SERENACE

What it is

Serenace tablets and liquid contain haloperidol. Serenace tablets contain either 0.5 mg, 1.5 mg, 5 mg or 20 mg haloperidol as the active ingredient. Serenace liquid contains 2 mg/mL haloperidol as the active ingredient.

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

There is considerable variation from patient to patient in the amount of medication required for therapy, and it is important to titrate the dose of Serenace in accordance with the clinical effect and the severity of the disease. Children and debilitated or geriatric patients may be more sensitive to Serenace, and the starting dose, maximum dose and maintenance doses are therefore generally lower for these patients. For adults with moderate symptomatology, 1–5 mg per day is recommended; for severe symptomatology, 5–15 mg per day. Daily oral dosages should be titrated against patient response and may be increased up to 20 mg. For geriatric or debilitated patients, 1–3 mg per day is usually sufficient. For children with severely aggressive or hostile behaviour or for the rare Gilles de la Tourette Syndrome, the initial dose should be 1–3 mg per day, with maintenance dose usually 0.05 mg/kg body weight per day.

Key safety warnings

A potentially fatal syndrome known as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations include hyperpyrexia, muscle rigidity, altered mental status (including catatonic signs) and autonomic instability. Additional signs may include elevated creatine phosphokinase (CPK), myoglobinuria and acute renal failure. The management of NMS should include immediate discontinuation of antipsychotic drugs, intensive symptomatic treatment and monitoring, and treatment of any serious medical problems for which specific treatments are available. A syndrome consisting of potentially irreversible, involuntary dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the dyskinetic syndrome may remit partially or completely if the medication is withdrawn, it is irreversible in some patients. The prevalence of this syndrome appears to be highest among the elderly, particularly elderly women. Since there is a significant prevalence of this syndrome associated with the use of neuroleptic drugs and since there is no known effective treatment, chronic use of these drugs should generally be restricted to patients for whom there is no alternative therapy available with better risk acceptability. The risk of developing irreversible tardive dyskinesias increases with the duration of treatment and total cumulative doses. Higher doses and intravenous administration of haloperidol appear to be associated with a higher risk of QT prolongation and Torsades de Pointes. Rare cases of sudden death have been reported even in the absence of predisposing factors. A baseline ECG is recommended before haloperidol is given. If repeated doses are given, continuous ECG monitoring is also recommended.

Contraindications

Serenace is contraindicated in comatose states; in the presence of central nervous system depression due to alcohol and other depressant drugs; in severe depressive states; in previous spastic diseases; in senile patients with pre-existing parkinsonian symptoms; in Parkinson's disease; in patients with known hypersensitivity to haloperidol; in patients with manifest occult lesions of the basal ganglia; and in patients with prolactin dependent tumours. In common with other neuroleptics, haloperidol has the potential to cause rare prolongation of the QT interval. Use of haloperidol is therefore contraindicated in patients with clinically significant cardiac disorders such as 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

Serenace is listed on the PBS in four strengths: oral solution 2 mg per mL (100 mL), tablet 1.5 mg, tablet 5 mg, and tablet 0.5 mg. All are listed as unrestricted items with ex-manufacturer prices of A$9.78, A$3.41, A$3.27, and A$3.06 respectively.

Regulatory history

Serenace was first registered on the ARTG on 30 August 1991, with registrations for tablets of 0.5 mg, 1.5 mg, 5 mg and 20 mg strengths, an oral liquid of 2 mg/mL, and an injection of 20 mg/2 mL. A 10 mg/1 mL injection was added on 10 December 2001, and a 5 mg/mL injection ampoule was added on 31 October 2011.