Ethacrynate Sodium: Uses, Side Effects and Dosage

What is ETHACRYNATE SODIUM used for?

• Increasing urination (diuretic).
• Decreasing the swelling caused by fluid retention (oedema) due to heart failure, liver disease or kidney disease.

How does ETHACRYNATE SODIUM work?

Ethacrynate sodium acts on your kidney by blocking its mechanisms for the reabsorption of sodium and chloride which leads to the abundant formation of urine.

What are the ingredients in ETHACRYNATE SODIUM?

Medicinal ingredients: Ethacrynate sodium

Non-medicinal ingredients: Mannitol

ETHACRYNATE SODIUM comes in the following dosage form:

Vial containing 50 mg of ethacrynic acid as its sodium salt.

Do not use ETHACRYNATE SODIUM if:

• You are allergic to ethacrynate sodium or ethacrynate acid or any of the other ingredients in ETHACRYNATE SODIUM listed in the “nonmedicinal ingredients” section above.
• You no longer urinate.
• You develop a medical condition called azotemia (abnormally high levels of nitrogen-containing compounds in your blood) or pass less than 400 milliliters of urine in a day.
• You are an infant.

See also warnings for pregnant women and nursing women.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ETHACRYNATE SODIUM. Talk about any health conditions or problems you may have, including if you:

• Are under a strict salt restriction diet. During therapy with ethacrynic acid, your Doctor may change your salt intake diet and recommend potassium supplements.
• Have liver disease like cirrhosis.
• Present sign of aldosteronism (excess aldosterone produced by the adrenal glands).
• Have small bowel lesions like narrowing of the passage or ulceration.
• Have a cardiac disease.
• Are using digitalis glycosides (drug that promote cardiac contraction and control heart rhythm.
• Have hearing problems.
• Have an imbalance or derangement in your electrolytes (sodium, potassium, chloride and hydrogen).
• Are prone to have diarrhea.
• Have renal problems.

Other warnings you should know about:

• Ethacrynate Sodium is not recommended if you are pregnant. Your Doctor will decide if you should continue to use Ethacrynate Sodium if you become pregnant.
• Ethacrynate Sodium must not be used if you are nursing women. If your doctor considers that Ethacrynate Sodium is essential for your health, you must stop nursing.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ETHACRYNATE SODIUM:

• Drugs to treat hypertension (high blood pressure)
• Antibiotics
• Warfarin (blood thinner)
• Lithium (used to treat bipolar disease)
• Corticosteroids (used to treat joint pain and swelling or for other conditions)

How to take ETHACRYNATE SODIUM:

ETHACRYNATE SODIUM will be administered by your doctor or nurse. This medication will be given to you slowly through an infusion or by direct intravenous injection over a period of several minutes.

Usual dose:

The usual intravenous dose for an average sized adult is 50 mg, or 0.5 to 1 mg per kg of body weight. Usually only one dose is sufficient; occasionally a second dose may be required.

Overdose:

What are possible side effects from using ETHACRYNATE SODIUM?

These are not all the possible side effects you may feel when taking ETHACRYNATE SODIUM. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

Gastrointestinal

Decrease appetite, malaise, abdominal discomfort or pain, difficulty in swallowing, nausea, vomiting, and diarrhea. In a few patients, stomach-intestinal bleeding, and sudden inflammation of the pancreas has been reported.

Metabolic

Reversible high level of uric acid in the blood, decreased urinary urate excretion, and high level of blood sugar have been reported. Acute gout has been precipitated. Rarely sudden symptomatic low blood sugar with convulsions, jaundice and abnormal tests of liver cells function have been reported.

Blood

Agranulocytosis (serious lowered white blood cell count), severe abnormally low number of white blood cell called neutrophils, decrease of platelets in blood, and Henoch-Schönlein purpura (a disease of the skin that produces small hemorrhages and joint and abdominal pain) have been reported rarely.

Special Senses

Vertigo, deafness, and "ringing of the ears”, with a sense of fullness in the ears and blurred vision have occurred (see WARNINGS AND PRECAUTIONS).

Central Nervous System

Fatigue, apprehension, and confusion.

Other

Skin rash, local irritation, pain, headache, fever, chills and presence of blood in the urine. In a rare instance of local thrombophlebitis (vein inflammation due to a blood clot) has been reported.

The use of diuretics has been a cause of death in some seriously ill patients. In general, these patients had either a severe heart disease or severe liver disease.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

Store at controlled room temperature between 15º C and 30º C.

Keep out of reach and sight of children.

If you want more information about ETHACRYNATE SODIUM:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html), the manufacturer’s website (http://www.sterimaxinc.com), or by calling toll-free 1-800-881-3550.

Last Revised FEB 28, 2024