HALOPERIDOL oral

Select language:
Permalink
On this page

    Last updated: February 2024

     

    Prescription under medical supervision

     

     
    Due to the numerous and potentially severe adverse effects of haloperidol, patients should be kept under close surveillance.

     

    Therapeutic action

    • Antipsychotic

    Indications

    • Acute confusional state (delirium) and acute alcohol intoxication 
    • Acute or chronic psychosis
    • Acute manic episode
    • Agitation or aggressive behaviour in patients with acute or chronic psychosis, in combination with promethazine

    Forms and strengths

    • 0.5 mg, 1.5 mg and 5 mg tablets
    • 2 mg/ml oral solution with pipette graduated in mg

    Dosage

    Acute confusional state (delirium) and acute alcohol intoxication

    • Adult: 0.5 to 1 mg 2 times daily 

     

    Acute or chronic psychosis

    • Adult: 0.5 to 1 mg 2 times daily. Gradually increase up to 10 mg daily if necessary (max. 15 mg daily).

     

    Acute manic episode

    • Adult: 5 mg once daily. Gradually increase up to 10 mg daily if necessary (max. 15 mg daily).

     

    Agitation or aggressive behaviour in patients with acute or chronic psychosis, with promethazine

    • Adult: 5 mg, to be repeated after 60 minutes if necessary

     

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

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

    Duration

    • Delirium and acute alcohol intoxication: as short as possible (max. 7 days)
    • Acute psychosis: at least 3 months
    • Chronic psychosis: at least one year
    • Manic episode: 8 weeks after remission of symptoms

     

    Discontinue treatment gradually (over 4 weeks). If signs of relapse occur, increase the dose then decrease it more gradually.

    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 older patients and patients with hypokalaemia, hypotension, hyperthyroidism, renal or hepatic impairment, history of seizures.
    • May cause: drowsiness (caution when driving/operating machinery), extrapyramidal symptoms, early or tardive dyskinesia, anticholinergic effects (constipation, dry mouth), hyperprolactinaemia, weight gain, sexual dysfunction, QT-prolongation, ventricular arrhythmia, orthostatic hypotension; neuroleptic malignant syndrome (unexplained hyperthermia with neuromuscular disorders), rare but requiring immediate treatment discontinuation. 
    • In case of extrapyramidal symptoms, try reducing the dose of haloperidol or, if the extrapyramidal symptoms are severe, add biperiden or trihexyphenidyl.
    • Avoid or monitor combination with:
      • central nervous system depressants (opioid analgesics, sedatives, H1 antihistamines, etc.); 
      • fluoxetine, paroxetine, sertraline, 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 (increased risk of adverse effects).
    • Pregnancy: re-evaluate whether the treatment is still necessary; if it is continued, use the lowest effective dose. Observe the neonate the first few days (risk of agitation, tremors, hypertonia/hypotonia, respiratory difficulties, sleeping disorders, etc.) if the mother was under treatment in the 3rd trimester.
    • Breast-feeding: if absolutely necessary, do not exceed 10 mg daily.

    Storage

     
    –  
     
    –  Below 25 °C