Sodium Phosphate, Monobasic, Monohydrate And Sodium Phosphate, Dibasic Anhydrous

Generic Name: sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous

Over-the-Counter (OTC)

Brand Names:

Sodium Phosphates

DESCRIPTION Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted.

Overview

DESCRIPTION Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. It must not be administered undiluted.

Uses

INDICATIONS AND USAGE Sodium Phosphates Injection, USP, 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

DOSAGE AND ADMINISTRATION Sodium Phosphates Injection, USP, 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.

Side Effects

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 American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnings

WARNINGS Sodium Phosphates Injection, USP, 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. CONTRAINDICATIONS Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.

Storage

HOW SUPPLIED Sodium Phosphates Injection, USP, 3mM P/mL is supplied as a clear, colorless solution as per below. Unit of Sale Concentration Unit of Use NDC 72572-309-25 Tray containing 25 vials 15 mM P/5 mL (3 mM P/mL) containing 20 mEq Na + /5 mL (4 mEq/mL) NDC 72572-309-01 5 mL Single-Dose Plastic Vial Each container is partially filled to provide air space needed for complete vacuum withdrawal...

Frequently Asked Questions

What is Sodium Phosphate, Monobasic, Monohydrate And Sodium Phosphate, Dibasic Anhydrous used for?

INDICATIONS AND USAGE Sodium Phosphates Injection, USP, 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.

What are the side effects of Sodium Phosphate, Monobasic, Monohydrate And Sodium Phosphate, Dibasic Anhydrous?

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 American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the important warnings for Sodium Phosphate, Monobasic, Monohydrate And Sodium Phosphate, Dibasic Anhydrous?

WARNINGS Sodium Phosphates Injection, USP, 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. CONTRAINDICATIONS Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.