A Potent Loop Diuretic with a Rapid Onset of Action

Intravenous Edecrin (ethacrynate sodium)

EDECRIN® and SODIUM EDECRIN®

POTENT. RAPID ONSET. EFFICACY

EDECRIN is a potent loop diuretic developed decades ago during the first wave of loop diuretics. In the decades since, EDECRIN has been prescribed for the treatment of edema when an agent with greater diuretic potential than those commonly employed is required.

INDICATIONS

EDECRIN is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required.

EDECRIN® (ethacrynic acid) Tablets

  • Congestive heart failure
  • Cirrhosis of the liver
  • Renal disease, including the nephrotic syndrome 

  • Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema 


SODIUM EDECRIN® (ethacrynate sodium) Intravenous Indication

  • Intravenous SODIUM EDECRIN 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.1

EDECRIN Should be Considered When a Potent Loop Diuretic is Needed

  • EDECRIN is often prescribed when a potent loop diuretic is needed.
  • EDECRIN may be appropriate for sulfa allergy-prone patients who face life-threatening edematous conditions.1

IMPORTANT SAFETY INFORMATION

EDECRIN is a potent diuretic which, if given in excessive amounts, may lead to profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, and dose and dosing schedule must be adjusted to the individual patient's needs.

Please see additional Important Safety Information below.

Onset of Action is Rapid With Both IV and Oral forms of EDECRIN

  • A single dose containing 50-mg of Intravenous Sodium EDECRIN usually has a 5-minute onset of action, with a peak diuretic effect within 30 minutes. Duration of action is 2 to 4 hours.1,2
  • A 25-mg tablet of EDECRIN taken orally usually has a 30-minute onset of action with peak diuretic effect within about 2 hours. Duration of action is about 6-8 hours.1,2

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.2

INDICATIONS AND USAGE

EDECRIN 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 sodium EDECRIN 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.

IMPORTANT SAFETY INFORMATION

EDECRIN® (ethacrynic acid and ethacrynate sodium) is a potent diuretic which, if given in excessive amounts, may lead to profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required, and dose and dose schedule must be adjusted to the individual patient's needs.

  • 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 EDECRIN is contraindicated. EDECRIN is contraindicated in individuals with a hypersensitivity to any component of this product.
  • The effects of EDECRIN on electrolytes are dose dependent. Treatment should be individualized and initiated with small doses on an intermittent schedule when possible. Dosing must be regulated carefully to prevent a more rapid or substantial loss of fluid or electrolytes than is indicated or necessary. Weighing the patient throughout the treatment period may help avoid the possibility of profound electrolyte and water loss.
  • Initiation of EDECRIN in cirrhotic patients with ascites is best carried out in the hospital. EDECRIN 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.
  • Overly vigorous diuresis evidenced by excessive and rapid weight loss may induce an acute hypotensive episode and increase the risk of thromboembolic episodes in elderly cardiac patients that may be fatal. Excessive loss of potassium in patients receiving digitalis glycosides may precipitate digitalis toxicity. Care should also be exercised in patients receiving potassium-depleting steroids.
  • A number of possibly drug-related deaths have occurred in critically ill patients refractory to other diuretics, generally involving acute hypokalemia with fatal arrhythmia in digitalis patients, or death from intensified electrolyte defect in severe hepatic cirrhosis with ascites.
  • Deafness, tinnitus, and vertigo have occurred, most frequently in patients with severe renal impairment. EDECRIN may increase the ototoxicity potential of other drugs such as aminoglycosides and some cephalosporin antibiotics. Their concurrent use should be avoided.
  • Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity.
  • During therapy, liberalization of salt intake and supplementary potassium chloride are often necessary especially in cirrhosis with ascites, to mitigate or prevent the hypokalemia.
  • Loop diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia.
  • Ethacrynic acid, has been shown to displace warfarin from plasma protein; a reduction in the usual anticoagulant dosage may be required in patients receiving both drugs.
  • EDECRIN may increase the risk of gastric hemorrhage associated with corticosteroid treatment.
  • The safety and efficacy of ethacrynic acid in hypertension have not been established.
  • Orthostatic hypotension may occur in patients receiving other antihypertensive agents when given ethacrynic acid.
  • Frequent serum electrolyte, CO2, and BUN determinations should be performed early in therapy and periodically thereafter during active diuresis, and any abnormalities corrected or the drug temporarily withdrawn.
  • Pregnancy Category B - no adequate and well-controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, EDECRIN should be used during pregnancy only if clearly needed.
  • Pediatric Use - There are no well-controlled clinical trials in pediatric patients. The information on oral dosing in pediatric patients, other than infants, is supported by evidence from empiric use in this age group. Safety and effectiveness of oral and parenteral use in infants have not been established. Safety and effectiveness of intravenous use in pediatric patients have not been established.
  • Adverse reactions that have been reported with the use of EDECRIN include: anorexia, malaise, abdominal discomfort or pain, dysphagia, nausea, vomiting, diarrhea, acute pancreatitis; reversible hyperuricemia and acute gout, acute symptomatic hypoglycemia with convulsions, hyperglycemia, jaundice and abnormal liver function tests; agranulocytosis or severe neutropenia, thrombocytopenia, Henoch-Schönlein purpura; deafness, tinnitus and vertigo with a sense of fullness in the ears, blurred vision; headache, fatigue, apprehension, confusion; skin rash, fever, chills, hematuria; and local irritation and pain after intravenous use.

Please click here for full Prescribing Information.

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REFERENCES

  1. EDECRIN Prescribing Information. Aton Pharma. 2011.
  2. Molnar J, Somberg J. The clinical pharmacology of ethacrynic acid. Am J Ther. 2009;16:86-92.