Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.

{ "type": "p", "children": [], "text": "Potassium chloride extended-release capsules are indicated for the treatment and prophylaxis of hypokalemia in adults and children with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient." }

If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation.

Monitoring

Monitor serum potassium and adjust dosages accordingly. 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 with meals and with a full glass of water or other liquid. Do not take on an empty stomach because of the potential for gastric irritation [ see Warnings and Precautions (5.1)] .

Patients who have difficulty swallowing capsules may sprinkle the contents of the capsule onto a spoonful of soft food. The soft food, such as applesauce or pudding, should be swallowed immediately without chewing and followed with a glass of water or juice to ensure complete swallowing of the microcapsules. Do not added to hot foods. Any microcapsule/food mixture should be used immediately and not stored for future use.

Dosage must be adjusted to the individual needs of each patient. Dosages greater than 40 mEq per day should be divided such that no more than 40 mEq is given in a single dose.

Treatment of hypokalemia: Typical dose range is 40 to 100 mEq per day.

Maintenance or Prophylaxis: Typical dose is 20 mEq per day.

Pediatric patients aged birth to 16 years old: Dosage must be adjusted to the individual needs of each patient. Do not exceed as a single dose 1 mEq/kg or 20 mEq, whichever is lower.

Treatment of hypokalemia: The recommended initial dose is 2 to 4 mEq/kg/day in divided doses. If deficits are severe or ongoing losses are great, consider intravenous therapy.

Maintenance or Prophylaxis: Typical dose is 1 mEq/kg/day.

8 mEq (600 mg): White opaque capsules printed with “G” on cap and “8 mEq” on the body.

{ "type": "p", "children": [], "text": "8 mEq (600 mg): White opaque capsules printed with “G” on cap and “8 mEq” on the body." }

10 mEq (750 mg): Dark blue opaque capsules printed with "G" on cap and "10 mEq" on the body.

{ "type": "p", "children": [], "text": "10 mEq (750 mg): Dark blue opaque capsules printed with \"G\" on cap and \"10 mEq\" on the body." }

Potassium chloride extended-release capsules are contraindicated in patients on amiloride or triamterene.

{ "type": "p", "children": [], "text": "Potassium chloride extended-release capsules are contraindicated in patients on amiloride or triamterene." }

Solid oral dosage forms of potassium chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract, particularly if the drug is 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 capsules and consider possibility of ulceration, obstruction or perforation.

Potassium chloride extended-release capsules should not be taken on an empty stomach because of its potential for gastric irritation [ see Dosage and Administration (2.1)].

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.

{ "type": "p", "children": [], "text": "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.

{ "type": "p", "children": [], "text": "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, and perforation.

{ "type": "p", "children": [], "text": "There have been reports of hyperkalemia and of upper and lower gastrointestinal conditions including, obstruction, bleeding, ulceration, and perforation." }

Skin rash has been reported rarely.

{ "type": "p", "children": [], "text": "Skin rash has been reported rarely." }

Use with triamterene or amiloride can produce severe hyperkalemia. Concomitant use is contraindicated [ see Contraindications (4)] .

Drugs that inhibit the renin-angiotensin-aldosterone system (RAAS) including angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), spironolactone, eplerenone, or aliskiren produces potassium retention by inhibiting aldosterone production. Closely monitor potassium in patients taking drugs that inhibit RAAS.

NSAIDs may produce potassium retention by reducing renal synthesis of prostaglandin E and impairing the renin-angiotensin system. Closely monitor potassium in patients taking NSAIDS.

Risk Summary

There are no human data related to use of potassium chloride extended-release capsules during pregnancy and animal reproductive 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 to 4% and 15 to 20%, respectively.

Risk Summary

The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium 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.

Clinical trial data from published literature have demonstrated the safety and effectiveness of potassium chloride in children with diarrhea and malnutrition from birth to 18 years.

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.

Based on publish 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 [ see Clinical Pharmacology (12.3)] .

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 nonsteroidal anti-inflammatory drugs, 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.

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.

Hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5 to 8 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 to 12 mEq/L).

Treatment measures for hyperkalemia include the following:

1. Monitor closely for arrhythmias and electrolyte changes. 2. Eliminate foods and medications containing potassium and 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 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 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.

The extended-release feature means that absorption and toxic effects may be delayed for hours. Consider standard measures to remove any unabsorbed drug.

Potassium chloride extended-release capsules, USP are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively.

{ "type": "p", "children": [], "text": "Potassium chloride extended-release capsules, USP are an oral dosage form of microencapsulated potassium chloride containing 600 mg and 750 mg of potassium chloride, USP, equivalent to 8 mEq and 10 mEq of potassium, respectively." }

The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. 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.

{ "type": "p", "children": [], "text": "The chemical name of the active ingredient is potassium chloride and the structural formula is KCl. It has a molecular mass of 74.55. 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." }

Inactive ingredients: ethylcellulose, hydroxypropyl cellulose. The empty gelatin capsules contain gelatin and titanium dioxide; the 10 mEq capsules contain FD&C Blue #1, FD&C Red #3 and FD&C Yellow #6. In addition, for 8mEq capsule imprinting ink black contains shellac, propylene glycol, black iron oxide, potassium hydroxide and for 10mEq white ink contains shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide.

{ "type": "p", "children": [], "text": "Inactive ingredients: ethylcellulose, hydroxypropyl cellulose. The empty gelatin capsules contain gelatin and titanium dioxide; the 10 mEq capsules contain FD&C Blue #1, FD&C Red #3 and FD&C Yellow #6. In addition, for 8mEq capsule imprinting ink black contains shellac, propylene glycol, black iron oxide, potassium hydroxide and for 10mEq white ink contains shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide." }

FDA approved dissolution test specifications differ from USP.

{ "type": "p", "children": [], "text": "\n\nFDA approved dissolution test specifications differ from USP.\n " }

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.

Each crystal of KCl is microencapsulated and allows for the controlled release of potassium and chloride ions over an eight- to ten-hour period.

Specific Populations

Cirrhotics

Based on publish 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.

Product: 50090-7469

{ "type": "p", "children": [], "text": "Product: 50090-7469" }

NDC: 50090-7469-0 30 CAPSULE, EXTENDED RELEASE in a BOTTLE

{ "type": "p", "children": [], "text": "NDC: 50090-7469-0 30 CAPSULE, EXTENDED RELEASE in a BOTTLE" }

NDC: 50090-7469-9 90 CAPSULE, EXTENDED RELEASE in a BOTTLE

{ "type": "p", "children": [], "text": "NDC: 50090-7469-9 90 CAPSULE, EXTENDED RELEASE in a BOTTLE" }

• Inform patients to take each dose with meals and with a full glass of water or other liquid.

{ "type": "p", "children": [], "text": "• Inform patients to take each dose with meals and with a full glass of water or other liquid." }

• Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal toxicity is noticed.

{ "type": "p", "children": [], "text": "• Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal toxicity is noticed." }

Manufactured by: Granules India Limited Hyderabad-500 081, India

{ "type": "p", "children": [], "text": "\nManufactured by:\n\n\nGranules India Limited\n \n\nHyderabad-500 081, India\n " }

Distributed by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 Rev.06/2024

{ "type": "p", "children": [], "text": "\nDistributed by:\n\n\nGranules Pharmaceuticals Inc.\n \n\nChantilly, VA 20151\n \n\nRev.06/2024\n " }

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.

{ "type": "p", "children": [], "text": "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." }

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.

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.

{ "type": "ul", "children": [ "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." ], "text": "" }

Potassium chloride is contraindicated in patients on triamterene or amiloride.

{ "type": "p", "children": [], "text": "Potassium chloride is contraindicated in patients on triamterene or amiloride." }

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)] .

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.

{ "type": "p", "children": [], "text": "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.

{ "type": "p", "children": [], "text": "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)] .

{ "type": "p", "children": [], "text": "There have been reports of hyperkalemia and of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, perforation\n \n [see Warnings and Precautions (\n \n 5.1) and Overdosage (\n \n 10)]\n \n .\n\n " }

Skin rash has been reported rarely.

{ "type": "p", "children": [], "text": "Skin rash has been reported rarely." }

Use with triamterene or amiloride can produce severe hyperkalemia. Avoid concomitant use [see Contraindications ( 4)] .

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.

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.

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.

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.

Safety and effectiveness of potassium chloride extended-release tablets in children have not been established.

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.

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.

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.

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).

Treatment measures for hyperkalemia include the following:

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.

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.

{ "type": "p", "children": [], "text": "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.

{ "type": "p", "children": [], "text": "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).

{ "type": "p", "children": [], "text": "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.

{ "type": "p", "children": [], "text": "FDA approved dissolution test specifications and assay sample preparation method differs from USP." }

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.

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)] .

Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent.

Potassium chloride extended-release tablets, USP contain 1500 mg of potassium chloride (equivalent to 20 mEq of potassium, respectively). Potassium chloride extended-release tablets are provided as film coated tablets in following strengths and package configurations:

{ "type": "p", "children": [], "text": "Potassium chloride extended-release tablets, USP contain 1500 mg of potassium chloride (equivalent to 20 mEq of potassium, respectively). Potassium chloride extended-release tablets are provided as film coated tablets in following strengths and package configurations:" }

<div class="scrollingtable"><table cellspacing="0"> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Strength</span> </p> </td><td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Description</span> </p> </td><td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">Bottle Count</span> </p> </td><td class="Botrule Lrule Rrule"> <p class="First"> <span class="Bold">NDC #</span> </p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule Rrule" rowspan="2"> <p class="First">20 mEq <br/> (1500 mg) </p> </td><td class="Botrule Lrule Rrule" rowspan="2"> <p class="First">White to off-white, film coated, capsule shaped tablet, debossed with “112” on one side and” Λ” on other side</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">500</p> </td><td align="center" class="Botrule Lrule Rrule"> <p class="First">72789-504-82</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table cellspacing=\"0\">\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">Strength</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">Description</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">Bottle Count</span>\n</p>\n</td><td class=\"Botrule Lrule Rrule\">\n<p class=\"First\">\n<span class=\"Bold\">NDC #</span>\n</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule Rrule\" rowspan=\"2\">\n<p class=\"First\">20 mEq \n <br/> (1500 mg)\n </p>\n</td><td class=\"Botrule Lrule Rrule\" rowspan=\"2\">\n<p class=\"First\">White to off-white, film coated, capsule shaped tablet, debossed with “112” on one side and” Λ” on other side</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">500</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\">\n<p class=\"First\">72789-504-82</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Recommended Storage

{ "type": "p", "children": [], "text": "\nRecommended Storage\n" }

Store at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].

{ "type": "p", "children": [], "text": "Store at room temperature 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]." }

{ "type": "ul", "children": [ "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." ], "text": "" }

All the brands are trademarks of their respective owners.

{ "type": "p", "children": [], "text": "All the brands are trademarks of their respective owners." }

Distributed By: Advagen Pharma Ltd., East Windsor, NJ 08520, USA.

{ "type": "p", "children": [], "text": "\nDistributed By:\n Advagen Pharma Ltd., \n East Windsor, NJ 08520, USA.\n\n " }

Manufactured by: Rubicon Research Pvt. Ltd., Thane, 421506 India. Rev. 01/2025

{ "type": "p", "children": [], "text": "\nManufactured by:\n Rubicon Research Pvt. Ltd., \n Thane, 421506 India. \n \n Rev. 01/2025\n\n " }

Potassium chloride extended-release tablets, USP 1500mg label

{ "type": "p", "children": [], "text": "\nPotassium chloride extended-release tablets, USP 1500mg label\n" }

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.

{ "type": "p", "children": [], "text": "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." }

If serum potassium concentration is <2.5 mEq/L, use intravenous potassium instead of oral supplementation.

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 potassium chloride for oral solution with at least 4 ounces of cold water [see Warnings and Precautions ( 5.1)].

Take with meals or immediately after eating.

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.

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.

Each pouch contains 1.5 g of potassium chloride supplying 20 mEq of potassium and 20 mEq of chloride.

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Potassium chloride is contraindicated in patients on potassium sparing diuretics.

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May cause gastrointestinal irritation. Increased dilution of the solution and taking with meals may reduce gastrointestinal irritation [ see Dosage and Administration (2.1)].

The most common adverse reactions to oral potassium salts are nausea, vomiting, flatulence, abdominal pain/discomfort, and diarrhea.

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Use with potassium-sparing diuretic can produce severe hyperkalemia. Avoid concomitant use.

Use with angiotensin converting enzyme (ACE) inhibitors produces potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Use with angiotensin receptor blockers (ARBs) produces potassium retention by inhibiting aldosterone production. Potassium supplements should be given to patients receiving ARBs only with close monitoring.

Pregnancy Category C

Animal reproduction studies have not been conducted with potassium chloride. It is unlikely that potassium supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

The normal potassium ion content of human milk is about 13 mEq per liter. Since oral potassium becomes part of the body potassium pool, so 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.

Clinical trial data from published literature have demonstrated the safety and effectiveness of potassium chloride in children with diarrhea and malnutrition from birth to 18 years.

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.

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)].

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.

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).

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.

Potassium Chloride is a white crystalline or colorless solid. It is soluble in water and slightly soluble in alcohol. Chemically, Potassium Chloride is K-Cl with a molecular mass of 74.55.

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Each pouch of light pink to orange 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: citric acid anhydrous, colloidal silicon dioxide, FD&C Yellow #6, natural and artificial orange flavor, and sucralose.

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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.

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.

Potassium Chloride for Oral Solution, is a light pink to orange powder available in one strength as follows:

{ "type": "p", "children": [], "text": "Potassium Chloride for Oral Solution, is a light pink to orange powder available in one strength as follows:" }

20 mEq NDC# 54288-125-01 pouch. Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq NDC# 54288-125-30 carton of 30 pouches NDC# 54288-125-10 carton of 100 pouches

{ "type": "p", "children": [], "text": "20 mEq NDC# 54288-125-01 pouch. Each pouch contains 1.5 g of potassium chloride providing potassium 20 mEq and chloride 20 mEq NDC# 54288-125-30 carton of 30 pouches NDC# 54288-125-10 carton of 100 pouches" }

Storage

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Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP PROTECT from LIGHT. Rx only

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Manufactured for: BPI Labs LLC 12393 Belcher Road S, Suite 450

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Largo, FL 33773, USA

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Revised Aug 2022

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L67I-BPI                         R-2303

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NDC# 54288-125-30

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Potassium Chloride for Oral Solution, USP

{ "type": "p", "children": [], "text": "Potassium Chloride for Oral Solution, USP" }

20 mEq

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Rx only

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30 Single-Dose Pouches

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BPI Labs LLC

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NDC# 54288-125-10

{ "type": "p", "children": [], "text": "NDC# 54288-125-10" }

Potassium Chloride for Oral Solution, USP

{ "type": "p", "children": [], "text": "Potassium Chloride for Oral Solution, USP" }

20 mEq

{ "type": "p", "children": [], "text": "20 mEq" }

Rx only

{ "type": "p", "children": [], "text": "Rx only" }

100 Single-Dose Pouches

{ "type": "p", "children": [], "text": "100 Single-Dose Pouches" }

BPI Labs LLC

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