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VANCOMYCIN, 5 g Pharmacy Bulk Package U.S. Physician Prescribing Information Description (vancomycin hydrochloride, USP)

DESCRIPTION

Vancomycin hydrochloride for injection, USP, is a lyophilized powder, for preparing intravenous (IV) infusions, in Pharmacy Bulk Package bottles containing the equivalent of 5 grams vancomycin base. 500 mg of the base is equivalent to 0.34 mmol, 750 mg of the base is equivalent to 0.51 mmol, and 1 g of the base is equivalent to 0.67 mmol. When reconstituted with Sterile Water for Injection to a concentration of 50 mg/mL for the 5 g 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 is a chromatographically purified tricyclic glycopeptide antibiotic derived from Amycolatopsis orientalis (formerly Nocardia orientalis) and has the molecular formula C66H75Cl2N9O24 • HCl. The molecular weight is 1485.74.

Vancomycin Hydrochloride has the following structural formula:

Structural formula vancomycin hydrochloride

Vancomycin hydrochloride is a white to tan lyophilized powder. When reconstituted with Sterile Water for Injection, USP, it forms a clear, light to dark tan solution. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. This product is oxygen sensitive.

The vancomycin hydrochloride 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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