Potassium phosphate, dibasic and potassium phosphate, monobasic

FDA label, Amneal Pharmaceuticals LLC, intravenous, effective 2025-09-01. Full label on DailyMed

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Dosing in kidney impairment

Renal Impairment Potassium and phosphorus are known to be substantially excreted by the kidney and the risk of adverse reactions to Potassium Phosphates in Sodium Chloride Injection may be greater in patients with impaired renal function [see Warnings and Precautions (5.3 , 5.4 )] . Potassium Phosphates in Sodium Chloride Injection is contraindicated due to the risk of hyperkalemia in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ) or end stage renal disease [see Contraindications ] .

In patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m 2 to < 60 mL/min/1.73 m 2 ), start at the low end of the dosage range and monitor serum potassium, phosphorus, calcium, and magnesium concentrations [see Dosage and Administration ].

Preparation and administration

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Important Preparation Instructions Potassium Phosphates in Sodium Chloride Injection is for intravenous infusion into a central or peripheral vein. No dilution of this product is required. 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.

If a dose of potassium phosphate is required that does not equal 15 mmoL of Potassium phosphates in Sodium Chloride Injection, then an alternative formulation of potassium phosphates should be considered. Visually inspect the solution for particulate matter and discoloration prior to administration. Do not administer unless solution is clear.

Always inspect the solution container before and after removal from the pouch. Place the solution container on a clean, flat surface. Remove the solution container from the pouch. Check the solution container for leaks by squeezing firmly. Discard if leaks are found. Immediately before inserting the infusion set, remove twist-off port from the infusion bag.

Use a non-vented infusion set or close the air-inlet on a vented set. Close the roller clamp of the infusion set. Hold the base of the infusion port, twist, and push spike until fully inserted. The infusion port contains a membrane that helps prevent leakage after removing the spike. The infusion port is not intended to be spiked more than once.

Suspend solution container from hanger hole. For single-dose only. Discard unused portion.

Important Administration Instructions Check serum potassium and calcium concentrations prior to administration. Normalize the serum calcium level before administering Potassium Phosphates in Sodium Chloride Injection [see Contraindications , Warnings and Precautions (5.3 , 5.4 )] . Potassium Phosphates in Sodium Chloride Injection is only for administration to a patient with a serum potassium concentration less than 4 mEq/dL [see Warnings and Precautions ] .

If the potassium concentration is 4 mEq/dL or more, use an alternative source of phosphorus. Use of this potassium phosphates in sodium chloride injection product increases the risk of hyperkalemia in adults and pediatric patients weighing less than 40 kg, including life threatening cardiac events [see Warnings and Precautions ] .

Do not infuse with calcium-containing intravenous fluids [see Warnings and Precautions ] . The rate of administration may be dependent on the patient and the specific institution policy [see Dosage and Administration ] . When administered peripherally, a generally recommended maximum concentration is phosphorus 6.8 mmol/100 mL (potassium 10 mEq/100 mL).

Serum Phosphorus ConcentrationaPhosphorus Dosageb, cCorresponding Potassium Content
1.8 mg/dL to lower end of the reference rangea0.16 mmol/kg to 0.31 mmol/kgPotassium 0.23 mEq/kg to 0.46 mEq/kg
1 mg/dL to 1.7 mg/dL 0.32 mmol/kg to 0.43 mmol/kg Potassium 0.47 mEq/kg to 0.63 mEq/kg
Less than 1 mg/dL 0.44 mmol/kg to 0.64 mmol/kgc Potassium 0.64 mEq/kg to 0.94 mEq/kg
a Serum phosphorus reported using 2.5 mg/dL as the lower end of the reference range for healthy adults and pediatric patients 12 months of age and older. Serum phosphorus 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 This single-dose preparation of Potassium Phosphates in Sodium Chloride Injection contains phosphorus 15 mmol and potassium 22 mEq. Additional dose(s) following the initial dose may be needed in some patients.
Route of AdministrationMaximum Infusion Rate
Peripheral Venous Catheterphosphorus 6.8 mmol/hour(potassium 10 mEq/hour)
Central Venous Catheterphosphorus 15 mmol/hour(potassium 22 mEq/hour)

Drug interactions

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Label text (3 paragraphs)

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) ] . Avoid use of Potassium Phosphates in Sodium Chloride Injection in patients receiving such products.

If use cannot be avoided, closely monitor serum potassium concentrations [see Dosage and Administration (2.2) ] .

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 Precautions (5.3) ] 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 )

Pregnancy and lactation

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. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Phosphorus is an essential mineral element. Intravenous replacement with potassium phosphate should be considered if a pregnant woman requires intravenous replacement to correct hypophosphatemia when the enteral route is not possible, insufficient or contraindicated.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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