SPL Set ID: 06dcfd36-942f-4752-86ad-4c5a6fc3e48f

1 drug(s) with this SPL Set ID

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Vancomycin VANCOMYCIN HYDROCHLORIDE
SAGENT PHARMACEUTICALS FDA Rx Only

Vancomycin Hydrochloride for Injection, USP is an off white to buff-colored lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 grams or 10 grams 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 per mL for the 5 gram Pharmacy Bulk Package bottle and 100 mg per mL for the 10 gram Pharmacy Bulk Package bottle, the pH of the solution is between 2.5 and 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 ( S a )-( 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. The molecular formula is C 66 H 75 Cl 2 N 9 O 24 •HCl and the molecular weight is 1,485.73. Vancomycin hydrochloride has the following 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. Structural Formula

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