HALOPERIDOL oral

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    Prescription under medical supervision

     

    Therapeutic action

    • Antipsychotic

    Indications

    • Acute or chronic psychosis
    • Acute moderate to severe manic episode

    Forms and strengths

    • 0.5 mg and 5 mg tablets
    • 2 mg/ml oral solution with pipette graduated in mg

    Dosage

    Acute or chronic psychosis

    • Adult: 0.5 to 1 mg 2 times daily. Gradually increased up to 10 mg daily if necessary (max. 20 mg daily). Once the patient is stable, the maintenance dose is administered once daily at bedtime.

     

    Acute manic episode

    • Adult: 2.5 mg 2 times daily. Gradually increase up to 10 mg daily if necessary (max. 15 mg daily).

     

    Reduce the dose by half in elderly patients (max. 5 mg daily).

    Use the lowest effective dose, especially in the event of prolonged treatment.

    Duration

    • Acute psychosis: minimum 3 months
    • Chronic psychosis: minimum one year
    • Manic episode: 3 to 6 weeks

     

    The treatment should be discontinued gradually (over 4 weeks). If signs of relapse occur, increase the dose.

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with cardiac disorders (heart 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, hyperthyroidism, renal or hepatic impairment, history of seizures.
    • May cause: drowsiness, extrapyramidal symptoms, early or tardive dyskinesia, anticholinergic effects (constipation, dry mouth), hyperprolactinaemia, sexual dysfunction, QT-prolongation, ventricular arrhythmia, orthostatic hypotension; neuroleptic malignant syndrome (unexplained hyperthermia with neuromuscular disorders), rare but requiring immediate treatment discontinuation. 
    • In the event of extrapyramidal symptoms, combine with biperiden or trihexyphenidyl.
    • 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.). 
    • Avoid alcohol during treatment.
    • Pregnancy: re-evaluate whether the treatment is still necessary; if it is continued, monitor the neonate the first few days (risk of hypertonia, tremors, sedation).
    • Breast-feeding: if absolutely necessary, do not exceed 10 mg daily.

    Storage

     
     
    - Below 25 °C