Potassium Phosphates Injection is a phosphorus replacement product indicated as a source of phosphorus:

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in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. (1)

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for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. (1)

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Administer intravenously only after dilution or admixing in a larger volume of fluid. (2.1)

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Potassium Phosphates Injection provides phosphorus 3 mmol/mL (potassium 4.4 mEq/mL). (2.2, 2.4)

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Monitor serum phosphorus, potassium, calcium, and magnesium concentrations. (2.2, 2.4)

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See full prescribing information for instructions on preparation and administration. (2.1, 2.3)

Recommended Dosage for Correction of Hypophosphatemia in Intravenous Fluids

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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. (2.1)

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The dosage is dependent upon the individual needs of the patient, and the contribution of phosphorus and potassium from other sources. (2.2)

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See full prescribing information for recommendations on initial or single dosing, repeated dosing, concentration and infusion rate. (2.1, 2.2)

Recommended Dosage for Administration in Parenteral Nutrition

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Individualize the dosage based upon the patient's clinical condition, nutritional requirements, and the contribution of oral or enteral phosphorus and potassium intake. (2.4)

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See full prescribing information for recommendations for daily and maximum dosage. (2.4)

Injection:

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phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 66 mEq/15 mL (4.4 mEq/mL) in a single-dose vial. (3)

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hyperkalemia (4)

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hyperphosphatemia (4)

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hypercalcemia or significant hypocalcemia (4)

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severe renal impairment (eGFR less than 30 mL/min/1.73m2) or end stage renal disease (4)

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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. (2.2, 5.1)

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Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. (5.2)

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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. (5.3, 7.1)

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Hyperphosphatemia and Hypocalcemia: Monitor serum phosphorus and calcium concentrations during and following infusion. (5.4)

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Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants. (5.5, 8.4).

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Hypomagnesemia: Reported in patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment. (5.6)

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Vein Damage and Thrombosis: Infuse concentrated or hypertonic solutions through a central catheter. (2.1, 2.3, 5.7)

Adverse reactions include hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Hospira, Inc. at 1-800-441-4100 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use of Other Medications that Increase Potassium: Avoid use in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations. (5.3, 7.1)