VANCOMYCIN HYDROCHLORIDE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Xellia Pharmaceuticals, ApS

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Composition:

VANCOMYCIN 500 mg

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vancomycin is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (beta-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 is indicated for initial therapy when methicillin-resistant staphylococci are suspected, but after susceptibility data are available, therapy should be adjusted accordingly. Vancomycin 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 infections are localized and purulent, antibiotics are used as adjuncts to appropriate surgical measur

Product summary:

Vancomycin Hydrochloride for Injection, USP equivalent to 500 mg vancomycin in a 10 mL flip-top vial, in packages of 1. NDC 45932-0028-1 Vancomycin Hydrochloride for Injection, USP equivalent to 500 mg vancomycin in a 10 mL flip-top vial, in packages of 10. NDC 45932-0028-2 Vancomycin Hydrochloride for Injection, USP equivalent to 1 g vancomycin in a 20 mL flip-top vial, in packages of 1. NDC 45932-0029-1 Vancomycin Hydrochloride for Injection, USP equivalent to 1 g vancomycin in a 20 mL flip-top vial, in packages of 10. NDC 45932-0029-2   Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Vial stoppers do not contain natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
XELLIA PHARMACEUTICALS, APS
----------
VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
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 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 Hydrochloride for Injection, USP is a tricyclic
glycopeptide antibiotic derived from
_Amycolatopasis orientalis_ (formerly _Nocardia orientalis_). The
chemical name for vancomycin
hydrochloride is (_S_
)-(3_S_,6_R_,7_R_,22_R_,23_S_,26_S_,36_R_,38a_R_)-44-[[2-_O_-(3-Amino-2,3,6-trideoxy-3-C-
methyl-α-L-_lyxo_-hexopyranosyl)-β-D-glucopyranosyl]oxy]-3-(carbamoylmethyl)-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-[(2_R_)-4-methyl-2-
(methylamino)]valeramido]-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 following
structural formula:
a
C
H CL
N O .HCL 1485.73
CLINICAL PHARMACOLOGY
Vancomycin is poorly absorbed after oral administration.
In subjects with normal kidney function, multiple intr