POTASSIUM CHLORIDE 14.9 g/100mL Injection, Solution, Concentrate — NDC 0264-1944-20 (Billing 00264-1944-20)

WARNINGS Strongly Hypertonic Solution. Must be properly diluted and thoroughly mixed before injection. 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. The drug product contains no more than 25 mcg/L of aluminum.

ADVERSE REACTIONS Reactions which may occur because of the potassium-containing solutions or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection or extravasation, hypervolemia, and hyperkalemia. To rapid infusion of hypertonic solutions may cause local pain and, rarely, vein irritation. Rate of administration should be adjusted according to tolerance.

Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation.

If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. Potassium-containing solutions are intrinsically irritating to tissues. Therefore, extreme care should be taken to avoid perivascular infiltration.

Local tissue necrosis and subsequent sloughing may result if extravasation occurs. Chemical phlebitis and venospasm have also been reported. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

PRECAUTIONS General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis.

Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. Solutions containing potassium in a greater concentration than 40 mEq/liter may result in significant irritation to peripheral or central veins.

For peripheral administration of solutions containing potassium, slowly infuse the solution through a small bore needle, placed well within the lumen of a large vein. Carefully avoid infiltration. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason.

If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. Use only if solution is clear and container and seals are intact.

Discard container within 4 hours after initial puncture. Pregnancy: (I) Teratogenic effects. Animal reproduction studies have not been conducted with potassium chloride injection.

It is also not known whether potassium chloride injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium chloride injection should be given to a pregnant woman only if clearly needed.