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potassium phosphate injection, USP Warnings and Precautions

WARNINGS

Potassium Phosphates Injection, USP, 3 mM P/mL must be diluted before use.
To avoid potassium or phosphorus intoxication, infuse solutions containing potassium phosphate slowly. In patients with severe renal or adrenal insufficiency, administration of potassium phosphate may cause potassium intoxication. Infusing high concentrations of phosphorus may cause hypocalcemia and calcium levels should be monitored.

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.

In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention.

WARNING: 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.


PRECAUTIONS

Do not administer unless solution is clear and seal is intact. Discard unused portion.

Phosphorus replacement therapy with potassium phosphate should be guided primarily by the serum inorganic phosphorus level and the limits imposed by the accompanying potassium (K+) ion.

High plasma concentrations of potassium may cause death through cardiac depression, arrhythmias or arrest.

Use with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease.

Pregnancy Category C. Animal reproduction studies have not been conducted with potassium phosphate. It is also not known whether potassium phosphate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium phosphate should be given to a pregnant woman only if clearly needed.

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