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warnings and cautions
5 WARNINGS AND PRECAUTIONS 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. ( 2.2 , 5.1 ) Pulmonary Embolism due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.2 ) 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 ) Hyperphosphatemia and Hypocalcemia : Monitor serum phosphorus and calcium concentrations during and following infusion. ( 5.4 ) Hypomagnesemia : Reported in patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment. ( 5.5 ) Vein Damage and Thrombosis : Infuse concentrated or hypertonic solutions through a central catheter. ( 2.1 , 2.3 , 5.6 ) 5.1 Serious Cardiac Adverse Reactions with Rapid Intravenous Administration Intravenous administration of potassium phosphates to correct hypophosphatemia in single-doses of phosphorus 50 mmol and greater and/or at rapid infusion rates (over 1 to 3 hours) has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia and seizures [see Overdosage (10) ]. Potassium Phosphates in Sodium Chloride Injection is for intravenous infusion . No dilution of this product is required. The maximum initial or single-dose of potassium phosphates to correct hypophosphatemia is phosphorus 45 mmol (potassium 66 mEq). The recommended infusion rate for administration through a peripheral venous catheter is approximately phosphorus 6.8 mmol/hour (potassium 10 mEq/hour). Continuous electrocardiographic (ECG) monitoring is recommended for higher infusion rates [see Dosage and Administration (2.1 , 2.2 )] . 5.2 Pulmonary Embolism Due to Pulmonary Vascular Precipitates Pulmonary vascular emboli and pulmonary distress related to precipitates in the pulmonary vasculature have been described in patients receiving admixed products containing calcium and phosphate. The cause of precipitate formation has not been determined in all cases; however, in some fatal cases, pulmonary emboli occurred as a result of calcium phosphate precipitates. Precipitation has occurred following passage through an in-line filter; in vivo precipitate formation may also have occurred. If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. In addition to inspection of the solution [see Dosage and Administration (2.3) ] , the infusion set and catheter should also periodically be checked for precipitates. 5.3 Hyperkalemia Potassium Phosphates in Sodium Chloride Injection may increase the risk of hyperkalemia, including life-threatening cardiac events, especially when administered in excessive doses or by rapid intravenous infusion [see Warnings and Precautions (5.1) ] . Patients with severe renal impairment and end stage renal disease are at increased risk of developing life-threatening hyperkalemia, when administered intravenous potassium [see Contraindications (4) ] . Other patients at increased risk of hyperkalemia include those with severe adrenal insufficiency or treated concurrently with other drugs that cause or increase the risk of hyperkalemia [see Drug Interactions (7.1) ] . Patients with cardiac disease may be more susceptible to the effects of hyperkalemia. Consider the amount of potassium from all sources when determining the dose of Potassium Phosphates in Sodium Chloride Injection and do not exceed the maximum age-appropriate recommended daily amount of potassium. In patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m 2 to < 60 mL/min/1.73 m 2 ), start at the low end of the dose range and monitor serum potassium, phosphorus, calcium, and magnesium concentrations [see Dosage and Administration (2.2) , Use in Specific Populations (8.6) ] . When administering Potassium Phosphates in Sodium Chloride Injection to correct hypophosphatemia, check the serum potassium concentration prior to administration. If the potassium concentration is 4 mEq/dL or more, do not administer Potassium Phosphates in Sodium Chloride Injection and use an alternative source of phosphorus [see Dosage and Administration (2.1) ] . The maximum initial or single-dose of potassium phosphates to correct hypophosphatemia is phosphorus 45 mmol (potassium 66 mEq). The recommended infusion rate of potassium through a peripheral venous catheter is 10 mEq/hour. Continuous electrocardiographic (ECG) monitoring is recommended for higher infusion rates of potassium [see Dosage and Administration (2.2) ] . 5.4 Hyperphosphatemia and Hypocalcemia Hyperphosphatemia can occur with intravenous administration of potassium phosphates, especially in patients with renal impairment. Hyperphosphatemia can cause the formation of insoluble calcium phosphorus products with consequent hypocalcemia, neurological irritability with tetany, nephrocalcinosis with acute kidney injury and more rarely, cardiac irritability with arrhythmias. Obtain serum calcium concentrations prior to administration and normalize the calcium before administering Potassium Phosphates in Sodium Chloride Injection. Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with hyperphosphatemia and/or hypercalcemia [see Contraindications (4) ]. Monitor serum phosphorus and calcium concentrations during treatment with Potassium Phosphates in Sodium Chloride Injection [see Dosage and Administration (2.2) ] . 5.5 Hypomagnesemia Intravenous infusion of phosphate has been reported to cause a decrease in serum magnesium (and calcium) concentrations when administered to patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment. 5.6 Vein Damage and Thrombosis The infusion of potassium phosphates solutions into a peripheral vein may result in vein irritation, vein damage, and/or thrombosis. The primary complication of peripheral administration is venous thrombophlebitis, which manifests as pain, erythema, tenderness, or a palpable cord. 5.7 Laboratory Monitoring Monitor serum phosphorus, potassium, calcium, and magnesium concentrations during treatment [see Dosage and Administration (2.2) ] .
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypomagnesemia [see Warnings and Precautions (5.5) ] Vein Damage and Thrombosis [see Warnings and Precautions (5.6) ] 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. TABLE 3: Adverse Reactions Reported in Clinical Studies or Post-marketing Reports with Intravenous Potassium Phosphates System Organ Class Adverse Reactions Metabolism and Nutrition Disorders pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.2) ], hyperkalemia [see Warnings and Precautions (5.3) ] , hyperphosphatemia [see Warnings and Precautions (5.4) ], hypocalcemia [see Warnings and Precautions (5.4) ] , hypovolemia and osmotic diuresis Cardiac Disorders hypotension, arrhythmia, heart block, cardiac arrest, bradycardia, chest pain, ECG changes [see Warnings and Precautions (5.1) ] and edema Respiratory, Thoracic, and Mediastinal Disorders dyspnea [see Warnings and Precautions (5.2) ] Renal and Urinary Disorders acute phosphate nephropathy (i.e., nephrocalcinosis with acute kidney injury), decreased urine output and transition to chronic kidney disease [see Warnings and Precautions (5.4) ] 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 Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.