Dibasic and Monobasic

Potassium Phosphates Injection is indicated as a source of phosphorus: • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. • for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. Potassium Phosphates Injection is a phosphorus replacement product indicated as a source of phosphorus: • in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. • for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated.

Phosphorus in the form of organic and inorganic phosphate has a variety of biochemical functions in all organs and tissues, including critical roles in nucleic acid structure, energy storage and transfer, cell signaling, cell membrane composition and structure, acid-base balance, mineral homeostasis and bone mineralization.

• Administer intravenously only after dilution or admixing in a larger volume of fluid. • Potassium Phosphates Injection provides phosphorus 3 mmol/mL (potassium 4.4 mEq/mL). • Monitor serum phosphorus, potassium, calcium, and magnesium concentrations. • See full prescribing information for instructions on preparation and administration. Recommended Dosage for Correction of Hypophosphatemia in Intravenous Fluids • POTASSIUM PHOSPHATES INJECTION is only for administration to a patient with a serum potassium concentration less than 4 mEq/dL, otherwise, use an alternative source of phosphorus. • The dosage is dependent upon the individual needs of the patient, and the contribution of phosphorus and potassium from other sources. • See full prescribing information for recommendations on initial or single dosing, repeated dosing, concentration and infusion rate.

Potassium Phosphates Injection is contraindicated in patients with: • hyperkalemia • severe renal impairment (eGFR less than 30 mL/min/1.73m 2 ) or end stage renal disease • hyperphosphatemia • hypercalcemia or significant hypocalcemia • hyperkalemia. • hyperphosphatemia. • hypercalcemia or significant hypocalcemia. • severe renal impairment (eGFR less than 30 mL/min/1.73m 2 ) or end stage renal disease

• Serious Cardiac Adverse Reactions with Undiluted, Bolus, or Rapid Intravenous Administration: Administer only after dilution or admixing, do not exceed the recommended infusion rate. Continuous electrocardiographic (ECG) monitoring may be needed during infusion. • Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. • Hyperkalemia: Increased risk in patients with renal impairment, severe adrenal insufficiency, or treated with drugs that increase potassium. Patients with cardiac disease may be more susceptible. Do not exceed the maximum daily amount of potassium or the recommended infusion rate. Continuous ECG monitoring may be needed during infusion. • Hyperphosphatemia and Hypocalcemia: Monitor serum phosphorus and calcium concentrations during and following infusion.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Aluminum Toxicity • Hypomagnesemia • Vein Damage and Thrombosis The following adverse reactions in Table 5 have been reported in clinical studies or postmarketing reports in patients receiving intravenously administered potassium phosphates. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Use of Other Medications that Increase Potassium: Avoid use in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations.

Store at 20°C to 25°C (68°F to 77°F). For storage of admixed solution