Potassium phosphate, dibasic and Potassium phosphate, monobasic

Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated. Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement 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.

Important Preparation Instructions Do NOT dilute prior to administration. Use this potassium phosphates in sodium chloride injection product only in patients who require the entire 15 mmoL phosphorus dose (potassium 22 mEq) and not any fraction thereof. Otherwise, consider an alternative formulation of potassium phosphate. Important Administration Instructions Potassium Phosphates in Sodium Chloride 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. Use of this potassium phosphates in sodium chloride injection product increases the risk of hyperkalemia in patients weighing less than 40 kg, including life threatening cardiac events. See full prescribing information for important administration instructions.

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

Serious Cardiac Adverse Reactions with Rapid Intravenous Administration: Do NOT dilute prior to administration, 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: Hypomagnesemia Vein Damage and Thrombosis The following adverse reactions in Table 3 have been reported in clinical studies or post-marketing 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), excursions permitted between 15°C to 30°C (59°F to 86°F).