HALOPERIDOL oral

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 3^rd trimester.
• Breast-feeding: if absolutely necessary, do not exceed 10 mg daily.

Storage