FDA

Potassium Phosphates

Approved 10 Oct 2023IntravenousSolution

The FDA lists this product in 19 strengths and forms.

Indications

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.

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

Contraindications

Potassium phosphates injection is contraindicated in patients with: Hyperkalemia [see Warning and Precautions (5.3) ]. Severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ) or end stage renal disease [see Warning and Precautions (5.3) ] . Hyperphosphatemia [see Warning and Precautions (5.4) ]. Hypercalcemia or significant hypocalcemia [see Warning and Precautions (5.4) ] . Hyperkalemia. ( 4 ) Hyperphosphatemia.

( 4 ) Hypercalcemia or significant hypocalcemia. ( 4 ) Severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ) or end stage renal disease. ( 4 )

Warnings and precautions

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 ) 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.

Indications

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

Contraindications

( 4 ) Hypercalcemia or significant hypocalcemia. ( 4 ) Severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ) or end stage renal disease. ( 4 )

Warnings and precautions

Adverse reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Aluminum Toxicity [see Warnings and Precautions (5.5) ] Hypomagnesemia [see Warnings and Precautions (5.6) ] Vein Damage and Thrombosis [see Warnings and Precautions (5.7) ] The following adverse reactions in Table 5 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 5: 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 (5.5) ] , 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 at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Potassium Phosphates

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

Potassium Phosphates

Indications

Contraindications

Warnings and precautions

Two medicines in one question?

5.1Serious Cardiac Adverse Reactions with Undiluted, Bolus or Rapid Intravenous Administration

5.2Pulmonary

5.3Hyperkalemia

5.4Hyperphosphatemia and Hypocalcemia

5.5Aluminum Toxicity

5.6Hypomagnesemia

5.7Vein Damage and Thrombosis

Interactions

7.1Other

Pregnancy and breastfeeding

Adverse reactions

Composition

Strengths and forms

Official product information

At a glance