FDA Approves Dextrose 5% Injection for Hydration and Calorie Source

Dextrose provides a source of calories and water for hydration. It is a simple sugar that is metabolized to carbon dioxide and water, yielding energy.

5% Dextrose Injection USP is indicated for use in adults and pediatric patients as sources of calories and water for hydration. It is also designed as a diluent and delivery system for intermittent intravenous administration of compatible drug additives.

This solution is for intravenous use only. Dosage is dependent upon the age, weight, and clinical condition of the patient as well as laboratory determinations. Do not use plastic container in series connection. If administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. It is recommended that intravenous administration apparatus be replaced at least once every 24 hours. Use only if solution is clear and container and seals are intact. When using as a diluent, consult prescribing information of the drug to be added. Addition of medication should be accomplished using aseptic technique. Physicochemical studies have shown that the container and solution can withstand freezing. Some additives may be incompatible. Consult with pharmacist. Mix thoroughly. Do not store. Pediatric Use: dosage and constant infusion rate must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of increased risk of hyperglycemia/hypoglycemia. Dose is dependent on weight, clinical condition, and laboratory results.

Trial data not available in label.

Warnings: Administration can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. Prolonged infusion of isotonic or hypotonic dextrose in water may increase extracellular fluid volume and cause water intoxication. Solutions containing dextrose without electrolytes should not be administered simultaneously with blood because of possible agglomeration. Excessive administration of potassium-free dextrose solutions may result in significant hypokalemia. In very low birth weight infants, excessive or rapid administration may result in increased serum osmolality and possible intracerebral hemorrhage. Contraindications: Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products. Do not administer simultaneously with blood because hemolysis or pseudoagglutination may occur.

5% Dextrose Injection is a standard isotonic solution used for maintenance hydration and as a diluent for compatible intravenous medications. It provides calories and water but lacks electrolytes, so it should be used with caution in patients at risk for electrolyte imbalances. It is not a balanced solution and is not suitable for resuscitation or replacement of significant fluid losses without electrolyte supplementation.