• Oedema associated with congestive heart failure
• Severe heart failure, (NYHA III-IV)
• As an adjuvant in treatment of resistant hypertension
• Nephrotic syndrome
• Liver cirrhosis with ascites and oedema
• Diagnosis and treatment of primary hyperaldosteronism (Conn’s syndrome)
The dosage should be determined individually depending on the condition and the degree of diuresis required. Dosage up to100 mg daily may be administered as a single dose or in divided doses.
Oedema associated with congestive heart failure
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 to 200 mg daily. Maintenance dose should be individually determined.
Severe heart failure (NYHA Class III-IV)
Treatment in conjunction with standard therapy should be initiated at a dose of spironolactone 25 mg once daily if serum potassium is ≤ 5.0 mEq/L and serum creatinine is ≤ 2.5 mg/dL (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. See Section 4.4 for advice on monitoring serum potassium and serum creatinine.
The starting dose for spironolactone should be 25mg daily in a single dose; the lowest effective dose should be found, very gradually titrating upwards to a dose of 100mg daily or more.
Usual dose is 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.
Hepatic cirrhosis with ascites and oedema
The starting dose is 100-200 mg per day, e.g. based on Na+/K+ ratio. If the response to 200 mg spironolactone within the first two weeks is not sufficient, furosemide is added and if necessary, the spironolactone dose is increased stepwise up to 400 mg per day. Maintenance dosage should be individually determined.
Diagnosis and treatment of primary aldosteronism
If primary hyperaldosteronism is suspected, spironolactone is given at a dose of 100 – 150 mg, or up to 400 mg daily. In the event of rapid onset of a strong diuretic and antihypertensive effect, this is a clear indication of elevated aldosterone production. In this case, 100 – 150 mg daily is administered for 3 – 5 weeks prior to surgery. If surgery is not an option, this dose is often sufficient to maintain blood pressure and potassium concentration at normal levels. In exceptional cases, higher doses are necessary, but the lowest possible dosage should be found.
Hyperkalaemia in patients with severe renal dysfunction who are receiving concomitant treatment with potassium supplements.
Hyponatraemia (in particular during combined intensive therapy with thiazide diuretics), hyperkalaemia in (1) patients with severe renal dysfunction, (2) patients receiving treatment with ACE inhibitors or potassium chloride, (3) the elderly, and (4) diabetic patients
Acidity of the blood (acidosis) in patients with liver problems
Insufficient fluid in the tissues (dehydration), porphyria, temporary increase in nitrogen levels in the blood and urine, hyperuricemia (may lead to gout in predisposed patients)
Reversible hyperchloraemic metabolic acidosis – usually accompanied by hyperkalaemia has been reported in some patients with decompensated hepatic cirrhosis, even where renal function was normal.
Nervous system disorders
Very common: headache
Common: weakness, lethargy in patients with cirrhosis, tingling (paraesthesia)
Rare: paralysis, paraplegia of the limbs due to hyperkalaemia
Not known: dizziness, ataxia
Inflammation of the vessel walls (vasculitis)
Nausea and vomiting
Gastric inflammation, gastric ulcers, intestinal haemorrhage, cramps
Skin and subcutaneous tissue disorders
Skin rash, urticaria, erythema, chloasma, pruritus, exanthema