HALOPERIDOL

What it is

Haloperidol Medsurge is an injection containing haloperidol 5 mg per 1 mL ampoule. It is a clear, colourless solution presented in amber glass ampoules. Haloperidol is a psychotropic drug of the butyrophenone series, chemically described as 4-[4-(4-chlorophenyl)-4-hydroxy-1-piperidinyl]-1-(4-fluorophenyl)-1-butanone.

Approved indications

— Management of manifestations of psychotic disorders such as schizophrenia, psychosis due to organic brain damage or mental deficiency, the manic phase of manic depressive illness, and Gilles de la Tourette syndrome — Treatment of acute alcoholism for the relief of delusions, hallucinations and confused states, and for the control of accompanying tremulousness and aggressive behaviour — Treatment of intractable nausea and vomiting associated with radiation or malignancy and not responding to other therapy — Neuroleptanalgesia

Dosing overview

Haloperidol solution for injection is recommended for intramuscular administration only. For agitation and aggressiveness associated with acute psychosis, the initial dose is 0.5–10 mg intramuscularly or intravenously, depending on the patient's age, physical status, and severity of symptoms, with subsequent doses given as often as half-hourly for intravenous injections or hourly for intramuscular injections, and the total daily dose not to exceed 20 mg. Once continuous therapeutic control is achieved, the maintenance dose may be calculated as half the total daily dose used to achieve control, given in divided doses morning and evening.

Key safety warnings

Higher doses and intravenous administration of haloperidol are associated with a higher risk of QT prolongation and Torsades de Pointes. A baseline electrocardiogram is recommended before haloperidol is given, and if repeated doses are given, continuous electrocardiogram monitoring is also recommended. Neuroleptic Malignant Syndrome is a potentially fatal syndrome reported in association with antipsychotic drugs, characterised by hyperpyrexia, muscle rigidity, altered mental status and autonomic instability, and management should include immediate discontinuation of antipsychotic drugs and intensive symptomatic treatment and monitoring. Haloperidol should be used cautiously in patients exposed to high temperatures, as hyperpyrexia and heat stroke have been reported. A syndrome of potentially irreversible, involuntary dyskinetic movements (tardive dyskinesia) may develop in patients treated with antipsychotic drugs, and although it may remit if medication is withdrawn, it is irreversible in some patients; chronic use should generally be restricted to patients for whom there is no alternative therapy available. Haloperidol may be given to epileptics but adequate anticonvulsant therapy should be maintained as haloperidol may decrease the seizure threshold and has been reported to trigger seizures in known epileptics that were previously controlled.

Contraindications

Haloperidol Medsurge is contraindicated in comatose states, in the presence of central nervous system depression due to alcohol and other depressant drugs, severe depressive states, previous spastic diseases, senile patients with pre-existing parkinsonian symptoms, Parkinson's disease, known hypersensitivity to haloperidol, in patients with manifest or occult lesions of the basal ganglia, and in patients with prolactin-dependent tumours. Use of haloperidol is contraindicated in patients with clinically significant cardiac disorders including recent acute myocardial infarction, uncompensated heart failure, arrhythmias treated with class IA and III antiarrhythmic medicinal products, QTc interval prolongation, history of ventricular arrhythmia or torsades de pointes, clinically significant bradycardia, second or third degree heart block, and uncorrected hypokalaemia.

PBS listing

Haloperidol Medsurge injection 5 mg in 1 mL is listed on the PBS with 3 items under different restriction types, with an ex-manufacturer price of A$10.42.

Regulatory history

Haloperidol Medsurge (ARTG 449666) was first registered on 28 July 2025 as a haloperidol 5 mg/1 mL solution for injection ampoule under licence category RE.