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:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Composition:

VANCOMYCIN 500 mg in 4 mL

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 equivalent to 500 mg or 1 gram of vancomycin is supplied as a sterile powder in single-dose vials. Vancomycin Hydrochloride for Injection USP equivalent to 500 mg and 1 gram of vancomycin is packed in individual cartons. Vancomycin Hydrochloride for Injection USP equivalent to 500 mg of vancomycin is supplied as. 500 mg single-dose vial (NDC 23155-217-31); Package of 1 vial (NDC 23155-217-31) 500 mg single-dose vial (NDC 23155-217-31); Package of 10 vials (NDC 23155-217-41) 500 mg single-dose vial (NDC 23155-217-31); Package of 25 vials (NDC 23155-217-42) Vancomycin Hydrochloride for Injection USP equivalent to 1 gram of vancomycin is supplied as. 1 g single-dose vial (NDC 23155-218-31); Package of 1 vial (NDC 23155-218-31) 1 g single-dose vial (NDC 23155-218-31); Package of 10 vials (NDC 23155-218-41) Store dry powder at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°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
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
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. 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 orientals_). 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:
CLINICAL PHARMACOLOGY
Vancomycin is poorl