Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,
Generic Name: potassium phosphate, monobasic potassium phosphate, dibasic injection,
Brand Names:
Potassium Phosphates
11 DESCRIPTION Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 15 mL single-dose vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate.
Overview
11 DESCRIPTION Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile clear, colorless, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in water for injection. It is supplied as a 15 mL single-dose vial. Monobasic potassium phosphate, USP is chemically designated potassium dihydrogen phosphate.
Uses
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.
Dosage
2 DOSAGE AND ADMINISTRATION Administer intravenously only after dilution or admixing in a larger volume of fluid. ( 2.1 ) Potassium phosphates injection provides phosphorus 3 mmol/mL (potassium 4.4 mEq/mL). ( 2.2 , 2.4 ) Monitor serum phosphorus, potassium, calcium and magnesium concentrations. ( 2.2 , 2.4 ) See full prescribing information for instructions on preparation and administration. ( 2.1 , 2.3 ) Recommended Dosage for Correction of Hypophosphatemia in Intravenous Fluids Potassium phosphates 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.
Side Effects
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 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.
Interactions
7 DRUG INTERACTIONS Use of Other Medications that Increase Potassium : Avoid use in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations. ( 5.3 , 7.1 ) 7.1 Other Products that Increase Serum Potassium Administration of potassium phosphates injection to patients treated concurrently or recently with products that increase serum potassium (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, digoxin or the immunosuppressants tacrolimus and cyclosporine) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia [see Warnings and Precautions (5.3) ] . Avoid use of potassium phosphates injection in patients receiving such products.
Warnings
5 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. 4 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) ].
Pregnancy
8.1 Pregnancy Risk Summary Administration of the recommended dose of potassium phosphates injection is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with potassium phosphates injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Phosphates Injection, USP is a sterile clear, colorless solution supplied as phosphorus 3 mmol/mL and potassium 4.4 mEq/mL as shown: Product Code Unit of Sale Strength Each 1691 NDC 80830-1691-9 Carton containing 10 units Phosphorus 45 mmol/15 mL and Potassium 66 mEq/15 mL NDC 80830-1691-3 15 mL single-dose, polypropylene vial Store at 20° to 25°C (68...
Frequently Asked Questions
What is Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection, used for?▼
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.
What are the side effects of Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,?▼
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 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.
Can I take Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection, during pregnancy?▼
8.1 Pregnancy Risk Summary Administration of the recommended dose of potassium phosphates injection is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with potassium phosphates injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S.
What are the important warnings for Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic Injection,?▼
5 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. 4 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) ].
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.