Consumer medicine information

Edecrin

Etacrynic acid

BRAND INFORMATION

Brand name

Edecrin

Active ingredient

Etacrynic acid

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Edecrin.

What is in this leaflet

This leaflet answers some common questions about EDECRIN. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking EDECRIN against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What EDECRIN is used for

EDECRIN helps to reduce the amount of fluid in the body for people who have:

  • swelling of the ankles, feet and legs, which is called oedema
  • fluid accumulation in the lungs, which is called pulmonary oedema
  • fluid accumulation around the eyes due to kidney disease
  • fluid accumulation in the stomach area, which is also called ascites, due to liver disease
  • a heart condition called congestive heart failure.

EDECRIN is also used in children over 2 years old to remove fluid that occurs in some heart and kidney conditions.

EDECRIN belongs to a group of medicines called diuretics or fluid tablets.

It works by making your kidneys pass more water and salt from the body.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

Before you take EDECRIN

When you must not take it

Do not take EDECRIN if you have an allergy to:

  • EDECRIN
  • any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

Do not take this medicine if you are pregnant or intend to become pregnant. Like most medicines, EDECRIN is not recommended for use during pregnancy.

Do not take this medicine if you are not passing urine.

Do not give this medicine to a child under the age of two years. Safety and effectiveness in children younger than two years have not been established.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have any allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • liver disease
  • heart disease
  • kidney disease.

Tell your doctor if you are breastfeeding or plan to breast-feed. Like most medicines, EDECRIN is not recommended for use while breast feeding. If it is necessary for you to take EDECRIN, your doctor may ask you to stop breast-feeding.

If you have not told your doctor about any of the above, tell them before you start taking EDECRIN.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and EDECRIN may interfere with each other. These include:

  • medicines used to treat high blood pressure
  • certain antibiotics such as aminoglycoside antibiotics and some cephalosporins
  • warfarin, a medicine used to prevent blood clots
  • lithium, a medicine used to treat severe mood swings
  • corticosteroids, such as prednisone and cortisone.

Ask your doctor or pharmacist if you are not sure if you are taking any of these medicines.

These medicines may be affected by EDECRIN or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take EDECRIN

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

Your doctor will tell you how many tablets you need to take each day. This depends on your condition and whether you are taking other medicines.

If you do not understand the instructions on this leaflet, ask your doctor or pharmacist for help.

How much to take

For adults, the usual starting dose is two 25mg tablets taken once a day. Depending on your response, your doctor may increase this dose. Most people take between 50 mg and 150 mg per day, which is 2 to 6 tablets per day. If you are taking more than two tablets per day, your dose will be divided into two doses per day.

The daily dose should not exceed 16 tablets (400 mg).

For children over 2 years of age, the usual starting dose is one 25 mg tablet taken once a day.

How to take it

Swallow the tablet whole with a full glass of water. Do not split the tablet.

When to take it

If you take EDECRIN once a day, take it immediately after breakfast.

If you take EDECRIN more than once a day, take your first dose immediately after breakfast and take your last dose no later than 6 p.m., unless your doctor tells you otherwise. EDECRIN may increase the amount of water (urine) you pass and also the number of times you go to the toilet. By taking the last dose no later than 6 p.m., there may be less chance of your sleep being disturbed.

Follow the above instructions even if you don't take EDECRIN every day.

Your doctor will determine whether or not you need to take EDECRIN every day.

How long to take it

Continue taking your medicine for as long as your doctor tells you. This medicine helps to control your condition, but does not cure it. It is important to keep taking your medicine even if you feel well.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre on 13 11 26 (Australia) for advice, or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much EDECRIN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too many tablets, you will probably feel light-headed, dizzy, or weak, or you may faint. You may also become very thirsty, confused, have a change in the amount of urine passed, have a fast heartbeat, have muscle cramps or feel a tingling sensation of the skin.

While you are using EDECRIN

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking EDECRIN.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery (even at the dentists), that needs a general anaesthetic, tell the doctor or dentist that you are taking this medicine. Your blood pressure may drop suddenly.

If you become pregnant while taking this medicine, tell your doctor immediately.

Keep all of your doctor's appointments and have your blood tests when your doctor asks you to, so that your doctor can check your progress and make sure your potassium and other electrolytes are at the right level.

EDECRIN may cause a loss of water, potassium, magnesium and other electrolytes from your body. This may cause:

  • dry mouth or thirst
  • weakness, tiredness, numbness tingling in the hands and/or feet
  • muscle pains or cramps
  • restlessness
  • irregular or fast heart beat
  • passing less urine than normal.
  • loss of appetite.

Tell your doctor if you get any of these symptoms.

Your doctor may ask you to take a potassium supplement while taking EDECRIN.

Things you must not do

Do not take EDECRIN to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or change the dosage without checking with your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking EDECRIN.

This medicine helps most people with some types of fluid accumulation, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • feeling sick(nausea), vomiting, loss of appetite
  • generally feeling unwell
  • headache, tiredness
  • stomach upset or pain, diarrhoea or watery diarrhoea
  • dry mouth or thirst
  • muscle pains or cramps
  • restlessness
  • passing more or less urine than normal
  • ringing in the ears
  • blurred vision
  • skin rash.

Tell your doctor as soon as possible if you notice any of the following:

  • yellowing of the skin and eyes, which is called jaundice
  • difficulty in swallowing
  • fever or severe chills
  • bruising more easily than normal
  • spinning sensation, which is called vertigo
  • numbness or tingling in the hands and/or feet
  • feeling anxious or confused
  • blood in the urine
  • pain in the small joints (may be a symptom of gout).

These are serious side effects that may require medical attention. Serious side effects are rare.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen:

  • irregular or fast heart beat
  • vomiting blood or material that looks like coffee grounds
  • bleeding from the back passage, black, sticky bowel motions (stools) or bloody diarrhoea
  • severe pain or tenderness in any part of the stomach
  • seizures or fits
  • deafness
  • irregular heart beat, sweaty, irritable, shaky, anxious and hungry. These may be symptoms of your blood sugar levels being too low.

These are very serious side effects. You may need urgent medical attention or hospitalisation. These very serious side effects are rare.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using EDECRIN

Storage

Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store EDECRIN or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

EDECRIN is a white capsule-shaped tablet, scored and engraved "VRX 205" on one side and the other side engraved "EDECRIN".

EDECRIN tablets are available in plastic bottles with child resistant closures. Each bottle contains 100 tablets.

Ingredients

EDECRIN contains 25 mg of etacrynic acid per tablet as the active ingredient.

Inactive ingredients:

  • lactose monohydrate
  • magnesium stearate
  • colloidal anhydrous silica
  • maize starch
  • purified talc.

This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.

Supplier

EDECRIN is supplied in Australia by:

A. Menarini Australia Pty Ltd
Level 8, 67 Albert Avenue
Chatswood NSW 2067
Medical Information: 1800 644 542

Under licence of Bausch Health US, Bridgewater, NJ. USA.

Australian Registration Number: AUST R 96871

This leaflet was revised in December 2019.

For the most up to date version of this leaflet, please go to www.menarini.com.au/cmi

[vA07-0]

Published by MIMS March 2020

BRAND INFORMATION

Brand name

Edecrin

Active ingredient

Etacrynic acid

Schedule

S4

 

1 Name of Medicine

Etacrynic acid.

6.7 Physicochemical Properties

Etacrynic acid is a white, or practically white, crystalline powder, very slightly soluble in water, but soluble in most organic solvents such as alcohols, chloroform, and benzene.
Etacrynic acid is an unsaturated ketone derivative of an aryloxyacetic acid. It is designated chemically as [2,3-dichloro-4-(2-methylene-1-oxobutyl)phenoxy] acetic acid, and has a molecular weight of 303.14.
Its empirical formula is C13H12Cl2O4.

Chemical structure.


CAS number.

58-54-8.

2 Qualitative and Quantitative Composition

Edecrin tablet contains 25 mg etacrynic acid.

Excipient with known effect.

Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Edecrin 25 mg tablets are white capsule-shaped tablets, scored and engraved "VRX 205" on one side and the other side engraved "Edecrin".
The splitting of Edecrin 25 mg tablets is not advised.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Edecrin is a potent saluretic-diuretic agent with rapid onset of action. When administered as directed, it has been used successfully in the management of oedema of cardiac, pulmonary, renal, or hepatic origin, even oedema refractory or unresponsive to other diuretic agents.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

In both animals and man, etacrynic acid causes a marked increase in excretion of salt and water under conditions of hydropenia as well as hydration. Experimental studies indicate that etacrynic acid influences both the diluting and concentrating mechanisms of the kidney. By inhibiting active sodium reabsorption in the ascending limb of the loop of Henle, as well as elsewhere in the nephron, it depresses reversibly the operation of the diluting mechanism and diminishes the increasing solute gradient of the kidney from the cortex to the medulla. The concentrating mechanism of the more distal nephron, which is dependent on this osmotic gradient from lumen to medullary interstitium, is likewise diminished. The net effect is the excretion of large amounts of virtually iso-osmotic urine. This renal effect is very different from that of the thiazides, mercurials, or other diuretics, and reflects a unique mechanism of action of etacrynic acid.
In dogs, etacrynic acid produces a maximal sodium excretion that is considerably greater than that which can be achieved with the thiazides. For example, moderate doses of etacrynic acid given intravenously (as a solution of the sodium salt) regularly caused the excretion of sodium in excess of 1,000 microequivalents/minute, whereas hydrochlorothiazide even in maximally effective doses seldom caused the excretion of 500 microequivalents/minute of sodium when the animals received no prior salt supplementation. Etacrynic acid induced a chloruresis at least equal to the natriuresis in magnitude. This is in contrast to the thiazides which, especially in high doses, tend to cause increased excretion of bicarbonate as well as chloride along with sodium. Of particular interest is the fact that, with intravenous doses of etacrynic acid (as a solution of the sodium salt) sufficient to induce a maximal rate of sodium excretion several fold that evoked by a maximal dose of hydrochlorothiazide, the kaliuretic response to the two agents was equivalent. Oral administration of etacrynic acid to dogs also caused greater saluresis than the maximum obtainable with hydrochlorothiazide.
In both acidotic and alkalotic dogs, the intravenous injection of etacrynic acid (as a solution of the sodium salt) caused an equally large excretion of sodium and of chloride. Potassium excretion also was increased to a lesser extent. Glomerular filtration rate was slightly depressed, reflecting the hypovolaemia secondary to the marked diuresis.
Following the addition of etacrynic acid (as a solution of the sodium salt) to an infusion of the maximally effective dose of hydrochlorothiazide given to dogs, the excretion of sodium, chloride, and urine increased greatly. Potassium excretion also increased, but less than proportionately. The diuretic and saluretic effects of moderate doses of etacrynic acid and hydrochlorothiazide were studied separately and together by the oral route in normal humans and in dogs. The joint effect, especially on sodium excretion, was greater than predicted from the separate effects. Etacrynic acid apparently can block an aspect of sodium reabsorption that is not affected by the thiazides.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Edecrin is indicated for the treatment of oedema when urgent diuresis by a potent saluretic/ diuretic agent with rapid onset of action is essential: congestive heart failure; pulmonary oedema; renal oedema; hepatic cirrhosis with ascites; oedema due to other causes.

Paediatric indications.

Edecrin tablets have been found useful in patients of the paediatric age group with the nephrotic syndrome. This experience has generally been limited to short-term therapy in hospitalised patients resistant to other therapy. Paediatric patients with congenital heart disease also have responded to Edecrin. Edecrin should not be given to infants under two years of age (see Section 4.3 Contraindications).

4.3 Contraindications

Anuria.
Oral Edecrin is contraindicated in infants.
Hypersensitivity to any component of this product.

4.4 Special Warnings and Precautions for Use

The effects of Edecrin on electrolytes are related to its renal pharmacologic activity and usually are dose related. If excessive diuresis occurs, the drug should be withdrawn until homeostasis is restored. When excessive electrolyte loss occurs, the dosage should be reduced or the drug temporarily withdrawn.
The possibility of profound electrolyte and water loss may be avoided by weighing the patient throughout the treatment period, by careful adjustment of dosage, by initiating treatment with small doses, and by using Edecrin on an intermittent schedule when possible.
Frequent serum electrolyte, CO2 and BUN determinations should be performed early in therapy and periodically thereafter during active diuresis. Any electrolyte abnormalities should be corrected or the drug temporarily withdrawn. If increasing electrolyte imbalance, azotaemia and/or oliguria occur during treatment of severe progressive renal disease, the diuretic should be discontinued.
Edecrin should be given with caution to patients with advanced cirrhosis of the liver, particularly those with a history of episodes of electrolyte imbalance or hepatic encephalopathy. Like other diuretics, it may precipitate hepatic coma and death.
When a metabolic alkalosis may be anticipated, e.g. in cirrhosis with ascites, the use of potassium chloride or a potassium sparing agent before and during therapy with Edecrin may mitigate or prevent the hypokalaemia.
Loop diuretics have been shown to increase the urinary excretion of magnesium; this may result in hypomagnesaemia.
Weakness, muscle cramps, paraesthesiae, thirst, anorexia and signs of hyponatraemia, hypokalaemia and/or hypochloraemic alkalosis may occur following vigorous or excessive diuresis and may be accentuated by rigid salt restriction. Rarely, tetany has been reported following vigorous diuresis. During therapy with Edecrin, liberalisation of salt intake and supplementary potassium chloride are often necessary.
Edecrin should be used with caution in critically ill patients, particularly those in the following two categories:
1. Patients with severe myocardial disease who have been receiving digitalis, who may develop acute hypokalaemia with fatal arrhythmia.
2. Patients with severely decompensated hepatic cirrhosis with ascites, with or without accompanying encephalopathy, who are in electrolyte imbalance which may become aggravated. A number of possible drug related deaths have occurred among such patients.
Deafness, tinnitus and vertigo with a sense of fullness in the ears have occurred in patients treated with etacrynic acid, most frequently in patients with severe impairment of renal function. A number of these patients were also receiving drugs known to be ototoxic. Edecrin may increase the ototoxic potential of other drugs (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Antihypertensive agents.

Orthostatic hypotension may occur in patients receiving antihypertensive agents when given etacrynic acid.

Antibiotics.

Edecrin may increase the ototoxic potential of other drugs such as aminoglycoside antibiotics and some cephalosporins. Their concurrent use should be avoided.

Warfarin.

A number of drugs, including etacrynic acid, have been shown to displace warfarin from plasma protein; a reduction in the usual anticoagulant dosage may be required in patients receiving both drugs.

Lithium.

Lithium should generally not be given to patients receiving diuretics, since the risk of lithium toxicity is high in such patients (see package circulars for lithium preparations before such concomitant therapy).

Corticosteroids.

Edecrin may increase the risk of gastric haemorrhage associated with corticosteroid treatment.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
Thiazides, related diuretics and loop diuretics enter the fetal circulation and may cause electrolyte disturbances. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics like frusemide and bumetanide are probably also associated with this risk. During the latter part of pregnancy products of this type should therefore only be given on sound indications, and then in the lowest effective dose.
Edecrin is not recommended for use in pregnancy.
Edecrin should not be given to nursing mothers. If use of the drug is deemed essential, the patient should stop nursing.

4.8 Adverse Effects (Undesirable Effects)

Gastrointestinal.

Anorexia, malaise, abdominal discomfort or pain, dysphagia, nausea, vomiting and diarrhoea. In a few patients watery profuse diarrhoea, gastrointestinal bleeding and acute pancreatitis have been reported.

Metabolic.

Reversible hyperuricaemia, decreased urinary urate excretion, and hyperglycaemia have been reported. Acute gout may be precipitated. Rarely, acute symptomatic hypoglycaemia with convulsions, jaundice and abnormal tests of hepatocellular function have been reported.

Haematologic.

Agranulocytosis, severe neutropenia, thrombocytopenia and Henoch-Schonlein purpura have been reported rarely.

Special senses.

Deafness, tinnitus and vertigo with a sense of fullness in the ears, and blurred vision have occurred.

Central nervous system.

Fatigue, apprehension and confusion.

Other.

Skin rash, headache, fever, chills and haematuria.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

The dosage must be carefully regulated so as to adjust the diuretic response to the rate and extent most desirable for the individual patient. Daily weighings and, when possible, serum electrolyte determinations will contribute greatly to the success of treatment.

Oral use.

The splitting of Edecrin 25 mg tablets is not advised.

Initial dosage.

The smallest dose required to produce a gradual weight loss (about 1/2 to 1 kg per day) is recommended.

Adults.

The recommended dose is 50 mg (2 tablets) daily immediately after breakfast. If necessary, increase the total daily dosage by amounts of 25 to 50 mg (1 to 2 tablets). The usual effective daily dosage is in the range of 50 to 150 mg (2 to 6 tablets).
Whenever a daily dosage higher than 50 mg (2 tablets) is required for desired diuresis, it should always be achieved gradually and should be divided into two doses and given after meals. In no case should a daily dosage exceed 400 mg (16 tablets).

Children.

The recommended dose is 25 mg (1 tablet) immediately after breakfast. If necessary, this dosage should be carefully increased by amounts of 25 mg (1 tablet) per day until an effective diuresis is achieved. Edecrin should not be given to infants under two years of age.

Maintenance dosage.

Treatment may be maintained either on a continuous or an intermittent basis. Intermittent therapy usually can be used without loss of therapeutic response.
The effective dosage of Edecrin may be given on alternate days or for two- or three-day treatment periods alternating with two- or three-day rest periods.
During treatment with Edecrin, use of supplemental potassium or potassium sparing agents is often advisable, especially in cirrhotic or nephrotic patients and in patients receiving digitalis.
Salt liberalisation usually prevents the development of hyponatraemia and hypochloraemia. During treatment with Edecrin, salt intake may be liberalised to a greater extent than with other diuretics. Cirrhotic patients, however, usually require at least moderate salt restriction concomitant with diuretic therapy.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalaemia, hypochloraemia, hyponatraemia) and dehydration resulting from excessive diuresis.
In the event of overdosage, symptomatic and supportive measures should be employed. Dehydration, electrolyte imbalance, hepatic coma and hypotension should be corrected by established procedures. If required, give oxygen or artificial respiration for respiratory impairment.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Edecrin 25 mg tablets contain lactose monohydrate, maize starch, colloidal anhydrous silica, purified talc and magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

The tablets are packed in high density polyethylene (HDPE) bottle with a child resistant cap.
Supplied in bottles of 100.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes