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. (6) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 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 or dextrose (4 , 5.1 ) • Clinically significant hyperkalemia (4 , 5.2) • Clinically significant hyperglycemia (4 , 5.3)

11 DESCRIPTION Potassium Chloride in 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 Size (mL) Composition (g/L) Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Osmolarity (mOsmol/L) (calc.) pH Ionic Concentration (mEq/L) Caloric Content (kcal/L) **Dextrose Hydrous, USP Potassium Chloride, USP (KCl) Potassium Chloride Potassium Chloride in 5% Dextrose Injection, USP mEq Potassium 20 mEq 1000 50 1.5 293 4.5 (3.5 to 6.5) 20 20 170 Dextrose is derived from corn. The VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. 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 can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. D-Glucose monohydrate 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 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 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 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 • Do not remove container from overwrap until ready to use. • Tear overwrap down side at slit and remove solution container. • Visually inspect the container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Evaluate the following: o If the outlet port protector is damaged, detached, or not present, discard container. o 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. o Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard container. Preparation for Administration 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. • When introducing additives, consult the instructions for use of the medication to be added and other relevant literature. To Add Medication Before Solution Administration 1. Prepare medication site. 2. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. 3. Mix solution and medication thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. 4. 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 1. Close clamp on the set. 2. Prepare medication site. 3. Using syringe with 19 to 22 gauge needle, puncture resealable medication port and inject. 4. Remove container from IV pole and/or turn to an upright position. 5. Evacuate both ports by squeezing them while container is in the upright position. 6. Mix solution and medication thoroughly. 7. 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. 8. 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 water, electrolytes and calories. Potassium Chloride in Dextrose Injection is indicated as a source of water, electrolytes and calories. (1)

10 OVERDOSAGE Excess administration of Potassium Chloride in Dextrose Injection can cause: Hyperkalemia • Manifestations of hyperkalemia may include: o 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) o hypotension, o muscle weakness up to and including muscular and respiratory paralysis, paresthesia of extremities, o 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 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.

20190715

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

Potassium Chloride in Dextrose Potassium Chloride and Dextrose Monohydrate POTASSIUM CHLORIDE POTASSIUM CATION CHLORIDE ION DEXTROSE MONOHYDRATE ANHYDROUS DEXTROSE WATER

NDA017634

Potassium Chloride in Dextrose

Potassium Chloride and Dextrose Monohydrate

0338-0683

HUMAN PRESCRIPTION DRUG

INTRAVENOUS

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Container Label 2B1134 NDC 0338-0683-04 DIN 00438049 20 mEq Potassium Chloride (20 mEq/L) Potassium Chloride in 5% Dextrose Injection USP 1000 mL EACH 100 mL CONTAINS 5 g DEXTROSE HYDROUS USP 150 mg POTASSIUM CHLORIDE USP pH 4.5 (3.5 TO 6.5) mEq/L POTASSIUM 20 CHLORIDE 20 OSMOLARITY 293 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES USE ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND MUST NOT BE USED IN SERIES CONNECTIONS DO NOT ADMINISTER SIMULTANEOUSLY WITH BLOOD DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C/77°F) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT VIAFLEX PLUS CONTAINER PL 146 PLASTIC BAXTER VIAFLEX AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC FOR PRODUCT INFORMATION 1-800-933-0303 Baxter Logo BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA DISTRIBUTED IN CANADA BY BAXTER CORPORATION TORONTO ONTARIO CANADA Potassium Chloride in Dextrose Representative Container Label NDC 0338-0683-04

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 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) ] Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA Distributed in Canada by Baxter Corporation Mississauga, ON L5N 0C2 07-19-75-361 Baxter and Viaflex are trademarks of Baxter International Inc.

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.

8.4 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, is a clear solution in 1000 mL single-dose, flexible containers available as follows: Code Size (mL) NDC Product Name 2B1134 1000 0338-0683-04 20 mEq Potassium Chloride in 5% Dextrose Injection, USP Storage: Avoid excessive heat. Store at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product.