pharmacopeia
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/api/v1/drug/potassium-chloride

Mechanism of action

Sourced from openFDA

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.

Indications

Sourced from openFDA
  • 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.ICD-10: E87.6

Contraindications

Sourced from openFDA
  • Potassium chloride is contraindicated in patients on triamterene and amiloride.contraindicated

Dosage & administration

Sourced from openFDA

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.

Warnings & precautions

Sourced from openFDA

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) ] .

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

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.

Pharmacokinetics

Sourced from openFDA
Metabolism
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.

Overdosage

Sourced from openFDA

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.

Approval history

Sourced from openFDA
  • Aug 13, 1975NDANDA017586Otsuka Icu Medcl
  • Aug 13, 1975NDANDA017608Otsuka Icu Medcl
  • Aug 13, 1975NDANDA017609Otsuka Icu Medcl
  • Jan 26, 1976NDANDA017641Otsuka Icu Medcl
  • Feb 2, 1979NDANDA017378Baxter Hlthcare
  • Feb 2, 1979NDANDA017648Baxter Hlthcare
  • Feb 2, 1979NDANDA017484Baxter Hlthcare
  • Feb 2, 1979NDANDA018037Baxter Hlthcare

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Klor-Con, Tablet, Extended Release, 600 mg (NDC 0245-5315-01)To be discontinued
    Sponsor: Upsher-Smith Laboratories, LLC
    Updated
  • Klor-Con, Tablet, Extended Release, 600 mg (NDC 0245-5315-11)To be discontinued
    Sponsor: Upsher-Smith Laboratories, LLC
    Updated
  • Klor-Con, Tablet, Extended Release, 600 mg (NDC 0245-5315-15)To be discontinued
    Sponsor: Upsher-Smith Laboratories, LLC
    Updated
  • Klor-Con, Tablet, Extended Release, 750 mg (NDC 0245-5316-01)To be discontinued
    Sponsor: Upsher-Smith Laboratories, LLC
    Updated
  • Klor-Con, Tablet, Extended Release, 750 mg (NDC 0245-5316-11)To be discontinued
    Sponsor: Upsher-Smith Laboratories, LLC
    Updated
  • Klor-Con, Tablet, Extended Release, 750 mg (NDC 0245-5316-15)To be discontinued
    Sponsor: Upsher-Smith Laboratories, LLC
    Updated
  • Potassium Chloride, Tablet, Extended Release, 10 meq (NDC 62037-710-01)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Potassium Chloride, Tablet, Extended Release, 20 meq (NDC 62037-720-01)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Potassium Chloride, Tablet, Extended Release, 20 meq (NDC 62037-720-05)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Potassium Chloride, Tablet, Extended Release, 20 meq (NDC 62037-720-10)To be discontinued
    Sponsor: Teva Pharmaceuticals USA, Inc.
    Updated
  • Potassium Chloride, Tablet, Extended Release, 600 mg (NDC 0832-5322-10)To be discontinued
    Sponsor: Upsher-Smith Laboratories, LLC
    Updated
  • Potassium Chloride, Tablet, Extended Release, 600 mg (NDC 0832-5322-11)To be discontinued
    Sponsor: Upsher-Smith Laboratories, LLC
    Updated
  • Potassium Chloride, Tablet, Extended Release, 750 mg (NDC 0832-5323-10)To be discontinued
    Sponsor: Upsher-Smith Laboratories, LLC
    Updated
  • Potassium Chloride, Tablet, Extended Release, 750 mg (NDC 0832-5323-11)To be discontinued
    Sponsor: Upsher-Smith Laboratories, LLC
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
118,676 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea8,8257.4%
  2. 2Diarrhoea8,3907.1%
  3. 3Dyspnoea8,2216.9%
  4. 4Fatigue7,9616.7%
  5. 5Vomiting6,4885.5%
  6. 6Death5,7104.8%
  7. 7Pneumonia5,4634.6%
  8. 8Headache5,2414.4%
  9. 9Asthenia5,2164.4%
  10. 10Dizziness5,0964.3%
  11. 11Pain4,9984.2%
  12. 12Drug Ineffective4,8774.1%
  13. 13Off Label Use4,6873.9%
  14. 14Fall4,6463.9%
  15. 15Malaise3,7913.2%

Literature

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Recent PubMed references pinned to Potassium Chloride as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 1,931 ClinicalTrials.gov registrations naming Potassium Chloride as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Potassium Chloride work?
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.
What is Potassium Chloride used for?
According to FDA labeling, Potassium Chloride carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Potassium Chloride?
Potassium Chloride is classified as Electrolyte solutions, Potassium, Acid-Base Activity, Electrolyte Activity, Cellular Activity Alteration, Increased Insulin Secretion, Organized Electrical Activity Alteration.
What are the brand names for Potassium Chloride?
Potassium Chloride is marketed under brand names including Aminosyn 8.5 % with Electrolytes, Sulfite-Free, Aminosyn II 8.5 % with Electrolytes, Sulfite-Free, BSS Ophthalmic Solution, GaviLyte-C, GaviLyte-N, Gavilyte-G, Gavilyte-H, Golytely.
What are the contraindications for Potassium Chloride?
Potassium Chloride labeling lists contraindications including: Potassium chloride is contraindicated in patients on triamterene and amiloride.. Always consult the full prescribing information and a clinician.
Note. Data for potassium-chloride is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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