Potasium

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 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)

• Monitor serum potassium and adjust dosages accordingly If serum potassium is less than 2.5 mEq/L, use intravenous potassium instead of oral supplementation
• Take with meals and with a glass of water or other liquid
• Swallow tablets whole without crushing, chewing or sucking
• Treatment of hypokalemia : Doses range from 40 to 100 mEq/day in divided doses
• Limit doses to 40 mEq per dose
• Prevention of hypokalemia : Typical dose is 20 mEq per day
• Administration and Monitoring If serum potassium concentration is less than 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 potassium chloride extended-release tablets with meals and with a glass of water or other liquid
• Do not take potassium chloride extended-release tablets on an empty stomach because of its potential for gastric irritation [see Warnings and Precautions ]
• Swallow tablets whole without crushing, chewing or sucking. …

Potassium Chloride Extended-Release Tablets, USP are supplied as: The 8 mEq (600 mg) tablets are white to off-white, round, biconvex, coated tablets, debossed with “YH” and “106” on one side, and “8” on the other side. The 10 mEq (750 mg) tablets are white to off-white, round, biconvex, coated tablets, debossed with “YH” and “105” on one side, and “10” on the other side. …

Safety and effectiveness in the pediatric population 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. …

• 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
• Inform patients that the wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool
• Advise patients seek medical attention if tarry stools or other evidence of gastrointestinal bleeding is noticed
• Distributed by: Epic Pharma, LLC Laurelton, NY 11413 Product of Israel
• Revised 06/2025 ZLN036

• Potassium chloride is contraindicated in patients on triamterene and amiloride
• Concomitant use with triamterene and amiloride

Triamterene and amiloride: Concomitant use is contraindicated (7.1) Renin-angiotensin-aldosterone inhibitors: Monitor for hyperkalemia (7.2) Nonsteroidal anti-inflammatory drugs: Monitor for hyperkalemia (7.3) 7.1 Triamterene or amiloride Use with triamterene or amiloride can produce severe hyperkalemia. Concomitant use is contraindicated [see Contraindications (4) ]. 7.2 Renin-angiotensin-aldosterone 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. …

Gastrointestinal Irritation: 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 if the drug maintains contact with the gastrointestinal mucosa for prolonged periods. 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. …

The most common adverse reactions are nausea, vomiting, flatulence, abdominal pain/discomfort and diarrhea. (6) To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma, LLC at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 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. …

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. …

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 and Warnings] . It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration (6.5 to 8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-wave, depression of S-T segment and prolongation of the QT interval). …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.