Rx Only

CAUTION: FOR INTRAVENOUS USE ONLY
               MUST BE DILUTED PRIOR TO ADMINISTRATION

DESCRIPTION:

Sodium Phosphates Injection, USP is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic and dibasic sodium phosphate in Water for Injection. It must be diluted prior to administration.

Each mL of the solution consists of two phosphate salts provided as follows:

The solution contains no bacteriostatic agent or other preservative.

The solution is intended to provide phosphate ion: (PO4-3) for addition to large volume infusion fluids for intravenous use. Unused portions should be discarded.

CLINICAL PHARMACOLOGY:

Phosphorus in the form of organic and inorganic phosphate has a variety of important biochemical functions in the body and is involved in many significant metabolic and enzyme reactions in almost all organs and tissues. It exerts a modifying influence on the steady state of calcium levels, a buffering effect on acid-base equilibrium and a primary role in the renal excretion of hydrogen ion.

Phosphorus is present in plasma and other extracellular fluid, in cell membranes and intracellular fluid, as well as in collagen and bone. Phosphorus in the extracellular fluid is primarily in inorganic form, and plasma levels may vary somewhat with age.

The ratio of disodium phosphate and monosodium phosphate in the extracellular fluid is 4:1 (80% : 20%) at the normal pH of 7.4. This buffer ratio varies with the pH, but owing to its relatively low concentration, it contributes little to the buffering-capacity of the extracellular fluids.

Phosphorus, present in large amounts in erythrocytes and other tissue cells, plays a significant intracellular role in the synthesis of high energy organic phosphates.

Hypophosphatemia should be avoided during periods of total parenteral nutrition, or other lengthy periods of intravenous infusions. Serum phosphorus levels should be regularly monitored, and appropriate amounts of phosphorus should be added to the infusions to maintain normal serum phosphorus levels. Intravenous infusion of inorganic phosphorus may be accompanied by a decrease in the serum level and urinary excretion of calcium. The normal level of serum inorganic phosphorus is 3.0 to 4.5 mg/dL in adults and 4.0 to 7.0 mg/dL in children. Intravenously infused phosphorus not taken up by the tissues is excreted almost entirely in the urine.

Sodium is the principal cation of extracellular fluids. The sodium ion exerts a primary role in controlling total body water and its distribution.

INDICATIONS AND USAGE:

Sodium Phosphates Injection, USP, 3mM 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 intravenous 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 content of such prepared solutions.

CONTRAINDICATIONS:

Sodium Phosphates Injection, USP is contraindicated in diseases where high sodium, high phosphorus or low calcium levels may be encountered.

WARNINGS

Sodium Phosphates Injection, USP 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 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.

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 particulary 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.

PRECAUTIONS:

Phosphorus replacement therapy with sodium phosphates should be guided primarily by the serum inorganic phosphorus levels and the limits imposed by the accompanying sodium (Na+) ion. Frequent monitoring of serum calcium and sodium as well as renal function is recommended.

Use with caution in patients with renal impairment, cirrhosis, cardiac failure or in conjunction with other edema causing medications. It should not be used with sodium retaining medications.

Caution must be exercised in the administration of parenteral fluids especially those containing sodium ion, to patients receiving corticosteroids or corticotropin.

ADVERSE REACTIONS:

Adverse reactions involve the possibility of combined sodium and phosphorus intoxication from overdosage.

Sodium replacement therapy should be guided primarily by the serum sodium level. Use with caution in patients with renal impairment, cirrhosis, cardiac failure or other edematous or sodium retaining states. Phosphorus intoxication results in a reduction of serum calcium, and the symptoms are those of hypocalcemic tetany. See WARNINGS.

DOSAGE AND ADMINISTRATION:

Sodium Phosphates Injection, USP is administered intravenously only after dilution 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.

Withdraw the calculated volume aseptically and transfer to appropriate intravenous fluid to provide the desired number of millimoles (mM) of phosphorus and milliequivalents (mEq) of sodium.

OVERDOSAGE:

In the event of overdosage, discontinue infusions containing Sodium Phosphates Injection, USP immediately, and institute corrective therapy. (See WARNINGS, PRECAUTIONS and ADVERSE REACTIONS).

Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit.

HOW SUPPLIED:

Sodium Phosphates Injection, USP 3mM Phosphorus/mL,

4 mEq Sodium/mL

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).

These products do not contain a bacteriostatic agent or other preservatives. Any unused portion should be discarded.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967
IN3405
Rev. 11/05

Principal Display Panel

Sodium Phosphates Injection, USP

15 mM/5 mL Phosphorus

20 mEq/5 mL Sodium

5 x 5 mL Single Dose Vials