Country: United States
Language: English
Source: NLM (National Library of Medicine)
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (DEXTROSE - UNII:IY9XDZ35W2)
Physicians Total Care, Inc.
DEXTROSE MONOHYDRATE
DEXTROSE MONOHYDRATE 25 g in 50 mL
INTRAVENOUS
PRESCRIPTION DRUG
50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to insure proper utilization of dextrose and avoid production of hyperglycemia. A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present, nor in the presence of delirium tremens if the patient is already dehydrated. Dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.
50% Dextrose Injection, USP is supplied in single-dose containers as follows: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. ©Hospira 2001 EN-0182 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA Abboject® is a trademark of the Abbott group of companies.
New Drug Application
DEXTROSE - DEXTROSE INJECTION, SOLUTION PHYSICIANS TOTAL CARE, INC. ---------- CONCENTRATED DEXTROSE FOR INTRAVENOUS ADMINISTRATION NOTE: THIS SOLUTION IS HYPERTONIC — SEE WARNINGS AND PRECAUTIONS. LIFESHIELD ABBOJECT® SYRINGE FLIPTOP CONTAINER ANS YR PLASTIC SYRINGE ANS YR II PLASTIC SYRINGE R only DESCRIPTION 50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection for intravenous injection as a fluid and nutrient replenisher. Each mL of fluid contains 0.5 g dextrose, hydrous which delivers 3.4 kcal/gram. The solution has an osmolarity of 2.53 mOsmol/mL (calc.), a pH of 4.2 (3.2 to 6.5) and may contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required, the unused portion should be discarded with the entire unit. Dextrose, USP is chemically designated C H O • H O (D-glucose monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has the following structural formula: Water for Injection, USP is chemically designated H O . The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration ® ® ® x 6 12 6 2 2 over the expected shelf life. 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 syringe material. CLINICAL PHARMACOLOGY When administered intravenously this solution restores blood glucose levels in hypoglycemia and provides a source of carbohydrate calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injection undergoes oxidation to carbon dioxide and water. Water is an essential Read the complete document