Potassium Phosphates Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic 224 mg/mL; 236 mg/mL Injection, Solution, Concentrate — NDC 72572-232-25 (Billing 72572-0232-25)
This is a package of Potassium Phosphates Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic 224 mg/mL; 236 mg/mL Injection, Solution, Concentrate from CIVICA, INC., marketed since Feb 2020 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 001285
- GCN: 03591
- HICL (First Databank): 000551
- AHFS class code: 40:12.00.00
- RxCUI (RxNorm): 1928569
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
- Great question. This IV form is used when your phosphate levels are too low to safely wait for a pill to work, or when you're not able to eat or take anything by mouth right now. I...
- Why am I getting this through an IV instead of just taking a phosphorus pill?
- It depends on how serious your kidney issues are. If you have severe kidney disease or are on dialysis, this specific product cannot be used — your kidneys would struggle to clear...
- Is it safe to get this if I have kidney problems?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 72572-0232-25 You're viewing this Main listing | 25 VIAL, SINGLE-DOSE in 1 TRAY / 15 mL in 1 VIAL, SINGLE-DOSE | 2026-07-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Potassium Phosphates 224 mg/mL; 236 mg/mL 00409-0032-01 | Hospira, | 25 vials | — | AP | FDA listed | — |
| Potassium Phosphates 224 mg/mL; 236 mg/mL 00517-2102-25 | American | 25 vials | — | AP | FDA listed | — |
| Potassium Phosphates 224 mg/mL; 236 mg/mL 65145-0195-25 | Caplin | 25 vials | — | AP | FDA listed | — |
| Potassium Phosphates 224 mg/mL; 236 mg/mL 65219-0054-29 | Fresenius | 25 vials | — | AP | FDA listed | — |
| Potassium Phosphates 224 mg/mL; 236 mg/mL 68462-0787-25 | GLENMARK | 25 vials | — | AP | FDA listed | — |
| Potassium Phosphates 224 mg/mL; 236 mg/mL 69097-0077-97 | Cipla | 25 vials | — | AP | FDA listed | — |
| Potassium Phosphate 224 mg/mL; 236 mg/mL 70069-0747-25 | Somerset | 25 bottles | — | AP | FDA listed | — |
| Potassium Phosphates 224 mg/mL; 236 mg/mLthis 72572-0232-25 | CIVICA, | 25 vials | — | AP | FDA listed | — |
| Potassium Phosphates 224 mg/mL; 236 mg/mL 80830-1691-02 | Amneal | 10 vials | — | AP | FDA listed | — |
| Potassium Phosphates 224 mg/mL; 236 mg/mL 65219-0052-29 | Fresenius | 25 vials | — | AP | FDA listed | — |
| Potassium Phosphates 224 mg/mL; 236 mg/mL 65219-0056-29 | Fresenius | 25 vials | — | AP | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11925661 ↗ | Method of use | U-4185 | Oct 12, 2041 |
| US 11925661 ↗ | Method of use | U-4185 | Oct 12, 2041 |
| US 11813291 ↗ | Method of use | U-4185 | Oct 12, 2041 |
| US 11813291 ↗ | Method of use | U-4185 | Oct 12, 2041 |
Is there a generic version of POTASSIUM PHOSP 45 MMOL/15 ML?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
1 inactive ingredient listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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. Potassium Phosphates Injection is a phosphorus replacement product 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.
( 1 ) • for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • 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 )
2.1Preparation 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. • 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 Population Peripheral Venous Catheter Central Venous Catheter Adults 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. Administration • Check 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 Stability • Single-Dose Vial (15 mL) o 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 tempe… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Potassium Phosphates Injection, USP is a clear and colorless solution supplied as: • phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 66 mEq/15 mL (4.4 mEq/mL) in a single-dose vial. Injection: • phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 66 mEq/15 mL (4.4 mEq/mL) in a single-dose vial. ( 3 )
⛔ Contraindications ▾
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/1.73m 2 ) 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 )] • 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 )
⚠️ Warnings and Cautions ▾
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. ( 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.
( 2.1 , 2.3 , 5.7 )
5.1Serious 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 )] .
5.2Pulmonary 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.
5.3Hyperkalemia 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 concur… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
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 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 Adverse reactions include hyperkalemia, hyperphosphatemia, hypocalcemia, and hypomagnesemia.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS 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 )
7.1Other 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 )] .
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric 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 ( 5.5 )] .
🧓 Geriatric Use ▾
8.5Geriatric 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 )] .
🆘 Overdosage ▾
10 OVERDOSAGE 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. 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 Management In 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.3Pharmacokinetics 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. 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.
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
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 CV860539 NDC 72572-232-25 Tray containing 25 units Phosphorus 45 mmol/15 mL and Potassium 66 mEq/15 mL NDC 72572-232-01 15 mL single dose, plastic vial Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. For storage of admixed solution [see Dosage and Administration ( 2.1 , 2.3 )]
📋 Description ▾
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 15 mL single-dose vial.
Monobasic Potassium Phosphate is chemically designated KH 2 PO 4 , molecular weight 136.09, white, odorless crystals or granules freely soluble in water. Dibasic Potassium Phosphate is chemically designated K 2 HPO 4 , 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 900 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.
💬 Information for Patients ▾
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 )] Distributed by: Civica, Inc.
Lehi, Utah 84048 U.S. Patent 12,539,283 451873 potas-img-01.jpg
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics 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. 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.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 15 mL Vial Label NDC 72572- 232 -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 CV860539 potas-label-01.jpg
PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Phosphates Inj, USP 15 mL Tray Label NDC 72572- 232 -25 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 25 x 15 mL Single-Dose Vials Discard Unused Portion CV860539 potas-label-02.jpg
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