CLOPIXOL

What it is

Clopixol contains zuclopenthixol, a potent neuroleptic of the thioxanthene series. The medicine is available in three formulations: film-coated tablets containing 10 mg zuclopenthixol as zuclopenthixol hydrochloride; Clopixol Acuphase injection containing zuclopenthixol acetate; and Clopixol Depot injection containing zuclopenthixol decanoate. The antipsychotic effect of neuroleptics is related to their dopamine receptor blocking activity.

Approved indications

**Clopixol tablets:** — Acute and chronic schizophrenia and other psychoses, especially those with symptoms such as hallucinations, delusions, thought disturbances, agitation, restlessness, hostility or aggressiveness. — Manic phase of manic depressive illness. **Clopixol Acuphase injection:** — Initial treatment of acute psychoses, mania and exacerbation of chronic psychoses. **Clopixol Depot injection:** — Maintenance treatment.

Dosing overview

Dosage should be adjusted individually. In general, small doses should be used initially and increased to the optimal effective level as rapidly as possible, based on the response. For Clopixol tablets: For acute schizophrenia and other acute psychoses, severe acute states of agitation and mania, the usual dose is 10–50 mg daily orally. In moderate to severe cases, initially 20 mg daily increasing, if necessary, by 10–20 mg every 2–3 days to 75 mg or more daily. For chronic schizophrenia and other chronic psychoses, the usual maintenance dose is 20–40 mg daily orally. For Clopixol Acuphase injection: The dose range is usually 50–150 mg (1–3 mL) intramuscularly, repeated if necessary, preferably at intervals of 2 to 3 days. Clopixol Acuphase is not intended for long-term use and the duration of treatment should not be more than 2 weeks. The maximum accumulated dosage in a course should not exceed 400 mg and the total number of injections should not exceed 4. For Clopixol Depot injection: The usual maintenance dose is 200–400 mg (1–2 mL) every second to fourth week.

Key safety warnings

A potentially fatal syndrome called neuroleptic malignant syndrome has been reported on occasion with antipsychotic drugs. The syndrome is characterised by muscle rigidity, fever, hyperthermia, altered consciousness and autonomic instability (for example, tachycardia, labile blood pressure, profuse sweating, dyspnoea). The management of neuroleptic malignant syndrome should include immediate discontinuation of antipsychotic drugs, intensive monitoring of symptoms and treatment of any associated medical problems. Extrapyramidal reactions may occur, especially in the first few days after an injection and in early phase of treatment. Dysphagia can occur secondary to extrapyramidal symptoms as well to sialorrhea, sedation and neuroleptic malignant syndrome and may lead to life-threatening complications such as aspiration pneumonia and choking. The possibility of the development of irreversible dyskinesia should be borne in mind when patients are on prolonged therapy with Clopixol. The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder, and close supervision of high risk patients should accompany therapy. As with other drugs belonging to the therapeutic class of antipsychotics, zuclopenthixol may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias.

Contraindications

Known hypersensitivity to the thioxanthenes. Acute alcohol, barbiturate or opiate intoxication. Circulatory collapse, depressed level of consciousness due to any cause, coma, suspected or established subcortical brain damage. Blood dyscrasias. Phaeochromocytoma. Leukopenia and/or previous agranulocytosis.

PBS listing

Clopixol Depot oily intramuscular injection 200 mg in 1 mL is listed on the PBS. There is 1 PBS item with restriction (authority required). The ex-manufacturer price is A$16.83.

Regulatory history

Clopixol tablets (10 mg) and Clopixol Acuphase injections (50 mg/1 mL and 100 mg/2 mL) and Clopixol Depot injection (200 mg/1 mL) were all first registered on the Australian Register of Therapeutic Goods on 20 September 1993.