SPIRONOLACTONE

Posology Adults:

Congestive cardiac failure with oedema For management of oedema an initial dose of 100 mg/day administered in either single or divided doses is recommended but may range from 25 mg to 200 mg daily. The 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.

Nephrotic syndrome Usual dose 100 mg/day to 200 mg/day. Spironolactone has not been shown to be anti- inflammatory, nor to affect the basic pathological process. Its use is only advised when glucocorticoids alone are insufficiently effective.

0 a daily dosage of 200 - 400 mg. The maintenance dosage should be individually determined. Malignant ascites Initial dose usually 100 mg/day to 200 mg/day. In severe cases, the dosage may be gradually increased up to 400 mg/day. When oedema is controlled, the maintenance dosage should be individually determined.

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 400 mg for 3 - 4 weeks. Correction of hypokalaemia and hypertension provides presumptive diagnosis of primary hyperaldosteronism.

Short Test:

Spironolactone is administered at a daily dosage of 400 mg 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 the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered in preparation for surgery at a dosage of 100 - 400 mg daily. For patients who are considered unsuitable for surgery spironolactone may be used for long-term maintenance therapy at the lowest possible effective dosage determined for the individual patient.

Elderly It is recommended that treatment is started with the lowest dose and titrated upwards as required to achieve maximum benefit. Care should be taken with severe hepatic and renal impairment, which may alter drug metabolism and excretion.

Paediatric population Initial daily dosage should provide 1-3 mg of spironolactone per kilogram body weight given in divided doses. 4). Children should only be treated under guidance of a paediatric specialist. 2). Method of administration For oral administration.

Administration of spironolactone once daily with a meal is recommended.

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: System Organ Class Very Common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncom mon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,00 0 Very Rare < 1/10,000 Frequency Not Known (cannot be estimated from the available data) Neoplasm s benign, malignant and unspecifie d (including cysts and polyps) Benign breast neoplas m (male) Blood and lymphatic system disorders Agranulocyto sis, Leukopenia, Thrombocyto penia Metabolis m and nutrition disorders Hyperkalae mia Electrol yte imbalan ce Psychiatri c disorders Confusiona l state Libido disorder System Organ Class Very Common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncom mon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,00 0 Very Rare < 1/10,000 Frequency Not Known (cannot be estimated from the available data) Nervous system disorders Dizziness, Headache, Drowsiness , Lethargy, Ataxia Gastrointe stinal disorders Nausea Vomiting, Abdominal pain, Diarrhoea Gastrointestin al disorder Hepatobili ary disorders Hepatotoxi city Hepatic function abnorma l Skin and subcutane ous tissue disorders Pruritus, Rash Urticaria Toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS), Alopecia, Hypertrichosi s, Pemphigoid Musculosk eletal and connective tissue disorders Muscle spasms Renal and urinary disorders Acute kidney injury System Organ Class Very Common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncom mon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,00 0 Very Rare < 1/10,000 Frequency Not Known (cannot be estimated from the available data) Reproduct ive system and breast disorders Gynaecom astia, Breast pain (male)a Menstru al disorder, Breast pain (female) b General disorders and administra tion site conditions Malaise Abbreviations: CDS = Core Data Sheet; F = female; LLT = lower level term; M = male; PT = preferred term; WHO-ART = World Health Organisation 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, 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 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 Spironolactone therapy may cause reversible increases in blood urea, especially in patients with pre-existing renal impairment. 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). Paediatric population Potassium-sparing diuretics should be used with caution in hypertensive paediatric patients with mild renal insufficiency because of the risk of hyperkalaemia. 3). Excipients Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1 • concomitant use of eplerenone or other potassium sparing diuretics Spironolactone is contraindicated in paediatric patients with moderate to severe renal impairment. Spironolactone should not be administered concurrently with other potassium conserving diuretics and potassium supplements should not be given routinely with spironolactone as hyperkalaemia may be induced.