pharmacopeia
GET
/api/v1/drug/potassium-citrate

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Alkalinizing Activity; Electrolyte Activity.

Indications

Sourced from openFDA
  • Potassium citrate extended-release tablets are a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones (1.1) Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2) Uric acid lithiasis with or without calcium stones (1.3) 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)] .

Contraindications

Sourced from openFDA
  • Potassium citrate extended-release tablets are contraindicated: In patients with hyperkalemia (or who have conditions predisposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).contraindicated

Dosage & administration

Sourced from openFDA

Objective: To restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 to 7.0. Severe hypocitraturia (urinary citrate < 150 mg/day): therapy should be initiated at 60 mEq per day; a dose of 30 mEq two times per day or 20 mEq three times per day with meals or within 30 minutes after meals or bedtime snack (2.2) Mild to moderate hypocitraturia (urinary citrate >150 mg/day): therapy should be initiated at 30 mEq per day; a dose of 15 mEq two times per day or 10 mEq three times per day with meals or within 30 minutes after meals or bedtime snack (2.3) 2.1 Dosing Instructions Treatment with extended release potassium citrate should be added to a regimen that limits salt intake (avoidance of foods with high salt content and of added salt at the table) and encourages high fluid intake (urine volume should be at least two liters per day). The objective of treatment with potassium citrate extended-release tablets is to provide potassium citrate in sufficient dosage to restore normal urinary citrate (greater than 320 mg/day and as close to the normal mean of 640 mg/day as possible), and to increase urinary pH to a level of 6.0 or 7.0. Monitor serum electrolytes (sodium, potassium, chloride and carbon dioxide), serum creatinine and complete blood counts every four months and more frequently in patients with cardiac disease, renal disease or acidosis. Perform electrocardiograms periodically.

Warnings & precautions

Sourced from openFDA

Hyperkalemia: In patients with impaired mechanisms for excreting potassium, potassium citrate administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium citrate in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided (5.1) Gastrointestinal lesions: if there is severe vomiting, abdominal pain or gastrointestinal bleeding, potassium citrate should be discontinued immediately and the possibility of bowel perforation or obstruction investigated (5.2) 5.1 Hyperkalemia In patients with impaired mechanisms for excreting potassium, potassium citrate administration can produce hyperkalemia and cardiac arrest. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of potassium citrate in patients with chronic renal failure, or any other condition which impairs potassium excretion such as severe myocardial damage or heart failure, should be avoided. Closely monitor for signs of hyperkalemia with periodic blood tests and ECGs. 5.2 Gastrointestinal Lesions Solid dosage forms of potassium chlorides have produced stenotic and/or ulcerative lesions of the small bowel and deaths. These lesions are caused by a high local concentration of potassium ions in the region of the dissolving tablets, which injured the bowel.

Adverse reactions

Sourced from openFDA

Some patients may develop minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These may be alleviated by taking the dose with meals or snacks or by reducing the dosage (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Camber Pharmaceuticals, Inc., at 1-866-495-8330 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Postmarketing Experience Some patients may develop minor gastrointestinal complaints during potassium citrate therapy, such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These symptoms are due to the irritation of the gastrointestinal tract, and may be alleviated by taking the dose with meals or snacks, or by reducing the dosage. Patients may find intact matrices in their feces.

Use in specific populations

Sourced from openFDA

Pregnant women: Animal reproduction studies have not been conducted. It is not known whether potassium citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium citrate should be given to a pregnant woman only if clearly needed (8.1) Nursing mothers: The normal potassium ion content of human milk is about 13 mEq/L. It is not known if potassium citrate has an effect on this content. Potassium citrate should be given to a woman who is breastfeeding only if clearly needed (8.3) Pediatric Use: Safety and effectiveness in children have not been established (8.4) 8.1 Pregnancy Animal reproduction studies have not been conducted. It is also not known whether potassium citrate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Potassium citrate should be given to a pregnant woman only if clearly needed. 8.3 Nursing Mothers The normal potassium ion content of human milk is about 13 mEq/L. It is not known if potassium citrate has an effect on this content. Potassium citrate should be given to a woman who is breast feeding only if clearly needed. 8.4 Pediatric Use Safety and effectiveness in children have not been established.

Overdosage

Sourced from openFDA

Treatment of Overdosage: The administration of potassium salts to persons without predisposing conditions for hyperkalemia rarely causes serious hyperkalemia at recommended dosages. It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of T-wave, 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. Treatment measures for hyperkalemia include the following: 1. Patients should be closely monitored for arrhythmias and electrolyte changes. 2. Elimination of medications containing potassium and of agents with potassium-sparing properties such as potassium-sparing diuretics, ARBs, ACE inhibitors, NSAIDs, certain nutritional supplements and many others. 3. Elimination of foods containing high levels of potassium such as almonds, apricots, bananas, beans (lima, pinto, white), cantaloupe, carrot juice (canned), figs, grapefruit juice, halibut, milk, oat bran, potato (with skin), salmon, spinach, tuna and many others. 4.

Approval history

Sourced from openFDA
  • Aug 30, 1985NDANDA019071Mission Pharma
  • Jun 8, 2006ANDAANDA077440Rising
  • Aug 6, 2014ANDAANDA203546Zydus Pharms
  • Sep 11, 2017ANDAANDA206813Strides Pharma
  • Mar 5, 2018ANDAANDA209758Teva Pharms Usa Inc
  • Jan 14, 2020ANDAANDA212779Ani Pharms
  • Feb 5, 2021ANDAANDA214420Ascent Pharms Inc

FDA shortages

View JSON

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

  • Potassium Citrate, Tablet, Extended Release, 10 meq (NDC 0591-2729-01)To be discontinued
    Sponsor: Watson Pharma Private Limited
    Updated
  • Potassium Citrate, Tablet, Extended Release, 15 meq (NDC 0591-2742-01)To be discontinued
    Sponsor: Watson Pharma Private Limited
    Updated
  • Potassium Citrate, Tablet, Extended Release, 5 meq (NDC 0591-2682-01)To be discontinued
    Sponsor: Watson Pharma Private Limited
    Updated

FAERS reports

View JSON
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.
5,376 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. 1Drug Ineffective4378.1%
  2. 2Fatigue3566.6%
  3. 3Nausea3296.1%
  4. 4Diarrhoea3286.1%
  5. 5Pain3025.6%
  6. 6Nephrolithiasis2735.1%
  7. 7Off Label Use2554.7%
  8. 8Dizziness2334.3%
  9. 9Dyspnoea2244.2%
  10. 10Headache2093.9%
  11. 11Fall2023.8%
  12. 12Vomiting1843.4%
  13. 13Pneumonia1562.9%
  14. 14Asthenia1542.9%
  15. 15Arthralgia1502.8%

Literature

View JSON

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

Clinical trials

View JSON

The 10 most recently updated of 167 ClinicalTrials.gov registrations naming Potassium Citrate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Potassium Citrate work?
Mechanism-of-action classes: Alkalinizing Activity; Electrolyte Activity.
What is Potassium Citrate used for?
According to FDA labeling, Potassium Citrate carries indications including: Potassium citrate extended-release tablets are a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones (1.1) Hypocitraturic calcium oxalate nephrolithiasis of any etiology (1.2) Uric acid lithiasis with or without calcium stones (1.3) 1.1 Renal Tubular Acidosis (RTA) with Calcium Stones Potassium citrate is indicated for the management of renal tubular acidosis [see Clinical Studies (14.1)]. 1.2 Hypocitraturic Calcium Oxalate Nephrolithiasis of any Etiology Potassium citrate is indicated for the management of Hypocitraturic calcium oxalate nephrolithiasis [see Clinical Studies (14.2)] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Potassium Citrate?
Potassium Citrate is classified as Potassium, Alkalinizing Activity, Electrolyte Activity, Renal Ion Transport Alteration.
What are the brand names for Potassium Citrate?
Potassium Citrate is marketed under brand names including Cytra-3, Cytra-K, Urocit-K.
What are the contraindications for Potassium Citrate?
Potassium Citrate labeling lists contraindications including: Potassium citrate extended-release tablets are contraindicated: In patients with hyperkalemia (or who have conditions predisposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. Such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride).. Always consult the full prescribing information and a clinician.
Note. Data for potassium-citrate 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.

Search pharmacopeia

Search drugs, classes, and ingredients