SPIRONOLACTONE WAYMADE

Posology Adults Congestive cardiac 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, 100 mg/day. 0, 200 mg/day to 400 mg/day. 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, maintenance dosage should be individually determined. Nephrotic syndrome Usual dose 100 mg/day to 200 mg/day. Spironolactone has not been shown to be antiinflammatory, 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 400 mg 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 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 at doses of 100 mg to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.

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 Agranulocyto sis, Leukopenia, Thrombocyto penia Metabolism and nutrition disorders Hyperkala emia Electrolyte imbalance Psychiatric disorders Confusion al state Libido disorder Nervous system disorders Dizziness Gastrointestinal disorders Nausea Gastrointestinal disorder Hepatobiliary disorders Hepatic function abnormal 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) Skin and subcutaneous tissue disorders Pruritus, Rash Urticaria Toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS), Alopecia, Hypertrichosi s, Pemphigoid Musculoskel etal and connective tissue disorders Muscle spasms Renal and urinary disorders Acute kidney injury Reproductive system and breast disorders Gynaeco mastia, Breast pain (male)a Menstrual disorder, Breast pain (female)b General disorders and administrati on 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.

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).

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 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.

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).

1. 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.