POTASSIUM CHLORIDE IN DEXTROSE

6 ADVERSE REACTIONS The following adverse reactions associated with the use of Potassium Chloride in 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. To report SUSPECTED ADVERSE REACTIONS, contact B. Braun Medical Inc. at 1-866-854-6851 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

4 CONTRAINDICATIONS Potassium Chloride in 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 and/or dextrose ( 5.1) clinically significant hyperkalemia (5.2) clinically significant hyperglycemia (5.3)

11 DESCRIPTION (See chart below for quantitative information.) Potassium Chloride in 5% Dextrose Injection USP is sterile, nonpyrogenic solution for fluid and electrolyte replenishment and caloric supply. It contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration. The formulas of the active ingredients are: Ingredients Molecular Formula Molecular Weight Potassium Chloride USP KCl 74.55 Hydrous Dextrose USP 198.17 Composition – Each 100 mL contains: Concentration of Electrolytes (mEq/liter) Calories per liter Calculated Osmolarity mOsmol/liter pH Solution Hydrous Dextrose USP Potassium Chloride USP Potassium Chloride 0.15% Potassium Chloride in 5% Dextrose Injection USP 5 g 0.15 g 20 20 170 295 4.3 (3.5-6.5) Water for Injection USP qs Dextrose is derived from corn. The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Chem structure

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 Dextrose Injection is only for intravenous infusion [see Warnings and Precautions (5.2)] . For patients receiving Potassium Chloride in Dextrose Injection at greater than maintenance rates, frequent monitoring of serum potassium concentrations and serial electrocardiograms (ECGs) are recommended. The osmolarity of Potassium Chloride in Dextrose Injection is 295 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 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 To Open Tear overwrap down at notch and remove solution container. Visually inspect the container. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Evaluate the following: Read the label. Ensure solution is the one ordered and is within the expiration date. If the outlet port protector is damaged, detached or not present, discard container. Invert the container and check to ensure the solution is clear and there is no haze or particulate matter. Discard if there is a color change and/or the appearance of precipitates, insoluble complexes or crystals. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration. Preparation for Administration Remove plastic protector from sterile set port at bottom of container. Attach administration set. Refer to complete directions accompanying set. 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 Potassium Chloride in Dextrose Injection and that the pH range of Potassium Chloride in Dextrose Injection 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. To Add Medication Before Solution Administration Prepare medication site. Using syringe with 18-22 gauge needle, puncture medication port and inner diaphragm and inject. Squeeze and tap ports while ports are upright and mix solution and medication 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, insoluble complexes or crystals. To Add Medication During Solution Administration Close clamp on the set. Prepare medication site. Using syringe with 18-22 gauge needle of appropriate length (at least 5/8 inch), puncture resealable medication port and inner diaphragm and inject. Remove container from IV pole and/or turn the container so the ports are in an upright position. Evacuate both ports by tapping and squeezing them while container ports are in the upright position. Mix solution and medication 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, insoluble complexes or crystals, do not use. 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 Dextrose Injection is indicated as a source of electrolytes, calories, and water for hydration. Potassium Chloride in Dextrose Injection is indicated as a source of electrolytes, calories, and water for hydration.

10 OVERDOSAGE Excess administration of Potassium Chloride in 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 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 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 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 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 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 supplied sterile and nonpyrogenic in 1000 mL single-dose, flexible container. Injection: 20 mEq Potassium Chloride in 5% Dextrose Injection, USP in a 1000 mL plastic container.

POTASSIUM CHLORIDE IN DEXTROSE DEXTROSE and POTASSIUM CHLORIDE DEXTROSE DEXTROSE POTASSIUM CHLORIDE POTASSIUM CATION WATER POTASSIUM CHLORIDE IN DEXTROSE DEXTROSE and POTASSIUM CHLORIDE DEXTROSE DEXTROSE POTASSIUM CHLORIDE POTASSIUM CATION WATER

NDA019699

POTASSIUM CHLORIDE IN DEXTROSE

DEXTROSE and POTASSIUM CHLORIDE

0264-7628

HUMAN PRESCRIPTION DRUG

INTRAVENOUS

PRINCIPAL DISPLAY PANEL - 1000 mL Container 0.15% Potassium Chloride in 5% Dextrose Injection USP REF L6250 NDC 0264-7625-00 DIN 01931539 1000 mL EXCEL® CONTAINER 20 mEq K+/liter Y94-003-344 LD-503-2 Each 100 mL contains: Hydrous Dextrose USP 5 g; Potassium Chloride USP 0.15 g; Water for Injection USP qs pH: 4.3 (3.5-6.5); Calc. Osmolarity: 295 mOsmol/liter Electrolytes (mEq/liter): K + 20; Cl – 20 Sterile, nonpyrogenic. Single dose container. Do not use in series connection. For intravenous use only. Use only if solution is clear and container and seals are intact. WARNINGS: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing. See Package Insert. Do not remove overwrap until ready for use. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. EXCEL is a registered trademark of B. Braun Medical Inc. Rx only B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y94-003-267 LD-168-2 EXP LOT Recycle logo 1000 mL Container

RECENT MAJOR CHANGES Contraindications (4) 07/2020 Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7) 07/2020

Rx Only EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 In Canada, distributed by: B. Braun of Canada, Ltd. Scarborough, Ontario M1H 2W4 Y36-002-975 LD-235-3

17 PATIENT COUNSELING INFORMATION Inform patients, caregivers or home healthcare providers of the following risks of Potassium Chloride in 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)]

8.5 Geriatric Use Potassium Chloride in 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.

8.2 Lactation Risk Summary Potassium is present in human breast milk. There are no data on the effects of Potassium Chloride in 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 Dextrose Injection and any potential adverse effects on the breastfed infant from Potassium Chloride in Dextrose Injection or from the underlying maternal condition.

8.4 Pediatric Use The safety profile of Potassium Chloride in 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 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 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 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 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 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 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 Dextrose Injection and any potential adverse effects on the breastfed infant from Potassium Chloride in Dextrose Injection or from the underlying maternal condition. 8.4 Pediatric Use The safety profile of Potassium Chloride in 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 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 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 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 supplied sterile and nonpyrogenic in 1000 mL EXCEL® Containers packaged 12 per case. REF Size NDC mEq Potassium Product Name L6250 1000 mL 0264-7625-00 (Canada DIN 01931539) 20 mEq Potassium Chloride in 5% Dextrose Injection, USP Not made with natural rubber latex, PVC or DEHP. Storage Avoid excessive heat. Protect from freezing. Store at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product. Storage in automated dispensing machines : Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.