Dextrose Injection 10%

10% Dextrose Injection, USP (concentrated dextrose in water) is a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection for intravenous administration after appropriate admixture or dilution.

10% Dextrose Injection, USP is provided as a 500 mL volume in a 1000 mL partial-fill container. The container is designed to facilitate admixture or dilution.

See table under HOW SUPPLIED for summary of content and characteristics of this concentrated solution.

The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection following admixture or dilution.

The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. 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 plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.

Dextrose Injection, USP is a parenteral fluid and nutrient replenisher.

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

Water for Injection, USP is chemically designated H2O.

A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present nor in the presence of delirium tremens if the patient is already dehydrated.

Dextrose Injection, USP without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

Concentrated dextrose in water should be administered only after suitable dilution. Hypertonic dextrose solutions should be given slowly. Significant hyperglycemia and possible hyperosmolar syndrome may result from too rapid administration. The physician should be aware of the symptoms of hyperosmolar syndrome, such as mental confusion and loss of consciousness, especially in patients with chronic uremia and those with known carbohydrate intolerance.

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

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

FOR PERIPHERAL VEIN ADMINISTRATION

Hypertonic dextrose solutions (above 5% concentration) should be given slowly, preferably through a small bore needle into a large vein, to minimize venous irritation.

FOR CENTRAL VENOUS ADMINISTRATION

Concentrated dextrose should be administered via central vein after appropriate admixture or dilution when required.

Electrolyte deficits, particularly in serum potassium and phosphate, may occur during prolonged use of concentrated dextrose solutions. Blood electrolyte monitoring is essential, and fluid and electrolyte imbalances should be corrected. Essential vitamins and minerals also should be provided as needed.

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

Care should be exercised to insure that the needle (or catheter) is well within the lumen of the vein and that extravasation does not occur.

Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly.

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

Pregnancy Catagory C. Animal reproduction studies have not been conducted with dextrose. It is also not known whether dextrose can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dextrose should be given to a pregnant woman only if clearly needed.

This product contains no more than 25 mcg/L of aluminum.

In the event of overhydration or solute overload during therapy, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS).

10% Dextrose Injection, USP is supplied in single-dose, partial-fill, flexible containers as follows: a 500 mL volume in a 1000 mL container. See the following table.

*Caloric value calculated on the basis of 3.4 kcal/g of dextrose, hydrous.

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

Revised: June, 2010

Printed in USA                             EN-2535

Hospira, Inc., Lake Forest, IL 60045 USA