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Neuroleptic malignant syndrome characterised by hyperthermia, muscle rigidity, autonomic dysfunction, impaired level of consciousness and increased serum levels of creatine kinase have been reported with antipsychotic agents.
The risk may possibly increase with drug potency.
Patients with pre-existing organic brain syndrome, mental retardation, and opiate or alcohol misuse are overrepresented among the fatal cases.
Treatment: Discontinuation of antipsychotics, symptomatic and general supportive in-patient treatment. The symptoms may persist for over a week following withdrawal of oral antipsychotics and somewhat longer with prolonged release formulations.
Caution must be exercised when using Flupentixol in patients with organic brain syndrome, convulsions and advanced liver disease.
Flupentixol in doses up to 25 mg daily is not recommended in excited or overactive patients, since the activating effect of the product can exacerbate these symptoms. When the patient is already being treated with sedatives or neuroleptic agents with a sedative effect, these should be gradually withdrawn.
Insulin and glucose response may be altered, and patients with diabetes may require adjustment of their hypoglycaemic treatment.
To determine whether the maintenance dose can be reduced, patients receiving long-term therapy, especially in high doses, should be monitored carefully at regular intervals.
Flupentixol may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Flupentixol should therefore be used with caution in susceptible individuals (patients with hypokalaemia, hypomagnesaemia or a genetic predisposition to arrhythmia) and in patients with a history of cardiovascular disorders such as QT prolongation, excessive bradycardia (< 50 beats per minute), a recent acute myocardial infarction, untreated heart failure or cardiac arrhythmia.
Concomitant treatment with other antipsychotics should be avoided (see Interactions).
Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with flupentixol and preventive measures undertaken.
Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including zuclopenthixol decanoate.
Long-acting depot antipsychotics should be used with caution in combination with other medicines known to have a myelosuppressive potential, as these cannot rapidly be removed from the body in conditions where this may be required.
Effects on ability to drive and use machines: Fluanxol Depot may have minor or moderate effect on the ability to drive vehicles and use machines, especially at the start of treatment or at dose increments.
Use in the Elderly: Cerebrovascular: Flupentixol should be used with caution in patients with risk factors for stroke.
An approximate 3-fold increased risk of cerebrovascular adverse events has been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics. The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations.
Increased Mortality in Elderly people with Dementia: Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.
Flupentixol is not licensed for the treatment of dementia-related behavioural disturbances.
