- 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
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.
- 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, 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 the event of extrapyramidal symptoms, combine with 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.
- 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.