Dextrose and Sodium Chloride

FDA Drug Profile — Dextrose and Sodium Chloride

Dextrose and Sodium Chloride is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Dextrose and Sodium Chloride. Available dosage form: injection, solution.

Drug Details

Generic Name
Dextrose and Sodium Chloride
Brand Names
Dextrose and Sodium Chloride
Application Number
NDA016683
Sponsor
Baxter Healthcare Company
NDC Codes
4
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE

Indications and Usage

INDICATIONS AND USAGE These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes, calories and water for hydration.

Warnings

WARNINGS The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. 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 is sodium retention with edema. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. Infusion of isotonic (0.9%) sodium chloride during or immediately after surgery may result in excessive sodium retention. Use the patient's circulatory system status as a guide. Excessive administration of potassium-free dextrose solutions may result in significant hypokalemia. Serum potassium levels should be maintained and potassium supplemented as required. Solutions containing dextrose and low electrolyte concentrations should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination or hemolysis.