FDA
Ethacrynate Sodium
The FDA lists this product in 4 strengths and forms.
Indications
Ethacrynate sodium is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. 1. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. 2. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. 3. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 4.
Intravenous ethacrynate sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable.
Contraindications
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. In a few patients this diuretic has produced severe, watery diarrhea. If this occurs, it should be discontinued and not used again. Until further experience in infants is accumulated, therapy with parenteral ethacrynate sodium is contraindicated.
Hypersensitivity to any component of this product.
Warnings and precautions
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 When excessive diuresis occurs, the drug should be withdrawn until homeostasis is restored.
When excessive electrolyte loss occurs, the dosage should be reduced or the drug temporarily withdrawn.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.
At a glance
- Brand name
- Ethacrynate Sodium
- Route
- Injection
- Dosage form
- Injectable
- Applicant
- PH Health
- Status
- Prescription
- FDA approval
- 29 Jul 2015
- Application
- ANDA205473-001



