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<table width="100%"><col width="60%"/><tbody><tr><td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">CONCENTRATE</content></paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph><content styleCode="italics">MUST BE DILUTED BEFORE USE.</content></paragraph></td></tr></tbody></table>

DESCRIPTION Potassium Chloride for Injection Concentrate, USP, is a sterile, nonpyrogenic, concentrated solution of potassium chloride, USP in water for injection administered by intravenous infusion only after dilution in a larger volume of fluid. They are provided in the following variety of concentrations and sizes comprising a choice of single-dose containers, all designed to provide the commonly prescribed amounts of potassium chloride for single-dose infusion after dilution in suitable large volume parenterals. Additive Solution May contain hydrochloric acid for pH adjustment. (conc. & size) K + mEq/mL KCl mg/mL mOsmol/mL (calc.) 10 mEq/5 mL 2 149 4 20 mEq/10 mL 2 149 4 40 mEq/20 mL 2 149 4 The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for single-dose injection (after dilution). When smaller doses are required, discard the unused portion. The pH is 4.6 (4.0 to 8.0). Potassium Chloride for Injection Concentrate, USP (appropriately diluted) is a parenteral fluid and electrolyte replenisher. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. The semi-rigid material used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

<table width="100%"><col width="25%"/><col width="25%"/><col width="24%"/><col width="25%"/><tbody><tr><td align="center" styleCode="Botrule Toprule " valign="top"><paragraph><content styleCode="bold">Additive Solution</content><footnote ID="_Ref411941260">May contain hydrochloric acid for pH adjustment.</footnote></paragraph><paragraph><content styleCode="bold">(conc. &amp; size)</content></paragraph></td><td align="center" styleCode="Botrule Toprule " valign="top"><paragraph><content styleCode="bold">K⁺</content></paragraph><paragraph><content styleCode="bold">mEq/mL</content></paragraph></td><td align="center" styleCode="Botrule Toprule " valign="top"><paragraph><content styleCode="bold">KCl</content></paragraph><paragraph><content styleCode="bold">mg/mL</content></paragraph></td><td align="center" styleCode="Botrule Toprule " valign="top"><paragraph><content styleCode="bold">mOsmol/mL</content></paragraph><paragraph><content styleCode="bold">(calc.)</content></paragraph></td></tr><tr><td align="center" valign="top"><paragraph>10 mEq/5 mL</paragraph></td><td align="center" valign="top"><paragraph>2</paragraph></td><td align="center" valign="top"><paragraph>149</paragraph></td><td align="center" valign="top"><paragraph>4</paragraph></td></tr><tr><td align="center" valign="top"><paragraph>20 mEq/10 mL</paragraph></td><td align="center" valign="top"><paragraph>2</paragraph></td><td align="center" valign="top"><paragraph>149</paragraph></td><td align="center" valign="top"><paragraph>4</paragraph></td></tr><tr><td align="center" styleCode="Botrule " valign="top"><paragraph>40 mEq/20 mL</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>2</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>149</paragraph></td><td align="center" styleCode="Botrule " valign="top"><paragraph>4</paragraph></td></tr></tbody></table>

CLINICAL PHARMACOLOGY Potassium is the chief cation of body cells (160 mEq/liter of intracellular water) and is concerned with the maintenance of body fluid composition and electrolyte balance. Potassium 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. Normally about 80 to 90% of the potassium intake is excreted in the urine, the remainder in the stools and, to a small extent, in perspiration. The kidney does not conserve potassium well so that during fasting, or in patients on a potassium-free diet, potassium loss from the body continues, resulting in potassium depletion. A deficiency of either potassium or chloride will lead to a deficit of the other.

CONTRAINDICATIONS Potassium Chloride for Injection Concentrate, USP is contraindicated in diseases where high potassium levels may be encountered, and in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present.

WARNINGS Potentially Fatal Cardiac Adverse Reactions with Undiluted Intravenous Administration Direct patient injection of potassium chloride at this concentration may be instantaneously fatal. Potassium Chloride for Injection Concentrate must be diluted before administration. Fatal cardiac arrhythmia and cardiac arrest have occurred when potassium chloride was administered in an undiluted form. To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with renal insufficiency, administration of potassium chloride may cause potassium intoxication and life-threatening hyperkalemia. The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. Pregnancy Teratogenic Effects : Animal reproduction studies have not been conducted with potassium chloride. It is also not known whether potassium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium chloride should be given to a pregnant woman only if clearly needed.

General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result.

Pregnancy Teratogenic Effects : Animal reproduction studies have not been conducted with potassium chloride. It is also not known whether potassium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium chloride should be given to a pregnant woman only if clearly needed.

ADVERSE REACTIONS 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, hypervolemia, and hyperkalemia. Too rapid infusion of hypertonic solutions may cause local pain and, rarely, vein irritation. Rate of administration should be adjusted according to tolerance. Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation. 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.

OVERDOSAGE In the event of fluid overload during parenteral therapy, re-evaluate the patient's condition, and institute appropriate corrective treatment. In the event of overdosage with potassium-containing solutions, discontinue the infusion immediately, and institute corrective therapy to reduce serum potassium levels. Treatment of hyperkalemia includes the following: 1. Dextrose Injection USP, 10% or 25%, containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, at a rate of 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. The use of potassium-containing foods or medications must be eliminated. However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

DOSAGE AND ADMINISTRATION Potassium Chloride for Injection Concentrate, USP must be diluted before administration. Care must be taken to ensure there is complete mixing of the potassium chloride with the large volume fluid, particularly if soft or bag type containers are used. The dose and rate of administration are dependent upon the specific condition of each patient. If the serum potassium level is greater than 2.5 mEq/liter, potassium can be given at a rate not to exceed 10 mEq/hour in a concentration of up to 40 mEq/liter. The 24-hour total dose should not exceed 200 mEq. If urgent treatment is indicated (serum potassium level less than 2.0 mEq/liter with electrocardiographic changes and/or muscle paralysis) potassium chloride may be infused very cautiously at a rate of up to 40 mEq/hour. In such cases, continuous cardiac monitoring is essential. As much as 400 mEq may be administered in a 24 hour period. In critical conditions, potassium chloride may be administered in saline (unless contraindicated), rather than in dextrose containing fluids, as dextrose may lower serum potassium levels. Prior to entering vial, remove the metal seal and cleanse the rubber closure with a suitable antiseptic agent. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. TO PREVENT NEEDLE-STICK INJURIES, NEEDLES SHOULD NOT BE RECAPPED, PURPOSELY BENT, OR BROKEN BY HAND.

HOW SUPPLIED Potassium Chloride for Injection Concentrate, USP, is supplied in single-dose containers as follows: Unit of Sale Concentration NDC 0409-6635-01 Tray of 25 single-dose containers 10 mEq/5 mL (2 mEq/mL) NDC 0409-6651-06 Tray of 25 single-dose containers 20 mEq/10 mL (2 mEq/mL) NDC 0409-6653-05 Tray of 25 single-dose containers 40 mEq/20 mL (2 mEq/mL) Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by: Hospira Inc., Lake Forest, IL 60045 USA LAB-1319-3.0 Revised: 01/2026 Logo

<table width="75%"><col width="36%"/><col width="38%"/><thead><tr><th align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Unit of Sale</content></th><th align="center" styleCode="Rrule Botrule Toprule " valign="top"><content styleCode="bold">Concentration</content></th></tr></thead><tbody><tr><td align="center" styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph><content styleCode="bold">NDC 0409-6635-01</content> Tray of 25 single-dose containers</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="top"><paragraph>10 mEq/5 mL (2 mEq/mL)</paragraph></td></tr><tr><td align="center" styleCode="Rrule Lrule Botrule " valign="top"><paragraph><content styleCode="bold">NDC 0409-6651-06</content> Tray of 25 single-dose containers</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>20 mEq/10 mL (2 mEq/mL)</paragraph></td></tr><tr><td align="center" styleCode="Rrule Botrule Lrule " valign="top"><paragraph><content styleCode="bold">NDC 0409-6653-05</content> Tray of 25 single-dose containers</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>40 mEq/20 mL (2 mEq/mL)</paragraph></td></tr></tbody></table>

DESCRIPTION Potassium Chloride for Injection Concentrate, USP, is a sterile, nonpyrogenic, concentrated solution of potassium chloride, USP in water for injection administered by intravenous infusion only after dilution in a larger volume of fluid. They are provided in the following variety of concentrations and sizes comprising a choice of single-dose containers, all designed to provide the commonly prescribed amounts of potassium chloride for single-dose infusion after dilution in suitable large volume parenterals. The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for single-dose injection (after dilution). When smaller doses are required, discard the unused portion. The pH is 4.6 (4.0 to 8.0). Potassium Chloride for Injection Concentrate, USP (appropriately diluted) is a parenteral fluid and electrolyte replenisher. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. The semi-rigid material used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration. Image2.jpg

WARNINGS To avoid potassium intoxication, do not infuse solutions rapidly. In patients with severe renal insufficiency, administration of potassium chloride may cause potassium intoxication and life threatening hyperkalemia. The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. Pregnancy Teratogenic Effects: Animal reproduction studies have not been conducted with potassium chloride. It is also not known whether potassium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium chloride should be given to a pregnant woman only if clearly needed.

HOW SUPPLIED Potassium Chloride for Injection Concentrate, USP, is supplied in single-dose containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Product repackaged by: Henry Schein, Inc., Bastian, VA 24314 From Original Manufacturer/Distributor's NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit NDC 0409-6651-06 Tray of 25 single-dose glass containers NDC 0404-9937-10 1 10 mL single-dose container in a bag (Container bears NDC 0409-6651-19) 20 mEq/10 mL (2 mEq/mL) Distributed by Hospira Inc., Lake Forest, IL 60045 USA Hospira LAB-1319-2.0 Revised: 10/2022 Image3.jpg

<table width="100%"><caption> Product repackaged by: Henry Schein, Inc., Bastian, VA 24314</caption><tbody><tr><td>From Original Manufacturer/Distributor&apos;s NDC and Unit of Sale</td><td>To Henry Schein Repackaged Product NDC and Unit of Sale</td><td>Total Strength/Total Volume (Concentration) per unit</td></tr><tr><td>NDC 0409-6651-06 Tray of 25 single-dose glass containers</td><td>NDC 0404-9937-10 1 10 mL single-dose container in a bag (Container bears NDC 0409-6651-19)</td><td>20 mEq/10 mL (2 mEq/mL)</td></tr></tbody></table>

Description Potassium Chloride for Injection Concentrate, USP, is a sterile, nonpyrogenic, concentrated solution of potassium chloride, USP in water for injection administered by intravenous infusion only after dilution in a larger volume of fluid. They are provided in the following variety of concentrations and sizes comprising a choice of single-dose containers, all designed to provide the commonly prescribed amounts of potassium chloride for single-dose infusion after dilution in suitable large volume parenterals. * May contain hydrochloric acid for pH adjustment. The solutions contain no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and each is intended only for single-dose injection (after dilution). When smaller doses are required, discard the unused portion. The pH is 4.6 (4.0 to 8.0). Potassium Chloride for Injection Concentrate, USP (appropriately diluted) is a parenteral fluid and electrolyte replenisher. Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. The semi-rigid material used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration. Description Chart

Clinical Pharmacology Section Potassium is the chief cation of body cells (160 mEq/liter of intracellular water) and is concerned with the maintenance of body fluid composition and electrolyte balance. Potassium 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. Normally about 80 to 90% of the potassium intake is excreted in the urine, the remainder in the stools and, to a small extent, in perspiration. The kidney does not conserve potassium well so that during fasting, or in patients on a potassium-free diet, potassium loss from the body continues, resulting in potassium depletion. A deficiency of either potassium or chloride will lead to a deficit of the other.

Contraindications Section Potassium Chloride for Injection Concentrate, USP is contraindicated in diseases where high potassium levels may be encountered, and in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present.

Warnings To avoid potassium intoxication, do not infuse solutions rapidly. In patients with severe renal insufficiency, administration of potassium chloride may cause potassium intoxication and life threatening hyperkalemia. The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. Pregnancy Teratogenic Effects: Animal reproduction studies have not been conducted with potassium chloride. It is also not known whether potassium chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium chloride should be given to a pregnant woman only if clearly needed.

Adverse Reactions 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, hypervolemia, and hyperkalemia. Too rapid infusion of hypertonic solutions may cause local pain and, rarely, vein irritation. Rate of administration should be adjusted according to tolerance. Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation. 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.

Overdosage Section In the event of fluid overload during parenteral therapy, re-evaluate the patient's condition, and institute appropriate corrective treatment. In the event of overdosage with potassium-containing solutions, discontinue the infusion immediately, and institute corrective therapy to reduce serum potassium levels. Treatment of hyperkalemia includes the following: 1. Dextrose Injection USP, 10% or 25%, containing 10 units of crystalline insulin per 20 grams of dextrose administered intravenously, at a rate of 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. The use of potassium-containing foods or medications must be eliminated. However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

Dosage & Administration Section Potassium Chloride for Injection Concentrate, USP must be diluted before administration. Care must be taken to ensure there is complete mixing of the potassium chloride with the large volume fluid, particularly if soft or bag type containers are used. The dose and rate of administration are dependent upon the specific condition of each patient. If the serum potassium level is greater than 2.5 mEq/liter, potassium can be given at a rate not to exceed 10 mEq/hour in a concentration of up to 40 mEq/liter. The 24-hour total dose should not exceed 200 mEq. If urgent treatment is indicated (serum potassium level less than 2.0 mEq/liter with electrocardiographic changes and/or muscle paralysis) potassium chloride may be infused very cautiously at a rate of up to 40 mEq/hour. In such cases, continuous cardiac monitoring is essential. As much as 400 mEq may be administered in a 24 hour period. In critical conditions, potassium chloride may be administered in saline (unless contraindicated), rather than in dextrose containing fluids, as dextrose may lower serum potassium levels. Prior to entering vial, remove the metal seal and cleanse the rubber closure with a suitable antiseptic agent. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. TO PREVENT NEEDLE-STICK INJURIES, NEEDLES SHOULD NOT BE RECAPPED, PURPOSELY BENT, OR BROKEN BY HAND.

How Supplied Section POTASSIUM CHLORIDE FOR INJECTION CONCENTRATE, USP is supplied in the following dosage forms. NDC 51662-1421 POTASSIUM CHLORIDE FOR INJECTION CONCENTRATE, USP 40 mEq/20 mL (2 mEq/mL) 20mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Potassium Chloride for Injection Concentrate, USP, is supplied in single-dose containers as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira Inc., Lake Forest, IL 60045 USA LAB-1319-1.0 Revised: 5/2018 How Supplied Hospira

1 INDICATIONS AND USAGE Potassium Chloride is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium Chloride is a potassium salt indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. ( 1 )

2 DOSAGE AND ADMINISTRATION Dilute prior to administration. ( 2.1 , 5.1 ) Monitor serum potassium and adjust dosage accordingly ( 2.2 , 2.3 ) If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation ( 2.1 ) Treatment of hypokalemia: • Adults: Initial doses range from 40-100 mEq/day in 2-5 divided doses: limit doses to 40 mEq per dose. Total daily dose should not exceed 200 mEq ( 2.2 ) • Pediatric patients aged birth to 16 years old: 2-4 mEq/kg/day in divided doses; not to exceed 1 mEq/kg as a single dose or 40 mEq whichever is lower; if deficits are severe or ongoing losses are great, consider intravenous therapy. Total daily dose should not exceed 100 mEq ( 2.3 ) Maintenance or Prophylaxis of hypokalemia: • Adults: Typical dose is 20 mEq per day ( 2.2 ) • Pediatric patients aged birth to 16 years old: typical dose is 1 mEq/kg/day. Do not to exceed 3 mEq/kg/day ( 2.3 ) 2.1 Administration and Monitoring Monitoring Monitor serum potassium and adjust dosages accordingly. For treatment of hypokalemia, monitor potassium levels daily or more often depending on the severity of hypokalemia until they return to normal. Monitor potassium levels monthly to biannually for maintenance or prophylaxis. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms and the clinical status of the patient. Correct volume status, acid-base balance and electrolyte deficits as appropriate. Administration Dilute the contents of 1 pouch of potassium chloride for oral solution in at least 4 ounces of cold water [see Warnings and Precautions (5.1) ] . Take with meals or immediately after eating. If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation. 2.2 Adult Dosing Treatment of hypokalemia: Daily dose range from 40 to 100 mEq. Give in 2 to 5 divided doses: limit doses to 40 mEq per dose. The total daily dose should not exceed 200 mEq in a 24 hour period. Maintenance or Prophylaxis Typical dose is 20 mEq per day. Individualize dose based upon serum potassium levels. Studies support the use of potassium replacement in digitalis toxicity. When alkalosis is present, normokalemia and hyperkalemia may obscure a total potassium deficit. The advisability of use of potassium replacement in the setting of hyperkalemia is uncertain. 2.3 Pediatric Dosing Treatment of hypokalemia: Pediatric patients aged birth to 16 years old: The initial dose is 2 to 4 mEq/kg/day in divided doses; do not exceed as a single dose 1 mEq/kg or 40 mEq, whichever is lower; maximum daily doses should not exceed 100 mEq. If deficits are severe or ongoing losses are great, consider intravenous therapy. Maintenance or Prophylaxis Pediatric patients aged birth to 16 years old: Typical dose is 1 mEq/kg/day. Do not exceed 3 mEq/kg/day.

3 DOSAGE FORMS AND STRENGTHS Each pouch contains 1.5 g of potassium chloride supplying 20 mEq of potassium and 20 mEq of chloride. • Potassium Chloride for Oral Solution USP, 20 mEq: Each pouch contains 1.5 g of Potassium Chloride providing potassium 20 mEq and chloride 20 mEq. ( 3 )

5 WARNINGS AND PRECAUTIONS • Gastrointestinal Irritation: Dilute before use, take with meals ( 5.1 ) 5.1 Gastrointestinal Irritation May cause gastrointestinal irritation. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation [see Dosage and Administration (2.1) ] .

6 ADVERSE REACTIONS The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Virtus Pharmaceuticals, LLC at 1-888-848-3593 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

7 DRUG INTERACTIONS • Potassium sparing diuretics: Avoid concomitant use ( 7.1 ) • Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia ( 7.2 ) • Nonsteroidal Anti-Inflammatory drugs: Monitor for hyperkalemia ( 7.3 ) 7.1 Potassium-Sparing Diuretics Use with potassium-sparing diuretics can produce severe hyperkalemia. Avoid concomitant use. 7.2 Renin-Angiotensin-Aldosterone System Inhibitors Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients receiving concomitant RAAS therapy. 7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) NSAIDS may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs.

8 USE IN SPECIFIC POPULATIONS Cirrhosis: Initiate therapy at the low end of the dosing range ( 8.5 ) Renal Impairment: Initiate therapy at the low end of the dosing range ( 8.6 ) 8.1 Pregnancy There are no human data related to use of Potassium Chloride during pregnancy, and animal studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in 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 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as Potassium Chloride becomes part of the body potassium pool, as long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk. 8.4 Pediatric Use Clinical trial data from published literature have demonstrated the safety and effectiveness of potassium chloride in children with diarrhea and malnutrition from birth to 16 years. 8.5 Geriatric Use Clinical studies of Potassium Chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually 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. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Cirrhotics Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently [see Clinical Pharmacology (12.3) ] . 8.7 Renal Impairment Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on ACE inhibitors, ARBs, or nonsteroidal anti-inflammatory drugs should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia. The serum potassium level should be monitored frequently. Renal function should be assessed periodically.

8.1 Pregnancy There are no human data related to use of Potassium Chloride during pregnancy, and animal studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in 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 2-4% and 15-20%, respectively.

8.5 Geriatric Use Clinical studies of Potassium Chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually 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. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

10 OVERDOSAGE 10.1 Symptoms The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if potassium is administered too rapidly potentially fatal hyperkalemia can result. Hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5–8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9–12 mEq/L). 10.2 Treatment Treatment measures for hyperkalemia include the following: 1. Monitor closely for arrhythmias and electrolyte changes. 2. Eliminate foods and medications containing potassium and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others. 3. Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity. 4. Administer intravenously 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1000 mL. 5. Correct acidosis, if present, with intravenous sodium bicarbonate. 6. Use exchange resins, hemodialysis, or peritoneal dialysis. In patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity.

11 DESCRIPTION Potassium Chloride is a white granular powder. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55. Each pouch of light orange mottled powder contains 1.5 g of potassium chloride, USP, which is equivalent to potassium 20 mEq and chloride 20 mEq and the following inactive ingredients: FD&C Yellow #6, sucralose, silicon dioxide, maltodextrin, citric acid, and orange flavor.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The potassium ion (K + ) is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent, and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day. 12.3 Pharmacokinetics Based on published literature, the rate of absorption and urinary excretion of potassium from KCl oral solution were higher during the first few hours after dosing relative to modified release KCl products. The bioavailability of potassium, as measured by the cumulative urinary excretion of K + over a 24 hour post dose period, is similar for KCl solution and modified release products. Specific Populations Cirrhotics Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 h after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load.

12.1 Mechanism of Action The potassium ion (K + ) is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent, and under steady-state conditions the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day.

12.3 Pharmacokinetics Based on published literature, the rate of absorption and urinary excretion of potassium from KCl oral solution were higher during the first few hours after dosing relative to modified release KCl products. The bioavailability of potassium, as measured by the cumulative urinary excretion of K + over a 24 hour post dose period, is similar for KCl solution and modified release products. Specific Populations Cirrhotics Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 h after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load.

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride Powder for Oral Solution USP, 20 mEq is a light orange mottled powder available as follows: NDC 69543-451-01 Pouch NDC 69543-451-30 Carton of 30 Pouches NDC 69543-451-10 Carton of 100 Pouches Storage Store at Controlled Room Temperature, 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Protect from light. Distributed by: Virtus Pharmaceuticals, LLC Langhorne, PA 19047 Rev. 09/2020 MF094VREV09/20 OE2980

1 INDICATIONS AND USAGE Potassium chloride extended-release tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium chloride extended-release tablets are potassium salt indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. (1)

2 DOSAGE AND ADMINISTRATION Monitor serum potassium and adjust dosages accordingly (2.1) If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation (2.1) Take with meals and with a glass of water or other liquid. Swallow tablets whole. (2.1) Treatment of hypokalemia: Typical dose range is 40-100 mEq per day in divided doses. Limit doses to 20 mEq per dose. (2.2) Prevention of hypokalemia: Typical dose is 20 mEq per day (2.2) 2.1 Monitoring and Administration If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring Monitor serum potassium and adjust the dose based on serum potassium level. Monitor serum potassium periodically during maintenance therapy to ensure potassium remains in desired range. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms, and the clinical status of the patient. Correct volume status, acid-base balance, and electrolyte deficits as appropriate. Administration Take potassium chloride extended-release tablets with meals and with a glass of water or other liquid. Do not take on an empty stomach because of its potential for gastric irritation [see Warnings and Precautions ( 5.1 )] . Swallow tablets whole without crushing, chewing or sucking. 2.2 Dosing Dosage must be adjusted to the individual needs of each patient. Dosages greater than 20 mEq per day should be divided such that no more than 20 mEq is given in a single dose. Treatment of hypokalemia: Typical dose range is 40-100 mEq per day. Prevention of hypokalemia: Typical dose is 20 mEq per day.

cking. 2.2 Dosing Dosage must be adjusted to the individual needs of each patient. Dosages greater than 20 mEq per day should be divided such that no more than 20 mEq is given in a single dose. Treatment of hypokalemia: Typical dose range is 40-100 mEq per day. Prevention of hypokalemia: Typical dose is 20 mEq per day. 2.1 Monitoring and Administration If serum potassium concentration is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation. Monitoring Monitor serum potassium and adjust the dose based on serum potassium level. Monitor serum potassium periodically during maintenance therapy to ensure potassium remains in desired range. The treatment of potassium depletion, particularly in the presence of cardiac disease, renal disease, or acidosis, requires careful attention to acid-base balance, volume status, electrolytes, including magnesium, sodium, chloride, phosphate, and calcium, electrocardiograms, and the clinical status of the patient. Correct volume status, acid-base balance, and electrolyte deficits as appropriate. Administration Take potassium chloride extended-release tablets with meals and with a glass of water or other liquid. Do not take on an empty stomach because of its potential for gastric irritation [see Warnings and Precautions ( 5.1 )] . Swallow tablets whole without crushing, chewing or sucking. 2.2 Dosing Dosage must be adjusted to the individual needs of each patient. Dosages greater than 20 mEq per day should be divided such that no more than 20 mEq is given in a single dose. Treatment of hypokalemia: Typical dose range is 40-100 mEq per day. Prevention of hypokalemia: Typical dose is 20 mEq per day.

3 DOSAGE FORMS AND STRENGTHS 10 mEq (750mg) : White to off-white, film coated, capsule shaped tablet, debossed with “111” on one side and” Λ” on other side. 15 mEq (1125 mg): Yellow colored, Film coated, Capsule shaped tablet, debossed with “E41” on one side and “Λ” on other side. 20 mEq (1500 mg): White to off-white, film coated, capsule shaped tablet, debossed with “112” on one side and” Λ” on other side. 10 mEq (750mg) oral tablets (3) 15 mEq (1125 mg) oral tablet (3) 20 mEq (1500 mg) oral tablets (3)

5 WARNINGS AND PRECAUTIONS Gastrointestinal Adverse Reactions: Can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly when in prolonged contact with the gastrointestinal mucosa. Take with meals. (5.1) 5.1 Gastrointestinal Adverse Reactions Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly when the drug remains in contact with the gastrointestinal mucosa for a prolonged period of time. Consider the use of liquid potassium in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders. If severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs, discontinue potassium chloride extended-release tablets and consider possibility of ulceration, obstruction or perforation. Potassium chloride extended-release tablets should not be taken on an empty stomach because of its potential for gastric irritation [see Dosage and Administration ( 2.1 )] . 5.1 Gastrointestinal Adverse Reactions Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly when the drug remains in contact with the gastrointestinal mucosa for a prolonged period of time. Consider the use of liquid potassium in patients with dysphagia, swallowing disorders, or severe gastrointestinal motility disorders. If severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs, discontinue potassium chloride extended-release tablets and consider possibility of ulceration, obstruction or perforation. Potassium chloride extended-release tablets should not be taken on an empty stomach because of its potential for gastric irritation [see Dosage and Administration ( 2.1 )] .

6 ADVERSE REACTIONS The following adverse reactions have been identified with use of oral potassium salts. 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. The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea. There have been reports of hyperkalemia and of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, perforation [see Warnings and Precautions ( 5.1 ) and Overdosage ( 10 )] . Skin rash has been reported rarely. Most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea (6) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 866-488-0312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 7.1 Triamterene and Amiloride Use with triamterene or amiloride can produce severe hyperkalemia. Avoid concomitant use [see Contraindications ( 4 )] .

7 DRUG INTERACTIONS Renin-angiotensin-aldosterone system inhibitors: Monitor for hyperkalemia (7.2) Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia (7.3) 7.1 Triamterene and Amiloride Use with triamterene or amiloride can produce severe hyperkalemia. Avoid concomitant use [see Contraindications ( 4 )] . 7.2 Renin-Angiotensin-Aldosterone System Inhibitors Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients receiving concomitant RAAS therapy. 7.3 Nonsteroidal Anti-Inflammatory Drugs Nonsteroidal anti-inflammatory drugs (NSAIDs) may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients receiving concomitant NSAID therapy. 7.2 Renin-Angiotensin-Aldosterone System Inhibitors Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produce potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients receiving concomitant RAAS therapy. 7.3 Nonsteroidal Anti-Inflammatory Drugs Nonsteroidal anti-inflammatory drugs (NSAIDs) may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients receiving concomitant NSAID therapy.

8 USE IN SPECIFIC POPULATIONS Cirrhosis: Initiate therapy at the low end of the dosing range (8.6) Renal Impairment: Initiate therapy at the low end of the dosing range (8.7) 8.1 Pregnancy Risk Summary There are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in 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 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as potassium chloride becomes part of the body potassium pool, as long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk. 8.4 Pediatric Use Safety and effectiveness of potassium chloride extended-release tablets in children have not been established. 8.5 Geriatric Use Clinical studies of potassium chloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually 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. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Cirrhotics Doses of potassium in patients with cirrhosis produce a larger increase in potassium levels compared to the response in normal patients. Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently. 8.7 Renal Impairment Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on RAAS inhibitors or NSAIDs, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see Drug Interactions ( 7.2 , 7.3 )] . The serum potassium level should be monitored frequently. Renal function should be assessed periodically.

icularly if the patient is on RAAS inhibitors or NSAIDs, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see Drug Interactions ( 7.2 , 7.3 )] . The serum potassium level should be monitored frequently. Renal function should be assessed periodically. 8.1 Pregnancy Risk Summary There are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction studies have not been conducted. Potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. The background risk for major birth defects and miscarriage in 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 2-4% and 15-20%, respectively. 8.2 Lactation Risk Summary The normal potassium ion content of human milk is about 13 mEq per liter. Since potassium from oral supplements such as potassium chloride becomes part of the body potassium pool, as long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk. 8.4 Pediatric Use Safety and effectiveness of potassium chloride extended-release tablets in children have not been established. 8.5 Geriatric Use Clinical studies of potassium chloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually 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. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Cirrhotics Doses of potassium in patients with cirrhosis produce a larger increase in potassium levels compared to the response in normal patients. Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. Patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently. 8.7 Renal Impairment Patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia. Patients with impaired renal function, particularly if the patient is on RAAS inhibitors or NSAIDs, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see Drug Interactions ( 7.2 , 7.3 )] . The serum potassium level should be monitored frequently. Renal function should be assessed periodically.

10 OVERDOSAGE 10.1 Symptoms The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, potentially fatal hyperkalemia can result [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . Hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss P-waves, depression of S-T segments, and prolongation of the QT intervals). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L). 10.2 Treatment Treatment measures for hyperkalemia include the following: Monitor closely for arrhythmias and electrolyte changes. Eliminate foods and medications containing potassium and of any agents with potassium sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements, and many others. Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity. Administer intravenously 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL. Correct acidosis, if present, with intravenous sodium bicarbonate. Use exchange resins, hemodialysis, or peritoneal dialysis. In patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity. The extended release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.

s, or peritoneal dialysis. In patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity. The extended release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug. 10.1 Symptoms The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired, potentially fatal hyperkalemia can result [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . Hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss P-waves, depression of S-T segments, and prolongation of the QT intervals). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L). 10.2 Treatment Treatment measures for hyperkalemia include the following: Monitor closely for arrhythmias and electrolyte changes. Eliminate foods and medications containing potassium and of any agents with potassium sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements, and many others. Administer intravenous calcium gluconate if the patient is at no risk or low risk of developing digitalis toxicity. Administer intravenously 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL. Correct acidosis, if present, with intravenous sodium bicarbonate. Use exchange resins, hemodialysis, or peritoneal dialysis. In patients who have been stabilized on digitalis, too rapid a lowering of the serum potassium concentration can produce digitalis toxicity. The extended release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.

11 DESCRIPTION Potassium chloride extended-release tablets are a solid oral dosage form of potassium chloride containing 750 mg, 1125 mg and 1500 mg of potassium chloride, USP, equivalent to 10 mEq, 15 mEq and 20 mEq of potassium, respectively, in a film-coated matrix tablet. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP, occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol. The 10 mEq, 15 mEq and 20 mEq tablets contain colloidal silicon dioxide, magnesium stearate, paraffin, polyethylene glycol, polyvinyl acetate, povidone, sodium lauryl sulphate, polyvinyl alcohol, talc, titanium dioxide, triethyl citrate, D&C yellow # 10 (for 15 mEq) and FD&C yellow # 6 (for 15 mEq). FDA approved dissolution test specifications and assay sample preparation method differs from USP.

12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The potassium ion (K + ) is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulse; the contraction of cardiac, skeletal and smooth muscle; and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent, and under steady state conditions, the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day. 12.2 Pharmacokinetics Specific Populations Cirrhotics Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load [see Use in Specific Populations ( 8.6 )] . 12.1 Mechanism of Action The potassium ion (K + ) is the principal intracellular cation of most body tissues. Potassium ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulse; the contraction of cardiac, skeletal and smooth muscle; and the maintenance of normal renal function. The intracellular concentration of potassium is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent, and under steady state conditions, the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day.

ransport system maintains this gradient across the plasma membrane. Potassium is a normal dietary constituent, and under steady state conditions, the amount of potassium absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of potassium is 50 to 100 mEq per day. 12.2 Pharmacokinetics Specific Populations Cirrhotics Based on published literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load [see Use in Specific Populations ( 8.6 )] .

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

16 HOW SUPPLIED/STORAGE AND HANDLING Potassium chloride extended-release tablets, USP contain 750 mg, 1125 mg and 1500 mg of potassium chloride (equivalent to 10 mEq, 15 mEq and 20 mEq of potassium, respectively). Potassium chloride extended-release tablets are provided as film coated tablets in following strengths and package configurations: Strength Description Bottle Count NDC # 10 mEq (750 mg) White to off-white, film coated, capsule shaped tablet, debossed with “111” on one side and” Λ” on other side 100 72888-075-01 500 72888-075-05 1000 72888-075-00 15 mEq (1125 mg) Yellow colored, Film coated, Capsule shaped tablet, debossed with “E41” on one side and “Λ” on other side. 100 72888-201-01 1000 72888-201-00 20 mEq (1500 mg) White to off-white, film coated, capsule shaped tablet, debossed with “112” on one side and” Λ” on other side 100 72888-076-01 500 72888-076-05 Recommended Storage Store at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

<table border="1" cellspacing="0" styleCode="Noautorules"><tbody><tr><td styleCode="Botrule Rrule Lrule Toprule"><paragraph><content styleCode="bold">Strength</content></paragraph></td><td styleCode="Botrule Rrule Lrule Toprule"><paragraph><content styleCode="bold">Description</content></paragraph></td><td styleCode="Botrule Rrule Lrule Toprule"><paragraph><content styleCode="bold">Bottle Count</content></paragraph></td><td styleCode="Botrule Rrule Lrule Toprule"><paragraph><content styleCode="bold">NDC #</content></paragraph></td></tr><tr><td rowspan="3" styleCode="Botrule Rrule Lrule Toprule"><paragraph>10 mEq (750 mg) </paragraph></td><td rowspan="3" styleCode="Botrule Rrule Lrule Toprule"><paragraph>White to off-white, film coated, capsule shaped tablet, debossed with &#x201C;111&#x201D; on one side and&#x201D; &#x39B;&#x201D; on other side</paragraph></td><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>100</paragraph></td><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>72888-075-01</paragraph></td></tr><tr><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>500</paragraph></td><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>72888-075-05</paragraph></td></tr><tr><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>1000</paragraph></td><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>72888-075-00</paragraph></td></tr><tr><td rowspan="2" styleCode="Botrule Rrule Lrule Toprule"><paragraph>15 mEq (1125 mg) </paragraph></td><td rowspan="2" styleCode="Botrule Rrule Lrule Toprule"><paragraph>Yellow colored, Film coated, Capsule shaped tablet, debossed with &#x201C;E41&#x201D; on one side and &#x201C;&#x39B;&#x201D; on other side.</paragraph></td><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>100</paragraph></td><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>72888-201-01</paragraph></td></tr><tr><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>1000</paragraph></td><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>72888-201-00</paragraph></td></tr><tr><td rowspan="2" styleCode="Botrule Rrule Lrule Toprule"><paragraph>20 mEq (1500 mg) </paragraph></td><td rowspan="2" styleCode="Botrule Rrule Lrule Toprule"><paragraph>White to off-white, film coated, capsule shaped tablet, debossed with &#x201C;112&#x201D; on one side and&#x201D; &#x39B;&#x201D; on other side</paragraph></td><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>100</paragraph></td><td align="center" styleCode="Botrule Rrule Lrule Toprule">72888-076-01</td></tr><tr><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>500</paragraph></td><td align="center" styleCode="Botrule Rrule Lrule Toprule"><paragraph>72888-076-05</paragraph></td></tr></tbody></table>

17 PATIENT COUNSELING INFORMATION Inform patients to take each dose with meals and with a full glass of water or other liquid, and to not crush, chew, or suck the tablets. Advise patients to seek medical attention if tarry stools or other evidence of gastrointestinal bleeding is noticed. Inform patients that the wax tablet is not absorbed and may be excreted intact in the stool. If the patient observes this, it is not an indication of lack of effect. All the brands are trademarks of their respective owners. Distributed By: Advagen Pharma Ltd., East Windsor, NJ 08520, USA. Manufactured by: Rubicon Research Limited Thane, 421506 India. Rev. 11/2025

Y36-003-064 LD-710-2 Prescribing Information EXCEL ® CONTAINER Potassium Chloride for Injection Concentrate USP 500 mEq/250 mL (2 mEq/mL) PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION FOR INTRAVENOUS INFUSION ONLY MUST BE DILUTED PRIOR TO INJECTION Rx only DESCRIPTION A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture service and are restricted to the preparation of admixtures for intravenous infusion. Potassium Chloride for Injection Concentrate USP is a sterile, nonpyrogenic, concentrated solution of Potassium Chloride USP in Water for Injection USP to be administered by intravenous infusion only after dilution in a larger volume of fluid. No bacteriostatic or antimicrobial agent has been added. Each 100 mL of Potassium Chloride contains: Potassium Chloride USP 14.9 g; Water for Injection USP qs pH: 5.4 (4.0–8.0); Calculated Osmolarity: 4000 mOsmol/liter Concentration of Electrolytes (mEq/mL): Potassium 2; Chloride 2 The formula of the active ingredient is: Ingredient Molecular Formula Molecular Weight Potassium Chloride USP KCl 74.55 Potassium chloride injection (approximately diluted) is a parenteral fluid and electrolyte replenisher. Excel container not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multi-layered film specifically developed for parenteral drugs. 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 admixing. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. The closure system has two ports; the one for the suitable transfer device or compounding set has a tamper evident plastic protector and the other is a non-accessible blocked port. Refer to the Directions for Use of the container. Revised: November 2022 EXCEL is a registered trademark of B. Braun Medical Inc. B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862 Prepared in USA. API from Germany.

<table><col/><col/><col/><thead><tr><th align="center" valign="top"> Ingredient</th><th align="center" valign="top"> Molecular Formula</th><th align="center" valign="top"> Molecular Weight</th></tr></thead><tbody><tr><td align="center" valign="top"> Potassium Chloride USP</td><td align="center" valign="top"> KCl</td><td align="center" valign="top"> 74.55</td></tr></tbody></table>

CLINICAL PHARMACOLOGY Potassium is the chief cation of body cells (160 mEq/liter of intracellular water) and is concerned with the maintenance of body fluid composition and electrolyte balance. Potassium 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. Normally about 80 to 90% of the potassium intake is excreted in the urine, the remainder in the stools and to a small extent, in the perspiration. The kidney does not conserve potassium well so that during fasting, or in patients on a potassium-free diet, potassium loss from the body continues resulting in potassium depletion. A deficiency of either potassium or chloride will lead to a deficit of the other.

INDICATIONS AND USAGE Potassium Chloride for Injection Concentrate USP is indicated in the treatment of potassium deficiency states when oral replacement is not feasible. This is a concentrated solution which is intended for use in a pharmacy admixture service and is restricted to the preparation of admixtures for intravenous infusion.

CONTRAINDICATIONS Potassium Chloride for Injection Concentrate USP is contraindicated in diseases where high potassium levels may be encountered, in patients with hyperkalemia, renal failure and in conditions in which potassium retention is present, or where additives of potassium and chloride could be clinically detrimental.

WARNINGS Strongly Hypertonic Solution. Must be properly diluted and thoroughly mixed before injection. Potentially Fatal Cardiac Adverse Reactions with Undiluted Intravenous Administration Direct patient injection of potassium chloride at this concentration may be instantaneously fatal. Potassium Chloride for Injection Concentrate must be diluted before administration. Fatal cardiac arrhythmia and cardiac arrest have occurred when potassium chloride was administered in an undiluted form. To avoid potassium intoxication, do not infuse these solutions rapidly. In patients with renal insufficiency, administration of potassium chloride may cause potassium intoxication and life-threatening hyperkalemia. The administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentration. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration. In patients with diminished renal function, administration of solutions containing potassium ions may result in potassium retention. This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration. The drug product contains no more than 25 mcg/L of aluminum.

PRECAUTIONS General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. Solutions containing potassium in a greater concentration than 40 mEq/liter may result in significant irritation to peripheral or central veins. For peripheral administration of solutions containing potassium, slowly infuse the solution through a small bore needle, placed well within the lumen of a large vein. Carefully avoid infiltration. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. Use only if solution is clear and container and seals are intact. Discard container within 4 hours after initial puncture. Pregnancy: (I) Teratogenic effects. Animal reproduction studies have not been conducted with potassium chloride injection. It is also not known whether potassium chloride injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium chloride injection should be given to a pregnant woman only if clearly needed.

General Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements, or the use of electrolyte-free dextrose solutions to which individualized electrolyte supplements may be added. Potassium therapy should be guided primarily by serial electrocardiograms, especially in patients receiving digitalis. Serum potassium levels are not necessarily indicative of tissue potassium levels. Solutions containing potassium should be used with caution in the presence of cardiac disease, particularly in the presence of renal disease, and in such instances, cardiac monitoring is recommended. Solutions containing potassium in a greater concentration than 40 mEq/liter may result in significant irritation to peripheral or central veins. For peripheral administration of solutions containing potassium, slowly infuse the solution through a small bore needle, placed well within the lumen of a large vein. Carefully avoid infiltration. Solutions containing dextrose should be used with caution in patients with overt or known subclinical diabetes mellitus, or carbohydrate intolerance for any reason. If the administration is controlled by a pumping device, care must be taken to discontinue pumping action before the container runs dry or air embolism may result. To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration. Use only if solution is clear and container and seals are intact. Discard container within 4 hours after initial puncture.

Pregnancy: (I) Teratogenic effects. Animal reproduction studies have not been conducted with potassium chloride injection. It is also not known whether potassium chloride injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium chloride injection should be given to a pregnant woman only if clearly needed.

Animal reproduction studies have not been conducted with potassium chloride injection. It is also not known whether potassium chloride injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium chloride injection should be given to a pregnant woman only if clearly needed.

ADVERSE REACTIONS Reactions which may occur because of the potassium-containing solutions or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection or extravasation, hypervolemia, and hyperkalemia. To rapid infusion of hypertonic solutions may cause local pain and, rarely, vein irritation. Rate of administration should be adjusted according to tolerance. Reactions reported with the use of potassium-containing solutions include nausea, vomiting, abdominal pain and diarrhea. The signs and symptoms of potassium intoxication include paresthesias of the extremities, areflexia, muscular or respiratory paralysis, mental confusion, weakness, hypotension, cardiac arrhythmias, heart block, electrocardiographic abnormalities and cardiac arrest. Potassium deficits result in disruption of neuromuscular function, and intestinal ileus and dilatation. If infused in large amounts, chloride ions may cause a loss of bicarbonate ions, resulting in an acidifying effect. Potassium-containing solutions are intrinsically irritating to tissues. Therefore, extreme care should be taken to avoid perivascular infiltration. Local tissue necrosis and subsequent sloughing may result if extravasation occurs. Chemical phlebitis and venospasm have also been reported. 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.

OVERDOSAGE In the event of fluid overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment. In the event of overdosage with potassium-containing solutions, discontinue the infusion immediately and institute corrective therapy to reduce serum potassium levels. Treatment of hyperkalemia includes the following: 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. Absorption and exchange of potassium using sodium or ammonium cycle cation exchange resin, orally and as retention enema. Hemodialysis and peritoneal dialysis. The use of potassium-containing foods or medications must be eliminated. However, in cases of digitalization, too rapid a lowering of plasma potassium concentration can cause digitalis toxicity.

DOSAGE AND ADMINISTRATION Not for direct patient injection. Potassium Chloride for Injection Concentrate USP, Pharmacy Bulk Package is for preparation of intravenous admixtures only and must be diluted before administration. Care must be taken to ensure there is complete mixing of the potassium chloride with the large volume fluid, particularly if soft or bag type containers are used. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Dosage and rate of administration are to be directed by the physician and are dependent upon the specific conditions of each patient (e.g., age, weight, clinical condition of the patient and laboratory determinations). Frequent laboratory determinations and clinical evaluation are essential to monitor changes in electrolyte concentrations, and fluid and electrolyte balance during prolonged parenteral therapy. If the serum potassium level is greater than 2.5 mEq/liter, potassium can be given at a rate not to exceed 10 mEq/hour and in a concentration of up to 40 mEq/liter. The 24 hour total dose should not exceed 200 mEq. If urgent treatment is indicated (serum potassium level less than 2.0 mEq/liter and electrocardiographic changes and/or muscle paralysis), potassium chloride may be infused very cautiously at a rate of up to 40 mEq/hour. In such cases, continuous cardiac monitoring is essential. As much as 400 mEq may be administered in a 24 hour period. In critical conditions, potassium chloride may be administered in saline (unless contraindicated) rather than in dextrose containing fluids, as dextrose may lower serum potassium levels. Directions for Use of Pharmacy Bulk Packages in EXCEL® Container with Blocked Medication Port Warning: Not for direct infusion. For preparation of admixtures for intravenous infusion. The Pharmacy Bulk Package is for use in a Pharmacy Admixture Service only. Use of this product is restricted to a suitable work area, such as a laminar flow hood (or an equivalent clean air compounding area). Additives should not be made to Pharmacy Bulk Packages. Caution : Do not use plastic containers in series connection. To Open Tear overwrap down at notch and remove solution container. Check for minute leaks by squeezing solution container firmly. If leaks are found, discard solution as sterility may be impaired. NOTE: Before use, perform the following checks: Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter. Any container which is suspect should not be used. Use only if solution is clear and container and seals are intact. Preparation for Admixing 1. Remove plastic protector from sterile set port at bottom of container. 2. Attach suitable transfer device or compounding set. Refer to complete directions accompanying device. Do Not Add Medication Transfer individual dose(s) to appropriate intravenous infusion solutions. Use of a syringe with needle is not recommended. Multiple entries increase the potential of microbial and particulate contamination. The container closure may be penetrated only one time, utilizing a suitable sterile dispensing set which allows measured dispensing of the contents.

priate intravenous infusion solutions. Use of a syringe with needle is not recommended. Multiple entries increase the potential of microbial and particulate contamination. The container closure may be penetrated only one time, utilizing a suitable sterile dispensing set which allows measured dispensing of the contents. For Pharmacy Bulk Packages: The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar air flow hood (or an equivalent clean air compounding area). For compounding only. Do not use for direct infusion. Do not use/penetrate blocked port. Attach suitable transfer device or compounding set. Refer to complete directions accompanying device. Hang container on suitable fixture. Once container closure has been penetrated, withdrawal of contents should be completed within 4 hours. Discard any unused portion. Important Admixing Instructions The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. Additives may be incompatible with the fluid withdrawn from this container. Consult with pharmacist. When compounding admixtures, use aseptic technique, mix thoroughly and discard unused portion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (See Warnings and Precautions, General).

HOW SUPPLIED Potassium Chloride for Injection Concentrate USP 500 mEq/250 mL (2 mEq/mL) is supplied sterile and nonpyrogenic in 250 mL Excel ® container with clear overwrap, Pharmacy Bulk Packages, packaged 24 per case. NDC REF Size Potassium Chloride for Injection Concentrate USP 0264-1944-20 P9402 250 mL Exposure of pharmaceutical products to heat should be minimized. Store at 20° to 25°C (68° to 77°F). Avoid excessive heat (40°C/104°F). Protect from freezing. Excursions permitted 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

<table><col/><col/><col/><thead><tr><th align="center" valign="top"> NDC</th><th align="center" valign="top"> REF</th><th align="center" valign="top"> Size</th></tr></thead><tbody><tr><td valign="top" colspan="3"> Potassium Chloride for Injection Concentrate USP</td></tr><tr><td valign="top"> 0264-1944-20</td><td align="center" valign="top"> P9402</td><td align="center" valign="top"> 250 mL</td></tr></tbody></table>

Exposure of pharmaceutical products to heat should be minimized. Store at 20° to 25°C (68° to 77°F). Avoid excessive heat (40°C/104°F). Protect from freezing. Excursions permitted 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]