SPIRONOLACTONE

Posology Spironolactone Tablets should always be administered with fluid and preferably with food to aid absorption. 0, 100mg/day. 0, 200mg/day to 400mg/day. Maintenance dosage should be individually determined. Malignant ascites Initial dose is usually 100mg/day to200mg/day.

In severe cases the dosage may be gradually increased up to 400mg/day. When oedema is controlled, maintenance dosage should be individually determined. Nephrotic syndrome Usually dose 100mg/day to 200mg/day. Spironolactone has not been shown to be anti- inflammatory, nor to affect the basic pathological process.

Its use is only advised if glucocorticoids by themselves are insufficiently effective. Congestive heart failure with oedema For management of oedema an initial daily dose of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 mg to 200 mg daily.

Maintenance dose should be individually determined. 5 mg/dL. Patients who tolerate 25 mg once daily may have their dose increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once daily may have their dose reduced to 25 mg every other day.

4 for advice on monitoring serum potassium and serum creatinine. Diagnosis and treatment of primary aldosteronism Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.

Long Test – Spironolactone is administered at a daily dosage of 400mg for 3 to 4 weeks. Correction of hypokalaemia and hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism. Short test - Spironolactone is administered at a daily dosage of 400mg for 4 days.

If serum potassium increases during spironolactone administration but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered. After diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered in doses of 100mg/day to 400mg/day in preparation for surgery.

For patients who are considered unsuitable for surgery, spironolactone may be employed for long-term maintenance therapy at lowest effective dosage determined for the individual patient. Elderly It is recommended that treatment should be started with the lowest dose and titrated upwards as required to achieve maximum benefit.

Gynaecomastia may develop in association with the use of spironolactone. Development appears to be related to both dosage level and duration of therapy and is normally reversible when the drug is discontinued. In rare instances some breast enlargement may persist.

4) Gastrointestinal disorders Nausea Gastrointe disorders, Gastritis, bleeding, gastrointe disturbanc stomach c Hepatobiliary disorders Hepatic function abnormal Hepatotox Skin and subcutaneous tissue disorder Pruritus, Rash Urticaria Toxic e necrolysis Stevens-J syndrome reaction eosinophi systemic symptoms (DRESS) Alopecia, Hypertric Pemphigo Musculo- skeletal and Connective tissue Muscle spasms Leg cram Osteomal disorders Renal and urinary disorders Acute Kidney injury Reproductive system and breast disorders Gynaecomastia, Breast pain (male)a Menstrual disorder, Breast pain (female)b Breast enlargement, Alteration in voice pitch, which may not be reversible, impotence and decreased sexual ability General disorders and administration site conditions Malaise Abbreviations: CDS = Core Data Sheet; F = female; LLT = lower level term; M = male; PT = preferred term; WHO-ART = World Health Organization Adverse Drug Reaction Terminology.

a The term Breast pain is mapped from CDS and the frequency is derived from WHO- ART term Breast pain (M); however, Breast pain male is the LLT. b Breast pain is the PT from CDS, and the frequency is derived from WHO-ART term Breast pain (F).

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Fluid and electrolyte balance Fluid and electrolyte status be regularly monitored particularly in the elderly and in those with significant renal and hepatic impairment. Hyperkalaemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities which may be fatal.

3). Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of normal renal function. Concomitant use of spironolactone with other potassium-sparing diuretics, angiotensin- converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin or other drugs or conditions known to cause hyperkalaemia, potassium supplements, a diet rich in potassium or salt substitutes containing potassium, may lead to severe hyperkalaemia.

Urea Reversible increases in blood urea have been reported in association with Spironolactone therapy, particularly in the presence of impaired renal function. Hyperkalaemia in Patients with Severe Heart Failure Hyperkalaemia may be fatal.

It is critical to monitor and manage serum potassium in patients with severe heart failure receiving spironolactone. Avoid using other potassium- sparing diuretics. 5 mEq/L. The recommended monitoring for potassium and creatinine is 1 week after initiation or increase in dose of spironolactone, monthly for the first 3 months, then quarterly for a year, and then every 6 months.

Discontinue or interrupt treatment for serum potassium >5 mEq/L or for serum creatinine >4 mg/dL. 2). Caution is required in severely ill patients and those with relatively small urine volumes who are at greater risk of developing hyperkalaemia.

Caution is required in patients with a predisposition to metabolic or respiratory acidosis. Acidosis potentiates the hyperkalaemic effects of spironolactone and spironolactone may potentiate acidosis. Spironolactone has been shown to produce tumours in rats when administered at high doses over a long period of time.

1. • Acute renal insufficiency, significant renal compromise, anuria. • Hyperkalaemia • Addison’s disease. • Concomitant use of eplerenone or other potassium sparing diuretics. Spironolactone is contraindicated in paediatric patients with moderate to severe renal impairment.

Spironolactone tablets should not be administered concurrently with other potassium conserving diuretics and potassium supplements should not be given routinely with Spironolactone tablets as hyperkalaemia may be induced.