POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE

FDA Drug Profile — Potassium Chloride in Lactated Ringers and Dextrose

Drug Details

Generic Name
POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, and DEXTROSE MONOHYDRATE
Brand Names
Potassium Chloride in Lactated Ringers and Dextrose
Application Number
NDA019685
Sponsor
ICU Medical Inc.
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
CALCIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE

Indications and Usage

INDICATIONS AND USAGE This solution is indicated in patients requiring parenteral administration of potassium chloride and the replacement of extracellular losses of fluids and electrolytes with minimal carbohydrate calories.

Warnings

WARNINGS Solutions containing calcium ions should not be administered simultaneously through the same administration set as blood because of the likelihood of coagulation. 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. 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. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing lactate ions should be used with great care in patients with metabolic or respiratory alkalosis. The administration of lactate ions should be done with great care where there is an increased level or an impaired utilization of lactate ions, as in severe hepatic insufficiency. 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.