SPIRONOLACTONE

Administration of Spironolactone Tablets once daily with a meal is recommended. 0, 100mg per day. 0, 200 - 400mg/day. Maintenance dosage should be individually determined. Malignant ascites Initial dose usually 100 - 200mg/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 Usual dose 100 - 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. Diagnosis and treatment of primary aldosteronism Spironolactone tablets may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.

Long tests:

Spironolactone tablets are administered at a daily dosage of 400mg for three to four weeks. Correction of hypokalaemia and of hypertension provides presumption evidence for the diagnosis of primary hyperaldosteronism.

Short test:

Spironolactone tablets are administered at a daily dosage of 400mg for four days. If serum potassium increases during Spironolactone tablet administration but drops when Spironolactone tablets are discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.

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

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

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 1-3mg of spironolactone per kilogram bodyweight, given in divided doses. 4). If necessary a suspension may be prepared by crushing Spironolactone tablets. A suitable suspending vehicle is Methylcellulose 20% v/v, purified water to 100%.

Such suspension is stable for one month when refrigerated. Children should only be treated under the guidance of a paediatric specialist. 2).

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 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Very Rare < 1/10,000 Frequency Not known (cannot be estimated from the available data) Neoplasms benign, malignant and unspecified (including cysts and polyps) Benign breast neoplasm (male) Blood and lymphatic system disorders Agranulocytosis, Leukopenia, Thrombocytopenia Metabolism and nutrition disorders Hyperkalaemia Electrolyte imbalance Psychiatric disorders Confusional state Libido disorder Nervous system disorders Dizziness Gastrointestinal disorders Nausea Gastrointestinal disorder Hepatobiliary disorders Hepatic function abnormal Skin and subcutaneous tissue disorders Pruritus, Rash Urticaria Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS), Alopecia, Hypertrichosis, Pemphigoid Musculoskeletal 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 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Very Rare < 1/10,000 Frequency Not known (cannot be estimated from the available data) Reproductive system and breast disorders Gynaecomastia, Breast pain (male)a Menstrual disorder, Breast pain (female)b 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 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 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 diurectics, angiotensin-converting enzyme (ACE) inhibitors, non-steroidal anti-inflammatory drugs, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin or other drugs 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 one 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).

Spironolactone is contraindicated in adults and paediatric patients with the following: • Acute renal insufficiency, significant renal compromise, anuria. 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.