NDC 65219-054 Potassium Phosphates

Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic

NDC Product Code 65219-054

NDC 65219-054-29

Package Description: 25 VIAL, SINGLE-DOSE in 1 TRAY > 15 mL in 1 VIAL, SINGLE-DOSE (65219-054-09)

NDC Product Information

Potassium Phosphates with NDC 65219-054 is a a human prescription drug product labeled by Fresenius Kabi Usa, Llc. The generic name of Potassium Phosphates is potassium phosphate, monobasic potassium phosphate, dibasic. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

Labeler Name: Fresenius Kabi Usa, Llc

Dosage Form: Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Potassium Phosphates Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • POTASSIUM PHOSPHATE, MONOBASIC 224 mg/mL
  • POTASSIUM PHOSPHATE, DIBASIC 236 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.
  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)
  • Potassium Compounds - [CS]
  • Potassium Salt - [EPC] (Established Pharmacologic Class)
  • Osmotic Laxative - [EPC] (Established Pharmacologic Class)
  • Increased Large Intestinal Motility - [PE] (Physiologic Effect)
  • Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
  • Osmotic Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Fresenius Kabi Usa, Llc
Labeler Code: 65219
FDA Application Number: NDA212832 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-10-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Potassium Phosphates Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

Other

  • PreparationPotassium Phosphates Injection is for intravenous infusion into a central or peripheral vein only after dilution.Using aseptic technique, withdraw the required amount from the vial and add to 0.9% 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. Central)
  • Patient PopulationPeripheral Venous CatheterCentral Venous CatheterAdults and Pediatric Patients 12 Years of Age and Older
  • Phosphorus 6.8 mmol/100 mL(potassium 10 mEq/100 mL)
  • Phosphorus 18 mmol/100 mL(potassium 26.4 mEq/100 mL)
  • Pediatric Patients Less than 12 Years of Age
  • Phosphorus 0.27 mmol/10 mL(potassium 0.4 mEq/10 mL)
  • Phosphorus 0.55 mmol/10 mL(potassium 0.8 mEq/10 mL)
  • Visually inspect the solution for particulate matter and discoloration before and after dilution and prior to administration. Do not administer unless solution is clear, and seal on the vial is intact.

  • AdministrationCheck serum potassium and calcium concentrations prior to administration. Normalize the calcium before administering Potassium Phosphates Injection [see Contraindications (4), Warnings and Precautions (5.3,5.4)].
  • Potassium Phosphates Injection is only for administration to a patient with a serum potassium concentration less than 4 mEq/dL [see Warnings and Precautions (5.3)]. If the potassium concentration is 4 mEq/dL or more, use an alternative source of phosphorus.
  • Do not infuse with calcium-containing intravenous fluids [see Warnings and Precautions (5.4)].
  • The rate of administration may be dependent on the patient and the specific institution policy [see Dosage and Administration (2.2)].

  • Storage and StabilitySingle-Dose Vial (5 mL and 15 mL)
  • For single use only. Discard used vial, including any unused contents.
  • Pharmacy Bulk Package Vial (50 mL)
  • Penetrate vial closure only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents.
  • Use Potassium Phosphates Injection promptly once the sterile transfer set has been inserted into the Pharmacy Bulk Package vial or a maximum of 4 hours at room temperature 20°C to 25°C (68°F to 77°F) (25°C to 77°F) after the container closure has been penetrated. Discard any remaining drug.
  • After dilution, the solution is stable for a maximum of 4 hours at room temperature 20°C to 25°C (68°F to 77°F) or 14 days under refrigeration at 2°C to 8°C (36°F to 46°F).

Initial or Single DoseThe 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. The maximum initial or single dose of phosphorus is 45 mmol (potassium 66 mEq) [see Warnings and Precautions (5.1)].
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 [see Use in Specific Populations (8.6)].
Monitor serum phosphorus, potassium, calcium and magnesium serum concentrations.
TABLE 2: Recommended Initial or Single Dose of Potassium Phosphates Injection in Intravenous Fluids to Correct Hypophosphatemia in Adults and Pediatric Patients
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 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.
Serum Phosphorus ConcentrationaPhosphorus Dosageb, cCorresponding Potassium Content1.8 mg/dL to lower end of the reference range a0.16 mmol/kg to 0.31 mmol/kg
potassium0.23 mEq/kg to 0.46 mEq/kg
1 mg/dL to 1.7 mg/dL0.32 mmol/kg to 0.43 mmol/kg
potassium0.47 mEq/kg to 0.63 mEq/kgLess than 1 mg/dL0.44 mmol/kg to 0.64 mmol/kgcpotassium0.64 mEq/kg to 0.94 mEq/kg

  • Concentration and Intravenous Infusion RateThe concentration of the diluted solution [see Table 1, Dosage and Administration (2.1)] 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.
  • TABLE 3: Maximum Recommended Infusion Rate of Potassium Phosphates Injection for Adults and Pediatric Patients 12 Years of Age and Older
  • Route of AdministrationMaximum Infusion RatePeripheral Venous Catheter
  • Phosphorus 6.8 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
  • Potassium 0.5 mEq/kg/hour for pediatric patients weighing less than 20 kg

Repeated DosingAdditional 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.

  • StorageProtect the parenteral nutrition solution from light during storage.

  • StabilitySingle-Dose Vial (5 mL and 15 mL)For single use only. Discard used vial, including any unused contents.
  • Pharmacy Bulk Package Vial (50 mL)Penetrate vial closure only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents.
  • Use Potassium Phosphates Injection for admixing promptly once the sterile transfer set has been inserted into the Pharmacy Bulk Package vial or a maximum of 4 hours at room temperature 20°C to 25°C (68°F to 77°F) (25ºC to 77ºF) after the container closure has been penetrated. Discard any remaining drug.
  • Use parenteral nutrition solution containing Potassium Phosphates Injection promptly after mixing. Any storage of the admixture should be under refrigeration from 2°C to 8°C (36°F 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.

MonitoringMonitor serum phosphorus, potassium, calcium and magnesium concentrations and adjust the dosage accordingly.

Risk SummaryAdministration of the recommended dose of Potassium Phosphates Injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with Potassium Phosphates Injection.
The estimated 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 RiskPhosphorus is an essential mineral element. Parenteral supplementation with potassium phosphates should be considered if a pregnant woman's requirements cannot be fulfilled by oral or enteral intake.

Risk SummaryPhosphorus and potassium are present in human milk. Administration of the recommended dose of Potassium Phosphates Injection is not expected to cause harm to a breastfed infant. There is no information on the effects of potassium phosphates on milk production. The development and health benefits of breastfeeding should be considered along with the mother's clinical need for Potassium Phosphates Injection and any potential adverse effects on the breastfed child from Potassium Phosphates Injection or from underlying maternal condition.

HyperphosphatemiaAdministration of excessive doses of intravenous potassium phosphates in intravenous fluids as a single dose ranging from approximately 50 to 270 mmol phosphorus and/or at rapid infusion rates (over 1 to 3 hours) has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia, seizures, and tetany.
Hyperphosphatemia is particularly a risk in patients with renal failure. Hyperphosphatemia leads in turn to hypocalcemia, which may be severe, and to ectopic calcification, particularly in patients with initial hypercalcemia. Tissue calcification may cause hypotension and organ damage and result in acute renal failure.

  • HyperkalemiaExcessive administration of phosphates given as potassium salts may also cause hyperkalemia. Manifestations of hyperkalemia include:
  • Disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation
  • Hypotension
  • Muscle weakness including paresthesia, muscular and respiratory paralysis

ManagementIn the event of overdosage, discontinue infusions containing potassium phosphates immediately and institute general supportive measures, including ECG monitoring, laboratory monitoring, and correction of serum electrolyte concentrations, especially potassium, phosphorus, calcium, and magnesium.

DistributionApproximately 85% of serum phosphates is free and ultra-filterable and 15% is protein-bound.

EliminationIntravenously infused phosphates not taken up by the tissues are excreted almost entirely in the urine. Serum phosphorus is believed to be filterable by the renal glomeruli and the major portion of filtered phosphorus (greater than 80%) is actively reabsorbed by the tubules.

2.2 Dosage For Administration In Intravenous Fluids To Correct Hypophosphatemia

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.

2.3 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. 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)].

2.4 Dosage For Administration In Parenteral Nutrition

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.
TABLE 4: Recommended Daily Dosage of Potassium Phosphates Injection for Parenteral Nutrition for Adults and Pediatric Patients
a 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.
Patient PopulationGenerally Recommended Phosphorus Daily Dosage(Potassium Content)Preterm and Term InfantsLess than 12 Months
2 mmol/kg/day(potassium 2.9 mEq/kg/day)
Pediatric Patients1 year to Less Than 12 years
1 mmol/kg/day; up to 40 mmol/day(potassium 1.5 mEq/kg/day; up to 58.7 mEq/day)
Adults and Pediatric Patients12 Years of Age and Older
20 mmol/day to 40 mmol/daya(potassium 29.3 mEq/day to 58.7 mEq/day)

3 Dosage Forms And Strengths

  • 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.

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/1.73m2) 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)]

5.1 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 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)].

5.2 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. 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.

5.3 Hyperkalemia

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)].

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

5.5 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.
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)].

5.6 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.

5.7 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.
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)].

5.8 Laboratory Monitoring

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

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 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 ClassAdverse ReactionsMetabolism and Nutrition Disorderspulmonary 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 Disordershypotension, arrhythmia, heart block, cardiac arrest, bradycardia, chest pain, ECG changes [see Warnings and Precautions (5.1)], and edema
  • Respiratory, Thoracic, and Mediastinal Disordersdyspnea [see Warnings and Precautions (5.2)]Renal and Urinary Disordersacute 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 Disordersdiarrhea, stomach pain
  • Musculoskeletal and Connective Tissue Disordersweakness
  • Nervous System Disordersconfusion, lethargy, paralysis, paresthesia

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)].

8.4 Pediatric Use

  • 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)].

8.5 Geriatric Use

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)].

8.6 Renal Impairment

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)].

11 Description

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.

12.1 Mechanism Of Action

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.

16 How Supplied/Storage And Handling

Potassium Phosphates Injection, USP is a clear and colorless solution supplied as phosphorus 3 mmol/mL and potassium 4.4 mEq/mL as shown:
Product Code
Unit of Sale
Strength
Each
860529
NDC 65219-052-29Tray containing 25 units
Phosphorus 15 mmol/5 mL andPotassium 22 mEq/5 mLNDC 65219-052-095 mL single dose, plastic vial
860539
NDC 65219-054-29Tray containing 25 units
Phosphorus 45 mmol/15 mL andPotassium 66 mEq/15 mLNDC 65219-054-0915 mL single dose, plastic vial
860569
NDC 65219-056-29Tray containing 25 units
Phosphorus 150 mmol/50 mL andPotassium 220 mEq/50 mLNDC 65219-056-0950 mL fill Pharmacy Bulk Package, plastic vial.
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.

17 Patient Counseling Information

  • 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)]Manufactured by:
  • Lake Zurich, IL 60047www.fresenius-kabi.com/us451653Issued: November 2019

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