Country: United States
Language: English
Source: NLM (National Library of Medicine)
VANCOMYCIN HYDROCHLORIDE (UNII: 71WO621TJD) (VANCOMYCIN - UNII:6Q205EH1VU)
BluePoint Laboratories
Vancomycin Hydrochloride
Vancomycin 500 mg
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 infecti
Vancomycin Hydrochloride for Injection, USP is supplied as follows: 68001-338-61 500 mg Vial 10 mL in 1 vial 68001-339-63 1 gram Vial 20 mL in 1 vial Vancomycin Hydrochloride for Injection, USP are packaged per the following: 68001-338-62 500 mg Vial – 10 mL vials are packaged 10 vials per shelf pack 68001-339-64 1 gram Vial – 20 mL vials are packaged 10 vials per shelf pack Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic, Preservative-free, Lyophilized. The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN INJECTION, SOLUTION BLUEPOINT LABORATORIES ---------- VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP (FOR INTRAVENOUS USE) RX ONLY 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 gram 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. This product is oxygen sensitive. 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 orientalis_). The chemical name for vancomycin hydrochloride is 3S- [3 _R_*, 6 _S_*( _S_*),7 _S_*,22 _S_*,23 _R_*,26 _R_*,36 _S_*,38a _S_*]]-3-(2-Amino-2-oxoethyl)-44-[[2-O-(3- amino-2,3,6-trideoxy-3-C-methyl-α-L-lyxo-hexopyranosyl)-ß-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-22 _H_-8,11:18,21-dietheno-23,36- (iminomethano)-13,16:31,35-dimetheno-1 _H_,16 _H_-[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 Read the complete document