SPIRONOLACTONE

Posology Spironolactone tablets should always be administered with fluid and preferably with food to aid absorption.

Adults 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.

0; 100mg daily. 0; 200-400mg daily. Maintenance doses should be individually determined.

Malignant ascites:

Initial dosage is usually 100-200mg daily. In severe cases the dosage may be gradually increased up to 400mg daily. When oedema is controlled, dosage should be individually determined.

Nephrotic syndrome:

Usually 100-200mg daily. 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.

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 3-4 weeks. Correction of hypokalaemia and of 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.

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.

The following adverse events have been reported in association with spironolactone therapy: 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.

aThe 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. bBreast 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 should 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.

Should hyperkalaemia develop, spironolactone should be discontinued, and if necessary, active measures taken to reduce the serum potassium to normal. 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 tablets 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.

Care should be taken in patients suffering from hyponatraemia. 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.

2). Spironolactone has been shown to produce tumours in rats when administered at high doses over a long period of time. The significance of these findings with respect to clinical use is not certain. However, the long-term use of spironolactone in young patients requires careful consideration of the benefits and the potential hazard involved.

1 • 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.