pharmacopeia
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Mechanism of action

Sourced from openFDA

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.

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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/1.73m 2 ) or end stage renal disease [see Warning and Precautions (5.3)] hyperkalemia (4) hyperphosphatemia (4) hypercalcemia or significant hypocalcemia (4) severe renal impairment (eGFR less than 30 mL/min/1.73m 2 ) or end stage renal disease (4)contraindicated

Dosage & administration

Sourced from openFDA

Administer intravenously only after dilution or admixing in a larger volume of fluid. (2.1) Potassium Phosphates Injection provides phosphorus 3 mmol/mL (potassium 4.4 mEq/mL). (2.2, 2.4) Monitor serum phosphorus, potassium, calcium, and magnesium concentrations. (2.2, 2.4) See full prescribing information for instructions on preparation and administration. (2.1, 2.3) 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. (2.1) The dosage is dependent upon the individual needs of the patient, and the contribution of phosphorus and potassium from other sources. (2.2) See full prescribing information for recommendations on initial or single dosing, repeated dosing, concentration and infusion rate. (2.1, 2.2) 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. (2.4) See full prescribing information for recommendations for daily and maximum dosage. (2.4) 2.1 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 .

Warnings & precautions

Sourced from openFDA

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. (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. (5.3, 7.1) Hyperphosphatemia and Hypocalcemia: Monitor serum phosphorus and calcium concentrations during and following infusion. (5.4) Aluminum Toxicity : Increased risk in patients with renal impairment, including preterm infants. (5.5, 8.4). Hypomagnesemia : Reported in patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment. (5.6) Vein Damage and Thrombosis : Infuse concentrated or hypertonic solutions through a central catheter.

Adverse reactions

Sourced from openFDA

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)] Ga…

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Administration 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 Risk Phosphorus 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. 8.2 Lactation Risk Summary Phosphorus 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.

Pharmacokinetics

Sourced from openFDA
Metabolism
Distribution Approximately 85% of serum phosphates is free and ultra-filterable and 15% is protein-bound. Elimination Intravenously infused phosphates not taken up by the tissues are excreted almost entirely in the urine.

Overdosage

Sourced from openFDA

Hyperphosphatemia Administration 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. Hyperkalemia Excessive administration of phosphates given as potassium salts may also cause hyperkalemia.

Approval history

Sourced from openFDA
  • Feb 2, 1979NDANDA017484Baxter Hlthcare
  • Feb 19, 1982NDANDA018508Baxter Hlthcare
  • May 8, 1986NDANDA019513Otsuka Icu Medcl
  • Sep 29, 1989NDANDA019696B Braun
  • Jun 10, 1993NDANDA019873B Braun
  • Mar 26, 1997NDANDA020678Baxter Hlthcare
  • Nov 26, 2019NDANDA212832Fresenius Kabi Usa
  • Oct 2, 2023ANDAANDA216274Am Regent

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,140 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Diarrhoea2237.1%
  2. 2Off Label Use2116.7%
  3. 3Fatigue1906.1%
  4. 4Rash1886.0%
  5. 5Nausea1835.8%
  6. 6Pain1725.5%
  7. 7Infection1685.4%
  8. 8Drug Ineffective1615.1%
  9. 9Sleep Disorder1534.9%
  10. 10Product Use Issue1514.8%
  11. 11Pneumonia1454.6%
  12. 12Dyspnoea1304.1%
  13. 13Vomiting1233.9%
  14. 14Pyrexia1213.9%
  15. 15Death1193.8%

Literature

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Recent PubMed references pinned to Potassium Phosphate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 97 ClinicalTrials.gov registrations naming Potassium Phosphate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Potassium Phosphate work?
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.
What is Potassium Phosphate used for?
According to FDA labeling, Potassium Phosphate carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Potassium Phosphate?
Potassium Phosphate is classified as Acid-Base Activity, Electrolyte Activity, Cellular Activity Alteration, Organized Electrical Activity Alteration.
What are the brand names for Potassium Phosphate?
Potassium Phosphate is marketed under brand names including Ionosol-MB, Isolyte S, Isolyte S in 5 % Dextrose, K-Phos, K-Phos Neutral, K-Phos No 2, Phospha 250 Neutral, Tis-U-Sol.
What are the contraindications for Potassium Phosphate?
Potassium Phosphate labeling lists contraindications including: 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/1.73m 2 ) or end stage renal disease [see Warning and Precautions (5.3)] hyperkalemia (4) hyperphosphatemia (4) hypercalcemia or significant hypocalcemia (4) severe renal impairment (eGFR less than 30 mL/min/1.73m 2 ) or end stage renal disease (4). Always consult the full prescribing information and a clinician.
Note. Data for potassium-phosphate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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