• Important Safety Information
• Prescribing Information

• About Edecrin^® and Sodium Edecrin^®
• About Sulfonamide Sensitivity
• Edecrin Publications
• Resources
• Frequently Asked Questions
• About Aton Pharma
• Patient Information
• 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.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.