25% Dextrose Infant

FDA Drug Profile — 25% Dextrose Infant

Drug Details

Generic Name
25% Dextrose Infant
Brand Names
25% Dextrose Infant
Application Number
NDA019445
Sponsor
HF Acquisition Co. LLC, DBA Health First
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
DEXTROSE MONOHYDRATE

Indications and Usage

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.

Warnings

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.