Potassium Chloride

6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in 5% Dextrose Injection were identified in post marketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity reactions : including anaphylaxis and chills [see Warnings and Precautions ( 5.1 )] . Hyperkalemia, including cardiac arrest, as a manifestation [see Warnings and Precautions ( 5.2 )] Hyponatremia and hyponatremic encephalopathy [see Warnings and Precautions ( 5.4 )] Hypokalemia [see Warnings and Precautions ( 5.5 )] Hypervolemia [see Warnings and Precautions ( 5.6 )] Injection site reactions : infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, infusion site rash, infusion site pain, infusion site vesicles, infusion site pruritus, pyrexia and chills Adverse reactions include electrolyte imbalances, hyperglycemia, and hypervolemia and injection site reactions. ( 6 ) 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 .

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 )

11 DESCRIPTION Potassium Chloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply in a single-dose container for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1 . Table 1 * Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. ** Size (mL) Composition (g/L) Ionic Concentration (mEq/L) Caloric Content (kcal/L) Potassium Chloride in 5% Dextrose Injection, USP **Dextrose Hydrous, USP Potassium Chloride, USP (KCl) *Osmolarity (mOsmol/L) (calc.) pH Potassium Chloride mEq Potassium 10 mEq 1000 50 0.75 272 4.5 (3.5 to 6.5) 10 10 170 20 mEq 1000 50 1.5 293 4.5 (3.5 to 6.5) 20 20 170 D-Glucose monohydrate Dextrose is derived from corn. The flexible plastic container is fabricated from a specially formulated nonplasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). The amount of water that can permeate from 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. Structural Formula

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, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique. When introducing additives, consult the instructions for use of the medication to be added and other relevant literature. To Add Medication Prior to Solution Administration Identify WHITE Additive Port with arrow pointing toward container. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. Hold base of WHITE Additive Port horizontally. Prepare medication site Insert an 18 to 23 gauge needle horizontally through the center of WHITE Additive Port's septum and inject additives. Mix container contents thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. After addition, 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. To Add Medication During Solution Administration Close the clamp on the set Identify WHITE Additive Port with arrow pointing toward container Immediately before injecting additives, if the Cap has not been broken off, break off WHITE Additive Port cap with the arrow pointing toward container. Hold base of WHITE Additive Port horizontally. Prepare medication site. Using a syringe with an 18 to 23 gauge needle, horizontally insert through the center of WHITE Additive Port's septum and inject additives. Remove container from IV pole and/or turn to an upright position. Mix container contents thoroughly. After addition, 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. Using aseptic technique, repeat steps 4-7 as necessary. Return container to in use position and continue administration. Storage Use promptly; do not store solutions containing additives. Single-dose container. Discard any unused portion.

1 INDICATIONS AND USAGE Potassium Chloride in 5% Dextrose Injection is indicated as a source of water, electrolytes and calories. Potassium Chloride in 5% Dextrose Injection is indicated as a source of water, electrolytes and calories. ( 1 )

10 OVERDOSAGE Excess administration of Potassium Chloride in 5% Dextrose Injection can cause: Hyperkalemia Manifestations of hyperkalemia may include: disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation, and ECG changes (peaking of T waves, loss of P waves, and QRS widening) hypotension, muscle weakness up to and including muscular and respiratory paralysis, paresthesia of extremities, gastrointestinal symptoms (ileus, nausea, vomiting, abdominal pain) The presence of any ECG findings that are suspected to be caused by hyperkalemia should be considered a medical emergency. If hyperkalemia is present or suspected, discontinue the infusion immediately and institute close ECG, laboratory and other monitoring and, as necessary, corrective therapy to reduce serum potassium concentrations [see Warnings and Precautions ( 5.2 )] . Other Electrolyte and Fluid Disorders Hyperglycemia, hyperosmolality, and adverse effects on water and electrolyte balance, and corresponding complications, which can be fatal [see Warnings and Precautions ( 5.3 , 5.6 )] . Hyponatremia, manifestations may include seizures, coma, cerebral edema and death) [see Warnings and Precautions ( 5.4 )] . Fluid overload (which can lead to central and/or peripheral edema) [see Warnings and Precautions ( 5.6 )] . Hypernatremia, especially in patients with severe renal impairment. Interventions include discontinuation of the infusion, dose reduction, monitoring of fluid balance, electrolyte concentrations and acid-base balance and institution of appropriate corrective measures such as administration of exogenous insulin.

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.

12 CLINICAL PHARMACOLOGY 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.

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.

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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 )

Potassium Chloride Potassium Chloride, Dextrose Monohydrate Potassium Chloride Potassium Cation Chloride Ion Dextrose Monohydrate Anhydrous Dextrose Potassium Chloride Potassium Chloride, Dextrose Monohydrate Potassium Chloride Potassium Cation Chloride Ion Dextrose Monohydrate Anhydrous Dextrose

ANDA212346

Potassium Chloride

Potassium Chloride, Dextrose Monohydrate

63323-667

HUMAN PRESCRIPTION DRUG

INTRAVENOUS

PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose Injection, USP 10 mEq/L Bag Label freeflex NDC 63323- 667 -01 1000 mL 10 mEq Potassium Chloride (10 mEq/L) Potassium Chloride in 5% Dextrose Injection, USP For Intravenous Use. Rx Only PACKAGE LABEL - PRINCIPAL DISPLAY – Potassium Chloride in 5% Dextrose Injection, USP 10 mEq/L Bag Label

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

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers or home healthcare providers of the following risks of Potassium Chloride in 5% Dextrose Injection: Hypersensitivity reactions [see Warnings and Precautions ( 5.1 )] Hyperkalemia [see Warnings and Precautions ( 5.2 )] Hyperglycemia and hyperosmolar hyperglycemic state [see Warnings and Precautions ( 5.3 )] Hyponatremia [see Warnings and Precautions ( 5.4 )] Hypokalemia [see Warnings and Precautions ( 5.5 )] Fluid overload [see Warnings and Precautions ( 5.6 )] Refeeding syndrome [see Warnings and Precautions ( 5.7 )] Manufactured for: Lake Zurich, IL 60047 Made in Norway www.fresenius-kabi.com/us 451697 Fresenius Kabi Logo

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, if available. If, in the informed judgment of the healthcare provider, it is deemed advisable to introduce additives, use aseptic technique. When introducing additives, consult the instructions for use of the medication to be added and other relevant literature. To Add Medication Prior to Solution Administration Identify WHITE Additive Port with arrow pointing toward container. Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. Hold base of WHITE Additive Port horizontally. Prepare medication site Insert an 18 to 23 gauge needle horizontally through the center of WHITE Additive Port's septum and inject additives. Mix container contents thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. After addition, 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. To Add Medication During Solution Administration Close the clamp on the set Identify WHITE Additive Port with arrow pointing toward container Immediately before injecting additives, if the Cap has not been broken off, break off WHITE Additive Port cap with the arrow pointing toward container. Hold base of WHITE Additive Port horizontally. Prepare medication site. Using a syringe with an 18 to 23 gauge needle, horizontally insert through the center of WHITE Additive Port's septum and inject additives. Remove container from IV pole and/or turn to an upright position. Mix container contents thoroughly. After addition, 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. Using aseptic technique, repeat steps 4-7 as necessary. Return container to in use position and continue administration. Storage Use promptly; do not store solutions containing additives. Single-dose container. Discard any unused portion.

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.

8.4 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.

8.1 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 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 )] .

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.