Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED: Sodium Phosphates Injection, USP, 3 mM P/mL in single dose vials, is supplied as follows: *The container is partially filled to provide air space needed for complete vacuum withdrawal of the contents into the IV container. Product Code Unit of Sale Strength Each 884106* NDC 63323-884-06 Unit of 25 15 mM P per 5 mL (3 mM P per mL) NDC 63323-884-01 5 mL Single Dose Vial 884116* NDC 63323-881-16 Unit of 25 45 mM P per 15 mL (3 mM P per mL) NDC 63323-881-01 15 mL Single Dose Vial 884156 NDC 63323-886-56 Unit of 25 150 mM P per 50 mL (3 mM P per mL) NDC 63323-886-01 50 mL Single Dose Vial STORE AT: 20 ° to 25 °C ( 68 ° to 7 7°F) [see USP Controlled Room Temperature]. Discard unused portion. The container closure is not made with natural rubber latex. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451540A Revised: November 2021 Logo; PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 5 mL Vial Label NDC 63323-884-01 Sodium Phosphates Injection, USP 15 mM P per 5 mL (3 mM P per mL) 20 mEq Na+ per 5 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 5 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 5 mL Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 5 mL Tray Label NDC 63323-884-06 Sodium Phosphates Injection, USP 15 mM P per 5 mL (3 mM P per mL) 20 mEq Na+ per 5 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 25 x 5 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 5 mL Tray Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 15 mL Vial Label NDC 63323-881-01 Sodium Phosphates Injection, USP 45 mM P per 15 mL (3 mM P per mL) 60 mEq Na+ per 15 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 15 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 15 mL Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 15 mL Tray Label NDC 63323-881-16 Sodium Phosphates Injection, USP 45 mM P per 15 mL (3 mM P per mL) 60 mEq Na+ per 15 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 25 x 15 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 15 mL Tray Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 50 mL Vial Label NDC 63323-886-01 Sodium Phosphates Injection, USP 150 mM P per 50 mL (3 mM P per mL) 200 mEq Na+ per 50 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 50 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 50 mL Vial Label; PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 50 mL Tray Label NDC 63323-886-56 Sodium Phosphates Injection, USP 150 mM P per 50 mL (3 mM P per mL) 200 mEq Na+ per 50 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 25 x 50 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 50 mL Tray Label
- HOW SUPPLIED: Sodium Phosphates Injection, USP, 3 mM P/mL in single dose vials, is supplied as follows: *The container is partially filled to provide air space needed for complete vacuum withdrawal of the contents into the IV container. Product Code Unit of Sale Strength Each 884106* NDC 63323-884-06 Unit of 25 15 mM P per 5 mL (3 mM P per mL) NDC 63323-884-01 5 mL Single Dose Vial 884116* NDC 63323-881-16 Unit of 25 45 mM P per 15 mL (3 mM P per mL) NDC 63323-881-01 15 mL Single Dose Vial 884156 NDC 63323-886-56 Unit of 25 150 mM P per 50 mL (3 mM P per mL) NDC 63323-886-01 50 mL Single Dose Vial STORE AT: 20 ° to 25 °C ( 68 ° to 7 7°F) [see USP Controlled Room Temperature]. Discard unused portion. The container closure is not made with natural rubber latex. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451540A Revised: November 2021 Logo
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 5 mL Vial Label NDC 63323-884-01 Sodium Phosphates Injection, USP 15 mM P per 5 mL (3 mM P per mL) 20 mEq Na+ per 5 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 5 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 5 mL Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 5 mL Tray Label NDC 63323-884-06 Sodium Phosphates Injection, USP 15 mM P per 5 mL (3 mM P per mL) 20 mEq Na+ per 5 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 25 x 5 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 5 mL Tray Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 15 mL Vial Label NDC 63323-881-01 Sodium Phosphates Injection, USP 45 mM P per 15 mL (3 mM P per mL) 60 mEq Na+ per 15 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 15 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 15 mL Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 15 mL Tray Label NDC 63323-881-16 Sodium Phosphates Injection, USP 45 mM P per 15 mL (3 mM P per mL) 60 mEq Na+ per 15 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 25 x 15 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 15 mL Tray Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 50 mL Vial Label NDC 63323-886-01 Sodium Phosphates Injection, USP 150 mM P per 50 mL (3 mM P per mL) 200 mEq Na+ per 50 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 50 mL Single Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 50 mL Vial Label
- PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 50 mL Tray Label NDC 63323-886-56 Sodium Phosphates Injection, USP 150 mM P per 50 mL (3 mM P per mL) 200 mEq Na+ per 50 mL (4 mEq Na+ per mL) CAUTION: MUST BE DILUTED For Intravenous Use Preservative free. 25 x 50 mL Single Dose Vials Rx only PACKAGE LABEL - PRINCIPAL DISPLAY – Sodium Phosphates Injection, USP 50 mL Tray Label
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 (preservative free) 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 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.
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 ).
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