FDA
Potassium Chloride in Plastic Container
The FDA lists this product in 2 strengths and forms.
Indications
Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.
Contraindications
Potassium Chloride for Injection Concentrate is contraindicated in diseases where high potassium levels may be encountered, and in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present.
Warnings and precautions
Potentially Fatal Cardiac Adverse Reactions with Undiluted Intravenous Administration Direct patient injection of potassium chloride at this concentration may be instantaneously fatal. Potassium Chloride for Injection Concentrate must be diluted before administration. Fatal cardiac arrhythmia and cardiac arrest have occurred when potassium chloride was administered in an undiluted form. To avoid potassium intoxication, do not infuse these solutions rapidly.
In patients with renal insufficiency, administration of potassium chloride may cause potassium intoxication and life-threatening hyperkalemia. 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. In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.



