QAIALDO

Posology Adults Congestive heart failure with oedema Usual dose - 100 mg/day. In difficult or severe cases the dose may be gradually increased up to 200 mg/day. When oedema is controlled, the usual maintenance level is 75 mg/day to 200 mg/day.

0 mEq/L and serum creatinine ≤ 221 μmol/L. 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 per day. 0, 200 mg/day to 400 mg/day. Maintenance dose should be individually determined. Malignant ascites Initial dose usually 100 mg/day to 200 mg/day. In severe cases the dose may be gradually increased up to 400 mg/day.

When oedema is controlled, maintenance dose should be individually determined. 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 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 dose of 400 mg for 3 to 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 dose 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 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 dose determined for the individual patient. Essential hypertension Usual dose – 50 mg/day to 100 mg/day, which for difficult or severe cases may be gradually increased at 2 weekly intervals up to 200 mg/day.

5% of patients, particularly in patients with renal impairment or if receiving ACE-inhibitors or angiotensin II antagonists concomitantly; gynaecomastia and breast pain, reported in 9% of males. The following undesirable effects have been observed in clinical trials and reported during treatment with spironolactone with the following frequencies: 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); not known (cannot be estimated from the available data).

Table 2 presented below is according to the MedDRA system organ classification and frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 2 Tabulated list of adverse reactions System organ class Frequency Adverse reactions Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon Benign breast neoplasm (male) Blood and lymphatic system Not known Leukopenia, Agranulocytosis, Thrombocytopenia, Anaemia, Eosinophilia disorders Purpura Very common Hyperkalaemia***Metabolism and nutrition disorders Uncommon Electrolyte imbalance Common Confusional statePsychiatric disorders Not known Libido disorder Common DizzinessNervous system disorders Not known Ataxia, Headache, Drowsiness, Lethargy Common NauseaGastrointestinal disorders Not known Gastrointestinal disorder Hepatobiliary disorders Uncommon Hepatic function abnormal Common Pruritus, Rash Uncommon Urticaria Skin and subcutaneous tissue disorders Not known Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, Drug reaction with eosinophilia and systemic symptoms (DRESS), Pemphigoid, Alopecia, Hypertrichosis Musculoskeletal and connective tissue disorders Common Muscle spasms Renal and urinary disorders Common Acute kidney injury Common Gynaecomastia*, Breast pain** Uncommon Menstrual disorder Reproductive system and breast disorders Not known Impotence Common MalaiseGeneral disorders and administration site conditions Not known Drug fever * Gynaecomastia may develop in association with the use of spironolactone.

Monitoring fluid and electrolyte state Patients who are being treated with this preparation require regular supervision with monitoring of fluid and electrolyte state. Periodic estimation of serum electrolytes is recommended due to the possibility of hyperkalaemia, hyponatremia and possible transient blood urea nitrogen (BUN) elevation, especially in the elderly and/or in patients with pre-existing impaired renal or hepatic function.

The preparation should only be used with particular caution in elderly patients or those with potential obstruction of the urinary tract, or with disorders rendering their electrolyte balance precarious. 5). Hyperkalaemia may also occur in patients with impaired renal function.

Cardiac dysrhythmias, occasionally fatal, may result. Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia, has been reported to occur in some patients with decompensated hepatic cirrhosis, even when renal function is normal.

5). 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). 5). Urea Reversible increases in blood urea may occur during use of spironolactone especially in the presence of impaired renal function.

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). 5 mg/150 ml. Increase in bilirubinaemia following its displacement from albumin may increase neonatal jaundice which may develop into kernicterus (non-conjugated bilirubin deposits in the brain tissue).

1. 5 mEq/L) - Concomitant use of eplerenone. Spironolactone is contraindicated in paediatric patients with moderate (GFR 30 - < 60 ml/min) to severe renal impairment (GFR < 30 ml/min). 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.