Dextrose
(Dextrose Monohydrate)Dextrose Prescribing Information
Intravenous solutions containing dextrose are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.
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.
5% 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.
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.
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (see
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.
Do not administer unless solution is clear and container is undamaged. Discard unused portion.
Studies with 5% Dextrose Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
Pregnancy Category 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.
Caution should be exercised when 5% Dextrose Injection, USP is administered to a nursing mother.
The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
Frequent monitoring of serum glucose concentrations is required when dextrose is prescribed to pediatric patients, particularly neonates and low birth weight infants.
In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolarity and possible intracerebral hemorrhage.
An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing dextrose in water for injection intended for intravenous administration.
Each 100 mL of 5% Dextrose Injection, USP, contains dextrose monohydrate, 5 g in water for injection. The caloric value is 170 kcal/L. The osmolarity is 252 mOsmol/L (calc.), which is slightly hypotonic.
The solution pH is 4.3 (3.2 to 6.5).
This solution 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 Injection, USP is a parenteral fluid and nutrient replenisher.
Dextrose, 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.
The flexible container is fabricated from a specially formulated non-plasticized film containing polypropylene and thermoplastic elastomers (