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Fluanxol

1. NAME OF THE MEDICINAL PRODUCT
Fluanxol Tablet 0.5mg

2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Fluanxol 0.5 mg: Each tablet contains 0.5 mg flupentixol (as 0.5840 mg flupentixol dihydrochloride)

Excipients with known effects:
Lactose monohydrate and Sucrose

For the full list of excipients see section 6.1

3. PHARMACEUTICAL FORM
Coated tablet
0.5 mg:Round, biconvex, ochre-yellow, sugar coated tablet.

4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Depression involving anxiety, asthenia and lack of initiative.
Chronic neuroses with anxiety, depression, and inactivity.
Psychosomatic disorders with asthenic reactions.
Acute and situational anxiety and tension states in which a sedative/ hypnotic effect is not required and especially when the patient is considered in danger of abusing minor tranquillizers.

4.2 Posology and method of administration
Posology
Adults
Initially 1 mg daily as a single morning dose or 0.5 mg twice daily.
After one week the dosage may be increased to 2 mg daily if there is inadequate clinical response. Daily dosage of more than 2 mg should be in divided doses up to a maximum of 3 mg.

Patients often respond to flupentixol within two or three days. If no effect has been observed within one week of maximum dosage (3 mg daily) the drug should be withdrawn.

Older patients
Older patients should receive half the recommended dosages.
The initial dosage for older patient is 0.5 mg as a single morning dose.
After one week, if response is inadequate, dosage may be increased to 1 mg daily.
Caution should be exercised in further increasing the dosage but occasional patients may require up to a maximum of 1.5 mg a day which
should be given in divided doses.

Reduced renal function
Flupentixol has not been studied in renal impairment. Increased cerebral sensitivity to antipsychotics has been noted in severe renal impairment.

Reduced liver function
Flupentixol has not been studied in hepatic impairment. It is extensively metabolised by the liver and particular caution should be used in this situation and serum level monitoring is advised.

Children
Not recommended for children

Method of administration
The tablets are swallowed with water.

4.3 Contra-indications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma.

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 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 tranquillizers 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 anti psychotics, 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, 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).

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 suicide 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 disorder. 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 behaviour 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 behaviour or thoughts and unusual changes in behaviour 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

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 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.

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. The tablets also contain sucrose. Patients with rare hereditary problems of fructose intolerance, glacose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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