SPIRONOLACTONE oral

Prescription under medical supervision


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.
– Storage: below 25 °C -