Potassium Phosphates
Generic: POTASSIUM PHOSPHATES, POTASSIUM PHOSPHATE, POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC
Basic Information
Manufacturer
American Regent, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
41a85cca-c463-4f39-9335-177b04c290a9
Indications & Usage
1 INDICATIONS AND USAGE 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 )
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 )
Adverse Reactions
6 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 postmarketing 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 Postmarketing 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 American Regent, Inc.
at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 Postmarketing 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 American Regent, Inc.
at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.