VANCOMYCIN HYDROCHLORIDE- vancomycin hydrochloride injection, powder, lyophilized, for solution VANCOMYCIN HYDROCHLORIDE inject

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VANCOMYCIN HYDROCHLORIDE (UNII: 71WO621TJD) (VANCOMYCIN - UNII:6Q205EH1VU)

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, and skin and skin-structure i

Product summary:

Vancomycin Hydrochloride for Injection, USP, supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE INJECTION,
POWDER, LYOPHILIZED, FOR SOLUTION
VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
FRESENIUS KABI USA, LLC
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VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
Rx only
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 an off white to
buff-colored lyophilized
powder, for preparing intravenous infusions, in vials each containing
the equivalent of
500 mg, 750 mg or 1 g vancomycin base. 500 mg of the base is
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
_Amycolatopsis orientalis_
(formerly _Nocardia orientalis_). The chemical name for vancomycin
hydrochloride is [3 _S_-
[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)-β-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.
Vancomycin hydrochloride has the follow