Potassium phosphates injection
Potassium phosphates injection
The first FDA-approved potassium phosphates injection formulation available, this is a safe and consistent choice for phosphate replacement, providing lower aluminum levels than the current unapproved version.
Why Potassium Phosphates Injection from CMP Pharma?
- It’s the first FDA-approved formulation available
- Market friendly priceCompetitively priced to ensure institutions and HCPs have the choice to purchase cost effective solutions for their patients.
- It addresses concerns from previous shortages of potassium phosphatesThe current phosphate repletion treatment market is strained due to previous shortages from unapproved versions. Potassium Phosphates Injection helps alleviate these shortages by providing a consistent supply of an FDA-approved formulation.
Potassium Phosphates Injection is indicated as a source of phosphorus in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated. Additionally, it is indicated as a source of phosphorous for parenteral nutrition in adults weighing at least 45 kg and pediatric patients 12 years of age and older weighing at least 40 kg when oral or enteral nutrition is not possible, insufficient or contraindicated as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE
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 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated.
- for parenteral nutrition in adults weighing at least 45 kg and pediatric patients 12 years of age and older weighing at least 40 kg when oral or enteral nutrition is not possible, insufficient or contraindicated.
- Limitations of Use: Safety has not been established for parenteral nutrition in adults weighing less than 45 kg or pediatric patients less than 12 years of age or weighing less than 40 kg due to the risk of aluminum toxicity.
- hypercalcemia or significant hypocalcemia
- severe renal impairment (eGFR less than 30 mL/min/1.73m2) and end stage renal disease
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.
- Pulmonary Embolism due to Pulmonary Vascular Precipitates: If signs of pulmonary distress occur, stop the infusion and initiate a medical evaluation.
- 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.
- Hyperphosphatemia and Hypocalcemia: Monitor serum phosphorus and calcium concentrations during and following infusion.
- Aluminum Toxicity: Increased risk in patients with renal impairment, including preterm infants.
- Hypomagnesemia: Reported in patients with hypercalcemia and diabetic ketoacidosis. Monitor serum magnesium concentrations during treatment.
- Vein Damage and Thrombosis: Infuse concentrated or hypertonic solutions through a central catheter.
- Use of Other Medications that Increase Potassium: Avoid use in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations.
DOSAGE AND ADMINISTRATION
- Administer intravenously only after dilution or admixing in a larger volume of fluid.
- POTASSIUM PHOSPHATES INJECTION provides phosphorus 3 mmol/mL (potassium 4.7 mEq/mL).
- Monitor serum phosphorus, potassium, calcium, and magnesium concentrations.
- See full prescribing information for instructions on preparation and administration.
Adverse reactions are hyperkalemia, hyperphosphatemia, hypocalcemia and hypomagnesemia.