Sodium Chloride and Potassium Chloride

FDA Drug Profile — Potassium Chloride in Sodium Chloride

Drug Details

Generic Name
Sodium Chloride and Potassium Chloride
Brand Names
Potassium Chloride in Sodium Chloride
Application Number
ANDA212347
Sponsor
Fresenius Kabi USA, LLC
NDC Codes
3
Dosage Forms
INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients
POTASSIUM CHLORIDE, SODIUM CHLORIDE

Indications and Usage

INDICATIONS AND USAGE Potassium Chloride in 0.9% Sodium Chloride Injection is indicated for use in adults and pediatric patients as a source of electrolytes 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. 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. In patients with diminished renal function, administration of solutions containing sodium or potassium ions may result in sodium or potassium retention. Solutions containing 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.