– Agitation or aggressive behaviour in patients with acute or chronic psychosis
Forms and strengths, route of administration
– 5 mg in 1 ml ampoule (5 mg/ml) for IM injection
– Adult: one injection of 2.5 mg. Subsequent doses, if needed, should be given at 1 to 8 hour intervals (max. 15 mg in 24 hours).
– Reduce the dose by half in elderly patients (max. 5 mg in 24 hours).
– Change to oral treatment as soon as possible.
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 elderly 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 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.).
– 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 and monitor the neonate for reversible extrapyramidal effects (tremors) if the mother was treated in the 3rd trimester.
– Breast-feeding: if absolutely necessary, do not exceed 10 mg in 24 hours.
– Haloperidol decanoate is a long-acting form used as maintenance therapy of chronic psychotic disorders after stablisation with oral treatment.
– Storage: below 25 °C -