HALOPERIDOL injectable

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    Prescription under medical supervision

     

    Therapeutic action

    • Antipsychotic

    Indications

    • Agitation or aggressive behaviour in patients with acute or chronic psychosis

    Forms and strengths, route of administration

    • 5 mg in 1 ml ampoule (5 mg/ml) for IM injection

    Dosage

    • Adult: one injection of 2.5 mg. Subsequent doses, if needed, should be given at 1 to 8 hour intervals (max. 15 mg in 24 hours).
    • Reduce the dose by half in elderly patients (max. 5 mg in 24 hours).

    Duration

    Change to oral treatment as soon as possible.

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with cardiac disorders (cardiac failure, recent myocardial infarction, conduction disorders, bradycardia, etc.), dementia (e.g. Alzheimer's disease), Parkinson's disease and history of neuroleptic malignant syndrome.
    • Administer with caution and carefully monitor use in elderly patients and patients with hypokalaemia, hypotension, hyperthyroidism, renal or hepatic impairment, history of seizures. 
    • May cause: drowsiness, extrapyramidal syndrome, dyskinesia, anticholinergic effects (constipation, dry mouth), sexual dysfunction, QT-prolongation, ventricular arrhythmia, orthostatic hypotension; neuroleptic malignant syndrome (unexplained hyperthermia with neuromuscular disorders), rare but requiring immediate treatment discontinuation. 
    • Avoid combination with:
      • central nervous system depressants (opioid analgesics, sedatives, H1 antihistamines, etc.);
      • fluoxetine, paroxetine, sertraline, promethazine, ritonavir (increased plasma concentrations of haloperidol);
      • carbamazepine, rifampicin, phenobarbital, phenytoin (decreased plasma concentrations of haloperidol);
      • antihypertensive drugs (risk of hypotension); drugs that prolong the QT interval (amiodarone, chloroquine, erythromycin, fluconazole, mefloquine, pentamidine, quinine, etc.).
    • Keep the patient in the supine position for 30 minutes after injection (risk of orthostatic hypotension):
    • Pregnancy: re-evaluate whether the treatment is still necessary; if it is continued, administer at the lowest effective dose and monitor the neonate for reversible extrapyramidal effects (tremors) if the mother was treated in the 3rd trimester.
    • Breast-feeding: if absolutely necessary, do not exceed 10 mg in 24 hours.

    Remarks

    • Haloperidol decanoate is a long-acting form used as maintenance therapy of chronic psychotic disorders after stablisation with oral treatment.

    Storage

     
    –  Below 25 °C