{"id":"potassium-chloride","rwe":[],"_fda":{"id":"3f74c669-3182-952f-e063-6294a90aad92","set_id":"00615fad-ad3b-46e8-a89d-48290d937ae2","openfda":{"upc":["0342806422106","0342806423103"],"unii":["660YQ98I10"],"route":["ORAL"],"rxcui":["312529","628953"],"spl_id":["3f74c669-3182-952f-e063-6294a90aad92"],"brand_name":["Potassium Chloride"],"spl_set_id":["00615fad-ad3b-46e8-a89d-48290d937ae2"],"package_ndc":["42806-423-01","42806-423-05","42806-423-10","42806-422-01","42806-422-05","42806-422-10"],"product_ndc":["42806-422","42806-423"],"generic_name":["POTASSIUM CHLORIDE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["POTASSIUM CHLORIDE"],"manufacturer_name":["Epic Pharma, LLC"],"application_number":["ANDA209314"],"is_original_packager":[true]},"version":"6","pregnancy":["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 to 4% and 15 to 20%, respectively."],"overdosage":["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 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). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9 to 12 mEq/L). 10.2 Treatment Treatment measures for hyperkalemia include the following: 1. Elimination of foods and medications containing potassium and of any agents with potassium-sparing properties. 2. Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10 to 20 units of crystalline insulin per 1,000 mL. 3. Correction of acidosis, if present, with intravenous sodium bicarbonate. 4. Use of exchange resins, hemodialysis or peritoneal dialysis. In treating hyperkalemia, it should be recalled that 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."],"description":["11 DESCRIPTION Potassium Chloride Extended-Release Tablets, USP are a solid oral dosage form of potassium chloride. Each contains 600 mg or 750 mg of potassium chloride equivalent to 8 mEq or 10 mEq of potassium in a wax matrix tablet. Potassium Chloride Extended-Release Tablets, USP are an electrolyte replenisher. The chemical name is potassium chloride, and the structural formula is KCl. Potassium chloride, USP is a white, granular powder or 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: colloidal silicon dioxide, hydroxypropyl cellulose and hydrogenated vegetable oil. The film coating contains lecithin, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. FDA approved dissolution test specifications differ from USP."],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING Potassium Chloride Extended-Release Tablets, USP contain 600 mg or 750 mg of Potassium Chloride, USP (equivalent to 8 mEq and 10 mEq respectively), and are provided as extended release tablets. Table 1: How Supplied Dose Shape Color Debossment Bottle of 100 tablets Bottle of 500 tablets Bottle of 1000 tablets 600 mg (8 mEq) Round White to off-white “YH” and “106” on one side, and “8” on the other side 42806-422-01 42806-422-05 42806-422-10 750 mg (10 mEq) Round White to off-white “YH” and “105” on one side, and “10” on the other side 42806-423-01 42806-423-05 42806-423-10 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight container as defined in the USP with a child-resistant closure."],"geriatric_use":["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."],"pediatric_use":["8.4 Pediatric Use Safety and effectiveness in the pediatric population have not been established."],"effective_time":"20250923","nursing_mothers":["8.2 Lactation 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, 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."],"pharmacokinetics":["12.3 Pharmacokinetics The potassium chloride in potassium chloride extended-release tablets is completely absorbed before it leaves the small intestine. The wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. When the bioavailability of the potassium ion from the potassium chloride extended-release tablets is compared to that of a true solution the extent of absorption is similar. The extended-release properties of potassium chloride extended-release tablets are demonstrated by the finding that a significant increase in time is required for renal excretion of the first 50% of the potassium chloride extended-release tablets dose as compared to the solution. Increased urinary potassium excretion is first observed 1 hour after administration of potassium chloride extended-release tablets, reaches a peak at approximately 4 hours, and extends up to 8 hours. Mean daily steady-state plasma levels of potassium following daily administration of potassium chloride extended-release tablets cannot be distinguished from those following administration of potassium chloride solution or from control plasma levels of potassium ion. 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."],"adverse_reactions":["6 ADVERSE REACTIONS 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. There have been reports hyperkalemia and of upper and lower gastrointestinal condition including obstruction, bleeding, ulceration, perforation. Skin rash has been reported rarely."],"contraindications":["4 CONTRAINDICATIONS Potassium chloride is contraindicated in patients on triamterene and amiloride. Concomitant use with triamterene and amiloride (4)"],"drug_interactions":["7 DRUG INTERACTIONS 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. Closely monitor potassium in patients on concomitant RAAS inhibitors. 7.3 Nonsteroidal Anti-inflammatory Drugs (NSAIDs) NSAIDS may produce potassium retention by reducing renal synthesis of prostaglandin E and imparing the renin-angiotensin system. Closely monitor potassium in patients on concomitant NSAIDs."],"how_supplied_table":["
Table 1: How Supplied
DoseShapeColorDebossmentBottle of 100 tabletsBottle of 500 tabletsBottle of 1000 tablets
600 mg (8 mEq) Round White to off-white “YH” and “106” on one side, and “8” on the other side42806-422-0142806-422-0542806-422-10
750 mg (10 mEq) Round White to off-white “YH” and “105” on one side, and “10” on the other side 42806-423-0142806-423-0542806-423-10
"],"mechanism_of_action":["12.1 Mechanism of Action The potassium ion 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."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The potassium ion 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 The potassium chloride in potassium chloride extended-release tablets is completely absorbed before it leaves the small intestine. The wax matrix is not absorbed and is excreted in the feces; in some instances the empty matrices may be noticeable in the stool. When the bioavailability of the potassium ion from the potassium chloride extended-release tablets is compared to that of a true solution the extent of absorption is similar. The extended-release properties of potassium chloride extended-release tablets are demonstrated by the finding that a significant increase in time is required for renal excretion of the first 50% of the potassium chloride extended-release tablets dose as compared to the solution. Increased urinary potassium excretion is first observed 1 hour after administration of potassium chloride extended-release tablets, reaches a peak at approximately 4 hours, and extends up to 8 hours. Mean daily steady-state plasma levels of potassium following daily administration of potassium chloride extended-release tablets cannot be distinguished from those following administration of potassium chloride solution or from control plasma levels of potassium ion. 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."],"indications_and_usage":["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 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)"],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS 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. 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) ] ."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent."],"information_for_patients":["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. 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"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Monitor serum potassium and adjust dosages accordingly (2.1) If serum potassium 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 without crushing, chewing or sucking. (2.1) Treatment of hypokalemia : Doses range from 40 to 100 mEq/day in divided doses. Limit doses to 40 mEq per dose. (2.2) Prevention of hypokalemia : Typical dose is 20 mEq per day. (2.2) 2.1 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 ( 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 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 range is 20 mEq per day."],"spl_product_data_elements":["Potassium Chloride Potassium Chloride HYDROGENATED COTTONSEED OIL HYDROXYPROPYL CELLULOSE, UNSPECIFIED SILICON DIOXIDE POLYVINYL ALCOHOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED LECITHIN, SOYBEAN TALC POTASSIUM CHLORIDE POTASSIUM CATION white to off-white Biconvex YH;105;10 Potassium Chloride Potassium Chloride LECITHIN, SOYBEAN TALC HYDROGENATED COTTONSEED OIL HYDROXYPROPYL CELLULOSE, UNSPECIFIED SILICON DIOXIDE POLYVINYL ALCOHOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED POTASSIUM CHLORIDE POTASSIUM CATION white to off-white Biconvex YH;106;8"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS 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. Tablets: 600 mg (8 mEq) and 750 mg (10 mEq) (3)"],"use_in_specific_populations":["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 to 4% and 15 to 20%, respectively. 8.2 Lactation 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, 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. 8.4 Pediatric Use Safety and effectiveness in the pediatric population 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 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) ] . 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."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 42806-422-01 Potassium Chloride Extended-release Tablets, USP 8 mEq (600 mg) 100 Tablets Rx only NDC 42806-422-05 Potassium Chloride Extended-release Tablets, USP 8 mEq (600 mg) 500 Tablets Rx only NDC 42806-422-10 Potassium Chloride Extended-release Tablets, USP 8 mEq (600 mg) 1000 Tablets Rx only NDC 42806-423-01 Potassium Chloride Extended-release Tablets, USP 10 mEq (750 mg 100 Tablets Rx only NDC 42806-423-05 Potassium Chloride Extended-release Tablets, USP 10 mEq (750 mg) 500 Tablets Rx only NDC 42806-423-10 Potassium Chloride Extended-release Tablets, USP 10 mEq (750 mg) 1000 Tablets Rx only 600mg-100ct-epic 600mg-500ct-epic 600mg-1000ct-epic 750mg-100ct-epic.jpg 750mg-500ct-epic.jpg 750mg-1000ct-epic"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, and Impairment of Fertility Carcinogenicity, mutagenicity and fertility studies in animals have not been performed. Potassium is a normal dietary constituent."]},"tags":[{"label":"potassium chloride","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Carbonic anhydrase 4","category":"target"},{"label":"CA4","category":"gene"},{"label":"A12BA01","category":"atc"},{"label":"Intrathecal","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"For Solution","category":"form"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Constipation","category":"indication"},{"label":"Hypokalemia","category":"indication"},{"label":"Hypokalemia Prevention","category":"indication"},{"label":"Incomplete passage of stool","category":"indication"},{"label":"Nesher Pharms","category":"company"},{"label":"Approved 1960s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"8630 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"8192 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"8031 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"7741 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"6325 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"5601 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"5371 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"5107 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"5066 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"4963 reports"}],"drugInteractions":[{"drug":"Triamterene or amiloride","severity":"major","mechanism":"Concurrent use can produce severe hyperkalemia.","management":"Concomitant use is contraindicated.","clinicalEffect":"Severe hyperkalemia"},{"drug":"Renin-angiotensin-aldosterone inhibitors (e.g., ACE inhibitors, ARBs, spironolactone, eplerenone, aliskiren)","severity":"moderate","mechanism":"Inhibition of aldosterone production leads to potassium retention.","management":"Closely monitor potassium levels.","clinicalEffect":"Hyperkalemia"},{"drug":"Nonsteroidal Anti-inflammatory Drugs (NSAIDs)","severity":"moderate","mechanism":"Reduction in renal synthesis of prostaglandin E and impairment of the renin-angiotensin system leads to potassium retention.","management":"Closely monitor potassium levels.","clinicalEffect":"Hyperkalemia"}],"commonSideEffects":[{"effect":"nausea","drugRate":"reported","severity":"unknown"},{"effect":"vomiting","drugRate":"reported","severity":"unknown"},{"effect":"flatulence","drugRate":"reported","severity":"unknown"},{"effect":"abdominal pain/discomfort","drugRate":"reported","severity":"unknown"},{"effect":"diarrhea","drugRate":"reported","severity":"unknown"}],"contraindications":["Potassium chloride is contraindicated in patients on triamterene and amiloride.","Concomitant use with triamterene and amiloride is contraindicated."],"specialPopulations":{"Pregnancy":"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.","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.","Paediatric use":"These products should not be used in pediatric patients at this time.","Renal impairment":"Initiate therapy at the low end of the dosing range."}},"trials":[],"aliases":[],"company":"Nesher Pharms","patents":[{"type":"Formulation","number":"12539314","applicant":"GENUS LIFE SCIENCES INC","territory":"US","tradeName":"POTASSIUM CHLORIDE","expiryDate":"2039-03-07"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.0551/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$20","description":"POTASSIUM CHLORIDE 10% (20 MEQ/15 ML) ORAL LIQUID","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=POTASSIUM CHLORIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:49:41.150771+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T00:49:41.150687+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:49:49.885858+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:49:40.266423+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=POTASSIUM CHLORIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:49:50.193181+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:38.524411+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:38.524464+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T00:49:52.492716+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:50:12.588841+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200731/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:49:51.420670+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:58.206321+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA209314","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:49:38.524469+00:00"}},"allNames":"micro-k 10","offLabel":[],"synonyms":["potassium chloride"],"timeline":[{"date":"1965-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from HOSPIRA to Nesher Pharms"},{"date":"1965-12-16","type":"positive","source":"DrugCentral","milestone":"FDA approval (Hospira)"},{"date":"1986-04-16","type":"positive","source":"FDA Orange Book","milestone":"Ten-K approved — 10MEQ"},{"date":"1986-06-13","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Schering)"},{"date":"1988-08-26","type":"positive","source":"FDA Orange Book","milestone":"Micro-K Ls approved — 20MEQ/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"1990-12-17","type":"positive","source":"FDA Orange Book","milestone":"Potassium Chloride 10Meq In Plastic Container approved — 746MG/100ML"},{"date":"1998-08-11","type":"positive","source":"FDA Orange Book","milestone":"Potassium Chloride 20Meq In Plastic Container approved — 29.8MG/ML"},{"date":"2014-12-22","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Genus Lifesciences)"},{"date":"2015-08-19","type":"positive","source":"FDA Orange Book","milestone":"New formulation approved (Genus)"}],"aiSummary":"Micro-K 10 is a potassium chloride medication originally developed by HOSPIRA and currently owned by Nesher Pharms. It is a small molecule that targets carbonic anhydrase 4 and is classified as a potassium chloride drug. Micro-K 10 is FDA-approved for treating constipation, hypokalemia, hypokalemia prevention, and incomplete passage of stool. The medication is off-patent, with 56 generic manufacturers available. As a potassium supplement, it is essential to monitor potassium levels and renal function in patients taking Micro-K 10.","approvals":[{"date":"1965-12-16","orphan":false,"company":"HOSPIRA","regulator":"FDA"}],"brandName":"Micro-K 10","ecosystem":[{"indication":"Constipation","otherDrugs":[{"name":"bisacodyl","slug":"bisacodyl","company":"Braintree"},{"name":"cholic acid","slug":"cholic-acid","company":"Rtrx"},{"name":"docusate sodium","slug":"docusate-sodium","company":""},{"name":"glycerol","slug":"glycerol","company":"B Braun"}],"globalPrevalence":1120000000},{"indication":"Hypokalemia","otherDrugs":[{"name":"aspartic acid","slug":"aspartic-acid","company":""},{"name":"calcium chloride","slug":"calcium-chloride","company":"Baxter Hlthcare"},{"name":"potassium acetate","slug":"potassium-acetate","company":"B Braun"},{"name":"potassium citrate","slug":"potassium-citrate","company":"Mission Pharma"}],"globalPrevalence":null},{"indication":"Hypokalemia Prevention","otherDrugs":[{"name":"amiloride","slug":"amiloride","company":"Paddock Llc"},{"name":"aspartic acid","slug":"aspartic-acid","company":""},{"name":"calcium chloride","slug":"calcium-chloride","company":"Baxter Hlthcare"},{"name":"potassium acetate","slug":"potassium-acetate","company":"B Braun"}],"globalPrevalence":null},{"indication":"Incomplete passage of stool","otherDrugs":[{"name":"bisacodyl","slug":"bisacodyl","company":"Braintree"},{"name":"cholic acid","slug":"cholic-acid","company":"Rtrx"},{"name":"homatropine","slug":"homatropine","company":""},{"name":"macrogol","slug":"macrogol","company":"Braintree"}],"globalPrevalence":null}],"mechanism":{"target":"Carbonic anhydrase 4","novelty":"Follow-on","targets":[{"gene":"CA4","source":"DrugCentral","target":"Carbonic anhydrase 4","protein":"Carbonic anhydrase 4"}],"modality":"Small Molecule","drugClass":"potassium chloride","explanation":"Metabolic Acidosis Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing potassium salt such as potassium bicarbonate, potassium citrate, potassium acetate, or potassium gluconate.","oneSentence":"Micro-K 10 works by replenishing potassium levels in the body, which helps regulate muscle and nerve function.","technicalDetail":"Micro-K 10 acts as a potassium supplement by increasing the concentration of potassium ions (K+) in the body, which is essential for maintaining proper muscle and nerve function. The medication is absorbed in the gastrointestinal tract and distributed throughout the body, where it helps regulate various physiological processes.","_target_confidence":0.5},"commercial":{"launchDate":"1965","_launchSource":"DrugCentral (FDA 1965-12-16, HOSPIRA)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4199","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=POTASSIUM%20CHLORIDE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=POTASSIUM CHLORIDE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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pediatric patients","usPrevalence":null,"globalPrevalence":1120000000,"prevalenceMethod":"curated","prevalenceSource":"Am J Gastroenterol, 2011 (PMID:21606976)"},{"name":"Hypokalemia","source":"DrugCentral","snomedId":43339004,"regulator":"FDA","eligibility":"adults and pediatric patients"},{"name":"Hypokalemia Prevention","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":"adults and pediatric patients"},{"name":"Incomplete passage of stool","source":"DrugCentral","snomedId":249515001,"regulator":"FDA","eligibility":"adults and pediatric patients"}],"offLabel":[],"pipeline":[]},"currentOwner":"Nesher Pharms","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"potassium-citrate","brandName":"potassium citrate","genericName":"potassium citrate","approvalYear":"1985","relationship":"same-class"},{"drugId":"potassium-bitartrate","brandName":"potassium bitartrate","genericName":"potassium 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