ℹ️ Compiled from public regulatory records · Last regulator revision: March 22, 2025🚩 Report this page
Ethacrynate
Active ingredient
CA Health Canada
Drug class
-
Availability
See label
Routes
Intravenous
Markets covered
1
Products on record
1
Overview
Ethacrynate is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised March 22, 2025[1]
AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS .................................................................................
5 ADVERSE REACTIONS................................................................................................... 7 DRUG INTERACTIONS ...................................................................................................
7 DOSAGE AND ADMINISTRATION ............................................................................... 8 OVERDOSAGE .................................................................................................................
9 ACTION AND CLINICAL PHARMACOLOGY ............................................................. 9 STORAGE AND STABILITY ......................................................................................... 10 SPECIAL HANDLING INSTRUCTIONS ......................................................................
Drug interactions
Known interactions involving Ethacrynate. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 383. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
[1]Health Canada (DPD) · 02462362 · revised March 22, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
10 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 10 PART II: SCIENTIFIC INFORMATION ............................................................................... 11 PHARMACEUTICAL INFORMATION .........................................................................
12 REFERENCES ................................................................................................................. 15 PART III: PATIENT MEDICATION INFORMATION ....................................................... 16 Product Monograph ETHACRYNATE SODIUM Page 3 of 19 PrETHACRYNATE SODIUM (Ethacrynate sodium for injection, USP) PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength Clinically Relevant Non-medicinal Ingredients Intravenous Injection / Ethacrynate sodium equivalent to 50 mg ethacrynic acid Mannitol For a complete listing see Dosage Forms, Composition and Packaging section.
INDICATIONS AND CLINICAL USE Ethacrynate Sodium (ethacrynate sodium for injection, USP) is especially useful in patients unresponsive to the commonly used diuretics.
Ethacrynic acid has been found useful in the following conditions:
Congestive Heart Failure Acute Pulmonary Oedema Renal Oedema (Nephrotic syndrome) Hepatic Cirrhosis with Ascites The majority of patients studied to date have been resistant in some degree to other diuretic agents; the remaining patients received ethacrynic acid as their first diuretic in the treatment of oedema or were placed on the drug for comparative evaluations.
Patients with chronic congestive heart failure many of whom were unresponsive to other diuretics have responded successfully to short or long term therapy. These include patients with arteriosclerotic heart disease, rheumatic heart disease, hypertensive cardiovascular disease, pulmonary heart disease, and congenital heart disease.
Long term studies in patients who have received ethacrynic acid for over six months have been in patients with cardiac oedema secondary to arteriosclerotic or valvular heart disease. The average duration of these studies has been about nine months.
Patients with acute pulmonary oedema have responded rapidly to the intravenous use of ethacrynate sodium. Clinical improvement is coincidental with the large increases in water and electrolyte excretion usually observed to begin within 5 minutes after injection.
Ethacrynate sodium offers advantages over other diuretics because of its rapid action and effectiveness. Ethacrynate Sodium is indicated for patients with the nephrotic syndrome. The greatest experience with this agent in renal oedema has been in patients with the nephrotic syndrome.
Product Monograph ETHACRYNATE SODIUM Page 4 of 19 Use of the drug in these patients usually has been of short duration, ranging from one to three months, with treatment usually being initiated in the hospital. Saluresis and diuresis may be achieved in patients unresponsive to other diuretics.
Patients whose response to other diuretics has been suboptimal may obtain a greater effect from ethacrynic acid. As with other diuretics, hypoproteinaemia may reduce responsiveness to ethacrynic acid and the use of salt-poor albumin should be considered.
In some patients, larger doses may be necessary to produce effective diuresis in renal than in cardiac oedema. Ethacrynic acid is effective in many patients who have significant degrees of renal insufficiency. It has little or no effect on renal blood flow except following pronounced reduction in plasma volume when associated with rapid diuresis.
The extreme sensitivity of patients with chronic renal failure to alterations in fluid or electrolyte balance dictates careful clinical and laboratory observation when diuretics are used, and these agents must be discontinued immediately if further deterioration in renal function occurs.
For reasons given below, 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.
Ethacrynic acid is usually effective in patients with cirrhosis who have ascites. Most studies have been of three months' duration, or less. Diuresis and saluresis have occurred in previously unresponsive patients. However, cirrhotic patients tolerate poorly acute shifts in electrolyte balance, and potassium excretion is often augmented as a result of associated aldosteronism.
Therefore, careful clinical and laboratory observation is essential to avoid serious loss of potassium and […]