Sodium Phosphates 142 mg/mL
sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
Sodium Phosphates is a injection, solution containing sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous at 142 mg/mL, taken intravenous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- Sodium Phosphates
- Generic Name
- sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous
- NDC Code (Product)
63323-881- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 142 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA209997
- Marketing Start
- 03/30/2022
Recall History
Central Admixture Pharmacy Services, Inc.
Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE Sodium phosphates injection, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na + 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.
Dosage & Administration
DOSAGE & ADMINISTRATION Sodium phosphates injection, 3 mM P/mL is administered intravenously only after dilution and thorough mixing in a larger volume of fluid. The dose and rate of administration are dependent upon the individual needs of the patient. Serum sodium, phosphorus and calcium levels should be monitored as a guide to dosage. Using aseptic technique, all or part of the contents of one or more vials may be added to other intravenous fluids to provide any desired number of millimoles (mM) of phosphorus. In patients on total parenteral nutrition, approximately 12 to 15 mM of phosphorus (equivalent to 372 to 465 mg elemental phosphorus) per liter bottle of TPN solution containing 250 g dextrose is usually adequate to maintain normal serum phosphorus, though larger amounts may be required in hypermetabolic states. The amount of sodium and phosphorus which accompanies the addition of sodium phosphate also should be kept in mind, and if necessary, serum sodium levels should be monitored. The suggested dose of phosphorus for infants receiving TPN is 1.5 to 2 mM P/kg/day. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to admi…
Warnings
WARNINGS Sodium phosphates injection, 3 mM P/mL must be diluted and thoroughly mixed before use. To avoid phosphorus intoxication, infuse solutions containing sodium phosphate slowly. Infusing high concentrations of phosphorus may result in a reduction of serum calcium and symptoms of hypocalcemic tetany. Calcium levels should be monitored. Solutions containing sodium ions should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention. In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accum…
Contraindications
CONTRAINDICATIONS Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.
Adverse Reactions
ADVERSE REACTIONS Adverse reactions involve the possibility of phosphorus intoxication. Phosphorus intoxication results in a reduction of serum calcium and the symptoms are those of hypocalcemic tetany. See WARNINGS . To report SUSPECTED ADVERSE REACTIONS, contact Caplin Steriles Limited at 1-866-978-6111 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Sodium Phosphates used for?
Sodium Phosphates contains sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Sodium Phosphates a controlled substance?
Sodium Phosphates is not classified as a controlled substance by the DEA.
What is the generic name for Sodium Phosphates?
The generic name for Sodium Phosphates is sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous. There are no other listed brand versions of sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous.
What is the NDC code for Sodium Phosphates 142 mg/mL?
The NDC (National Drug Code) for Sodium Phosphates 142 mg/mL is 63323-881, listed by Fresenius Kabi USA, LLC.
Other Sodium Phosphates Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)