Potassium Phosphates 236 mg/mL
Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic · INJECTION, SOLUTION · American Regent, Inc.
Potassium Phosphates is a injection, solution containing potassium phosphate, monobasic potassium phosphate, dibasic at 236 mg/mL, taken intravenous. Manufactured by American Regent, Inc..
Key Facts
- Brand Name
- Potassium Phosphates
- Generic Name
- Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic
- NDC Code (Product)
0517-2505- Manufacturer
- American Regent, Inc.
- Strength
- 236 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA216274
- Marketing Start
- 10/13/2023
Recall History
Hospira a Pfizer Company
Lack of Sterility Assurance
Zions RX Formulations Services LLC dba RX Formuations Serv.
Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic practices observed at the firm.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 )
Dosage & Administration
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. ( 2.1 ) The dosage is dependent upon the individual needs of the patient and the contribution of phosphorus and potassium from other sources. ( 2.2 ) See full prescribing information for recommendations on initial or single dosing, repeated dosing, concentration and infusion rate. ( 2.1 , 2.2 ) Recommended Dosage for Administration in Parenteral Nutrition Individualize the dosage based upon the patient’s clinical condition, nutritional requirements and the contribution of oral or enteral phosphorus and potassium intake. ( 2.4 ) S…
Contraindications
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) ]. 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 )
Drug 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. If use cannot be avoided, closely monitor serum potassium concentrations [see Dosage and Administration (2.2 , 2.4) ] .
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 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, arrh…
Frequently Asked Questions
What is Potassium Phosphates used for?
Potassium Phosphates contains Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Potassium Phosphates a controlled substance?
Potassium Phosphates is not classified as a controlled substance by the DEA.
What is the generic name for Potassium Phosphates?
The generic name for Potassium Phosphates is Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic. There are 3 other brand versions of Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic.
What is the NDC code for Potassium Phosphates 236 mg/mL?
The NDC (National Drug Code) for Potassium Phosphates 236 mg/mL is 0517-2505, listed by American Regent, Inc..