25% Dextrose Infant

25% Dextrose Infant is an FDA-registered drug product whose active ingredient is 25% DEXTROSE INFANT. It is labelled by HF Acquisition Co. LLC, DBA Health First taken by intravenous and marketed as a human prescription drug product. Identifiers on file: NDC 51662-1213, application NDA019445, label effective 20221209. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing 25% DEXTROSE INFANT are most often described in connection with: dextrose injection, indications usage, treatment acute, symptomatic episodes, neonate older, infant restore, depressed blood, glucose levels. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS & USAGE 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 & 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 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.

ADVERSE REACTIONS 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.

What is 25% Dextrose Infant used for?
INDICATIONS & USAGE 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 …

Who makes 25% Dextrose Infant?
HF Acquisition Co. LLC, DBA Health First is the labeler of record for 25% Dextrose Infant.

What form does 25% Dextrose Infant come in?
administered by intravenous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is 25% Dextrose Infant prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has 25% Dextrose Infant been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.