potassium phosphates in 0.9% sodium chloride
Pharmaranks rates Potassium Phosphates in 0.9% Sodium Chloride 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Potassium Phosphates in 0.9% Sodium Chloride is a combination medicine containing Potassium Phosphate, Dibasic, Potassium Phosphate, and Monobasic.
Potassium Phosphate, Dibasic and Potassium Phosphate, Monobasic · by Fresenius Kabi USA
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Potassium Phosphate, Dibasic and Potassium Phosphate, Monobasic
- Form
- Injectable, Solution
- Strength
- Potassium PHOSPHATE, Dibasic 1.18GM/100ML (11.8MG/ML); Potassium PHOSPHATE, Monobasic 1.12GM/100ML (11.2MG/ML) · Potassium PHOSPHATE, Dibasic 1.18GM/250ML (4.72MG/ML); Potassium PHOSPHATE, Monobasic 1.12GM/250ML (4.48MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Fresenius Kabi USA
- FDA application
- NDA212832
What is Potassium Phosphates in 0.9% Sodium Chloride?
From the FDA label:Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product. It is a sterile, non-pyrogenic, solution containing a mixture of monobasic potassium phosphate and dibasic potassium phosphate in sodium chloride. It is supplied as a 100 mL and 250 mL ready-to-use single dose container for intravenous use and does not require further dilution. 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. For 100 mL single-dose container: Each mL contains 11.2 mg of monobasic potassium phosphate and 11.8 mg of dibasic potassium phosphate. Each mL contains 0.15 mmol phosphorus (equivalent to 4.65 mg phosphorus), and 0.22 mEq potassium (equivalent to 8.50 mg of potassium). For 250 mL single-dose container: Each mL contains 4.48 mg of monobasic potassium phosphate and 4.72 mg of dibasic potassium phosphate. Each mL contains 0.06 mmol phosphorus (equivalent to 1.86 mg phosphorus), and 0.088 mEq potassium (equivalent to 3.40 mg of potassium). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. In addition, each mL of solution contains 9 mg sodium chloride for isotonicity. The pH is 6.0 to 7.0. This product contains no more…
How to use
Potassium Phosphates in 0.9% Sodium Chloride is sold in more than one form (Injectable and Solution), and each is dosed differently. The instructions below come from the FDA label for application NDA212832 — follow the label that came with the product you were actually prescribed.
Important Preparation Instructions • Do NOT dilute prior to administration. ( 2.1 ) • Use this potassium phosphates in sodium chloride injection product only in patients who require the entire 15 mmoL phosphorus dose (potassium 22 mEq) and not any fraction thereof. If the entire 15 mmol phosphorus dose is not required, consider an alternative formulation of potassium phosphate. ( 2.1 ) Important Administration Instructions • Potassium Phosphates in Sodium Chloride 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. ( 2.2 ) • This product contains phosphorus 15 mmol and potassium 22 mEq. ( 2.2 ) o The 100 mL ready-to-use container is for intravenous infusion into a central vein. o The 250 mL ready-to-use container is for intravenous infusion into a central or peripheral vein. Recommended Dosage • See full prescribing information for recommendations on initial or single dosing, repeated dosing, concentration and infusion rate. ( 2.3 ) • Monitor serum phosphorus, potassium, calcium, and magnesium concentrations. ( 2.3 ) • Patients with moderate renal impairment should start at the low end of the dosage range. Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with severe renal impairment. ( 2.4 , 4 ) 2.1 Important Preparation Instructions •…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Cardiac Adverse Reactions with Bolus or Rapid Intravenous Administration [see Warnings and Precautions ( 5.1 )] • Hyperkalemia [see Warnings and Precautions ( 5.2 )] • Pulmonary Embolism due to Pulmonary Vascular Precipitates [see Warnings and Precautions ( 5.3 )] • Hyperphosphatemia and Hypocalcemia [see Warnings and Precautions ( 5.4 )] • Hypomagnesemia [see Warnings and Precautions ( 5.5 )] • Vein Damage and Thrombosis [see Warnings and Precautions ( 5.6 )] The following adverse reactions have been reported in clinical studies or post-marketing 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. Metabolism and Nutrition Disorders: hyperkalemia, hyperphosphatemia, hypocalcemia, hypovolemia, osmotic diuresis, pulmonary embolism Cardiac Disorders: arrhythmia, bradycardia, cardiac arrest, chest pain, ECG changes, edema, heart block, hypotension Respiratory, Thoracic, and Mediastinal Disorders: dyspnea Renal and Urinary Disorders: acute phosphate nephropathy (i.e., nephrocalcinosis with acute kidney injury), decreased urine output,…
Warnings
Important safety information
Serious Cardiac Adverse Reactions with Bolus, or Rapid Intravenous Administration : Do not exceed the recommended infusion rate. Continuous electrocardiographic (ECG) monitoring may be needed during infusion. ( 2.3 , 5.1 ) • 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. ( 5.2 , 7.1 ) • Pulmonary Embolism due to Pulmonary Vascular Precipitates : If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation. ( 5.3 ) • Hyperphosphatemia and Hypocalcemia : Monitor serum phosphorus and calcium concentrations during and following infusion. ( 5.4 ) • Hypomagnesemia : Reported in patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment. ( 5.5 ) • Vein Damage and Thrombosis : Infuse hypertonic solutions through a central catheter. ( 2.1 , 5.6 ) 5.1 Serious Cardiac Adverse Reactions with 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) has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia, and seizures [see Overdosage ( 10 )] . Continuous electrocardiographic (ECG) monitoring is recommended for infusion rates higher than potassium 10 mEq/hour [see Dosage and Administration ( 2.1 , 2.2 )] . 5.2 Hyperkalemia Potassium Phosphates in Sodium Chloride Injection may increase the risk of hyperkalemia, including life-threatening cardiac events, especially when administered in excessive doses or by rapid intravenous infusion [see Warnings and Precautions ( 5.1 )] . Patients with renal impairment and are at increased risk of developing life-threatening hyperkalemia, when administered intravenous potassium. Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ) and dosage adjustment is required for patients with moderate renal impairment (eGFR ≥30 mL/min/1.73 m 2 to <60 mL/min/1.73 m 2 ) [see Dosage and Administration ( 2.2 ), Contraindications ( 4 ), Use in Specific Populations ( 8.6 )] . 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 adverse effects of hyperkalemia. Consider the amount of potassium from all sources when determining the dose of Potassium Phosphates in Sodium Chloride Injection and do not exceed the maximum age-appropriate recommended daily amount of potassium. When administering Potassium Phosphates in Sodium Chloride Injection to correct hypophosphatemia, check the serum potassium concentration prior to administration [see Dosage and Administration ( 2.2 )] . Continuous electrocardiographic (ECG) monitoring is recommended for infusion rates higher than 10 mEq/hour [see Warnings and Precautions ( 5.1 ), Dosage and Administration ( 2.3 )] . 5.3 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 infusion and initiate a medical evaluation. In addition to inspection of the solution, the infusion set and catheter should also be checked periodically for precipitates. [see Dosage and Administration ( 2.1 )]. 5.4 Hyperphosphatemia and Hypocalcemia Hyperphosphatemia can occur with intravenous administration of potassium phosphates, especially in patients with renal impairment [see Contraindications ( 4 )] . 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 in Sodium Chloride Injection. Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with hyperphosphatemia and/or hypercalcemia [see Contraindications ( 4 )] . Monitor serum phosphorus and calcium concentrations during treatment with Potassium Phosphates in Sodium Chloride Injection [see Dosage and Administration ( 2.3 )] . 5.5 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. 5.6 Vein Damage and Thrombosis 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 to correct hypophosphatemia, a generally recommended maximum concentration is phosphorus 6.8 mmol/100 mL (potassium 10 mEq/100 mL) [see Dosage and Administration ( 2.2 )]. 5.7 Laboratory Monitoring Monitor serum phosphorus, potassium, calcium, and magnesium concentrations during treatment [see Dosage and Administration ( 2.3 )] .
Who should not take Potassium Phosphates in 0.9% Sodium Chloride
Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with: • hyperkalemia [see Warning and Precautions ( 5.2 )] • 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 ) [see Warning and Precautions ( 5.2 )] • hyperkalemia ( 4 ) • hyperphosphatemia ( 4 ) • hypercalcemia or significant hypocalcemia ( 4 ) • severe renal impairment (eGFR less than 30 mL/min/1.73m 2 ) ( 4 )
Overdose — what happens if you take too much
Hyperphosphatemia Administration of excessive doses of intravenous potassium phosphates 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, and death. • 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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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. ( 5.2 , 7.1 ) 7.1 Other Products that Increase Serum Potassium Administration of Potassium Phosphates in Sodium Chloride Injection to patients treated concurrently or recently with products that increase serum potassium (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, digoxin, or the immunosuppressants tacrolimus and cyclosporine) increases the risk of severe and potentially fatal hyperkalemia, especially in the presence of other risk factors for hyperkalemia [see Warnings and Precautions ( 5.2 )] . Avoid use of Potassium Phosphates in Sodium Chloride Injection in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations [see Dosage and Administration ( 2.3 )] .
Dosage forms
Injectable and Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- How is Potassium Phosphates in 0.9% Sodium Chloride rated?
- pharmaranks gives Potassium Phosphates in 0.9% Sodium Chloride a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Potassium Phosphates in 0.9% Sodium Chloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Potassium Phosphates in 0.9% Sodium Chloride. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Potassium Phosphates in 0.9% Sodium Chloride?
- Potassium Phosphates in 0.9% Sodium Chloride is marketed by Fresenius Kabi USA. You can see Fresenius Kabi USA's full profile, rating, and other products on pharmaranks.
- Is Potassium Phosphates in 0.9% Sodium Chloride a brand-name or generic drug?
- Potassium Phosphates in 0.9% Sodium Chloride is a brand-name product with the active ingredient Potassium Phosphate, Dibasic and Potassium Phosphate, Monobasic.
- Is Potassium Phosphates in 0.9% Sodium Chloride available over the counter?
- No. Potassium Phosphates in 0.9% Sodium Chloride is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Potassium Phosphates in 0.9% Sodium Chloride come in?
- Potassium Phosphates in 0.9% Sodium Chloride is currently marketed as injectable and solution, per the FDA's National Drug Code Directory.
- Is Potassium Phosphates in 0.9% Sodium Chloride FDA-registered?
- Potassium Phosphates in 0.9% Sodium Chloride is on record with the U.S. FDA under application number NDA212832. You can verify this on its official FDA label.
- Has Potassium Phosphates in 0.9% Sodium Chloride been recalled by the FDA?
- Potassium Phosphates in 0.9% Sodium Chloride has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Potassium Phosphates in 0.9% Sodium Chloride safe?
- There's no single safe-or-not verdict. pharmaranks gives Potassium Phosphates in 0.9% Sodium Chloride a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Potassium Phosphates in 0.9% Sodium Chloride?
- Potassium Phosphates in 0.9% Sodium Chloride's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Cardiac Adverse Reactions with Bolus or Rapid Intravenous Administration [see Warnings and Precautions ( 5.1 )] • Hyperkalemia [see Warnings and Precautions ( 5.2 )] • Pulmonary Embolism due to… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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