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VANCOMYCIN, 10 g Pharmacy Bulk Package U.S. Physician Prescribing Information Description (vancomycin hydrochloride, USP)

DESCRIPTION

Vancomycin hydrochloride for injection, USP is a white to tan lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 10 grams vancomycin base. 500 mg of the base is equivalent to 0.34 mmol. When reconstituted as directed each 5 mL contains 500 mg and each 10 mL contains 1 gram. The reconstituted product is a clear light to dark tan solution with a pH in the range of 2.5 to 4.5. Vancomycin Hydrochloride for Injection, USP should be administered intravenously in diluted solution (see DOSAGE AND ADMINISTRATION).

Vancomycin hydrochloride for injection, USP 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)-ß-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 [4,5m][10,2,16]benzoxadiazacyclotetracosine-26-carboxylic acid, monohydrochloride. The molecular formula is C66H75Cl2N9O24 • HCl and the molecular weight is 1485.71. Vancomycin hydrochloride has the following structural formula:

Vancomycin Hydrochloride Structural Formula

A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents of this pharmacy bulk package are intended for use by a pharmacy admixture service for addition to suitable parenteral fluids in the preparation of admixtures for intravenous infusion (see DOSAGE AND ADMINISTRATION, Directions for Proper Use of Pharmacy Bulk Package). FURTHER DILUTION IS REQUIRED. NOT FOR DIRECT INFUSION.

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