Potassium Phosphates

Fresenius Kabi USA, LLC

Potassium Phosphates Injection USP

FULL PRESCRIBING INFORMATION: CONTENTS*

• POTASSIUM PHOSPHATES DESCRIPTION
• CLINICAL PHARMACOLOGY
• POTASSIUM PHOSPHATES INDICATIONS AND USAGE
• POTASSIUM PHOSPHATES CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• POTASSIUM PHOSPHATES ADVERSE REACTIONS
• POTASSIUM PHOSPHATES DOSAGE AND ADMINISTRATION
• OVERDOSAGE
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

3 mmol Phosphate/mL and 4.4 mEq Potassium/mL

FOR INTRAVENOUS USE ONLY MUST BE DILUTED PRIOR TO ADMINISTRATION

POTASSIUM PHOSPHATES DESCRIPTION

Potassium Phosphates Injection, USP is a sterile, nonpyrogenic, concentrated solution containing a mixture of mono and dibasic potassium phosphate in Water for Injection q.s.  It must be diluted prior to administration.

7.4 mOsmol/mL     pH 6.2 to 6.8

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

The solution contains no bacteriostatic agent or other preservatives.  Unused portions should be discarded.

The solution is intended to provide phosphate ion; (PO₄ ^3-) for addition to large volume infusion fluids for intravenous use.

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 tissues.  Phosphate 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.

Phosphate, 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 phosphate levels should be regularly monitored, and appropriate amounts of phosphate should be added to the infusions to maintain normal serum phosphate levels.  Intravenous infusion of inorganic phosphate may be accompanied by a decrease in the serum level and urinary excretion of calcium.  Intravenously infused phosphate not taken up by the tissues is excreted almost entirely in the urine.

POTASSIUM PHOSPHATES INDICATIONS AND USAGE

Potassium 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 intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte of nutrient solutions.

POTASSIUM PHOSPHATES CONTRAINDICATIONS

Potassium phosphates is contraindicated in diseases where high potassium, high phosphate or low calcium levels may be encountered.

WARNINGS

Potassium phosphates must be diluted before use.

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.

To avoid potassium or phosphate intoxication, infuse solutions containing potassium phosphates slowly.  In patients with severe renal or adrenal insufficiency, administration of potassium phosphates may cause potassium intoxication, infusing high concentrations of phosphate may cause hypocalcemia, and calcium levels should be monitored.

PRECAUTIONS

Phosphate replacement therapy with potassium phosphates should be guided primarily by the serum inorganic phosphate level and the limits imposed by the accompanying potassium (K+) ion.

High plasma concentrations of potassium may cause death through cardiac depression, arrhythmias or arrest.

Use with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease.

POTASSIUM PHOSPHATES ADVERSE REACTIONS

Adverse reactions involve the possibility of combined potassium and phosphate intoxication from overdosage.  The signs and symptoms of potassium intoxication include paresthesias of the extremities, flaccid paralysis, listlessness, mental confusion, weakness and heaviness of the legs, hypotension, cardiac arrhythmias, heartblock, electrocardiographic abnormalities such as disappearance of P waves, spreading and slurring of the QRS complex with development of a biphasic curve and cardiac arrest.  Phosphate intoxication results in a reduction of serum calcium, and the symptoms are those of hypocalcemic tetany, (see WARNINGS ).

POTASSIUM PHOSPHATES DOSAGE AND ADMINISTRATION

Potassium phosphates 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 potassium, 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 (mmol) of phosphate and milliequivalent (mEq) of Potassium (K+).

OVERDOSAGE

In the event of overdosage, discontinue infusions containing potassium phosphates immediately, and institute corrective therapy to restore depressed serum calcium and to reduce elevated serum potassium levels.

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

HOW SUPPLIED

Potassium Phosphates Injection, USP, 3 mmol/mL, packaged 25 per carton is available as follows:

The quantity of phosphate/mL is 285 mg and the quantity of potassium/mL is 170 mg.  This product is preservative free.  Any unused portion should be discarded.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

45809E

Revised: August 2013

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Potassium Phosphates 50 mL Single Dose Vial

NDC 63323-086-50

8650

Potassium Phosphates Injection, USP

Phosphorus 150 mmol / 50 mL  (3 mmol/mL)

Potassium 220 mEq / 50 mL  (4.4 mEq/mL)

For IV Use Only After Dilution

50 mL Single Dose Vial

Rx only