POTASSIUM CHLORIDE

Potassium Chloride for Injection Concentrate, USP is a sterile, nonpyrogenic concentrated solution of Potassium Chloride, USP in Water for Injection to be administered by intravenous infusion only after dilution in a larger volume of fluid. Each mL of Potassium Chloride for Injection Concentrate contains 2 mEq of K + and Cl – equivalent to 149 mg of potassium chloride and has an osmolarity of 4000 mOsmol/L (calc). A more concentrated Potassium Chloride for Injection Concentrate is also available. Each mL of this injection contains 3 mEq of K + and Cl – equivalent to 224 mg of potassium chloride and has an osmolarity of 6000 mOsmol/L(calc). pH (4.0-8.0) may have been adjusted with hydrochloric acid and if necessary, potassium hydroxide. Some packages are intended for multiple dose use and contain preservatives (0.05% methylparaben and 0.005% propylparaben). A summary of the available products is presented in the HOW SUPPLIED section. Potassium Chloride for Injection Concentrate (appropriately diluted) is a parenteral fluid and electrolyte replenisher.

Potassium Chloride for Injection Concentrate, USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible.

Potassium Chloride for Injection Concentrate must be diluted before administration. Care must be taken to ensure there is complete mixing of the potassium chloride with the large volume fluid, particularly if soft of bag type containers are used. The dose and rate of administration are dependent upon the specific condition of each patient. If the serum potassium level is greater than 2.5 mEq/L, potassium can be given at a rate not to exceed 10 mEq/hour and in a concentration of up to 40 mEq/L. The 24 hour total dose should not exceed 200 mEq. If urgent treatment is indicated (serum potassium level less than 2mEq/L and electrocardiographic changes and/or muscle paralysis), potassium chloride may be infused very cautiously at a rate of up to 40 mEq/hour. In such cases, continuous cardiac monitoring is essential. As much as 400 mEq may be administered in a 24 hour period. In critical conditions, potassium chloride may be administered in saline (unless contraindicated) rather than in dextrose containing fluids, as a dextrose may lower serum potassium levels. Prior to entering a vial, cleanse the rubber closure with a suitable antiseptic agent. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Potassium chloride for Injection Concentrate is contraindicated in diseases where high potassium levels may be encountered, and in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, hypervolemia, and hyperkalemia. Too rapid infusion of hypertonic solutions may cause local pain and, rarely, vein irritation. Rate of administration should be adjusted according to tolerance. Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.