Fluanxol/Fluanxol Depot

Fluanxol/Fluanxol Depot Special Precautions

flupentixol

Manufacturer:

Lundbeck

Distributor:

B L Hua
Full Prescribing Info
Special Precautions
Fluanxol: 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 drug.
Like other neuroleptics flupentixol should be used with caution in patients with organic brain syndrome, convulsion and advanced hepatic disease.
Not recommended for excitable or overactive patients in doses up to 25 mg/day since its activating effect may lead to exaggeration of these characteristics. If previously the patient has been treated with tranquilizers or neuroleptics with sedative effect, these should be withdrawn gradually.
As described for other psychotropics flupentixol 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 may cause QT prolongation. Persistently prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, flupentixol should be used with caution in susceptible individuals (with hypokalemia, hypomagnesemia or genetic predisposition) and in patients with a history of cardiovascular disorders, e.g. QT prolongation, significant bradycardia (<50 beats per minutes), a recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia. Concomitant treatment with other antipsychotics should be avoided (see Interactions).
Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicidal may increase in the early stages of recovery.
Other psychiatric conditions for which flupentixol is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorders. The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders.
Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behavior with antidepressants compared to placebo in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behavior or thoughts and unusual changes in behavior and to seek medical advice immediately if these symptoms present.
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.
Excipients: The tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not receive this medicine.
3 mg and 5 mg tablets also contain Sunset yellow FCF (E110), which may cause allergic reactions.
Fluanxol Depot: Talk to the doctor or pharmacist before taking Fluanxol Depot if the patient has a liver problem; has a history of convulsions or fits; has diabetes (patient may need an adjustment of the antidiabetic therapy); has an organic brain syndrome (which may be a resulting condition after poisoning with alcohol or organic solvents); has risk factors for stroke (e.g. smoking, hypertension); has hypokalemia or hypomagnesemia (too little potassium or magnesium in the blood or genetic predisposition for any of these); has a history of cardiovascular disorders; uses other antipsychotic medicine; is more excited or overactive than normal, since this medicine may increase these feelings; or someone else in the family has a history of blood clots, as medicines like these have been associated with formation of blood clots; is treated for cancer.
Effects on ability to drive and use machines: Fluanxol: Fluanxol is a non-sedating drug in the low-moderate dosage range.
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.
Fluanxol Depot: There is a risk of feeling drowsy and dizzy when using Fluanxol Depot. If this happens do not drive or use any tools or machines until these effects wear off.
Use in Children: Fluanxol Depot is not recommended in this patient group.
Use in Elderly: Fluanxol: Cerebrovascular: An approximately 3-fold increased risk of cerebrovascular adverse events have been seen in randomized 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 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 is not licensed for the treatment of dementia-related behavioural disturbances.
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