Dextrose and Sodium Chloride

Rx only

5% Dextrose and 0.45% Sodium Chloride Injection, USP solutions are sterile and nonpyrogenic. They are large volume parenteral solutions containing 5 grams per 100 mL of Dextrose monohydrate and 0.45 grams per 100 mL of Sodium Chloride in water for injection intended for intravenous administration.

Each 100 mL of 5% Dextrose and 0.45% Sodium Chloride Injection, USP contains dextrose, hydrous 5 g and sodium chloride 0.45 g in water for injection. Electrolytes per 1000 mL: sodium (Na⁺), 77 mEq; chloride (Cl^-) 77 mEq. The osmolarity is 406 mOsmol/L (calc.), which is hypertonic. The caloric value is 170 kcal/L. The pH is 4.3 (3.5 to 6.5).

5% Dextrose and 0.45% Sodium Chloride Injection, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended only as a single-dose injection. When smaller doses are required the unused portion should be discarded.

5% Dextrose and 0.45% Sodium Chloride Injection, USP is a parenteral fluid, nutrient and electrolyte replenisher.

Dextrose, USP is chemically designated D-glucose monohydrate (C₆H₁₂O₆ • H₂O), a hexose sugar freely soluble in water. It has the following structural formula:

Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.

Water for Injection, USP is chemically designated H₂O.

The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (free flex ^® bag). The amount of water that can permeate from the container into the overwrap is insufficient to affect the solution significantly.

Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

When administered intravenously, these solutions provide a source of water, carbohydrate and electrolytes.

Solutions which provide combinations of hypotonic or isotonic concentrations of dextrose and of sodium chloride are suitable for parenteral maintenance or replacement of water and electrolyte requirements with minimal carbohydrate calories.

Solutions containing carbohydrate in the form of dextrose restore blood glucose levels and provide calories. Carbohydrate in the form of dextrose may aid in minimizing liver glycogen depletion and exerts a protein-sparing action. Dextrose injected parenterally undergoes oxidation to carbon dioxide and water.

Sodium chloride in water dissociates to provide sodium (Na⁺) and chloride (Cl¯) ions. Sodium (Na⁺) is the principal cation of the extracellular fluid and plays a large part in the therapy of fluid and electrolyte disturbances. Chloride (Cl¯) has an integral role in buffering action when oxygen and carbon dioxide exchange occurs in the red blood cells. The distribution and excretion of sodium (Na⁺) and chloride (Cl¯) are largely under the control of the kidney which maintains a balance between intake and output.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirements range from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na⁺) plays a major role in maintaining physiologic equilibrium.

Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.

None known.

Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.

Excessive administration of potassium-free solutions may result in significant hypokalemia.

In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.

The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.

The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Solutions containing dextrose should be used with caution in patients with known subclinical or overt diabetes mellitus.

Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions to patients receiving corticosteroids or corticotropin.

Do not administer unless solution is clear and container is undamaged. Discard unused portion.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

The dose is dependent upon the age, weight and clinical condition of the patient.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/hypoglycemia.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

5% Dextrose and 0.45% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers in 250 mL, 500 mL and 1000 mL sizes as follows:

The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.

Protect from freezing. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Fresenius Kabi Logo

Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417 USA
For product inquiry: 1-800-523-0502
Distributed by BD.
Manufactured by Fresenius Kabi.

Revised: February 2024

PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250mL Bag Label

freeflex^®          NDC 17271-734-05         250 mL

5% Dextrose and

0.45% Sodium Chloride

Injection, USP

For intravenous use.          Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 250mL Shipper Label

NDC 17271-734-05           1727173405

5% Dextrose and 0.45% Sodium Chloride

Injection, USP

250 mL x 30

QTY 30

PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500mL Bag Label

freeflex^®          NDC 17271-734-06          500 mL

5% Dextrose and

0.45% Sodium Chloride

Injection, USP

For intravenous use. Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 500mL Shipper Label

NDC 17271-734-06          1727173406

5% Dextrose and 0.45% Sodium Chloride

Injection, USP

500 mL x 20

QTY 20

PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1,000mL Bag Label

freeflex^®          NDC 17271-734-07          1000 mL

5% Dextrose and

0.45% Sodium Chloride

Injection, USP

For intravenous use. Rx only

PACKAGE LABEL - PRINCIPAL DISPLAY – Dextrose and Sodium Chloride 1000mL Shipper Label

NDC 17271-734-07          727173407

5% Dextrose and 0.45% Sodium Chloride
Injection, USP

1,000 mL x 10

QTY 10