DIGOXIN injectable

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    Prescription under medical supervision

     

     
    Due to narrow margin between therapeutic and toxic dose, patients should be kept under close surveillance.

     

    Therapeutic action

    • Cardiotonic

    Indications

    • Supraventricular arrhythmias (fibrillation, flutter, paroxysmal tachycardia)
    • Heart failure

    Forms and strengths, route of administration

    • 500 micrograms ampoule (250 micrograms/ml, 2 ml) for slow IV injection or infusion in 5% glucose or 0.9% sodium chloride

    Dosage

    • Adult:
      • Loading dose: 500 to 1000 micrograms
        The loading dose can be administered either by intravenous infusion as a single dose given over 2 hours minimum or in divided doses, by slow IV injections over 5 minutes minimum.
      • Maintenance dose: change to oral treatment
    • Reduce the dose by one half in older patients and in patients with renal impairment.

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with bradycardia, ill defined arrhythmia, coronary artery disease.
    • It is essential to monitor heart rate in the initial stage of treatment.
    • Narrow margin between therapeutic and toxic dose.
    • May cause in the event of overdose: gastrointestinal disturbances (nausea, vomiting, diarrhoea), blurred vision, headache, confusion, conduction and rhythm disorders. If so, reduce dose or stop treatment.
    • Do not combine with calcium, particularly by IV injection (serious arrhythmias).
    • Monitor combination with:
      • amiodarone, macrolides, itraconazole, quinine, chloroquine (increased digoxin concentration);
      • potassium-depleting drugs: diuretics, corticoids, amphotericin B (increased risk of digoxin toxicity).
    • Monitor if possible serum potassium level in patients taking potassium-depleting drugs and serum creatinine level in patients with renal impairment.
    • Pregnancy: no contra-indication
    • Breast-feeding: no contra-indication

    Remarks

    • A loading dose may be administered in arrhythmias if a rapid digitalisation is required. It is usually not required for heart failure.

    Storage

     
    – Below 25 °C