Potassium Chloride in Lactated Ringers and Dextrose

Dosage and Administration ( 2.1 , 2.2 , 2.3 , 2.4 ) 10/2025 Contraindications ( 4 ) 10/2025 Warnings and Precautions ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 , 5.8 , 5.9 , 5.10 , 5.11 ) 10/2025

1 INDICATIONS AND USAGE Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients. Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is indicated for use as a source of water, electrolytes, and calories or as an alkalinizing agent in adults and pediatric patients. ( 1 )

2 DOSAGE AND ADMINISTRATION • The recommended dosage and duration are based on the patient’s age, weight, clinical condition, and concomitant therapy. ( 2.1 ) • To reduce the risk of air embolism, adhere to the preparation instructions. ( 2.2 , 5.2 ) • Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is for intravenous use. ( 2.3 ) • Use a peripheral vein to administer if the final dextrose concentration is 5% or less, and the osmolarity is less than 900 mOsm/L. ( 2.3 ). • Consider using a central vein to administer hypertonic solutions with osmolarity of 900 mOsm/L or more to avoid venous irritation, including phlebitis. ( 2.3 ) • Do not administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection simultaneously with ceftriaxone in neonates (28 days of age or younger) due to serious risks. ( 2.4 ) • See full prescribing information for information dosage considerations, preparation, administration, and drug incompatibilities. ( 2 ) 2.1 Dosage Considerations The recommended dosage and duration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is based on the patient’s age, weight, clinical condition, and concomitant therapy. Evaluate the patient’s clinical status and monitor changes in blood glucose and electrolyte concentrations especially during prolonged use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to optimize clinical status. 2.2 Important Preparation Instructions Visually inspect the Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection solution for particulate matter and discoloration. Do not administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection unless the solution is clear and the container seals are intact. If additives are determined to be compatible with Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection then using aseptic technique, mix thoroughly; do not store solutions containing additives. After mixing, do not use if there is discoloration or formation of precipitates. To reduce the risk of air embolism, adhere to the following preparation instructions for Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection [see Warnings and Precautions (5.2) ] : • Use a non-vented infusion set or close the vent on a vented set. • Use a dedicated line without any connections (do not connect flexible containers in series). • The use of pressure infusion is not recommended as a method to increase flow rates. However, if pressure infusion is required, ensure that any air within the bag is fully evacuated prior to initiation of infusion. • If using a pumping device to administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection, turn off the pump before the container is empty. Preparation Instructions 1. Tear overwrap downside at slit and remove solution container. 2. Visually inspect the container. o If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. o 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. 3. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. 4. If supplemental medication is desired, follow directions below [see Dosage and Administration (2.3) ] . Preparation for Administration 1. Suspend container from eyelet support. 2. Remove protector from outlet port at bottom of container. 3. Attach administration set according to its accompanying directions. 2.3 Important Administration Instructions Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is for intravenous use. Use immediately after removing the overwrap. Discard the unused portion. • Use a peripheral vein to administer Potassium Chloride in Lactated Ringer’s and Dextrose (5%) …

3 DOSAGE FORMS AND STRENGTHS Injection: Potassium Chloride (20 mEq) in Lactated Ringer’s and Dextrose (5%) Injection, USP as a clear, sterile, and nonpyrogenic solution packaged in a single-dose VIAFLEX plastic container: 1,000 mL. Injection: Potassium Chloride (20 mEq) in Lactated Ringer’s and Dextrose (5%) Injection, USP packaged in a single-dose VIAFLEX plastic container: 1000 mL. ( 3 )

4 CONTRAINDICATIONS Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in: • Neonates (28 days of age or younger) who are receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream [see Warnings and Precautions (5.1) and Specific Populations (8.4) ] . • Patients with known hypersensitivity to any of the components of Potassium Chloride in Lactated Ringer’s solution and Dextrose (5%) Injection [see Warnings and Precautions (5.3) ] . • Patients with clinically significant hyperkalemia [see Warnings and Precautions (5.4) ] . • Patients with clinically significant hyperglycemia [see Warnings and Precautions (5.7) ] . • Concomitant treatment with ceftriaxone in neonates (28 days of age or younger). ( 4 ) • Patients with known hypersensitivity to any of the components of Potassium Chloride in Lactated Ringer’s solution and Dextrose (5%) Injection ( 4 ) • Patients with clinically significant hyperkalemia ( 4 ). • Patients with clinically significant hyperglycemia ( 4 ).

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Serious Risk with Concomitant Use with Ceftriaxone [see Warnings and Precautions (5.1) ] • Air Embolism [see Warnings and Precautions (5.2) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] • Potassium Imbalances [see Warnings and Precautions (5.4) ] • Hyponatremia [see Warnings and Precautions (5.5) ] • Neonatal Hypoglycemia [see Warnings and Precautions (5.6) ] • Hyperglycemia and Hyperosmolar Hyperglycemic State [see Warnings and Precautions (5.7) ] • Hypercalcemia [see Warnings and Precautions (5.8) ] • Fluid Overload [see Warnings and Precautions (5.9) ] • Acid/Base Imbalances [see Warnings and Precautions (5.10) ] The following adverse reactions have been identified during postapproval use of Lactated Ringer’s products. Because these reactions are 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: General Disorders and Administration Site Conditions: Phlebitis, extravasation, infusion site inflammation, infusion site swelling, infusion site rash, infusion site pruritus, infusion site erythema, infusion site pain, infusion site burning, and infusion site hypoaesthesia. Hypersensitivity Reactions and Infusion Reactions: Angioedema, chest pain/discomfort, bradycardia or tachycardia, hypotension, respiratory distress, bronchospasm, dyspnea, cough, urticaria, rash, pruritus, erythema, flushing, throat irritation, paresthesia, oral hypoesthesia, dysgeusia, nausea, anxiety, pyrexia, and headache, laryngeal edema, sneezing, injection site infection. Metabolism and Nutrition Disorders: Hyperkalemia, hyponatremia, and hypervolemia. Nervous System Disorders: Hyponatremic encephalopathy. Common adverse reactions include infusion site reactions and symptoms of hypersensitivity reactions (e.g., pruritus, dyspnea, urticaria, rash, cough). ( 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.

7 DRUG INTERACTIONS • Drugs that Affect Electrolyte and/or Fluid Balance : Avoid concomitant use. If concomitant use cannot be avoided, closely monitor electrolyte concentrations and fluid balance. ( 7.1 ) • Lithium : Avoid concomitant use. If concomitant use is unavoidable, monitor serum lithium concentrations more frequently. ( 7.2 ) • Digoxin : Consider reducing the volume or rate of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection due to the increased risk of digoxin toxicity with calcium-containing solutions. ( 7.3 ) • Drugs with pH-Dependent Renal Elimination : Renal clearance of acidic drugs may be increased. In contrast, renal clearance of alkaline drugs may be decreased. ( 7.4 ) 7.1 Drugs that Affect Electrolyte and/or Fluid Balance Hyperkalemia Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients concomitantly treated or recently treated with drugs that are associated with hyperkalemia increases the risk of severe and potentially fatal hyperkalemia, especially in the presence of other hyperkalemia risk factors. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving drugs that are associated with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, or calcineurin inhibitors). If concomitant use cannot be avoided, closely monitor serum potassium concentrations during concomitant use [see Warnings and Precautions (5.4) ]. Hyponatremia Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients treated concomitantly with drugs associated with hyponatremia may increase the risk of developing hyponatremia. These drugs include diuretics and those that cause SIADH (e.g., arginine vasopressin analogs, certain antiepileptic, psychotropic, or cytotoxic drugs). Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving such drugs. If use cannot be avoided, closely monitor serum sodium concentrations during concomitant use [see Warnings and Precautions (5.5) ]. Hypercalcemia Avoid the use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients treated with thiazide diuretics or vitamin D because these drugs can increase the risk of hypercalcemia. If use cannot be avoided, closely monitor serum calcium concentrations during concomitant use [see Warnings and Precautions (5.8) ]. Hypernatremia and Fluid Retention Administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to patients treated concomitantly with drugs associated with sodium and fluid retention (e.g., corticosteroids or corticotropin) may increase the risk of hypernatremia and volume overload. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving such drugs. If use cannot be avoided, closely monitor serum electrolytes, fluid balance, and acid-base balance during concomitant use. 7.2 Lithium Renal sodium and lithium clearance may be increased during concomitant use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection and lithium and may result in decreased lithium concentrations. Avoid use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection in patients receiving lithium. If use cannot be avoided, increase the frequency of monitoring of serum lithium concentrations during concomitant use. 7.3 Digoxin Administration of calcium via use of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection may increase digoxin’s effects and lead to digoxin toxicity including serious or fatal cardiac arrhythmias. In digoxin-treated patients, consider reducing the volume and/or rate of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection administration. 7.4 Drugs with pH-Dependent Renal Elimination Due to the alkalinizing action of lactate (formation of bicarbonate), Potassium Chloride …

8 USE IN SPECIFIC POPULATIONS • Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function. ( 8.4 ) • Neonates are at increased risk of developing hypo- or hyperglycemia. Closely monitor to ensure adequate glycemic control. ( 8.4 ) • Geriatric patients are more likely to have decreased renal function. Consider monitoring renal function and starting the infusion at the low end of the dosing range. ( 8.5 ) • Avoid in patients with severe renal impairment. ( 8.6 ) • Patients with severe hepatic impairment may have impaired lactate metabolism. Closely monitor serum lactate levels and acid-base status. ( 8.7 ) 8.1 Pregnancy Risk Summary Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection as a source of water and electrolytes has been used for decades during labor and delivery. Appropriate administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with this drug. The 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 Lactated Ringer’s as a source of water and electrolytes and Dextrose (5%) Injection have been used for decades and is not expected to cause harm to a breastfed infant. There are no data on the presence of Lactated Ringer’s and Dextrose (5%) Injection in human milk, the effects on the breastfed infant, or the effects on milk production. Potassium is present in human breast milk. There are no data on the effects of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) 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 Lactated Ringer’s and Dextrose (5%) Injection and any potential adverse effects on the breastfed infant from Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection or from the underlying maternal condition. 8.4 Pediatric Use Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is contraindicated in neonates (28 days of age or younger) who are receiving ceftriaxone due to reported deaths that occurred when neonates received ceftriaxone and intravenous calcium-containing solutions concomitantly [see Warnings and Precautions (5.1) ]. The safety and effectiveness of Lactated Ringer’s Injection for use as a source of water, electrolytes, and calories or as an alkalinizing agent have been established in pediatric patients of all ages, including neonates. The safety profile of Potassium Chloride in Dextrose Injection in pediatric patients is similar to adults. Closely monitor plasma electrolyte concentrations in young pediatric patients with immature kidney function who may have decreased ability to maintain fluid and electrolyte balance [see Warnings and Precautions (5.4 , 5.5 , 5.8 , 5.9 )]. Administration of a lactate-containing intravenous solution, including Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection to pediatric patients should account for liver and kidney maturation (the kidney function affects the biotransformation and renal excretion of lactate) [see Warnings and Precautions (5.9) ]. Pediatric patients are at increased risk for developing hyponatremic encephalopathy [see Warnings and Precautions (5.5) ] . Neonates, especially preterm neonates with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose solutions including Potassiu …

12.1 Mechanism of Action Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection is a source of water, electrolytes, and calories, and produces an alkalinizing effect. • Sodium, the major cation of the extracellular fluid, functions primarily in the control of water distribution, fluid balance, and osmotic pressure of body fluids. Sodium is also associated with chloride and bicarbonate in the regulation of the acid-base equilibrium of body fluid. • Potassium, the principal cation of intracellular fluid, participates in carbohydrate utilization and protein synthesis and is critical in the regulation of nerve conduction and muscle contraction, particularly in the heart. • Chloride, the major extracellular anion, closely follows the metabolism of sodium, and changes in the acid-base balance of the body are reflected by changes in the chloride concentration. • Calcium, an important cation, provides the framework of bones and teeth in the form of calcium phosphate and calcium carbonate. In the ionized form, calcium is essential for the functional mechanism of the clotting of blood, normal cardiac function, and regulation of neuromuscular irritability. • Sodium lactate provides sodium and lactate ions. The lactate anion is in equilibrium with pyruvate and has an alkalinizing effect resulting from simultaneous removal by the liver of lactate and hydrogen ions. The sodium ion combines with bicarbonate ion produced from carbon dioxide of the body and thus retains bicarbonate to combat metabolic acidosis (bicarbonate deficiency). • Dextrose provides a source of calories. Dextrose may decrease losses of body protein and nitrogen, promotes glycogen deposition and decreases or prevents ketosis if sufficient doses are provided.

DESCRIPTION Intravenous solution with potassium chloride (I.V. solutions with KCl) is a sterile and nonpyrogenic solution in water for injection. This solution is for administration by intravenous infusion only. See Table 1 below for summary of content and characteristics of this solution. Table 1 COMPOSITION (g/L) Calculated Osmolarity (mOsmol/L) Potassium Chloride in Lactated Ringer's and 5% Dextrose Injection, USP mEq Potassium Added Size (mL) Dextrose, Hydrous Potassium Chloride Sodium Chloride Sodium Lactate, Anhydrous Calcium Chloride Dihydrate 20 mEq 1000 50 1.79 6 3.1 0.2 563 pH Approx. Ionic Concentrations (mEq/L) Approx. kcal/L Calcium (Ca++) Sodium (Na+) Potassium (K+) Chloride (Cl-) Lactate 4.9 (3.5 to 6.5) 2.7 130 24 129 28 179 May contain HCl for pH adjustment. The solution contains no bacteriostat, antimicrobial agent or added buffer and each is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. This solution is a parenteral fluid, nutrient and/or electrolyte replenisher. Dextrose, USP is chemically designated D-glucose, monohydrate (C 6 H 12 O 6 • H 2 O), a hexose sugar freely soluble in water. It has the following structural formula: Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. Calcium Chloride, USP is chemically designated calcium chloride dihydrate (CaCl 2 • 2H 2 O), white fragments or granules freely soluble in water. Sodium Lactate, USP is chemically designated monosodium lactate [CH 3 CH(OH)COONa], a 50% aqueous solution miscible in water. It has the following structural formula: Water for Injection, USP is chemically designated H 2 0. The flexible plastic container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers ( free flex ® bag). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in the 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. Dextrose Structural Formula Calcium Chloride Structural Formula

10 OVERDOSAGE Excessive administration of Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection can cause: • Hyperkalemia and hypernatremia, especially in patients with severe renal impairment. • Fluid overload (which can lead to pulmonary and/or peripheral edema). • Hyperglycemia, hyperosmolarity, and osmotic diuresis, dehydration, and electrolyte loss. • Metabolic alkalosis with or without hypokalemia. • Loss of bicarbonate with an acidifying effect. • Hypercalcemia. Overdose interventions include Potassium Chloride in Lactated Ringer’s and Dextrose (5%) Injection discontinuation, treatment of electrolyte imbalances, treatment of hyperglycemia, and close monitoring of fluid balance, electrolyte concentrations, and acid-base balance [see Warnings and Precautions (5.4 , 5.5 , 5.6 , 5.7 , 5.9 , 5.10 )]

HOW SUPPLIED Intravenous solution with potassium chloride (I.V. solution with KCl) is supplied in single-dose flexible plastic container. See Table: Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP List No. mEq Potassium Added Size (mL) COMPOSITION (g/L) Calculated Osmolarity (mOsmol/L) Dextrose, Hydrous Potassium Chloride Sodium Chloride Sodium Lactate, Anhydrous Calcium Chloride Dihydrate 7111 20 mEq 1000 50 1.79 6 3.1 0.2 563 NDC No. 0409-7111-09 0990-7111-09 Potassium Chloride in Lactated Ringer’s and 5% Dextrose Injection, USP (Continued) pH Approx. Ionic Concentrations (mEq/L) Approx. kcal/L Calcium (Ca++) Sodium (Na + ) Potassium (K + ) Chloride (Cl ̄) Lactate 4.9 (3.5 to 6.5) 2.7 130 24 129 28 179 ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. May contain HCl for pH adjustment. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: March, 2020 IFU0000167 ICU Medical, Inc., Lake Forest, Illinois, 60045, USA