Potassium Acetate

American Regent, Inc.

FULL PRESCRIBING INFORMATION

Rx Only

39.2% (4 mEq/mL)
7989 mOsmol/L Calculated
pH (5.5-8.0)
(8 mOsmol/mL)

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

Potassium Acetate for Injection, USPCONCENTRATE, 4 mEq/mL, is a sterile, non-pyrogenic, concentrated solution of Potassium Acetate (C₂H₃KO₂) in Water for Injection. It must be diluted prior to administration.

Each 50 mL vial contains 19.6 grams of Potassium Acetate (anhydrous) which provides 200 mEq each of Potassium (K⁺) and Acetate (CH₃COO^-).

The pH is adjusted with acetic acid and the solution contains no bacteriostatic agent or other preservative.

The solution is intended as an alternative to Potassium Chloride to provide potassium (K⁺) for addition to large volume infusion fluids for intravenous use. Unused portion should be discarded.

Potassium is found in low concentration in plasma and extracellular fluids. It is the chief cation of body cells, and is concerned with the maintenance of body fluid composition and electrolyte balance. The major amount of potassium is excreted in the urine. Therefore, the kidney normally determines potassium balance.

The acetate ion is completely metabolized in the body, providing a source of hydrogen ion acceptors.

Potassium Acetate for Injection, USPCONCENTRATEis indicated in the treatment of potassium deficiency states when oral replacement therapy is not feasible.

Potassium administration is contraindicated in diseases where high potassium levels may be encountered.

To avoid potassium intoxication, infuse potassium containing solutions slowly. In patients with severe renal insufficiency or adrenal insufficiency, administration of Potassium Acetate for Injection, USPCONCENTRATEmay cause potassium intoxication.

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.

Potassium replacement therapy should be guided primarily by serial electrocardiograms. Plasma potassium levels are not necessarily indicative of tissue potassium levels.

High plasma concentrations of potassium may cause death through cardiac depression, arrhythmias or arrest. Potassium Acetate for Injection, USPCONCENTRATEshould be used with caution in the presence of cardiac disease, particularly in digitalized patients or in the presence of renal disease.

Nausea, vomiting, abdominal pain and diarrhea have been reported. 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, heart block, electrocardiographic abnormalities such as disappearance of p waves, spreading and slurring of the QRS complex with development of a biphasic curve, and cardiac arrest. SeeWARNINGS.

USE IN PREGNANCY

Safety for use in pregnancy has not been established. Use of potassium acetate in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.

Potassium Acetate for Injection, USPCONCENTRATE(4 mEq/mL), must be diluted before administration. The dose and rate of injection are dependent upon the individual condition of each patient. ECG and serum potassium should be monitored as a guide to dosage. Withdraw the calculated volume aseptically and transfer to appropriate intravenous fluids to provide the desired number of milliequivalents of potassium (K⁺) with an equal number of milliequivalents of acetate (CH₃COO^-).

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

In the event of overdosage, discontinue the infusion immediately, and institute intensive corrective therapy to reduce the serum potassium levels.

Potassium Acetate for Injection, USP Concentrate (4 mEq/mL)

NDC 0517-5024-25 50 mL Single Dose Vial packed in boxes of 25

Store at 20^o-25^oC (68^o-77^oF); excursions permitted to 15^o-30^oC (59^o-86^oF) (See USP Controlled Room Temperature).

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN5024
Rev. 11/05

PRINCIPLE DISPLAY PANEL – 50 mL Container

NDC 0517-5024-25

POTASSIUM ACETATE
FOR INJECTION, USP
CONCENTRATE

200 mEq/50 mL
(4 mEq/mL)

50mL SINGLE DOSE VIAL

FOR IV USE AFTER DILUTION

Rx Only

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967