FDA approved Dextrose 5% Injection for Source of Water and CaloriesFDA approved Dextrose 5% Injection to provide fluids and calories intravenously.

FDA From the archive Source published March 4, 1971 Summary added June 16, 2026 DOI ↗ Editorial oversight: Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

AI-generated summary of the cited source, checked by automated accuracy review. How we work

Key Takeaway

Consider Dextrose Injection for IV fluid and caloric support, but monitor blood glucose closely, especially in neonates.

The FDA has approved Dextrose 5% Injection (dextrose 5% in plastic container) as a source of water and calories for intravenous administration. The approval, dated March 4, 1971, covers the use of this solution for patients who require fluid and caloric support. Dextrose Injection provides a source of water and calories, and is intended for intravenous infusion. Clinicians should note that the choice of dextrose concentration, rate, and volume depends on the patient's age, weight, and clinical condition. The approval is based on the drug's established role in parenteral therapy; no specific clinical trial data were included in the label.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Dextrose Injection provides a source of water and calories. Dextrose is metabolized to carbon dioxide and water, yielding energy.

Indication & Patient Population

Dextrose Injection is indicated as a source of water and calories. It is for intravenous use in patients requiring fluid and caloric supplementation.

Dosing & Administration

Dextrose Injection is for intravenous infusion only. Peripheral administration of 5% dextrose is generally acceptable; consider central vein for concentrations >5% or osmolarity ≥900 mOsm/L. Dosage depends on age, weight, clinical and metabolic conditions. Electrolyte supplementation may be indicated. For premature infants, increase rate gradually with frequent blood glucose monitoring.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Contraindicated in patients with clinically significant hyperglycemia or known hypersensitivity to dextrose. Warnings include risk of hyperglycemia, hypersensitivity reactions, and administration precautions (e.g., avoid simultaneous administration with blood products, prevent air embolism).

Place in Therapy

Dextrose Injection is a basic component of parenteral therapy for providing water and calories. It is used when oral intake is insufficient or impossible. The choice of concentration and rate should be individualized based on patient needs and tolerance.

The FDA has approved Dextrose 5% Injection, a solution of sugar (dextrose) in water, for intravenous use. This means it is given directly into a vein. The drug provides water and calories to patients who need fluid and energy support, such as those who are dehydrated or cannot eat or drink normally.

This approval is for a basic, widely used type of intravenous fluid. Doctors choose the right strength, amount, and speed of infusion based on each patient's age, weight, and medical condition. The approval is based on the drug's long established role in medical care, not on new clinical trials.

For patients, this means there is now an FDA approved option for this specific formulation. However, it does not mean that everyone who needs intravenous fluids should receive this product. Other types of fluids may be more appropriate depending on a patient's needs.

If you or a loved one might need intravenous fluids, talk to your doctor. They can explain the benefits and risks of this treatment and help decide if it is right for you. Always follow your healthcare provider's guidance.

What this means for you:

Dextrose 5% Injection is an FDA approved IV fluid that provides water and calories; talk to your doctor if you need IV fluids.

Study Details

Study typeFda approval

PublishedMar 1971

View Original Abstract ↓

1 INDICATIONS AND USAGE Dextrose Injection is indicated as source of water and calories. Dextrose Injection is indicated as a source of water and calories. ( 1 )

FDA approved Dextrose 5% Injection for Source of Water and CaloriesFDA approved Dextrose 5% Injection to provide fluids and calories intravenously.

Study Details

Mazdutide monotherapy reduces HbA1c and promotes weight loss in Chinese adults with type 2 diabetes over 48 weeks

New Drug Lowers Sugar and Shrinks Weight in Diabetes

Clinical research that matters. Delivered to your inbox.

FDA approved Dextrose 5% Injection for Source of Water and CaloriesFDA approved Dextrose 5% Injection to provide fluids and calories intravenously.

Study Details

Mazdutide monotherapy reduces HbA1c and promotes weight loss in Chinese adults with type 2 diabetes over 48 weeks

New Drug Lowers Sugar and Shrinks Weight in Diabetes

Clinical research that matters. Delivered to your inbox.

Related in Drug Pipeline

From Other Specialties