5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing 50 mg/mL of dextrose, hydrous in water for injection and is intended for intravenous administration after admixing with an ADD-Vantage vial, or single-dose powdered drug vials with 20 mm closure using the ADD-Vantage ADDAPTORTM (WARNING: DO NOT USE WITH CHEMOTHERAPY AGENTS).
The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded.
The solution is slightly hypotonic (253 mOsmol/liter; calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 4.3 (3.2 - 6.5).
The solution is a parenteral fluid and nutrient replenisher.
Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6 • H2O), a hexose sugar freely soluble in water. It has the following structural formula:
Water for Injection, USP is chemically designated H2O.
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.