VANCOMYCIN HYDROCHLORIDE- vancomycin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Vancomycin Hydrochloride (UNII: 71WO621TJD) (Vancomycin - UNII:6Q205EH1VU)

Available from:

Breckenridge Pharmaceutical, Inc.

INN (International Name):

Vancomycin Hydrochloride

Composition:

Vancomycin 500 mg

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 infecti

Product summary:

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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN INJECTION, SOLUTION
BRECKENRIDGE PHARMACEUTICAL, INC.
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VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
(FOR INTRAVENOUS USE)
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 gram
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 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)-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:
66
75
2
9
24
CLINICAL PHARMACOLOGY
Vancomycin is poorly absorbed after or