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:

Pfizer Laboratories Div Pfizer Inc.

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Composition:

VANCOMYCIN 10 g in 100 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
PFIZER LABORATORIES DIV PFIZER INC.
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VANCOMYCIN HYDROCHLORIDE FOR INJECTION, USP
PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION
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. Each Vancomycin Hydrochloride for Injection, USP 10 g
Pharmacy Bulk Package bottle
contains vancomycin hydrochloride equivalent to 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 100
mg/mL for the 10 g Pharmacy Bulk Package bottle, the pH of the
solution is between 2.5 to 4.5.
Vancomycin Hydrochloride for injection, USP should be administered
intravenously in diluted solution
(see DOSAGE AND ADMINISTRATION).
Vancomycin is a tricyclic glycopeptide antibiotic derived from
_Amycolatopasis orientalis _(formerly
_Nocardia orientalis_). The chemical name for Vancomycin hydrochloride
is (Sa)-
(3S,6R,7R,22R,23S,26S,36R,38aR)-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-[(2R)-4-methyl-2-
(methylamino)]valeramido]-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.
Vancomycin hydrochloride has
following structural formula:
CHEMICAL STRUCTURE
C
H Cl
N O
. HCl 1485.71
A Pharmacy Bulk Package is a sterile dosage form containing many