Marketed in 39 countries across Europe, the Americas, the Middle East, and the Asia-Pacific region, Aldactone is a globally distributed brand of spironolactone, classified as a potassium-sparing diuretic with hypotensive properties. For an international audience, the brand is one of the more recognisable names in this particular corner of the diuretic class, and travellers who have been prescribed it at home will often find either Aldactone itself or a spironolactone generic available in the country they are visiting.
Spironolactone is prescribed in the management of several distinct clinical situations: cirrhosis and ascites, primary and secondary hyperaldosteronism, nephrotic syndrome, and the prevention or correction of hypokalaemia in patients on other diuretics. The structured indication block further down this page sets out each registered use in detail, alongside the full country list and the pharmacological classification.
Because Aldactone has such a broad regulatory footprint — with marketing authorisation in markets as varied as Brazil, Germany, India, Canada, and Egypt — the brand name on the box may be Aldactone in one country and a different spironolactone-containing product in the next. Packaging, prescription pathways, and which strengths are stocked routinely all vary by jurisdiction, and a local pharmacist is usually the fastest route to confirming whether a familiar molecule is sitting on the shelf under an unfamiliar label.
Other medications within the broader diuretic family, including other potassium-sparing agents, are also available internationally under their own active ingredients and brand names, though they are not interchangeable without clinical input. Anyone who takes Aldactone, has been newly prescribed it abroad, or is trying to identify a local equivalent should treat the question as a clinical one and discuss it with a healthcare provider.
Shelf life
5 years.
Incompatibilities
Not applicable.
Date of revision of the text
04/2018
Marketing authorisation holder
Pfizer Limited
Ramsgate Road
Sandwich
Kent, CT13 9NJ
United Kingdom
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Amber glass or plastic bottles containing 100 or 500 tablets.
HDPE containers of 50 or 1,000 tablets.
PVC/foil blister packs containing 100 or 500 tablets and PVC/foil blister calendar pack of 28 tablets.
Not all pack sizes may be marketed.
Marketing authorisation number(s)
PL 00057/0927
Special precautions for disposal and other handling
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Date of first authorisation/renewal of the authorisation
Date of change of ownership: 16 September 2014
Date of latest renewal: 7 February 2002
