1 INDICATIONS AND USAGE 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.

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6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Cardiac Adverse Reactions with Bolus or Rapid Intravenous Administration [see Warnings and Precautions ( 5.1 )] • Hyperkalemia [see Warnings and Precautions ( 5.2 )] • Pulmonary Embolism due to Pulmonary Vascular Precipitates [see Warnings and Precautions ( 5.3 )] • Hyperphosphatemia and Hypocalcemia [see Warnings and Precautions ( 5.4 )] • Hypomagnesemia [see Warnings and Precautions ( 5.5 )] • Vein Damage and Thrombosis [see Warnings and Precautions ( 5.6 )] The following adverse reactions 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.

Metabolism and Nutrition Disorders: hyperkalemia, hyperphosphatemia, hypocalcemia, hypovolemia, osmotic diuresis, pulmonary embolism Cardiac Disorders: arrhythmia, bradycardia, cardiac arrest, chest pain, ECG changes, edema, heart block, hypotension Respiratory, Thoracic, and Mediastinal Disorders: dyspnea Renal and Urinary Disorders: acute phosphate nephropathy (i.e., nephrocalcinosis with acute kidney injury), decreased urine output, transition to chronic kidney disease Gastrointestinal Disorders: diarrhea, stomach pain Musculoskeletal and Connective Tissue Disorders: weakness Nervous System Disorders: confusion, lethargy, paralysis, paresthesia Adverse reactions include hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .