Ethacrynate

• Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1.ICD-10: R60.9

• All diuretics, including ethacrynic acid, are contraindicated in anuria. If increasing electrolyte imbalance, azotemia, and/or oliguria occur during treatment of severe, progressive renal disease, the diuretic should be discontinued.contraindicated

Dosage must be regulated carefully to prevent a more rapid or substantial loss of fluid or electrolyte than is indicated or necessary. The magnitude of diuresis and natriuresis is largely dependent on the degree of fluid accumulation present in the patient. Similarly, the extent of potassium excretion is determined in large measure by the presence and magnitude of aldosteronism. Oral Use Ethacrynic Acid Tablets USP are available as 25 mg tablets. Dosage: To Initiate Diuresis In Adults: The smallest dose required to produce gradual weight loss (about 1 to 2 pounds per day) is recommended. Onset of diuresis usually occurs at 50 to 100 mg for adults. After diuresis has been achieved, the minimally effective dose (usually from 50 to 200 mg daily) may be given on a continuous or intermittent dosage schedule. Dosage adjustments are usually in 25 to 50 mg increments to avoid derangement of water and electrolyte excretion. The patient should be weighed under standard conditions before and during the institution of diuretic therapy with this compound. Small alterations in dose should effectively prevent a massive diuretic response. The following schedule may be helpful in determining the smallest effective dose. Day 1 - 50 mg once daily after a meal Day 2 - 50 mg twice daily after meals, if necessary Day 3 - 100 mg in the morning and 50 to 100 mg following the afternoon or evening meal, depending upon response to the morning dose. A few patients may require initial and maintenance doses as high as 200 mg twice daily.

The effects of ethacrynate sodium on electrolytes are related to its renal pharmacologic activity and are dose dependent. The possibility of profound electrolyte and water loss may be avoided by weighing the patient throughout the treatment period, by careful adjustment of dosage, by initiating treatment with small doses, and by using the drug on an intermittent schedule when possible. When excessive diuresis occurs, the drug should be withdrawn until homeostasis is restored. When excessive electrolyte loss occurs, the dosage should be reduced or the drug temporarily withdrawn. Initiation of diuretic therapy with ethacrynate sodium in the cirrhotic patient with ascites is best carried out in the hospital. When maintenance therapy has been established, the individual can be satisfactorily followed as an outpatient. Ethacrynate sodium should be given with caution to patients with advanced cirrhosis of the liver, particularly those with a history of previous episodes of electrolyte imbalance or hepatic encephalopathy. Like other diuretics it may precipitate hepatic coma and death. Too vigorous a diuresis, as evidenced by rapid and excessive weight loss, may induce an acute hypotensive episode. In elderly cardiac patients, rapid contraction of plasma volume and the resultant hemoconcentration should be avoided to prevent the development of thromboembolic episodes, such as cerebral vascular thromboses and pulmonary emboli which may be fatal. Excessive loss of potassium in patients receiving digitalis glycosides may precipitate digitalis toxicity.

Gastrointestinal Anorexia, malaise, abdominal discomfort or pain, dysphagia, nausea, vomiting, and diarrhea have occurred. These are more frequent with large doses or after one to three months of continuous therapy. A few patients have had sudden onset of profuse, watery diarrhea. Discontinue ethacrynate sodium if diarrhea is severe and do not give it again. Gastrointestinal bleeding has occurred in some patients. Rarely, acute pancreatitis has been reported. Metabolic Reversible hyperuricemia and acute gout have been reported. Acute symptomatic hypoglycemia with convulsions occurred in two uremic patients who received doses above those recommended. Hyperglycemia has been reported. Rarely, jaundice and abnormal liver function tests have been reported in seriously ill patients receiving multiple drug therapy, including ethacrynate sodium. Hematologic Agranulocytosis or severe neutropenia has been reported in a few critically ill patients also receiving agents known to produce this effect. Thrombocytopenia has been reported rarely. Henoch-Schönlein purpura has been reported rarely in patients with rheumatic heart disease receiving multiple drug therapy, including ethacrynate sodium. Special Senses (see WARNINGS ) Deafness, tinnitus and vertigo with a sense of fullness in the ears, and blurred vision have occurred. Central Nervous System Headache, fatigue, apprehension, confusion. Miscellaneous Skin rash, fever, chills, hematuria. Ethacrynate sodium occasionally has caused local irritation and pain after intravenous use.

Pregnancy Reproduction studies in the mouse and rabbit at doses up to 50 times the human dose showed no evidence of external abnormalities of the fetus due to ethacrynate sodium. In a two-litter study in the dog and rat, oral doses of 5 or 20 mg/kg/day (2 1/2; or 10 times the human dose), respectively, did not interfere with pregnancy or with growth and development of the pups. Although there was reduction in the mean body weights of the fetuses in a teratogenic study in the rat at a dose level of 100 mg/kg (50 times the human dose), there was no effect on mortality or postnatal development. Functional and morphologic abnormalities were not observed. There are, however, no adequate and well-controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, ethacrynate sodium should be used during pregnancy only if clearly needed.

Metabolism

and Metabolism Ethacrynate sodium acts on the ascending limb of the loop of Henle and on the proximal and distal tubules. Urinary output is usually dose dependent and related to the magnitude of fluid accumulation.

Overdosage may lead to excessive diuresis with electrolyte depletion and dehydration. In the event of overdosage, symptomatic and supportive measures should be employed. Emesis should be induced or gastric lavage performed. Correct dehydration, electrolyte imbalance, hepatic coma, and hypotension by established procedures. If required, give oxygen or artificial respiration for respiratory impairment. In the mouse, the oral LD 50 of ethacrynic acid is 627 mg/kg and the intravenous LD 50 of ethacrynate sodium is 175 mg/kg.

• Jul 29, 2015ANDAANDA205473Ph Health
• Jun 9, 2020ANDAANDA208663Sterimax

1. 1Diarrhoea233%
2. 2Hypersensitivity233%
3. 3Alanine Aminotransferase Increased117%
4. 4Angioedema117%
5. 5Anti-transglutaminase Antibody Negative117%
6. 6Ascites117%
7. 7Blood Creatine Phosphokinase Increased117%
8. 8Coeliac Disease117%
9. 9Compartment Syndrome117%
10. 10Drug Ineffective117%
11. 11Drug Ineffective For Unapproved Indication117%
12. 12Hyperpyrexia117%
13. 13Hypoxia117%
14. 14Obstructive Airways Disorder117%
15. 15Oedema117%

The 5 most recently updated of 5 ClinicalTrials.gov registrations naming Ethacrynate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Pharmacokinetics of Drugs Administered to Children
  Recruiting · Observational · 200 enrolled · Duke University
  NCT03481881updated 2026-01-07
• ACEI or ARB and COVID-19 Severity and Mortality in US Veterans
  Completed · Observational · 22,213 enrolled · University of Utah
  NCT04467931updated 2021-04-28
• Ethacrynic Acid Elimination in Non-Muscle Invasive Bladder Cancer Patients Undergoing Transurethral Resection
  Completed · Phase 1 · Interventional · 12 enrolled · Eugene Lee, MD
  NCT02852564updated 2017-08-22
• Novel Drug Delivery Technique Via Retroject Device
  Completed · Phase 1 · Phase 2 · Interventional · 9 enrolled · Molly Walsh
  NCT02051946updated 2017-02-17
• Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease
  Completed · Phase 3 · Interventional · 74 enrolled · Bambino Gesù Hospital and Research Institute
  NCT01628731updated 2014-07-24

Frequently asked questions

What is Ethacrynate used for?

According to FDA labeling, Ethacrynate carries indications including: Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the brand names for Ethacrynate?

Ethacrynate is marketed under brand names including Edecrin.

What are the contraindications for Ethacrynate?

Ethacrynate labeling lists contraindications including: All diuretics, including ethacrynic acid, are contraindicated in anuria. If increasing electrolyte imbalance, azotemia, and/or oliguria occur during treatment of severe, progressive renal disease, the diuretic should be discontinued.. Always consult the full prescribing information and a clinician.