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:

Hospira, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vancomycin hydrochloride for injection 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 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 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 localiz

Product summary:

Vancomycin Hydrochloride for Injection, USP is supplied as a sterile powder in single-dose fliptop vials that contain the vancomycin equivalent of either 500 mg, 750 mg, 1 g or 1.5 g. NDC 0409-4332-01 Tray of 10 Single-dose Fliptop Vials 500 mg/vial NDC 0409-6531-02 Tray of 10 Single-dose Fliptop Vials 750 mg/vial NDC 0409-6533-01 Tray of 10 Single-dose Fliptop Vials 1 g/vial NDC 0409-6533-21 Carton of 10 Single-dose Fliptop Vials 1 g/vial NDC 0409-3515-01 Tray of 10 Single-dose Fliptop Vials 1.5 g/vial Prior to reconstitution, store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED, FOR SOLUTION
HOSPIRA, 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 and other antibacterial drugs,
vancomycin
hydrochloride for injection 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, 750 mg, 1
g or 1.5 g vancomycin base. 500 mg of the base are equivalent to 0.34
mmol, 750 mg
of the base are equivalent to 0.51 mmol, 1 g of the base are
equivalent to 0.67 mmol
and 1.5 g of the base are equivalent to 1.01 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 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)-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.
The molecular
formula is C
H
Cl
N O
∙ HCl and