SPIRONOLACTONE oral

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    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