50% DEXTROSE

FDA Drug Profile — 50% DEXTROSE

Drug Details

Generic Name
50% DEXTROSE
Brand Names
50% DEXTROSE
Application Number
NDA019445
Sponsor
HF Acquisition Co LLC, DBA HealthFirst
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
DEXTROSE MONOHYDRATE

Indications and Usage

INDICATIONS & 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.

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.