Potassium Phosphates In Sodium Chloride
Generic Name: potassium phosphates in sodium chloride
Brand Names:
Potassium Phosphates
11 DESCRIPTION Potassium Phosphates in 0.9% Sodium Chloride Injection, for intravenous use, is a phosphorus replacement product containing phosphorus 0.06 mmol/mL and potassium 0.088 mEq/mL. It is a sterile, non-pyrogenic, ready-to-use diluted solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in 0.9% sodium chloride. No dilution is required before administration. It is supplied in 250 mL single-dose intravenous infusion bag.
Overview
11 DESCRIPTION Potassium Phosphates in 0.9% Sodium Chloride Injection, for intravenous use, is a phosphorus replacement product containing phosphorus 0.06 mmol/mL and potassium 0.088 mEq/mL. It is a sterile, non-pyrogenic, ready-to-use diluted solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in 0.9% sodium chloride. No dilution is required before administration. It is supplied in 250 mL single-dose intravenous infusion bag.
Uses
1 INDICATIONS AND USAGE Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated. Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient or contraindicated. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Important Preparation Instructions Do NOT dilute prior to administration. ( 2.1 ) Use this potassium phosphates in sodium chloride injection product only in patients who require the entire 15 mmoL phosphorus dose (potassium 22 mEq) and not any fraction thereof. Otherwise, consider an alternative formulation of potassium phosphate. ( 2.1 ) Important Administration Instructions Potassium Phosphates in Sodium Chloride 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. ( 2.2 ) Use of this potassium phosphates in sodium chloride injection product increases the risk of hyperkalemia in patients weighing less than 40 kg, including life threatening cardiac events.
Side Effects
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.
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 in Sodium Chloride 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) ] .
Warnings
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. 4 CONTRAINDICATIONS Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with: hyperkalemia [see Warnings and Precautions (5.3) ] hyperphosphatemia [see Warnings and Precautions (5.4) ] hypercalcemia or significant hypocalcemia [see Warnings and Precautions (5.4) ] severe renal impairment (eGFR less than 30 mL/min/1.73m 2 ) or end stage renal disease [see Warnings and P...
Pregnancy
8.1 Pregnancy Risk Summary Administration of the recommended dose of Potassium Phosphates in Sodium Chloride Injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider potassium phosphate replacement if correction of hypophosphatemia via the enteral route is not possible (see Clinical Considerations). Animal reproduction studies have not been conducted with Potassium Phosphates in Sodium Chloride Injection. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Phosphates in 0.9% Sodium Chloride Injection is a clear, colorless solution filled in an intravenous infusion bag containing phosphorus 15 mmol/250 mL (0.06 mmol/mL) and potassium 22mEq/250mL (0.088 mEq/mL).
Frequently Asked Questions
What is Potassium Phosphates In Sodium Chloride used for?▼
1 INDICATIONS AND USAGE Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated. Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient or contraindicated. ( 1 )
What are the side effects of Potassium Phosphates In Sodium Chloride?▼
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.
Can I take Potassium Phosphates In Sodium Chloride during pregnancy?▼
8.1 Pregnancy Risk Summary Administration of the recommended dose of Potassium Phosphates in Sodium Chloride Injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider potassium phosphate replacement if correction of hypophosphatemia via the enteral route is not possible (see Clinical Considerations). Animal reproduction studies have not been conducted with Potassium Phosphates in Sodium Chloride Injection. The background risk of major birth defects and miscarriage for the indicated population is unknown.
What are the important warnings for Potassium Phosphates In Sodium Chloride?▼
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. 4 CONTRAINDICATIONS Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with: hyperkalemia [see Warnings and Precautions (5.3) ] hyperphosphatemia [see Warnings and Precautions (5.4) ] hypercalcemia or significant hypocalcemia [see Warnings and Precautions (5.4) ] severe renal impairment (eGFR less than 30 mL/min/1.73m 2 ) or end stage renal disease [see Warnings and P...
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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.