Dextrose

DEXTROSE MONOHYDRATE INTRAVENOUS HUMAN PRESCRIPTION DRUG

Dextrose is an FDA drug label for the active ingredient DEXTROSE MONOHYDRATE manufactured by Medical Purchasing Solutions, LLC administered by INTRAVENOUS. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230530.

Generic name
DEXTROSE MONOHYDRATE
Manufacturer
Medical Purchasing Solutions, LLC
Product type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Dosage form
N/A
NDC
71872-7057
Application
NDA019445
Label effective
20230530

Indications & Usage

INDICATIONS AND USAGE 50% Dextrose Injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. The solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. Slow infusion of hypertonic solutions is essential to insure proper utilization of dextrose and avoid production of hyperglycemia.

Dosage & Administration

DOSAGE AND ADMINISTRATION For peripheral vein administration: Injection of the solution should be made slowly . The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg of body weight/hour. About 95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr. In insulin-induced hypoglycemia, intravenous injection of 10 to 25 grams of dextrose (20 to 50 mL of 50% dextrose) is usually adequate. Repeated doses and supportive treatment may be required in severe cases. 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. For central venous administration: For total parenteral nutrition 50% Dextrose Injection, USP is administered by slow intravenous infusion (a) after admixture with amino acid solutions via an indwelling catheter with the tip positioned in a large central vein, preferably the superior vena cava, or (b) after dilution with sterile water for injection. Dosage should be adjusted to meet individual patient requirements. 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. The maximum rate of dextrose administration which does not result in glycosuria is the same as cited above. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See CONTRAINDICATIONS .

Contraindications

CONTRAINDICATIONS 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 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.

Warnings

WARNINGS 50% Dextrose Injection 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 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. Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store. For peripheral vein administration: The solution 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 only after suitable dilution.

Adverse Reactions

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, 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.

More products with the same ingredient

DEXTROSE MONOHYDRATE

DEXTROSE

Baxter Healthcare Corporation View label