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:

Gland Pharma Limited

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, skin and skin structure infections. When staphylococcal infect

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
GLAND PHARMA LIMITED
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VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
RX ONLY
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION
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 (IV) infusions, in Pharmacy Bulk
Package bottles
containing the equivalent of 5 g or 10 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 for
the 5 g Pharmacy Bulk Package bottle and 100 mg/mL for the 10 g
Pharmacy Bulk
Package bottle, 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-
[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-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-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
C66H75Cl2N9O24• HCl
and