Potassium Phosphates Injection, Solution
FDA Label NDC 0517-2102

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 provides phosphorus 3 mmol/mL (potassium 4.4 mEq/mL).

The dosage is dependent upon the individual needs of the patient, and the contribution of phosphorus and potassium from other sources.

• 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. Excess addition of calcium and phosphate, especially in the form of mineral salts, may result in the formation of calcium-phosphate precipitates [see Warnings and Precautions (5.2)]. 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. Solutions with osmolarity of 900 mOsmol/L or greater must be infused through a central catheter [see Warnings and Precautions (5.7)].

Potassium Phosphates Injection provides phosphorus 3 mmol/mL (potassium 4.4 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.

Potassium Phosphates Injection, USP is a clear and colorless solution supplied as:

• phosphorus 15 mmol/5 mL (3 mmol/mL) and potassium 22 mEq/5 mL (4.4 mEq /mL) in a single-dose vial.
• phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 66 mEq/15 mL (4.4 mEq/mL) in a single-dose vial.
• phosphorus 150 mmol/50 mL (3 mmol/mL) and potassium 220 mEq/50 mL (4.4 mEq/mL) in Pharmacy Bulk Package vial.

Potassium Phosphates Injection is contraindicated in patients with:

• hyperkalemia [see Warning and Precautions (5.3)]
• hyperphosphatemia [see Warning and Precautions (5.4)]
• hypercalcemia or significant hypocalcemia [see Warning and Precautions (5.4)]
• severe renal impairment (eGFR less than 30 mL/min/1.73m²) or end stage renal disease [see Warning and Precautions (5.3)]

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 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 “IV push” has resulted in cardiac arrest, cardiac arrhythmias, hypotension, and death.

Potassium Phosphates Injection is for intravenous infusion only after dilution or admixing. 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 for administration through a peripheral venous catheter is approximately phosphorus 6.8 mmol/hour (potassium 10 mEq/hour). Continuous electrocardiographic (ECG) monitoring is recommended for higher infusion rates [see Dosage and Administration (2.1, 2.2)].

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. In addition to inspection of the solution [see Dosage and Administration (2.3)], the infusion set and catheter should also periodically be checked for precipitates.

Potassium Phosphates Injection may increase the risk of hyperkalemia, including life-threatening cardiac events, especially when administered in excessive doses, undiluted or by rapid intravenous infusion [see Warnings and Precautions (5.1)]. 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)]. Other patients at increased risk of hyperkalemia include those with severe adrenal insufficiency or treated concurrently with other drugs that cause or increase the risk of hyperkalemia [see Drug Interactions (7.1)]. 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. In patients with moderate renal impairment (eGFR ≥30 mL/min/1.73 m² to <60 mL/min/1.73 m²), start at the low end of the dose range and monitor serum potassium, phosphorus, calcium, and magnesium concentrations [see Dosage and Administration (2.2, 2.4), Use in Specific Populations (8.6)].

When administering Potassium Phosphates Injection in intravenous fluids to correct hypophosphatemia, check the serum potassium concentration prior to administration. If the 

potassium concentration is 4 mEq/dL or more, do not administer Potassium Phosphates Injection and use an alternative source of phosphorus [see Dosage and Administration (2.1)].

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. Continuous electrocardiographic (ECG) monitoring is recommended for higher infusion rates of potassium [see Dosage and Administration (2.2)].

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)].

Monitor serum phosphorus and calcium concentrations during treatment with Potassium Phosphates Injection [see Dosage and Administration (2.2, 2.4)].

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.

Exposure to aluminum from Potassium Phosphates Injection is not more than 1.4 mcg/kg/day when patients are administered the recommended dosage [see Dosage and Administration (2.4), Description (11)].

When prescribing Potassium Phosphates Injection for use in parenteral nutrition solutions containing other small volume parenteral products, the total daily patient exposure to aluminum from the admixture should be considered and maintained at no more than 5 mcg/kg/day [see Use in Specific Populations (8.4)].

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.

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.

When administered peripherally in intravenous fluids to correct hypophosphatemia, a generally recommended maximum concentration is phosphorus 6.8 mmol/100 mL (potassium 10 mEq/100 mL) [see Dosage and Administration (2.1)].

Parenteral nutrition solutions with an osmolarity of 900 mOsmol/L or greater must be infused through a central catheter [see Dosage and Administration (2.3)].

Monitor serum phosphorus, potassium, calcium and magnesium concentrations during treatment [see Dosage and Administration (2.2, 2.4)].

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 postmarketing 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 Postmarketing 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, arrhythmia, heart block, cardiac arrest, bradycardia, chest pain, ECG changes [see Warnings and Precautions (5.1)], and edema
Respiratory, Thoracic, and Mediastinal Disorders	dyspnea [see Warnings and Precautions (5.2)]
Renal and Urinary Disorders	acute phosphate nephropathy (i.e., nephrocalcinosis with acute kidney injury), decreased urine output, and transition to chronic kidney disease [see Warnings and Precautions (5.4)]
Gastrointestinal Disorders	diarrhea, stomach pain
Musculoskeletal and Connective Tissue Disorders	weakness
Nervous System Disorders	confusion, lethargy, paralysis, paresthesia

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)].

Potassium Phosphates Injection, USP, a phosphorus replacement product containing phosphorus 3 mmol/mL and potassium 4.4 mEq/mL. It is a sterile, non-pyrogenic, concentrated solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in water for injection. It is supplied as a 5 mL, and 15 mL single-dose vials and a 50 mL Pharmacy Bulk Package vial.

Monobasic Potassium Phosphate is chemically designated KH₂PO₄, molecular weight 136.09, white, odorless crystals or granules freely soluble in water.

Dibasic Potassium Phosphate is chemically designated K₂HPO₄, molecular weight 174.18, colorless or white granular salt freely soluble in water.

Each mL contains 224 mg of monobasic potassium phosphate and 236 mg of dibasic potassium phosphate.

Each mL contains 3 mmol phosphorus (equivalent to 93 mg phosphorus) and 4.4 mEq potassium (equivalent to 170 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. The pH is 6.0 to 7.0.

This product contains no more than 2000 mcg/L of aluminum [see Warnings and Precautions (5.5)].

The osmolarity is 7.4 mOsmol/mL (calc).

The solution is administered after dilution or admixing by the intravenous route.

Safety and effectiveness of Potassium Phosphates Injection have been established in pediatric patients as a source of phosphorus:

• in intravenous fluids to correct hypophosphatemia when oral or enteral replacement is not possible, insufficient, or contraindicated.
• for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.

Because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with Potassium Phosphates Injection may be at higher risk of aluminum toxicity. [see Warnings and Precautions (5.6)].

In general, dose selection of Potassium Phosphates Injection for an elderly patient should be cautious, starting at the low end of the dosing range because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. It may be useful to monitor renal function during treatment [see Use in Specific Populations (8.6)].

Potassium and phosphorus are known to be substantially excreted by the kidney and the risk of adverse reactions to Potassium Phosphates Injection may be greater in patients with impaired renal function [see Warnings and Precautions (5.3, 5.4, 5.5)].

Potassium Phosphates Injection is contraindicated due to the risk of hyperkalemia in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m²) or end stage renal disease [see Contraindications (4)].

In patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m² to < 60 mL/min/1.73 m²), start at the low end of the dosage range and monitor serum potassium, phosphorus, calcium, and magnesium concentrations [see Dosage and Administration (2.2, 2.4)].

Phosphorus in the form of organic and inorganic phosphate has a variety of biochemical functions in all organs and tissues, including critical roles in nucleic acid structure, energy storage and transfer, cell signaling, cell membrane composition and structure, acid-base balance, mineral homeostasis and bone mineralization.

Potassium Phosphates Injection, USP is a clear and colorless solution supplied as phosphorus 3 mmol/mL and potassium 4.4 mEq/mL as shown:

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Pharmacy Bulk Package vial: Discard within 4 hours of initial entry [see Dosage and Administration (2.3)].

For storage of admixed solution see Dosage and Administration 2.1, 2.3.

Inform patients, caregivers or home healthcare providers of the following risks of Potassium Phosphates Injection:

• Serious Cardiac Adverse Reactions with Undiluted, Bolus or Rapid Intravenous Administration [see Warnings and Precautions (5.1)]
• Pulmonary Embolism due to Pulmonary Vascular Precipitates [see Warnings and Precautions (5.2)]
• Hyperkalemia [see Warnings and Precautions (5.3)]
• Hyperphosphatemia and Hypocalcemia [see Warnings and Precautions (5.4)]
• 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)]
  


Ari Logo (Potassium Phosphates Anda 216274 1)





RQ1103-A
Rev. 2/2022

NDC 0517-2051-01                            Rx only

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 15 mmol/5 mL
(3 mmol/mL)

Potassium 22 mEq/5 mL
(4.4 mEq/mL)

CAUTION: MUST BE DILUTED

For Intravenous use only

5 mL Single-Dose Vial  

Discard Unused Portion

5mlvial (Potassium Phosphates Anda 216274 2)

NDC 0517-2051-25                   25 x 5 mL

Potassium Phosphates          Single-Dose Vials

Injection, USP                          Discard Unused Portion

Phosphorus 15 mmol/5 mL  (3 mmol/mL)  Rx Only

Potassium 22 mEq/5 mL  (4.4 mEq/mL)

CAUTION: MUST BE DILUTED

For Intravenous use only

5mltray (Potassium Phosphates Anda 216274 3)

NDC 0517-2102-01    Rx only

POTASSIUM PHOSPHATES

INJECTION, USP

Phosphorus 45 mmol/15 mL

(3 mmol/mL)

Potassium 66 mEq/15 mL

(4.4 mEq/mL)

CAUTION: MUST BE DILUTED

For Intravenous use only

15 mL Single-Dose Vial

Discard Unused Portion  

15mlvial (Potassium Phosphates Anda 216274 4)

NDC 0517-2102-25                                                                   25 x 15 mL

Potassium Phosphates                                                          Single-Dose Vials

Injection, USP                                                                           Discard Unused Portion

Phosphorus 45 mmol/15 mL  (3 mmol/mL)                               Rx Only

Potassium 66 mEq/15 mL  (4.4 mEq/mL)

CAUTION: MUST BE DILUTED

For Intravenous use only

15mltray (Potassium Phosphates Anda 216274 5)

NDC 0517-2505-01                            Rx only

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 150 mmol/50 mL
(3 mmol/mL)

Potassium 220 mEq/50 mL
(4.4 mEq/mL)

Pharmacy Bulk Package - 

Not for Direct Infusion

CAUTION: MUST BE DILUTED

For Intravenous use only

50 mL Single-Dose Vial - Discard Unused Portion

50mlvial (Potassium Phosphates Anda 216274 6)

NDC 0517-2505-25                                                                   25 x 50 mL

Potassium Phosphates                                                          Pharmacy Bulk Package

Injection, USP                                                                           Not for Direct Infusion

Phosphorus 150 mmol/50 mL  (3 mmol/mL)                             Discard Unused Portion

Potassium 220 mEq/50 mL  (4.4 mEq/mL)                               Rx Only

CAUTION: MUST BE DILUTED

For Intravenous use only

50 mL Tray (Potassium Phosphates Anda 216274 7)