DEXTROSE- dextrose monohydrate injection, solution
5% Dextrose Injection, USP solution is sterile and nonpyrogenic. It is a parenteral solution containing 50 mg/mL of dextrose, hydrous in water for injection and is intended for intravenous administration after admixing with an ADD-Vantage vial, or single-dose powdered drug vials with 20 mm closure using the ADD-Vantage ADDAPTORTM (WARNING: DO NOT USE WITH CHEMOTHERAPY AGENTS).
The 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.
The solution is slightly hypotonic (253 mOsmol/liter; calc.) in relation to the extracellular fluid (approx. 280 mOsmol/liter). The pH of the solution is 4.3 (3.2 - 6.5).
The solution 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 plastic container is fabricated from a specially formulated polyvinylchloride. 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.
When administered intravenously, this solution provides a source of water and carbohydrate.
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.
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 are indicated for parenteral replenishment of fluid and minimal carbohydrate calories as required by the clinical condition of the patient.
In this dosage form, 5% Dextrose Injection, USP is intended to be used as a diluent for the contents of an ADD-Vantage vial, or single-dose vials with 20 mm closure using the ADD-Vantage ADDAPTORTM.
Dextrose Injection 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.
Excessive administration of potassium-free solutions may result in significant hypokalemia.
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.
Do not administer unless solution is clear and container is undamaged. Discard unused portion.
Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with solutions from ADD-Vantage flexible plastic containers 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 only be given to a pregnant woman if clearly needed.
Nursing Mothers: Caution should be exercised when solutions from ADD-Vantage flexible containers are administered to a nursing woman.
Pediatric Use: 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.
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.
The dose is dependent on 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 Injection, USP is supplied in single-dose flexible plastic ADD-VantageTM diluent containers.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]
Unit of Sale
Case containing 50
50 mL bags
Case containing 50
100 mL bags
Case containing 24
250 mL bags
INSTRUCTIONS FOR USE WITH ADD-VANTAGE VIAL
These instructions for use should be made available to the individuals who perform the reconstitution steps.
Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.
To Assemble Vial and Flexible Diluent Container:
(Use Aseptic Technique)
Fig. 3 Fig. 4
To Reconstitute the Drug:
If the rubber stopper is not removed from the vial and medication is not released on the first attempt, the inner cap may be manipulated back into the rubber stopper without removing the drug vial from the diluent container. Repeat steps 3 through 5.
Preparation for Administration:
(Use Aseptic Technique)
WARNING: Do not use flexible container in series connections.
INSTRUCTIONS FOR USE WITH ADD-VANTAGE ADDAPTORTM
The instructions for use provided with the ADD-Vantage ADDAPTORTM should be made available to the individuals who perform the reconstitution steps.