- Acute confusional state (delirium) and acute alcohol intoxication
- Agitation or aggressive behaviour in patients with acute or chronic psychosis, in combination with promethazine
Forms and strengths, route of administration
- 5 mg in 1 ml ampoule (5 mg/ml) for IM injection
Dosage and duration
Acute confusional state (delirium) and acute alcohol intoxication
- Adult: 0.5 to 1 mg, to be repeated after 30 to 60 minutes if necessary. If needed, administer additional doses every 4 hours (max. 5 mg) for 7 days max.
Agitation or aggressive behaviour in patients with acute or chronic psychosis, with promethazine
- Adult: 5 mg, to be repeated after 30 minutes if necessary
Change to oral treatment as soon as possible.
Reduce the dose by half in older patients (max. 5 mg daily).
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 older 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 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.).
- 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. 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.
- Haloperidol decanoate is a long-acting form used as maintenance therapy of chronic psychotic disorders after stablisation with oral treatment.