HALOPERIDOL oral

Prescription under medical supervision

Therapeutic action

– Antipsychotic

Indications

– Acute or chronic psychosis
– Acute moderate to severe manic episode

Forms and strengths

– 0.5 mg and 5 mg tablets
– 2 mg/ml oral solution with pipette graduated in mg

Dosage

– Acute or chronic psychosis
Adult: 0.5 to 1 mg 2 times daily. Gradually increased up to 10 mg daily if necessary (max. 20 mg daily). Once the patient is stable, the maintenance dose is administered once daily at bedtime.

– Acute manic episode
Adult: 2.5 mg 2 times daily. Gradually increase up to 10 mg daily if necessary (max. 15 mg daily).

– Reduce the dose by half in elderly patients (max. 5 mg daily).
– Use the lowest effective dose, especially in the event of prolonged treatment.

Duration

 Acute psychosis: minimum 3 months; chronic psychosis: minimum one year; manic episode: 3 to 6 weeks. The treatment should be discontinued gradually (over 4 weeks). If signs of relapse occur, increase the dose.

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 elderly patients and patients with hypokalaemia, hyperthyroidism, renal or hepatic impairment, history of seizures.
May cause: drowsiness, extrapyramidal symptoms, early or tardive dyskinesia, anticholinergic effects (constipation, dry mouth), hyperprolactinaemia, 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 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.). 
– Avoid alcohol during treatment.
– Pregnancy: re-evaluate whether the treatment is still necessary; if it is continued, monitor the neonate the first few days (risk of hypertonia, tremors, sedation).
– Breast-feeding: if absolutely necessary, do not exceed 10 mg daily.

Remarks

 Storage: below 25 °C  -