Ethacrynic Acid 25 mg/1
Ethacrynic Acid · TABLET · Amneal Pharmaceuticals NY LLC
Ethacrynic Acid is a tablet containing ethacrynic acid at 25 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals NY LLC.
Key Facts
- Brand Name
- Ethacrynic Acid
- Generic Name
- Ethacrynic Acid
- NDC Code (Product)
69238-1126- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Strength
- 25 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA208805
- Drug Class
- Loop Diuretic [EPC]
- Marketing Start
- 05/14/2018
Recall History
West-Ward Columbus Inc
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Ethacrynic acid tablets, USP are indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required. Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema. Short-term management of hospitalized pediatric patients, other than infants, with congenital heart disease or the nephrotic syndrome. 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION D o sa g e 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. O ral Use Ethacrynic acid is available for oral use as 25 mg tablets. Do sage: To Initiate Diuresis I n 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…
Warnings
WARNINGS The effects of ethacrynic acid 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 ethacrynic acid 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 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…
Contraindications
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 oral and parenteral ethacrynic acid is contraindicated. Hypersensitivity to any component of this product.
Adverse Reactions
ADVERSE REACTIONS G a strointestinal 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 ethacrynic acid 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 ethacrynic acid. He matologic 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 ethac…
Frequently Asked Questions
What is Ethacrynic Acid used for?
Ethacrynic Acid contains Ethacrynic Acid. It is a tablet taken oral. Consult your doctor for specific uses.
Is Ethacrynic Acid a controlled substance?
Ethacrynic Acid is not classified as a controlled substance by the DEA.
What is the generic name for Ethacrynic Acid?
The generic name for Ethacrynic Acid is Ethacrynic Acid. There are 3 other brand versions of Ethacrynic Acid.
What is the NDC code for Ethacrynic Acid 25 mg/1?
The NDC (National Drug Code) for Ethacrynic Acid 25 mg/1 is 69238-1126, listed by Amneal Pharmaceuticals NY LLC.