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FDA approved Dextrose 5% Injection for Hydration and Calorie SourceFDA approved dextrose 5% injection for hydration and as drug diluent

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Key Takeaway
Consider using Dextrose 5% Injection for hydration and as a diluent, but monitor for fluid overload and electrolyte disturbances.

The FDA has approved Dextrose 5% Injection (5% Dextrose Injection USP) for use in adults and pediatric patients as a source of calories and water for hydration. The product is also designed as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. This approval provides clinicians with a standard isotonic dextrose solution for maintenance hydration and as a vehicle for drug delivery. The labeling emphasizes that dosage depends on patient age, weight, clinical condition, and laboratory values. Clinicians should be aware of risks including fluid overload, electrolyte disturbances, and hyperglycemia, particularly in pediatric and neonatal patients. The product is contraindicated in patients with hypersensitivity to corn products and should not be administered simultaneously with blood due to risk of hemolysis or pseudoagglutination.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

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.

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

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.

Place in Therapy

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.

The FDA has approved Dextrose 5% Injection, a sterile solution of sugar and water, for use in adults and children. The drug provides calories and water to help keep patients hydrated. It can also be used as a liquid to mix with other medicines that are given through a vein. This approval gives healthcare providers a standard, ready-to-use option for intravenous fluid therapy.

Dextrose 5% is for patients who need extra fluids or a way to deliver certain medications. The right dose depends on the patient's age, weight, health condition, and lab test results. Doctors will decide if this treatment is appropriate for each individual.

This approval means that a well-known, basic fluid solution is now officially available for these uses. However, it is not a new drug for a specific disease. It is a tool that doctors can use as part of a patient's overall care plan.

Patients should talk to their doctor about any concerns. This treatment may not be safe for everyone, especially those with corn allergies or certain blood conditions. Always follow your healthcare provider's instructions.

What this means for you:
Dextrose 5% Injection is a standard IV fluid for hydration and mixing medicines; talk to your doctor if you have questions.

Study Details

Study typeFda approval
PublishedDec 1973
View Original Abstract ↓
INDICATIONS AND USAGE 5% Dextrose Injection USP is indicated for use in adults and pediatric patients as sources of calories and water for hydration. This product is designed for use as a diluent and delivery system for intermittent intravenous administration of compatible drug additives. Consult prescribing information for INDICATIONS AND USAGE of drug additives to be administered in this manner.
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