POTASSIUM CHLORIDE

Contraindications ( 4 ) 07/2019 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 ) 07/2019

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.

2 DOSAGE AND ADMINISTRATION Only for intravenous infusion. ( 2.1 , 5.2 ) See full prescribing information for information on preparation, administration, dosing considerations and instructions for use. ( 2.1 , 2.2 , 2.3 ) 2.1 Important Administration Instructions Potassium Chloride in 5% Dextrose Injection is only for intravenous infusion [see Warnings and Precautions ( 5.2 )] . For patients receiving Potassium Chloride in 5% Dextrose Injection at greater than maintenance rates, frequent monitoring of serum potassium concentrations and serial electrocardiograms (ECGs) are recommended. The osmolarity of 10 mEq Potassium Chloride in 5% Dextrose Injection is 272 mOsmol/L (calc). The osmolarity of 20 mEq Potassium Chloride in 5% Dextrose is 293 mOsmol/L (calc). Peripheral administration is generally acceptable; however; consider central vein administration if there is peripheral vein irritation, phlebitis, and/or associated pain. Do not administer Potassium Chloride in 5% Dextrose Injection simultaneously with blood products through the same administration set because of the possibility of pseudo agglutination or hemolysis. To prevent air embolism, use a non-vented infusion set or close the vent on a vented set, avoid multiple connections, do not connect flexible containers in series, fully evacuate residual gas in the container prior to administration, do not pressurize the flexible container to increase flow rates, and if administration is controlled by a pumping device, turn off pump before the container runs dry. Prior to infusion, visually inspect the solution for particulate matter. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear and container is undamaged. Use of a final filter is recommended during administration of parenteral solutions, where possible. 2.2 Recommended Dosage The infusion rate and volume depends on the age, weight, clinical and metabolic conditions of the patient and concomitant therapy. Electrolyte supplementation may be indicated according to the clinical needs of the patient. The administration rate should be governed, especially for premature infants with low birth weight, during the first few days of therapy, by the patient's tolerance to dextrose. Increase the infusion rate gradually as indicated by frequent monitoring of blood glucose concentrations [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] . 2.3 Instructions for Use Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. Flexible Plastic Container ( free flex ® bag) To Open Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. Check to ensure the solution is clear and there are no precipitates. Discard if there is a color change and/or the appearance of precipitates. Preparation for Administration Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container. Use a non-vented infusion set or close the air-inlet on a vented set. Close the roller clamp of the infusion set. Hold the base of BLUE Infusion Port. Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE: See full directions accompanying administration set. Suspend solution container from hanger hole. To Add Medication Additives may be incompatible. Complete information is not available. Do not use additives known or determined to be incompatible. Before adding a substance or medication, verify that it is soluble and/or stable in this drug product and that the pH range of this drug product is appropriate. Consult with pharmacist, …

3 DOSAGE FORMS AND STRENGTHS Potassium Chloride in 5% Dextrose Injection, USP is a clear solution in a 1000 mL single-dose, flexible container ( free flex ® ): 10 mEq Potassium Chloride and 5% Dextrose 20 mEq Potassium Chloride and 5% Dextrose Injection: 10 mEq Potassium Chloride in 5% Dextrose Injection, USP in a 1000 mL single-dose flexible container. 20 mEq Potassium Chloride in 5% Dextrose Injection, USP in a 1000 mL single-dose flexible container. ( 3 )

4 CONTRAINDICATIONS Potassium Chloride in 5% Dextrose Injection is contraindicated in patients with: known hypersensitivity to potassium chloride and/or dextrose [see Warnings and Precautions 5.1 )] clinically significant hyperkalemia [see Warnings and Precautions ( 5.2 )] clinically significant hyperglycemia [see Warnings and Precautions ( 5.3 )] Known hypersensitivity to potassium chloride or dextrose ( 4 , 5.1 ) Clinically significant hyperkalemia ( 4 , 5.2 ) Clinically significant hyperglycemia ( 4 , 5.3 )

ADVERSE REACTIONS Potassium intoxication with mild or severe hyperkalemia has been reported. The signs and symptoms of intoxication include paresthesia of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmia, heart block, electrographic abnormalities and cardiac arrest. EKG abnormalities serve as a clinical reflection of the seriousness of changes in serum potassium concentrations: peaked T waves and prolonged P-R intervals usually occur with modest elevations above the upper limit of normal potassium concentrations; P waves disappear, the QRS complex widens, and eventual asystole usually occurs with higher elevations. 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 and hypervolemia. Infusion of highly concentrated potassium chloride solutions may cause local pain and vein irritation. (See WARNINGS ). Reactions reported with the use of potassium-containing solutions include nausea, vomiting, and abdominal pain and diarrhea. 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.

7 DRUG INTERACTIONS Other Products that Cause Hyperkalemia : Avoid use in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations. ( 7.1 ) Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance : Monitor blood glucose concentrations, fluid balance serum electrolyte concentrations and acid-base balance. ( 7.2 ) 7.1 Other Products that Cause Hyperkalemia Administration of Potassium Chloride in 5% Dextrose 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, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia [see Warnings and Precautions ( 5.2 )] . Avoid use of Potassium Chloride in 5% Dextrose Injection in patients receiving such products. If use cannot be avoided, monitor serum potassium concentrations. 7.2 Other Products that Affect Glycemic Control, Vasopressin or Fluid and/or Electrolyte Balance Potassium Chloride in 5% Dextrose Injection can affect glycemic control, vasopressin and fluid and/or electrolyte balance [see Warnings and Precautions ( 5.3 , 5.4 , 5.5 , 5.6 )] . Monitor blood glucose concentrations, fluid balance, serum electrolyte concentrations and acid-base balance when using Potassium Chloride in 5% Dextrose Injection in patients treated with other substances that affect glycemic control, vasopressin or fluid and/or electrolyte balance.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Appropriate administration of Potassium Chloride in 5% Dextrose Injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. Animal reproduction studies have not been conducted with Potassium Chloride in 5% Dextrose Injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 8.2 Lactation Risk Summary Potassium is present in human breast milk. There are no data on the effects of Potassium Chloride in 5% Dextrose Injection on a breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Potassium Chloride in 5% Dextrose Injection and any potential adverse effects on the breastfed infant from Potassium Chloride in 5% Dextrose Injection or from the underlying maternal condition. 8.4 Pediatric Use The safety profile of Potassium Chloride in 5% Dextrose Injection in pediatric patients is similar to adults. Neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions to ensure adequate glycemic control in order to avoid potential long term adverse effects. Closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. In very low birth weight infants, excessive or rapid administration of Potassium Chloride in 5% Dextrose Injection may result in increased serum osmolality and risk of intracerebral hemorrhage. Children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy. 8.5 Geriatric Use Potassium Chloride in 5% Dextrose Injection is known to be substantially excreted by the kidney, and the risk of adverse reactions to this product may be greater in patients with impaired renal function [see Warnings and Precautions ( 5.2 , 5.3 )] . Elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] . Dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. 8.6 Renal Impairment Administration of Potassium Chloride in 5% Dextrose Injection in patients with renal impairment may result in hyperkalemia, hyponatremia, and/or fluid overload. Monitor patients with renal impairment for development of these adverse reactions [see Warnings and Precautions ( 5.2 , 5.4 , 5.6 )] .

12.1 Mechanism of Action Potassium Chloride in 5% Dextrose Injection is a source of water, electrolytes and calories. It is capable of inducing diuresis depending on the clinical condition of the patient.

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. Potassium Chloride Injection mEq Potassium/Container Composition (g/L) Potassium Chloride, USP (KCl) Osmolarity Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥ 600 mOsmol/L) may cause vein damage. (mOsmol/L) (calc) pH Ionic Concentration (mEq/L) 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 This Viaflex Plus plastic container is fabricated from a specially formulated polyvinyl chloride. 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 plastic container may leach out certain of its chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

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: 1. 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. 2. Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema. 3. Hemodialysis and peritoneal dialysis. In cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride in 5% Dextrose Injection, USP is a clear solution in 1000 mL single-dose, flexible containers available as follows: Product code Unit of Use Strength Unit of Sale 667110 NDC 63323-667-01 One 1000 mL free flex ® Bag 10 mEq Potassium NDC 63323-667-10 Package of 10 free flex ® Bags 669110 NDC 63323-669-01 One 1000 mL free flex ® Bag 20 mEq Potassium NDC 63323-669-10 Package of 10 free flex ® Bags Avoid excessive heat. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; brief exposure up to 40°C does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.