Drug Facts
Composition & Profile
Identifiers & Packaging
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 0517-7305-25 Tray containing 25 vials 15 mM P/5 mL (3 mM P/mL) containing 20 mEq Na + /5 mL (4 mEq/mL) NDC 0517-7305-01 5 mL Single-Dose Plastic Vial NDC 0517-7315-25 Tray containing 25 vials 45 mM P/15 mL (3 mM P/mL) containing 60 mEq Na + /15 mL (4 mEq/mL) NDC 0517-7315-01 15 mL Single-Dose Plastic Vial NDC 0517-7350-25 Tray containing 25 vials 150 mM P/50 mL (3 mM P/mL) containing 200 mEq Na + /50 mL (4 mEq/mL) NDC 0517-7350-01 50 mL Single-Dose Plastic Vial Each container is partially filled to provide air space needed for complete vacuum withdrawal of the contents into the I.V. container. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] RQ1105-A Rev. 01/2024 ARL Logo; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label & Carton Labeling - 5 mL NDC 0517-7305-01 Rx Only Sodium Phosphates Injection, USP 15 mM P/5 mL (3 mM P/mL) 20 mEq Na + / 5 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 5 mL Single-Dose Vial Discard Unused Portion 25 Units/NDC 0517-7305-25 Rx Only Sodium Phosphates Injection, USP 15 mM P/5 mL (3 mM P/mL) 20 mEq Na + / 5 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 5 mL Single-Dose Vial Discard Unused Portion AMERICAN REGENT, INC. SHIRLEY, NY 11967 Container Label (5 mL) Carton Labeling - 5 mL Container Label & Carton Labeling - 15 mL NDC 0517-7315-01 Rx Only Sodium Phosphates Injection, USP 45 mM P/15 mL (3 mM P/mL) 60 mEq Na + / 15 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 15 mL Single-Dose Vial Discard Unused Portion 25 Units/NDC 0517-7315-25 Rx Only Sodium Phosphates Injection, USP 45 mM P/15 mL (3 mM P/mL) 60 mEq Na + / 15 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 15 mL Single-Dose Vial Discard Unused Portion AMERICAN REGENT, INC. SHIRLEY, NY 11967 Container Label - 15 mL Carton Labeling - 15 mL Container Label & Carton Labeling - 50 mL NDC 0517-7350-01 Rx Only Sodium Phosphates Injection, USP 150 mM P/50 mL (3 mM P/mL) 200 mEq Na + / 50 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 50 mL Single-Dose Vial Discard Unused Portion 25 Units/NDC 0517-7350-25 Rx Only Sodium Phosphates Injection, USP 150 mM P/50 mL (3 mM P/mL) 200 mEq Na + / 50 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 50 mL Single-Dose Vial Discard Unused Portion AMERICAN REGENT, INC. SHIRLEY, NY 11967 Container Label - 50 mL Carton Labeling - 50 mL
- 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 0517-7305-25 Tray containing 25 vials 15 mM P/5 mL (3 mM P/mL) containing 20 mEq Na + /5 mL (4 mEq/mL) NDC 0517-7305-01 5 mL Single-Dose Plastic Vial NDC 0517-7315-25 Tray containing 25 vials 45 mM P/15 mL (3 mM P/mL) containing 60 mEq Na + /15 mL (4 mEq/mL) NDC 0517-7315-01 15 mL Single-Dose Plastic Vial NDC 0517-7350-25 Tray containing 25 vials 150 mM P/50 mL (3 mM P/mL) containing 200 mEq Na + /50 mL (4 mEq/mL) NDC 0517-7350-01 50 mL Single-Dose Plastic Vial Each container is partially filled to provide air space needed for complete vacuum withdrawal of the contents into the I.V. container. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] RQ1105-A Rev. 01/2024 ARL Logo
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label & Carton Labeling - 5 mL NDC 0517-7305-01 Rx Only Sodium Phosphates Injection, USP 15 mM P/5 mL (3 mM P/mL) 20 mEq Na + / 5 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 5 mL Single-Dose Vial Discard Unused Portion 25 Units/NDC 0517-7305-25 Rx Only Sodium Phosphates Injection, USP 15 mM P/5 mL (3 mM P/mL) 20 mEq Na + / 5 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 5 mL Single-Dose Vial Discard Unused Portion AMERICAN REGENT, INC. SHIRLEY, NY 11967 Container Label (5 mL) Carton Labeling - 5 mL Container Label & Carton Labeling - 15 mL NDC 0517-7315-01 Rx Only Sodium Phosphates Injection, USP 45 mM P/15 mL (3 mM P/mL) 60 mEq Na + / 15 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 15 mL Single-Dose Vial Discard Unused Portion 25 Units/NDC 0517-7315-25 Rx Only Sodium Phosphates Injection, USP 45 mM P/15 mL (3 mM P/mL) 60 mEq Na + / 15 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 15 mL Single-Dose Vial Discard Unused Portion AMERICAN REGENT, INC. SHIRLEY, NY 11967 Container Label - 15 mL Carton Labeling - 15 mL Container Label & Carton Labeling - 50 mL NDC 0517-7350-01 Rx Only Sodium Phosphates Injection, USP 150 mM P/50 mL (3 mM P/mL) 200 mEq Na + / 50 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 50 mL Single-Dose Vial Discard Unused Portion 25 Units/NDC 0517-7350-25 Rx Only Sodium Phosphates Injection, USP 150 mM P/50 mL (3 mM P/mL) 200 mEq Na + / 50 mL (4 mEq/mL) CAUTION: MUST BE DILUTED For Intravenous Use 50 mL Single-Dose Vial Discard Unused Portion AMERICAN REGENT, INC. SHIRLEY, NY 11967 Container Label - 50 mL Carton Labeling - 50 mL
Overview
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. Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO 4 . It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as a 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH 2 PO 4 • H 2 O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na 2 HPO 4 , colorless or white granular salt freely soluble in water. The semi-rigid container is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.
Indications & 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 & 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. 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 administration, whenever solution and container permit. See PRECAUTIONS.
Warnings & Precautions
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. 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 accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
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 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.
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