Special Warning : אזהרת שימוש

4.4      Special warnings and precautions for use
The possibility of development of neuroleptic malignant syndrome (hyperthermia, muscle rigidity, fluctuating consciousness, instability of the autonomous nervous system) exists with any neuroleptic. The risk is possibly greater with the more potent agents. Patients with pre-existing organic brain syndrome, mental retardation, and opiate and alcohol abuse are over-represented among fatal cases.

Treatment: Discontinuation of the neuroleptic. Symptomatic treatment and use of general supportive measures.
Dantrolene and bromocriptine may be helpful.
Symptoms may persist for more than a week after oral neuroleptics are discontinued and somewhat longer when associated with the depot forms of the drugs.

Like other neuroleptics flupentixol decanoate should be used with caution in patients with organic brain syndrome, convulsion and advanced hepatic disease.

In the lower dosage range flupentixol decanoate is not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.
As described for other psychotropics flupentixol decanoate may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients.

Patients on long-term therapy, particularly on high doses, should be monitored carefully and evaluated periodically to decide whether the maintenance dosage can be lowered.

As with other drugs belonging to the therapeutic class of antipsychotics, flupentixol decanoate may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, flupentixol decanoate should be used with caution in susceptible individuals (with hypokalemia, hypomagnesia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minute), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.
Concomitant treatment with other antipsychotics should be avoided (see section 4.5).

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 decanoate and preventive measures undertaken.

Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including .flupentixol 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

Older people

Cerebrovascular
An approximately 3-fold increased risk of cerebrovascular adverse events have 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. Flupentixol decanoate should be used with caution in patients with risk factors for stroke.

Increased Mortality in Older people with Dementia
Data from two large observational studies showed that older 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 decanoate is not licensed for the treatment of dementia-related behavioural disturbances.

Effects on Driving

4.7      Effects on ability to drive and use machines

Fluanxol Depot is a non-sedating drug in the low-moderate dosage range (up to 100 mg/2nd week).
However, patients who are prescribed psychotropic medication may be expected to have some impairment in general attention and concentration and should be cautioned about their ability to drive or operate machinery.