Download Ethacrynic acid (Edecrin) tablets

Ethacrynic acid (Edecrin) tablets
Summary
PBS listing
Ethacrynic acid is a restricted benefit for patients hypersensitive to other
oral diuretics.
Reason for PBS listing
The PBAC recommended listing of the new strength, ethacrynic acid 25 mg
tablets, to replace the discontinued 50 mg strength.
Place in therapy
Ethacrynic acid may be prescribed in patients requiring a loop diuretic who
are either allergic or refractory to frusemide or bumetanide therapy.
Safety issues
Ethacrynic acid appears more likely to cause ototoxicity than either
frusemide or bumetanide.
Dosing issues
Ethacrynic acid 50 mg has a diuretic effect equivalent to frusemide 40 mg.
PBS Listing
Restricted benefit
For patients hypersensitive to other oral diuretics.
Reason for PBS listing
The PBAC recommended listing of the new strength, ethacrynic acid 25 mg tablets, to replace the
discontinued 50 mg strength1 called Edecril (note the slight change in brand name for the 25 mg tablets).
Place in therapy
From May 2003, bumetanide (Burinex) was removed from the Schedule of Pharmaceutical Benefits; while
the product continues to be available privately in Australia, companies often review the commercial
viability of ongoing supply in such cases and future availability cannot be guaranteed. Consequently, the
only PBS-subsidised, alternative loop diuretic to frusemide is ethacrynic acid.
Use in patients for whom frusemide or bumetanide are not appropriate
Ethacrynic acid may be prescribed in patients requiring a loop diuretic who are either allergic or
refractory to frusemide or bumetanide therapy, but has a greater risk of some adverse effects2 (see Safety
issues).
Loop diuretics are no more potent as antihypertensives than thiazides; their role in hypertension is limited
to management of excess salt and water retention inadequately controlled by a thiazide diuretic.2
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Safety issues
Ethacrynic acid appears more likely to cause ototoxicity than either frusemide or bumetanide.
Adverse Drug Reactions
Ototoxicity with ethacrynic acid is more likely with use in renal impairment, at higher doses, or when used
concurrently with other ototoxic drugs. Vertigo, tinnitus with a sense of fullness in the ears, and
temporary deafness have occurred following ethacrynic acid use;3 there have been reports where some
degree of hearing impairment has been permanent.4
Gastrointestinal disturbances may be more common and severe with ethacrynic acid.5 Severe, profuse
watery diarrhoea may occur in a few patients; the drug should be permanently discontinued if this
occurs.3,5
Dosing issues
Ethacrynic acid 50 mg has a diuretic effect equivalent to frusemide 40 mg.2
High doses of ethacrynic acid are more likely to be associated with adverse effects. The dose should be
reduced in renal impairment.
Information for patients
Advise patients to request the Edecrin Consumer Medicine Information (CMI) leaflet.
References
1. Department of Health & Ageing. June 2003 PBAC outcomes √ positive recommendations.
http://www.health.gov.au/pbs/general/listing/pbacrec/jun03/positive.htm#ethac Accessed 6/8/03.
2. Australian Medicines Handbook 2003.
3. American Society of Health-System Pharmacists. AHFS Drug Information 2003. Bethesda: ASHP; 2003.
4. Pillay VKG, et al. Lancet 1969a;1:77√9.
5. Sweetman SC (ed). Martindale: The complete drug reference. London: Pharmaceutical Press; 2003.
Date prepared: July 2004
The information contained in this material is derived from a critical analysis of a wide range of authoritative evidence. Any
treatment decisions based on this information should be made in the context of the individual clinical circumstances of each patient.
NPS is an independent, Australian organisation for Quality Use of Medicines
National Prescribing Service Limited ACN 082 034 393 Level 7, 418A Elizabeth Street, Surry Hills, NSW 2010
Phone: 02 8217 8700 Fax: 02 9211 7578 email: [email protected] web: http://www.nps.org.au
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