POTASSIUM CHLORIDE

INDICATIONS AND USAGE Potassium Chloride Injection is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. THIS HIGHLY CONCENTRATED, READY-TO-USE POTASSIUM CHLORIDE INJECTION IS INTENDED FOR THE MAINTENANCE OF SERUM K + LEVELS AND FOR POTASSIUM SUPPLEMENTATION IN FLUID RESTRICTED PATIENTS WHO CANNOT ACCOMMODATE ADDITIONAL VOLUMES OF FLUID ASSOCIATED WITH POTASSIUM SOLUTIONS OF LOWER CONCENTRATION. When using these products, these patients should be on continuous cardiac monitoring and frequent testing for serum potassium concentration and acid-base balance.

DOSAGE AND ADMINISTRATION The dose and rate of administration are dependent upon the specific condition of each patient. Administer intravenously only with a calibrated infusion device at a slow, controlled rate. Highest concentrations (400 mEq/L) should be exclusively administered via central intravenous route. Whenever possible, administration via a central route is recommended for all concentrations of Potassium Chloride Injection for thorough dilution by the blood stream and decreasing the risk of extravasation and to avoid pain and phlebitis associated with peripheral infusion (see WARNINGS ). Correct placement of the catheter should be verified before administration. Recommended administration rates should not usually exceed 10 mEq per hour or 200 mEq for a 24 hour period if the serum potassium level is greater than 2.5 mEq per liter. In urgent cases where the serum potassium level is less than 2.0 mEq per liter or where severe hypokalemia is a threat, (serum potassium level less than 2.0 mEq per liter and electrocardiographic changes and/or muscle paralysis), rates up to 40 mEq per hour or 400 mEq over a 24 hour period can be administered very carefully when guided by continuous monitoring of the EKG and frequent serum K + determinations to avoid hyperkalemia and cardiac arrest. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. Do not administer unless solution is clear and seal is intact. Use of a final filter is recommended during administration of all parenteral solutions where possible. Do not add supplementary medication.

CONTRAINDICATIONS Potassium Chloride Injection is contraindicated in patients with: hyperkalemia known hypersensitivity to Potassium Chloride Injection

ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride Injection were identified in postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Immune system disorders: Hypersensitivity, as manifested by rash and angioedema Metabolism and nutrition disorders: Hyperkalemia, hyponatremia Cardiac disorders: Cardiac arrest*, asystole*, ventricular fibrillation*, bradycardia *as a manifestation of rapid intravenous administration and/or of hyperkalemia Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea General disorders and administration site conditions: Chest pain, infusion site thrombosis, infusion site phlebitis, infusion site erythema, infusion site swelling, infusion site pain, infusion site irritation, and/or a burning sensation. Nervous System Disorders: Hyponatremic encephalopathy The following adverse reactions were reported in association with extravasation: Skin necrosis, skin ulcer, soft tissue necrosis, muscle necrosis, nerve injury, tendon injury, and vascular injury. 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.

Drug Interactions Other Products that Cause Hyperkalemia Administration of Potassium Chloride Injection in patients treated concurrently or recently with other products that can cause hyperkalemia or increase the risk of hyperkalemia, (e.g., potassium- sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, cyclosporine and tacrolimus) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia (see WARNINGS ). Avoid use of Potassium Chloride Injection in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations. Other Drugs that Increase the Risk of Hyponatremia Administration of Potassium Chloride Injection in patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia (see WARNINGS ). Avoid use of Potassium Chloride Injection in patients receiving drugs that may increase the risk of hyponatremia, such as diuretics and antiepileptics. Drugs that increase the vasopressin effect reduce renal electrolyte free water excretion and may also increase the risk of hyponatremia following treatment with intravenous fluids. If use cannot be avoided, monitor serum sodium concentrations.

DESCRIPTION This Potassium Chloride Injection, is a sterile, nonpyrogenic, highly concentrated, ready-to-use, solution of Potassium Chloride, USP in Water for Injection, USP for electrolyte replenishment in a single dose container for intravenous administration. It contains no antimicrobial agents. *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. Composition (g/L) Osmolarity* (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) Potassium Chloride Injection mEq Potassium/Container Potassium Chloride, USP (KCI) Potassium Chloride 10 mEq/100 mL 7.46 200 5.0 (4.0 to 8.0) 100 100 10 mEq/50 mL 20 mEq/100 mL 14.9 400 5.0 (4.0 to 8.0) 200 200 20 mEq/50 mL 40 mEq/100 mL 29.8 799 5.0 (4.0 to 8.0) 400 400 The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers.

OVERDOSAGE Potassium overdose can cause potentially fatal hyperkalemia. Manifestations of hyperkalemia include: Disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation Hypotension Muscle weakness up to and including muscular and respiratory paralysis, paresthesia Gastrointestinal symptoms (ileus, nausea, vomiting, abdominal pain) Frequently, mild or moderate hyperkalemia is asymptomatic and may be manifested only by increased serum potassium concentrations and, possibly, characteristic electrocardiographic changes. However, fatal arrhythmias can develop at any time. In addition to arrhythmias and conduction disorders, the EKG shows progressive changes that occur with increasing potassium levels. Possible changes include: Peaking of T waves, Loss of P waves, and QRS widening. However, the correlation between potassium levels and EKG changes is not precise, and whether or at which potassium level certain EKG signs develop depends on factors such as patient sensitivity, the presence of other electrolyte disorders, and the rapidity of the development of hyperkalemia. The presence of any EKG findings that are suspected to be caused by hyperkalemia should be considered a medical emergency. In the event of hyperkalemia, discontinue the infusion immediately and institute close EKG, laboratory and other monitoring and, as necessary, corrective therapy to reduce serum potassium levels as necessary. The use of potassium containing foods or medications must also be eliminated. Treatment of mild to severe hyperkalemia with signs and symptoms of potassium intoxication includes the following: Dextrose Injection, USP, 10% or 25%, containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, 300 to 500 mL per hour. Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema. Hemodialysis and peritoneal dialysis. In cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

HOW SUPPLIED Potassium Chloride Injection in free flex ® is available as follows: Product Code Unit of Use Strength Unit of Sale 129121 NDC 65219-012-00 one 100 mL fill in 100 mL free flex ® bag 10 mEq/100 mL NDC 65219-012-01 Package of 50 free flex ® bags 129041 NDC 65219-004-00 one 50 mL fill in 100 mL free flex ® bag 10 mEq/50 mL NDC 65219-004-01 Package of 60 free flex ® bags 129061 NDC 65219-006-00 one 100 mL fill in 100 mL free flex ® bag 20 mEq/100 mL NDC 65219-006-01 Package of 50 free flex ® bags 129081 NDC 65219-008-50 one 50 mL fill in 100 mL free flex ® bag 20 mEq/50 mL NDC 65219-008-51 Package of 60 free flex ® bags 129101 NDC 65219-010-00 one 100 mL fill in 100 mL free flex ® bag 40 mEq/100 mL NDC 65219-010-01 Package of 50 free flex ® bags Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.