL
INTRAVENOUS
PRESCRIPTION DRUG
Vancomycin hydrochloride for injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin hydrochloride for injection, USP is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin hydrochloride for injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin, and skin structure infections. When staphylococcal infect
Vancomycin Hydrochloride for Injection, USP is supplied as a sterile powder in single-dose fliptop vials that contain the vancomycin equivalent to 500 mg, individually packaged in a carton. 500 mg single-vial (NDC 0781-3187-70); Package of 10 vials ( NDC 0781-3187-95) Vancomycin Hydrochloride for Injection, USP is supplied as a sterile powder in single-dose fliptop vials that contain the vancomycin equivalent to 1 g, individually packaged in a carton. 1 g single-vial (NDC 0781-3188-80); Package of 10 vials (0781-3188-95) Prior to reconstitution , store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION SANDOZ INC ---------- VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP FLIPTOP VIAL FOR INTRAVENOUS USE To reduce the development of drug-resistant bacteria and maintain the effectiveness of vancomycin hydrochloride for injection, USP and other antibacterial drugs, vancomycin hydrochloride for injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DESCRIPTION Vancomycin Hydrochloride for Injection, USP is a lyophilized powder, for preparing intravenous (IV) infusions, in vials each containing the equivalent of 500 mg or 1 g vancomycin base. 500 mg of the base are equivalent to 0.34 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL, the pH of the solution is between 2.5 and 4.5. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION), AFTER RECONSTITUTION FURTHER DILUTION IS REQUIRED BEFORE USE. Vancomycin is a tricyclic glycopeptide antibiotic derived from Amycolatopasis orientalis (formerly Nocardia orientals). The chemical name for vancomycin hydrochloride is 3S- [3R*,6S*(S*),7S*,22S*,23R*,26R*,36S*,38aS*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3-amino-2,3,6- trideoxy-3-C-methyl- -L-lyxo-hexopyranosyl)- -D-glucopyranosyl]oxy]-10,19-dichloro- 2,3,4,5,6,7,23,24,25,26,36, 37,38,38a-tetradecahydro-7,22,28,30,32-pentahydroxy-6-[[4-methyl-2- (methylamino)-1-oxopentyl]amino]-2,5,24,38,39-pentaoxo-22H-8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1H,16H-[1,6,9]oxadiazacyclohexadecino[4,5-m][10,2,16]- benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C H Cl N O • HCl and the molecular weight is 1,485.74. Vancomycin hydrochloride has the following structural formula: 66 75 2 9 24 CLINICAL PHARMACOLOGY Vancomycin is poorly absorbed after oral administration. In subjects with normal kidney Read the complete document