dextrose monohydrate and potassium chloride injection, solution

FDA Drug Profile — Potassium Chloride in Dextrose

Drug Details

Generic Name
dextrose monohydrate and potassium chloride injection, solution
Brand Names
Potassium Chloride in Dextrose
Application Number
NDA018371
Sponsor
ICU Medical Inc.
NDC Codes
1
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE

Indications and Usage

INDICATIONS AND USAGE This solution is indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories.

Warnings

WARNINGS Solutions which contain potassium ions should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present. To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with severe renal insufficiency or adrenal insufficiency, administration of potassium chloride may cause potassium intoxication. In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention. 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. The risk of dilutional states is inversely proportional to the electrolyte concentration 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.