SPIRONOLACTONE oral

Therapeutic action

• Potassium-sparing diuretic, antagonist of aldosterone

Indications

• Oedema associated with heart failure, hepatic cirrhosis and nephrotic syndrome

Forms and strengths

• 25 mg tablet

Dosage

Adjunctive therapy in heart failure

• Adult: 25 mg once daily

Ascites in hepatic cirrhosis

• Adult: 100 to 400 mg daily.

When weight is stable, administer the lowest possible maintenance dose, in order to prevent adverse effects.

Oedema in nephrotic syndrome

• Adult: 100 to 200 mg daily

The daily dose can be administered in 2 to 3 divided doses or once daily.

Duration

• According to clinical response; avoid prolonged use.

Contra-indications, adverse effects, precautions

• Do not administer to patients with severe renal impairment, anuria, hyperkalaemia > 5 mmol/litre, hyponatraemia.
• Do not combine with potassium salts, potassium-sparing diuretics; lithium (risk of lithium toxicity).
• Avoid or closely monitor combination with angiotensin-converting enzyme inhibitors (risk of severe, potentially fatal hyperkalaemia), digoxin (risk of digoxin toxicity) and reduce dosages.
• May cause:
  • hyperkalaemia (especially in elderly or diabetics patients, patients with renal impairment or patients taking NSAIDs), hyponatraemia; metabolic acidosis (in patients with decompensated cirrhosis);
  • gynecomastia, metrorrhagia, impotence, amenorrhoea, gastrointestinal disturbances, headache, skin rash, drowsiness.
• Administer with caution in patients with hepatic or renal impairment or diabetes.
• Monitor regularly plasma-potassium levels.
• Pregnancy: avoid, use only if clearly needed (risk of feminisation of foetus); spironolactone is not indicated in the treatment of pregnancy-related oedema.
• Breast-feeding: no contra-indication

Remarks

• In children with oedema, the daily dose is 1 to 3 mg/kg once daily or 0.5 to 1.5 mg/kg 2 times daily.
• Spironolactone is also used for the diagnosis and treatment of primary hyperaldosteronism.

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