25% Dextrose Infant
Injection, Solution · Intravenous
Uses
25% Dextrose Injection is indicated in the treatment of acute symptomatic episodes of hypoglycemia in the neonate or older infant to restore depressed blood glucose levels and control symptoms. Other drugs, such as epinephrine and glucagon, should be considered in patients unresponsive or intolerant to dextrose (glucose). Oral feeding of dextrose may be necessary in infants with frequently recurring hypoglycemic episodes or to prevent recurrences due to hyperinsulinemia. 25% Dextrose Injection also provides a minimal source of carbohydrate calories.
Dosage and administration
When possible, glucose concentrations of greater than 12% should be administered by central vein to reduce the risk for phlebitis and thrombosis. 25% Dextrose Injection, USP is administered only by slow intravenous injection. The dosage and constant infusion rate of intravenous dextrose must be selected with caution, particularly in neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia. In the neonate, an injection of 250 to 500 mg (1 to 2 mL)/kg/dose (5 to 10 mL of 25% dextrose in a 5 kg infant) is recommended to control acute symptomatic hypoglycemia (tremors, convulsions, etc.). Larger or repeated single doses (up to 10 or 12 mL of 25% dextrose) may be required in severe cases or older infants. A specimen for blood glucose determination should be taken before injecting the dextrose. In such emergencies, dextrose should be administered promptly without awaiting pretreatment test results. Subsequent continuous intravenous infusion of 10% dextrose injection may be needed to stabilize blood glucose levels. Further treatment should be guided by evaluation of the underlying disorder. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. (See PRECAUTIONS ).
Contraindications
CONTRAINDICATIONS A concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present.
Warnings
25% Dextrose Injection, USP is hypertonic and may cause phlebitis and thrombosis at the site of injection. 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 loss of consciousness.
Precautions
Frequent monitoring of serum glucose concentrations is required when intravenous dextrose is given to pediatric patients, particularly neonates and low birth weight infants. Do not administer unless the solution is clear and seal is intact. Discard unused portion. Solutions containing dextrose should be used with caution in infants of diabetic mothers except as may be indicated in neonates who are hypoglycemic. Care should be exercised to insure that the needle is well within the lumen of the vein and that extravasation does not occur. If thrombosis should occur during administration, the injection should be stopped and corrective measures instituted. Concentrated dextrose solutions should not be administered subcutaneously or intramuscularly. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with 25% dextrose solutions in polypropylene syringes 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.
Side effects
Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause mental confusion and/or loss of consciousness. 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 and extravasation. 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.
Overdosage
In the event of overdosage (hyperglycemia) during therapy, re-evaluate the patient and institute appropriate corrective measures. (See WARNINGS and PRECAUTIONS .)
Description
25% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for injection administered by intravenous injection to restore blood glucose levels in hypoglycemia and as a source of carbohydrate calories. Each milliliter (mL) of fluid contains dextrose, hydrous, 250 mg which delivers 3.4 kcal/gram (0.85 kcal/mL). The solution has an osmolarity of 1.39 mOsmol/mL (calc.). pH is 4.5 (3.2 to 6.5). May contain hydrochloric acid and sodium hydroxide for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded with the entire unit. 25% Dextrose Injection, USP is a dextrose (glucose) and nutrient (carbohydrate) replenisher. Dextrose, USP is chemically designated D-glucose monohydrate, (C6H12O6
• H2O), a hexose sugar freely soluble in water. It has the following structural formula: The syringe is molded from a specially formulated polypropylene. Water permeates from inside the container at an extremely slow rate which will have an insignificant effect on solution concentration over the expected shelf life. 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 syringe material. Dextrose Structure
How supplied
25% DEXTROSE INJECTION is supplied in the following dosage forms. NDC 51662-1213-1 INFANT 25% DEXTROSE INJECTION, USP 2.5g (250mg/mL) ANSYR SYR HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufactures dosage forms 25% Dextrose Injection, USP is supplied in single-dose containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Revised: November, 2009 Printed in USA EN-2304 Hospira, Inc., Lake Forest, IL 60045 USA HOW SUPPLIED
Label text from the FDA structured product label by HF Acquisition Co. LLC, DBA Health First (revised Dec 9, 2022). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dextrose Monohydrate in 1 product
25% Dextrose Infant NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 51662-1213 | Dextrose Monohydrate 250 mg/mL Injection, Solution | HF Acquisition Co. LLC, DBA Health First | NDA |
Frequently asked questions
What is 25% Dextrose Infant used for?
25% Dextrose Injection is indicated in the treatment of acute symptomatic episodes of hypoglycemia in the neonate or older infant to restore depressed blood glucose levels and control symptoms. Other drugs, such as epinephrine and glucagon, should be considered in patients unresponsive or intolerant to dextrose (glucose). Oral feeding of dextrose may be necessary in infants with frequently…
What are the side effects of 25% Dextrose Infant?
Hyperosmolar syndrome, resulting from excessively rapid administration of concentrated dextrose may cause mental confusion and/or loss of consciousness. 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 and extravasation. If an… See the full label for the complete list.
Who makes 25% Dextrose Infant?
25% Dextrose Infant is listed by 1 labeler in the FDA NDC directory, including HF Acquisition Co. LLC, DBA Health First.