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Frequently Asked Questions

EDECRIN® (Ethacrynic Acid and Ethacrynate Sodium)

Will this medication change my bowel or bladder habits?
In a few patients Edecrin has produced severe, watery diarrhea. If this occurs it should be discontinued and not used again.

Will my urine change color?
This side effect has not been reported with the usage of Edecrin. However, please contact your physician if you experience any side effects.

Can I take this medication if I have glaucoma?
Edecrin therapy is not contraindicated in patients having glaucoma. Your doctor will decide whether edecrin is right for you.

Do I need to be monitored or have lab work done while I am taking this medication? If so how often and what are they looking for?
Yes, blood testing to determine serum levels of potassium and sodium is recommended at intervals to be decided by your doctor.

How long will it take for this medication to start working?
Intravenous Edecrin usually begins to work within five minutes and Oral Edecrin begins to work in about 30 minutes.

Will I experience weight loss with this medication?
You may lose weight due to the loss of water. Please contact your doctor for more information.

Will this medication cause a change in my blood pressure?
You may lower your blood pressure due to reduced volume of water in your circulation. Please contact your doctor for more information.

What are some of the common side effects of this medication?
This is something that you should discuss with your doctor, since there are many possible side effects, but only some may be relevant to your condition. Some side effects that have been experienced include tinnitus, diarrhea, nausea, vomiting, and headaches. Please refer to the prescribing information for a complete list of side effects.

Should I take this medication the same time each day?
Please ask your doctor.

What do I do if I miss a dose?
Please ask your doctor.

Does this medication require special storage?
The medication should be stored in the container that it is dispensed in and should be kept at room temperature.

Can I take this medication if I have diabetes?
Edecrin therapy is not contraindicated in patients having diabetes. Your doctor will decide whether edecrin is right for you.

Is the medication safe to use if I am pregnant or contemplating becoming pregnant?
There are no adequate and well-controlled studies in pregnant women. That is a question only your physician can discuss with you.

What herbal supplements, if any, should I avoid while on this medication?
You should talk to your doctor before beginning any herbal and/or vitamin supplements and over the counter medications.

Is this medication safe for use by mothers who are breastfeeding?
It is not known if this medication is safe for breastfeeding mothers. Please ask you physician this question for your specific situation.

Is this medication safe for pediatric use?
Edecrin is contraindicated in infants. Please ask your physician.

If I am allergic to IVP dye can I use this medication?
Edecrin does not contain IVP dye, but it is best to discuss this with your physician.

Are there any specific food restrictions I should be aware of while I am taking this medication?
Your physician may suggest specific dietary recommendations as part of treatment for your condition.

Will this medication draw calcium out of my bones?
Please ask your physician to be certain given your specific condition.

Do I have to stay on the medication for the rest of my life to achieve the desired effect?
That depends on your condition and is something that only your doctor can answer since he or she knows you best.

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.

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