POTASSIUM PHOSPHATES is a brand name for Potassium Phosphate. The medicine, its uses, side effects and dosage are the same regardless of brand.
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…
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2 DOSAGE AND ADMINISTRATION Administer intravenously only after dilution or admixing in a larger volume of fluid. 4 mEq/mL). 4 ) Monitor serum phosphorus, potassium, calcium and magnesium concentrations. 4 ) See full prescribing information for instructions on preparation and administration.
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.
1 ) The dosage is dependent upon the individual needs of the patient and the contribution of phosphorus and potassium from other sources. 2 ) See full prescribing information for recommendations on initial or single dosing, repeated dosing, concentration and infusion rate.
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.
4 ) See full prescribing information for recommendations for daily and maximum dosage. 1 Preparation and Administration in Intravenous Fluids to Correct Hypophosphatemia Preparation Potassium phosphates injection is for intravenous infusion into a central or peripheral vein only after dilution .
9% Sodium Chloride Injection, USP (normal saline) or 5% Dextrose Injection, USP (D5W). For adults and pediatric patients 12 years of age and older a total volume of 100 mL or 250 mL is recommended. For pediatric patients less than 12 years of age, use the smallest recommended volume, considering daily fluid requirements and the maximum concentration for peripheral and central administration shown in Table 1.
The concentration of the diluted solution should take into consideration the age of the patient, the amounts of phosphorus and potassium in the dose and is dependent upon whether administration will be through a peripheral or central venous catheter.
The recommended maximum concentrations are shown in Table 1:
Table 1: Maximum Recommended Concentration of Potassium Phosphates Injection by Age and Route of Administration (Peripheral vs. 8 mEq/10 mL) Visually inspect the solution for particulate matter and discoloration before and after dilution and prior to administration.
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.
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.
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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.
1 ) Pulmonary Embolism due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. 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. 1 ) Hyperphosphatemia and Hypocalcemia : Monitor serum phosphorus and calcium concentrations during and following infusion.
4 ) Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm infants. 4 ) Hypomagnesemia : Reported in patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment.
6 ) Vein Damage and Thrombosis : Infuse concentrated or hypertonic solutions through a central catheter. 1 Serious Cardiac Adverse Reactions with Undiluted, Bolus or Rapid Intravenous Administration Intravenous administration of potassium phosphates to correct hypophosphatemia in single-doses of phosphorus 50 mmol and greater and/or at rapid infusion rates (over 1 hour to 3 hours) in intravenous fluids has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia and seizures [see Overdosage (10) ].
In addition, inappropriate intravenous administration of undiluted or insufficiently diluted potassium phosphates as a rapid “intravenous push” has resulted in cardiac arrest, cardiac arrhythmias, hypotension and death. Potassium phosphates injection is for intravenous infusion only after dilution or admixing .
3) ]. 3) ] . 4) ]. 4) ] . Hyperkalemia. ( 4 ) Hyperphosphatemia. ( 4 ) Hypercalcemia or significant hypocalcemia. 73 m 2 ) or end stage renal disease. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Do not administer unless solution is clear and seal on the vial is intact. Administration Check serum potassium and calcium concentrations prior to administration. 4) ] . 3) ] . If the potassium concentration is 4 mEq/dL or more, use an alternative source of phosphorus.
4) ] . 2) ] . Storage and Stability Single-Dose Vial (15 mL) For single use only. Discard used vial, including any unused contents. After dilution, the solution is stable for a maximum of 4 hours at room temperature 20° to 25°C (68° to 77°F) or 14 days under refrigeration at 2° to 8°C (36° to 46°F).
4 mEq/mL). The dosage is dependent upon the individual needs of the patient and the contribution of phosphorus and potassium from other sources. Initial or Single-Dose The phosphorus doses in Table 2 are general recommendations for an initial or single-dose and are intended for most patients.
Based upon clinical requirements, some patients may require a lower or higher dose. 1) ] . 6) ] . Monitor serum phosphorus, potassium, calcium and magnesium serum concentrations. 5 mg/dL as the lower end of the reference range for healthy adults and pediatric patients 12 months of age and older.
Serum phosphorus reported using 4 mg/dL as the lower end of the reference range for preterm and term infants less than 12 months of age. Serum phosphorus concentrations may vary depending on the assay used and the laboratory reference range.
b Weight is in terms of actual body weight. Limited information is available regarding dosing of patients significantly above ideal body weight; consider using an adjusted body weight for these patients. c up to a maximum of phosphorus 45 mmol (potassium 66 mEq) as a single-dose.
1) ] and the infusion rate is dependent upon whether administration will be through a peripheral or central venous catheter. The maximum recommended infusion rates are shown in Table 3 for adults and pediatric patients 12 years of age and older.
8 mmol/hour (potassium 10 mEq/hour) Central Venous Catheter phosphorus 15 mmol/hour (potassium 22 mEq/hour) Continuous electrocardiographic (ECG) monitoring and infusion through a central venous catheter is recommended for infusion rates higher than: Potassium 10 mEq/hour for adults and pediatric patients weighing 20 kg or greater.
5 mEq/kg/hour for pediatric patients weighing less than 20 kg. Repeated Dosing Additional dose(s) following the initial dose may be needed in some patients. Prior to administration of additional doses, assess the patient clinically, obtain serum phosphorus, calcium and potassium concentrations and adjust the dose accordingly.
3 Preparation and Administration in Parenteral Nutrition Potassium phosphates injection is for intravenous infusion into a peripheral or central vein only after dilution and admixing . Potassium phosphates injection is to be prepared only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
The key factor in the preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients. Transfer the required amount of potassium phosphates injection to the parenteral nutrition solution following the admixture of amino acids, dextrose, electrolytes solutions and prior to lipids (if added).
Because additives may be incompatible, evaluate all additions to the parenteral nutrition container for compatibility and stability of the resulting preparation. Calcium and phosphate ratios must be considered. 2) ] . Calcium-phosphate stability in parenteral nutrition solutions is dependent upon the pH of the solution, temperature and relative concentration of each ion.
Discard if any precipitates are observed. Inspect the final parenteral solution containing potassium phosphates injection to ensure that: precipitates have not formed during mixing or addition of additives and inspect again before administration.
the emulsion has not separated, if lipids have been added. Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion. The final parenteral nutrition solution is for intravenous infusion into a peripheral or central vein.
The choice of a peripheral or central venous route should depend on the osmolarity of the final infusate. 7) ] . Storage Protect the parenteral nutrition solution from light during storage. Stability Single-Dose Vial (15 mL) For single use only.
Discard used vial, including any unused contents. Use parenteral nutrition solution containing potassium phosphates injection promptly after mixing. Any storage of the admixture should be under refrigeration from 2° to 8°C (36° to 46°F) and limited to a brief period of time, no longer than 24 hours.
After removal from refrigeration, bring to room temperature and use promptly and complete the infusion within 24 hours. Discard any remaining admixture. 4 mEq/mL). The recommended daily dosage in parenteral nutrition is shown in Table 4.
Individualize the dosage based upon the patient’s clinical condition, nutritional requirements and the contribution of oral or enteral phosphorus and potassium intake. The amount of phosphorus that can be added to parenteral nutrition may be limited by the amount of calcium that is also added to the solution.
73 m 2 ), start at the low end of the dosage range. Monitoring Monitor serum phosphorus, potassium, calcium and magnesium concentrations and adjust the dosage accordingly.
The maximum initial or single-dose of potassium phosphates injection in intravenous fluids to correct hypophosphatemia is phosphorus 45 mmol (potassium 66 mEq). 8 mmol/hour (potassium 10 mEq/hour). 2) ] . 2 Pulmonary Embolism due to Pulmonary Vascular Precipitates Pulmonary vascular emboli and pulmonary distress related to precipitates in the pulmonary vasculature have been described in patients receiving admixed products containing calcium and phosphate or parenteral nutrition.
The cause of precipitate formation has not been determined in all cases; however, in some fatal cases, pulmonary emboli occurred as a result of calcium phosphate precipitates. Precipitation has occurred following passage through an in-line filter; in vivo precipitate formation may also have occurred.
If signs of pulmonary distress occur, stop the parenteral nutrition infusion and initiate a medical evaluation. 3) ] , the infusion set and catheter should also periodically be checked for precipitates. 1) ] . Patients with severe renal impairment and end stage renal disease are at increased risk of developing life-threatening hyperkalemia, when administered intravenous potassium [see Contraindications (4) ] .
1) ] . Patients with cardiac disease may be more susceptible to the effects of hyperkalemia. Consider the amount of potassium from all sources when determining the dose of potassium phosphates injection and do not exceed the maximum age-appropriate recommended daily amount of potassium.
6) ] . When administering potassium phosphates injection in intravenous fluids to correct hypophosphatemia, check the serum potassium concentration prior to administration. 1) ] . The maximum initial or single-dose of potassium phosphates injection in intravenous fluids to correct hypophosphatemia is phosphorus 45 mmol (potassium 66 mEq).
The recommended infusion rate of potassium through a peripheral venous catheter is 10 mEq/hour. 2) ] . 4 Hyperphosphatemia and Hypocalcemia Hyperphosphatemia can occur with intravenous administration of potassium phosphates, especially in patients with renal impairment.
Hyperphosphatemia can cause the formation of insoluble calcium phosphorus products with consequent hypocalcemia, neurological irritability with tetany, nephrocalcinosis with acute kidney injury and more rarely, cardiac irritability with arrhythmias.
Obtain serum calcium concentrations prior to administration and normalize the calcium before administering potassium phosphates injection. Potassium phosphates injection is contraindicated in patients with hyperphosphatemia and/or hypercalcemia [see Contraindications (4) ] .
4) ] . 5 Aluminum Toxicity Potassium phosphates injection contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration in patients with renal impairment. Preterm infants are particularly at risk for aluminum toxicity because their kidneys are immature and they require large amounts of calcium and phosphate containing solutions, which also contain aluminum.
Patients with renal impairment, including preterm infants, who receive greater than 4 to 5 mcg/kg/day of parenteral aluminum can accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
4) , Description (11) ] . 4) ] . 6 Hypomagnesemia Intravenous infusion of phosphate has been reported to cause a decrease in serum magnesium (and calcium) concentrations when administered to patients with hypercalcemia and diabetic ketoacidosis.
Monitor serum magnesium concentrations during treatment. 7 Vein Damage and Thrombosis Potassium phosphates injection must be diluted and administered in intravenous fluids or used as an admixture in parenteral nutrition. It is not for direct intravenous infusion.
The infusion of hypertonic solutions into a peripheral vein may result in vein irritation, vein damage and/or thrombosis. The primary complication of peripheral administration is venous thrombophlebitis, which manifests as pain, erythema, tenderness or a palpable cord.
Remove the catheter as soon as possible and initiate appropriate medical treatment if thrombophlebitis develops. 1) ]. 3) ] . 4) ] .