País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
Dextrose Monohydrate (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)
General Injectables & Vaccines, Inc
Dextrose Monohydrate
Dextrose Monohydrate 250 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
25% Dextrose Injection is indicated in the treatment of acute symptomatic episodes of hypoglycemia in the neonate or older infant to restore depressed blood glucose levels and control symptoms. Other drugs, such as epinephrine and glucagon, should be considered in patients unresponsive or intolerant to dextrose (glucose). Oral feeding of dextrose may be necessary in infants with frequently recurring hypoglycemic episodes or to prevent recurrences due to hyperinsulinemia. 25% Dextrose Injection also provides a minimal source of carbohydrate calories. A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present.
25% Dextrose Injection, USP is supplied in single-dose containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1057-4.0 Revised: August 2020
New Drug Application
INFANT DEXTROSE - DEXTROSE INJECTION, SOLUTION GENERAL INJECTABLES & VACCINES, INC ---------- INFANT DEXTROSE 25% 250 MG/ML INJECTION, USP 10 ML PREFILLED SYRINGE DESCRIPTION 25% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection administered by intravenous injection to restore blood glucose levels in hypoglycemia and as a source of carbohydrate calories. Each milliliter (mL) of fluid contains dextrose, hydrous, 250 mg which delivers 3.4 kcal/gram (0.85 kcal/mL). The solution has an osmolarity of 1.39 mOsmol/mL (calc.). pH is 4.5 (3.2 to 6.5). May contain hydrochloric acid and sodium hydroxide 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. 25% Dextrose Injection, USP is a dextrose (glucose) and nutrient (carbohydrate) replenisher. Dextrose, USP is chemically designated D-glucose monohydrate, (C6H12O6• H2O), a hexose sugar freely soluble in water. It has the following structural formula: 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 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. 25% Dextrose Injection, USP provides a concentrated solution sufficiently Llegiu el document complet