Potassium Phosphates In Sodium Chloride
FDA Drug Information • Also known as: Potassium Phosphates
- Brand Names
- Potassium Phosphates
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION Potassium Phosphates in 0.9% Sodium Chloride Injection, for intravenous use, is a phosphorus replacement product containing phosphorus 0.06 mmol/mL and potassium 0.088 mEq/mL. It is a sterile, non-pyrogenic, ready-to-use diluted solution containing a mixture of monobasic potassium phosphate, USP and dibasic potassium phosphate, USP in 0.9% sodium chloride. No dilution is required before administration. It is supplied in 250 mL single-dose intravenous infusion bag. 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 4.48 mg of monobasic potassium phosphate, USP and 4.72 mg of dibasic potassium phosphate, USP. Each mL contains phosphorus, 0.06 mmol (equivalent to 1.86 mg phosphorus); potassium, 0.088 mEq (equivalent to 3.40 mg of potassium); sodium chloride, USP, 9 mg and water for injection, USP (q.s.). Note: 1 mmol of phosphorus is equal to 1 mmol phosphate. This product contains no more than 25 mcg/L of aluminum. The pH is 5.8 to 7.2 and the osmolarity is 0.455 mOsmol/mL (calc).
What Is Potassium Phosphates In Sodium Chloride Used For?
1 INDICATIONS AND USAGE Potassium Phosphates in Sodium Chloride Injection is indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient, or contraindicated. Potassium Phosphates in Sodium Chloride Injection is a phosphorus replacement product indicated as a source of phosphorus to correct hypophosphatemia in adults and pediatric patients who weigh 40 kg or greater when oral or enteral replacement is not possible, insufficient or contraindicated. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION 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. Otherwise, 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 ) Use of this potassium phosphates in sodium chloride injection product increases the risk of hyperkalemia in patients weighing less than 40 kg, including life threatening cardiac events. ( 5.3 ) See full prescribing information for important administration instructions. ( 2.2 ) Recommended Dosage This product contains phosphorus 15 mmol and potassium 22 mEq (phosphorus 0.06 mmol/mL and potassium 0.088 mEq/mL). ( 2.3 ) Monitor serum phosphorus, potassium, calcium and magnesium concentrations. ( 2.3 ) See full prescribing information for recommendations on initial or single dosing, repeated dosing, concentration and infusion rate. ( 2.1 , 2.2 , 2.3 ) 2.1 Important Preparation Instructions Potassium Phosphates in Sodium Chloride Injection is for intravenous infusion into a central or peripheral vein. No dilution of this product is required. 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 a dose of potassium phosphate is required that does not equal 15 mmoL of Potassium phosphates in Sodium Chloride Injection, then an alternative formulation of potassium phosphates should be considered. Visually inspect the solution for particulate matter and discoloration prior to administration. Do not administer unless solution is clear. Always inspect the solution container before and after removal from the pouch. Place the solution container on a clean, flat surface. Remove the solution container from the pouch. Check the solution container for leaks by squeezing firmly. Discard if leaks are found. Immediately before inserting the infusion set, remove twist-off port from the infusion bag. Use a non-vented infusion set or close the air-inlet on a vented set. Close the roller clamp of the infusion set. Hold the base of the infusion port, twist, and push spike until fully inserted. The infusion port contains a membrane that helps prevent leakage after removing the spike. The infusion port is not intended to be spiked more than once. Suspend solution container from hanger hole. For single-dose only. Discard unused portion. 2.2 Important Administration Instructions Check serum potassium and calcium concentrations prior to administration. Normalize the serum calcium level before administering Potassium Phosphates in Sodium Chloride...
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypomagnesemia [see Warnings and Precautions (5.5) ] Vein Damage and Thrombosis [see Warnings and Precautions (5.6) ] The following adverse reactions in Table 3 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. TABLE 3: Adverse Reactions Reported in Clinical Studies or Post-marketing 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 (5.4) ] , 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 Amneal Pharmaceuticals LLC at 1-877-835-5472 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 ) 7.1 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, in particular in the presence of other risk factors for hyperkalemia [see Warnings and Precautions (5.3) ] . 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 (2.2) ] .
Contraindications
4 CONTRAINDICATIONS Potassium Phosphates in Sodium Chloride Injection is contraindicated in patients with: hyperkalemia [see Warnings and Precautions (5.3) ] hyperphosphatemia [see Warnings and Precautions (5.4) ] hypercalcemia or significant hypocalcemia [see Warnings and Precautions (5.4) ] severe renal impairment (eGFR less than 30 mL/min/1.73m 2 ) or end stage renal disease [see Warnings and Precautions (5.3) ] hyperkalemia. ( 4 ) hyperphosphatemia. ( 4 ) hypercalcemia or significant hypocalcemia. ( 4 ) severe renal impairment (eGFR less than 30 mL/min/1.73 m 2 ) or end stage renal disease. ( 4 )
Pregnancy and Breastfeeding
8.1 Pregnancy Risk Summary Administration of the recommended dose of Potassium Phosphates in Sodium Chloride Injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider potassium phosphate replacement if correction of hypophosphatemia via the enteral route is not possible (see Clinical Considerations). Animal reproduction studies have not been conducted with Potassium Phosphates in Sodium Chloride Injection. The 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. Intravenous replacement with potassium phosphate should be considered if a pregnant woman requires intravenous replacement to correct hypophosphatemia when the enteral route is not possible, insufficient or contraindicated.
Overdosage
10 OVERDOSAGE 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. 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.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Phosphates in 0.9% Sodium Chloride Injection is a clear, colorless solution filled in an intravenous infusion bag containing phosphorus 15 mmol/250 mL (0.06 mmol/mL) and potassium 22mEq/250mL (0.088 mEq/mL). It is supplied as: One 250 mL Single-dose Infusion Bag in a Pouch: NDC 70121-1722-1 24 Pouches in a Shipper (Unit of sale): NDC 70121-1722-9 Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep covered in a pouch until time of use. Each ready-to-use infusion bag contains no preservatives. Once the ready-to-use infusion bag has been removed from the pouch, the ready-to-use infusion bag should be used within 24 hours, with any unused portion discarded.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.