About EDECRIN and SODIUM EDECRIN

A loop diuretic with an important therapeutic role

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EDECRIN, a unique loop diuretic, is indicated for treatment of edema when an agent with greater diuretic potential than those commonly employed is required.  In its tablet form, EDECRIN is used for:

  • 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 SODIUM EDECRIN (Ethacrynate Sodium) is indicated when a rapid onset of diuresis is desired -- for example, in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practical.

Onset of action with either formulation is rapid, usually within 30 minutes after an oral dose of EDECRIN or within 5 minutes after an intravenous injection of SODIUM EDECRIN.  After oral use, diuresis peaks in about 2 hours and lasts about 6 to 8 hours.

The Only Sulfonamide-Free Loop Diuretic

As the only loop diuretic that is not sulfonamide-based, EDECRIN is uniquely well suited to patients who are at risk for an allergic reaction to sulfonamide diuretics.

EDECRIN is available as 25-mg tablets for oral use.  The usual intravenous dose for the average-sized adult is 50 mg, or 0.5 to 1.0 mg per kg of body weight.  Because of the potential for water and electrolyte depletion if the medication is given in excessive amounts, dosing must be carefully adjusted to the individual patient’s needs (See Dosage and Administration in full Prescribing Information).

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) is contraindicated in anuria and infants. EDECRIN is a potent diuretic which, if given in excessive amounts, may lead to profound diuresis with water and electrolyte depletion. 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.

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, EDECRIN has produced severe, watery diarrhea. If this occurs, discontinue EDECRIN. The effects of EDECRIN on electrolytes are dose dependent. Overly vigorous diuresis evidenced by excessive and rapid weight loss may induce an acute hypotensive episode and increase the risk of thromboembolic episodes. Initiation of EDECRIN in cirrhotic patients with ascites is best carried out in the hospital.

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 cephalosporin antibiotics. Lithium generally should not be given with diuretics and precaution taken if given with concomitant warfarin.

During therapy, liberalization of salt intake and supplementary potassium chloride are often necessary. Loop diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesemia. EDECRIN may increase the risk of gastric hemorrhage associated with corticosteroid treatment. 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.

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