DEXTROSE MONOHYDRATE and SODIUM CHLORIDE

FDA Drug Profile — Dextrose and Sodium Chloride

Drug Details

Generic Name
DEXTROSE MONOHYDRATE and SODIUM CHLORIDE
Brand Names
Dextrose and Sodium Chloride
Application Number
ANDA211211
Sponsor
BECTON DICKINSON AND COMPANY
NDC Codes
10
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE

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.