dextrose monohydrate

FDA Drug Profile — Dextrose, DEXTROSE

Drug Details

Generic Name
dextrose monohydrate
Brand Names
Dextrose, DEXTROSE
Application Number
NDA018080
Sponsor
ICU Medical, Inc.
NDC Codes
24
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE, INJECTION, SOLUTION, INJECTION
Routes
INTRAVENOUS
Active Ingredients
DEXTROSE MONOHYDRATE

Indications and Usage

INDICATIONS AND USAGE Intravenous solutions containing dextrose and sodium chloride are indicated for parenteral replenishment of fluid, minimal carbohydrate calories, and sodium chloride as required by the clinical condition of the patient.

Warnings

WARNINGS Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. Excessive administration of potassium-free solutions may result in significant hypokalemia. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of such solutions.