Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Product No. NDC No. Volume 17005PX 63323-170-05 5 mL in a 10 mL vial 17015PX 63323-170-15 15 mL in a 30 mL vial 11850 63323-118-50 50 mL in a 50 mL vial These vials are flip-top, Single Dose Vials, packaged 25 vials per tray. The vials marked with ‘‘PX’’ are partially filled to facilitate transfer of the contents. Do not administer unless solution is clear and seal intact. Discard unused portion. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 5 mL Single Dose Vial Label NDC 63323-170-05 17005PX SODIUM PHOSPHATES INJECTION, USP Phosphorus 15 mmol / 5 mL (3 mmol/mL) Sodium 20 mEq / 5mL (4 mEq/mL) MUST BE DILUTED PRIOR TO IV USE 5 mL Single Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 5 mL Single Dose Vial Label; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 5 mL Single Dose Vial Tray Label NDC 63323-170-05 17005PX SODIUM PHOSPHATES INJECTION, USP Phosphorus 15 mmol / 5 mL (3 mmol/mL) Sodium 20 mEq / 5mL (4 mEq/mL) MUST BE DILUTED PRIOR TO IV USE 25 x 5 mL Single Dose Vials PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 5 mL Single Dose Vial Tray Label; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 15 mL Single Dose Vial Label NDC 63323-170-15 17015PX SODIUM PHOSPHATES INJECTION, USP Phosphorus 45 mmol / 15 mL (3 mmol/mL) Sodium 60 mEq / 15mL (4 mEq/mL) MUST BE DILUTED PRIOR TO IV USE 15 mL Rx only Single Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 15 mL Single Dose Vial Label; PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 15 mL Single Dose Vial Tray Label NDC 63323-170-15 17015PX SODIUM PHOSPHATES INJECTION, USP Phosphorus 45 mmol / 15 mL (3 mmol/mL) Sodium 60 mEq / 15mL (4 mEq/mL) MUST BE DILUTED PRIOR TO IV USE 25 x 15 mL Rx only Single Dose Vials PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 15 mL Single Dose Vial Tray Label
- HOW SUPPLIED Product No. NDC No. Volume 17005PX 63323-170-05 5 mL in a 10 mL vial 17015PX 63323-170-15 15 mL in a 30 mL vial 11850 63323-118-50 50 mL in a 50 mL vial These vials are flip-top, Single Dose Vials, packaged 25 vials per tray. The vials marked with ‘‘PX’’ are partially filled to facilitate transfer of the contents. Do not administer unless solution is clear and seal intact. Discard unused portion. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 5 mL Single Dose Vial Label NDC 63323-170-05 17005PX SODIUM PHOSPHATES INJECTION, USP Phosphorus 15 mmol / 5 mL (3 mmol/mL) Sodium 20 mEq / 5mL (4 mEq/mL) MUST BE DILUTED PRIOR TO IV USE 5 mL Single Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 5 mL Single Dose Vial Label
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 5 mL Single Dose Vial Tray Label NDC 63323-170-05 17005PX SODIUM PHOSPHATES INJECTION, USP Phosphorus 15 mmol / 5 mL (3 mmol/mL) Sodium 20 mEq / 5mL (4 mEq/mL) MUST BE DILUTED PRIOR TO IV USE 25 x 5 mL Single Dose Vials PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 5 mL Single Dose Vial Tray Label
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 15 mL Single Dose Vial Label NDC 63323-170-15 17015PX SODIUM PHOSPHATES INJECTION, USP Phosphorus 45 mmol / 15 mL (3 mmol/mL) Sodium 60 mEq / 15mL (4 mEq/mL) MUST BE DILUTED PRIOR TO IV USE 15 mL Rx only Single Dose Vial PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 15 mL Single Dose Vial Label
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 15 mL Single Dose Vial Tray Label NDC 63323-170-15 17015PX SODIUM PHOSPHATES INJECTION, USP Phosphorus 45 mmol / 15 mL (3 mmol/mL) Sodium 60 mEq / 15mL (4 mEq/mL) MUST BE DILUTED PRIOR TO IV USE 25 x 15 mL Rx only Single Dose Vials PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Sodium Phosphates 15 mL Single Dose Vial Tray Label
Overview
Sodium Phosphates Injection, USP, 3 mmol/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: Monobasic sodium phosphate, monohydrate, 276 mg; dibasic sodium phosphate, anhydrous, 142 mg (equivalent to dibasic sodium phosphate, heptahydrate, 268 mg); Water for Injection q.s. In the 5 mL and 15 mL product, phosphoric acid and/or NaOH may have been added for pH adjustment. Each mL provides 3 mmol of phosphorus and 4 mEq sodium. It contains no bacteriostat, antimicrobial agent or added buffer. The pH is 5.7 (approx.). The osmolar concentration is 7 mOsmol/mL (calc.) The solution is intended as an alternative to potassium phosphate to provide phosphate ion (PO 4 3- ) for addition to large volume infusion fluids for intravenous use. Sodium Phosphates, USP, monohydrate monobasic is chemically designated NaH 2 PO 4 • H 2 O. Occurs as white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP, anhydrous, is chemically designated Na 2 HPO 4 . Occurs as a colorless or white granular salt freely soluble in water.
Indications & Usage
Sodium Phosphates Injection, USP is indicated as a source of phosphate, 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 (4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions.
Dosage & Administration
Sodium Phosphates Injection 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, inorganic 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 of phosphate and milliequivalents of sodium. In patients on TPN, approximately 10 to 15 mmol of phosphorus (equivalent to 310 to 465 mg elemental phosphorus) per liter bottle of TPN solution is usually adequate to maintain normal serum phosphate, though larger amounts may be required in hypermetabolic states. The amount of sodium which accompanies the addition of 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 mmol/kg/day. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
WARNINGS 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. Sodium Phosphates Injection must be diluted and thoroughly mixed before use. To avoid phosphate intoxication, infuse solutions containing sodium phosphate slowly. Infusing high concentrations of phosphate may result in a reduction of serum calcium and symptoms of hypocalcemic tetany. Calcium levels should be monitored. Solutions containing sodium ion 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.
Contraindications
Sodium phosphate is contraindicated in diseases where high phosphate or low calcium levels may be encountered, and in patients with hypernatremia.
Adverse Reactions
Adverse reactions involve the possibility of phosphate intoxication. Phosphate intoxication results in a reduction of serum calcium and the symptoms are those of hypocalcemic tetany (see WARNINGS ).
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