WARNINGS

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. Tissue loading may occur at even lower rates of administration.