STERILE 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 5 g in 100 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

STERILE VANCOMYCIN HYDROCHLORIDE- VANCOMYCIN HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
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STERILE VANCOMYCIN HYDROCHLORIDE, USP
RX ONLY
PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of vancomycin and
other antibacterial drugs, vancomycin should be used only to treat or
prevent infections that are proven
or strongly suspected to be caused by bacteria.
DESCRIPTION
Sterile Vancomycin Hydrochloride, USP is a lyophilized powder, for
preparing intravenous (IV)
infusions. Each Pharmacy Bulk Package contains vancomycin
hydrochloride equivalent to 5 grams of
vancomycin base. When reconstituted as directed each 10 mL contains
500 mg and each 20 mL contains
1 gram. Vancomycin hydrochloride is an off-white to tan colored
lyophilized powder. It may contain
hydrochloric acid and/or sodium hydroxide for pH adjustment. When
reconstituted with Sterile Water
for Injection, USP it forms a clear solution with the pH of the
solution between 2.5 and 4.5. This
product is oxygen sensitive.
This Pharmacy Bulk Package is a sterile preparation for intravenous
use that contains many single
doses. The contents are intended for use in a pharmacy admixture
service.
Vancomycin hydrochloride is prepared as a solution and lyophilized in
its final container.
Vancomycin is a tricyclic glycopeptide antibiotic derived from_
Amycolatopsis orientalis _(formerly
_Nocardia orientalis_). The molecular formula is C
H Cl
N O •HCl and the molecular weight is
1,485.71.
Vancomycin Hydrochloride has the following chemical designation:
(_S_)-(3_S_,6_R,_7
_R,_22_R,_23_S_,26_S_,36_R,_38a_R_)-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-[(2_R_)-4-methyl-2-
(methylamino)]valeramido]-2,5,24,38,39-pentaoxo-22_H_-8,11:18,21-dietheno-23,36-(iminomethano