Fluanxol/Fluanxol Depot

Fluanxol/Fluanxol Depot

flupentixol

Manufacturer:

Lundbeck

Distributor:

B L Hua
Full Prescribing Info
Contents
Fluanxol: Flupentixol dihydrochloride.
Fluanxol Depot: Flupentixol decanoate.
Description
Fluanxol: Each tablet contains 3 mg flupentixol (as 3.504 mg flupentixol dihydrochloride).
Excipients with known effect: Lactose Monohydrate, Sunset yellow FCF (E110).
Fluanxol Depot: Each millilitre (ml) of Fluanxol Depot contains 20 mg or 100 mg flupentixol decanoate.
Excipients/Inactive Ingredients: Fluanxol: Tablet core: Betadex, Lactose monohydrate, Maize starch, Hydroxypropylcellulose, Microcrystalline cellulose, Croscarmellose sodium, Talc, hydrogenated Vegetable oil, Magnesium stearate.
Coating and color: partly hydrolyzed Polyvinyl alcohol, Macrogol/PEG 3350, Talc, Iron oxide yellow (E172), Iron oxide red (172), Titanium dioxide (E171), Sunset yellow FCF (E110), Macrogol/PEG 6000.
Fluanxol Depot: The other ingredient is thin vegetable oil (triglycerides, medium chain).
Action
Pharmacotherapeutic group: Neuroleptics (antipsychotics). ATC-code: N05AF01.
Pharmacology: Fluanxol Depot: Fluanxol Depot contains the active substance flupentixol decanoate. Fluanxol Depot belongs to a group of medicines known as antipsychotics (also called neuroleptics).
These medicines act on nerve pathways in specific areas of the brain and help to correct certain chemical imbalances in the brain that are causing the symptoms of the illness.
Pharmacodynamics:
Mechanism of action: Fluanxol: Flupentixol is a neuroleptic of the thioxanthene group.
Flupentixol is a mixture of two geometric isomers, the active flupentixol (cis(Z)-flupentixol) and trans(E)-flupentixol, approximately in the ratio of 1:1.
The antipsychotic effect of neuroleptics is related to their dopamine receptor blocking effect but possibly also 5-HT (5-hydroxytryptamine) receptor blockade contributes. In vitro and in vivo flupentixol has high affinity for both dopamine D1 and D2 receptors whereas fluphenazine is almost D2 selective in vivo. The atypical antipsychotic, clozapine, shows – as flupentixol – equiaffinity to D1 and D2 receptors both in vitro and in vivo.
Flupentixol has high affinity for α1-adrenoceptors and 5-HT2 receptors, although lower than that of chlorprothixene, high-dose phenothiazines and clozapine, but no affinity for cholinergic muscarine receptors. It has only slight antihistaminergic properties and no α2-adrenoceptor blocking activity.
Flupentixol has proven to be a potent neuroleptic in all the behavioural studies for neuroleptic (dopamine receptor blocking) activity. Correlation is found in the in vivo test models, the affinity for dopamine D2 binding sites in vitro and the average, daily oral antipsychotic doses.
Perioral movements in rats are dependent on D1 receptor stimulation or blockade of the D2 receptor population. The movements can be prevented by flupentixol. Likewise, the results from investigations in monkeys indicate that oral hyperkinesia is more related to D1 receptor stimulation and to a less degree to D2 receptor supersensitivity. This leads to the suggestion that D1 activation is responsible for similar effects in man, i.e. dyskinesia. Therefore, blockade of D1 receptors should be advantageous.
Flupentixol prolongs alcohol- and barbiturate-induced sleeping time in mice in only very high doses indicating a very weak sedative action in clinical use.
Like most other neuroleptics, flupentixol dose-dependently increases the serum prolactin level.
Clinical efficacy and safety: In clinical use flupentixol has a broad spectrum of activity that varies according to the dosage.
Flupentixol in low dosages (1-2 mg/day) has antidepressant, anxiolytic and activating effects.
In moderate dosages (3-25 mg/day) flupentixol is intended for the treatment of acute and chronic psychoses. In this dosage range flupentixol has practically no unspecific sedative effect and is not suited for patients with severe psychomotor agitation. Besides causing a significant reduction or complete elimination of the nuclear symptoms of schizophrenia such as hallucinations, delusions and thought disturbances flupentixol also has disinhibiting (antiautistic and activating) and mood-elevating properties making flupentixol particularly useful in the treatment of apathetic, withdrawn, depressed and poorly motivated patients.
The antipsychotic effect increases with increasing dosage; in addition some sedation should be anticipated. Flupentixol has within the whole dosage range a pronounced anxiolytic effect and even in high-dose treatment the mood elevating and disinhibiting effects of flupentixol are retained. High dose treatment does not increase the frequency of extrapyramidal symptoms.
Pharmacokinetics: The following data concerns the active cis(Z)-isomer.
Absorption: Oral administration results in maximum serum levels in about 4-5 hours. Oral bioavailability is about 40%.
Distribution: The apparent volume of distribution (Vd)β is about 14.1 l/kg. The plasma protein binding is about 99%.
Biotransformation: The metabolism of flupentixol proceeds along three main routes – sulphoxidation, side chain N-dealkylation and glucuronic acid conjugation. The metabolites are devoid of psychopharmacological activity. Flupentixol dominates over metabolites in brain and other tissues.
Elimination: The elimination half-life (T½ β) is about 35 hours and the mean systemic clearance (Cls) is about 0.29 l/min.
Flupentixol is excreted mainly with faeces, but also to some degree with the urine. When tritium labelled flupentixol was administered to man the excretion pattern showed the excretion via faeces to be about 4 times the urinary excretion.
In nursing mothers flupentixol is excreted in small amounts with the breast milk. The ratio milk conc./serum conc. in women is on an average 1.3.
Linearity: The kinetics is linear. Steady state plasma levels are achieved in about 7 days. The mean minimum steady state level corresponding to 5 mg flupentixol orally once-a-day was about 1.7 ng/ml (3.9 nmol/l).
Older patients: Pharmacokinetic investigations have not been done in older patients. However, for the related thioxanthene drug, zuclopenthixol, the pharmacokinetic parameters are widely independent of the age of the patients.
Reduced renal function: Based on the previously mentioned characteristics for elimination it is reasonable to assume that reduced kidney function is likely not to have much influence on the serum levels of parent drug.
Reduced hepatic function: No data available.
Pharmacokinetic/Pharmacodynamic relationship: A minimum (i.e. concentration measured just before administration of a dose) serum (plasma) concentration of 1-3 ng/ml (2-8 nmol/l) is suggested as a guideline for maintenance treatment of schizophrenic patients with a low-moderate degree of illness.
Toxicology: Preclinical safety data: Acute toxicity: Flupentixol has low acute toxicity.
Chronic toxicity: In chronic toxicity studies there were no findings of concern for the therapeutic use of flupentixol.
Reproduction toxicity: In fertility studies in rats, flupentixol slightly affected the pregnancy rate of female rats. Effects were seen at doses well in excess of those applied during clinical use.
Animal reproduction studies in mice, rats and rabbits have not shown evidence of teratogenic effects. Embryotoxic effects in terms of increased post implantation loss/increased absorption rates or occasional abortions were seen in rats and rabbits at doses associated with maternal toxicity.
Carcinogenicity: Flupentixol has no carcinogenic potential.
Indications/Uses
Fluanxol: Schizophrenia and allied psychoses, especially with symptoms such as hallucinations, delusions and thought disturbances along with apathy, lack of energy, lowered mood and withdrawal.
Fluanxol Depot: Fluanxol Depot is used for the treatment of schizophrenia and other related psychoses.
Dosage/Direction for Use
Fluanxol: Posology: Adults: Schizophrenia and allied psychoses: Dosage should be individually adjusted according to the patient's condition. In general, small doses should be used initially and increased to the optimal effective level as rapidly as possible based on the therapeutic response. The maintenance dose can usually be given as a single morning dose.
Initially 3-15 mg/day divided in two or three daily doses, increased, if necessary, to 40 mg/day.
Maintenance dose usually is 5-20 mg/day.
Older patients: Older patients usually should receive dosages in the lower end of the dosage range.
Reduced renal function: Flupentixol can be given in usual doses to patients with reduced renal function.
Reduced liver function: Careful dosing and, if possible, a serum level determination is advisable.
Children: Flupentixol is not recommended for use in children due to lack of clinical experience.
Method of administration: The tablets are swallowed with water.
Fluanxol Depot: How to use Fluanxol Depot: A small volume of Fluanxol Depot is drawn up into a syringe and then injected into muscle of the buttock.
The doctor will decide on the correct volume of medicine to give, and how often to give it. The medicine is slowly released from the injection that the patient received in the buttock such that a fairly constant amount of medicine gets into the blood during the period in between injections.
The recommended dose is: Adults: Fluanxol Depot 20 mg/ml: Usually it will be 1-2 ml and the interval between injections will usually be 1 to 4 weeks.
If the patient needs more than 2 ml of medicine it will probably be divided between 2 injection sites.
Fluanxol Depot 100 mg/ml: Usually it will be about 1 ml (but may vary between 0.5 ml and 4 ml) and the interval between injections will usually be 1 to 4 weeks.
If the patient needs more than 2 ml of medicine it will probably be divided between 2 injection sites.
If the patient has been treated with Fluanxol tablets and is being transferred to Fluanxol Depot the patient may be asked to continue taking the tablets for several days after the first injection.
The doctor may decide to adjust the amount given, or the interval between injections, from time to time.
Older people (above 65 years): Are usually treated with doses in the lower end of the dosage range.
Patients with special risks: Patients with liver complaints normally receive doses in the lower end of the dosage range.
Use in Children: Fluanxol Depot is not recommended for children.
If the patient has the impression that the effect of Fluanxol Depot is too strong or too weak, the patient should talk to the doctor.
Duration of treatment: It is important that the patient continues to receive medicine at regular intervals even if the patient is feeling completely well, because the underlying illness may persist for a long time. If the patient stops treatment too soon, symptoms may return.
The doctor decides the duration of treatment.
Overdosage
Fluanxol: Symptoms: Somnolence, coma, movement disorder, convulsion, shock, hyperthermia/hypothermia.
The highest orally administered single dose in clinical trials was 80 mg, and up to 320 mg/day has been given.
ECG changes, QT prolongation, Torsade de Pointes, cardiac arrest and ventricular arrhythmias have been reported when administered in overdose together with drugs known to affect the heart.
Treatment: Treatment is symptomatic and supportive. Gastric lavage should be carried out as soon as possible after oral ingestion and activated charcoal may be administered. Measures to support the respiratory and cardiovascular systems should be instituted. Epinephrine (adrenaline) should not be used as further lowering of blood pressure may result. Convulsion may be treated with diazepam and extrapyramidal symptoms with biperiden.
Fluanxol Depot: The medicine will be given by the doctor/nurse.
In the unlikely event that the patient receives too much Fluanxol Depot, the patient may experience some symptoms.
Symptoms of overdose may include: Drowsiness; Unconsciousness; Muscle movements or stiffness; Convulsions; Low blood pressure, weak pulse, fast heart rate, pallor, restlessness; High or low body temperature; Changes in heart beat including irregular heart beat or slow heart rate has been seen when Fluanxol Depot has been given in overdose together with medicines known to affect the heart.
Symptomatic and supportive treatment will be initiated by the doctor/nurse.
Contraindications
Fluanxol: Hypersensitivity to the active substance or to any of the excipients listed in Description.
Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturates or opiates), coma.
Fluanxol Depot: Do not use Fluanxol Depot: If the patient is allergic (hypersensitive) to flupentixol or any of the other ingredients of this medicine (listed in Description).
If the patient has diminished consciousness.
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.
Use In Pregnancy & Lactation
Fluanxol Depot: If the patient is pregnant or breast-feeding, thinks she might be pregnant or is planning to have a baby, the patient should ask the doctor for advice before taking this medicine.
Pregnancy: Fluanxol: Flupentixol should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus.
Neonates exposed to antipsychotics (including flupentixol) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Animal studies have shown reproduction toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Fluanxol Depot: If the patient is pregnant or thinks she might be pregnant, tell the doctor. Fluanxol Depot should not be used during pregnancy unless clearly necessary.
The following symptoms may occur in newborn babies, of mothers that have used Fluanxol Depot in the last trimester (last three months of the pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If the baby develops any of these symptoms patient may need to contact the doctor.
Breast-feeding: Fluanxol: As flupentixol is found in breast milk in low concentrations it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is less than 0.5% of the weight related maternal daily dose. Breast-feeding can be continued during flupentixol therapy if considered of clinical importance but observation of the infant is recommended, particularly in the first 4 weeks after giving birth.
Fluanxol Depot: If patient is breastfeeding, ask the doctor for advice. Do not use Fluanxol Depot when breast-feeding, as small amounts of the medicine can pass into the breast milk.
Fertility: Fluanxol: In humans, adverse events such as hyperprolactinaemia, galactorrhoea, amenorrhoea, libido decreased, erectile dysfunction and ejaculation failure have been reported (see Adverse Reactions). These events may have a negative impact on female and/or male sexual function and fertility.
If clinical significant hyperprolactinaemia, galactorrhoea, amenorrhoea or sexual dysfunctions occur, a dose reduction (if possible) or discontinuation should be considered. The effects are reversible on discontinuation.
In preclinical fertility studies in rats, flupentixol slightly affected the pregnancy rate of female rats. Effects were seen at dose well in excess of those applied during clinical use.
Fluanxol Depot: Animal studies have shown that Fluanxol Depot affects the fertility. Please ask the doctor for advice.
Adverse Reactions
Fluanxol: Undesirable effects are for the majority dose dependent. The frequency and severity are most pronounced in the early phase of treatment and decline during continued treatment.
Extrapyramidal reactions may occur, especially in the early phase of treatment. In most cases these side effects can be satisfactorily controlled by reduction of dosage and/or use of antiparkinsonian drugs. The routine prophylactic use of antiparkinsonian drugs is not recommended. Antiparkinsonian drugs do not alleviate tardive dyskinesia and may aggravate them. Reduction in dosage or, if possible, discontinuation of flupentixol therapy is recommended. In persistent akathisia a benzodiazepine or propranolol may be useful.
Frequencies are taken from the literature and spontaneous reporting. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). (See Table.)

Click on icon to see table/diagram/image

As with other drugs belonging to the therapeutic class of antipsychotics, rare cases of QT prolongation, ventricular arrhythmias-ventricular fibrillation, ventricular tachycardia, Torsade de Pointes and sudden unexplained death have been reported for flupentixol (see Precautions).
Abrupt discontinuation of flupentixol may be accompanied by withdrawal symptoms. The most common symptoms are nausea, vomiting, anorexia, diarrhea, rhinorrhoea, sweating, myalgias, paraesthesias, insomnia, restlessness, anxiety, and agitation. Patients may also experience vertigo, alternate feelings of warmth and coldness, and tremor. Symptoms generally begin within 1 to 4 days of withdrawal and abate within 7 to 14 days.
Side Effects
Fluanxol Depot: Like all medicines, Fluanxol Depot can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should contact the doctor or go to the hospital straight away: Uncommon (in more than 1 out of 1,000 and less than 1 out of 100 persons): Unusual movements of the mouth and tongue; this may be an early sign of a condition known as tardive dyskinesia.
Very rare (in less than 1 out of 10,000 persons): High fever, unusual stiffness of the muscles and disorder of consciousness, especially if occurring with sweating and fast heart rate; these symptoms may be signs of a rare condition called neuroleptic malignant syndrome which has been reported with the use of different antipsychotics.
Yellowing of the skin and the white in the eyes, this may mean that the liver is affected and a sign of a condition known as jaundice.
The following side effects are most pronounced in the beginning of the treatment and most of them usually wear off during continued treatment: Very common (in 1 or more out of 10 persons): Sleepiness (somnolence), inability to sit still or remain motionless (akathisia), involuntary movements (hyperkinesia), slow or diminished movements (hypokinesia); Dry mouth.
Common (in more than 1 out of 100 persons and less than 1 out of 10 persons): Racing heart (tachycardia), a sensation of a rapid, forceful, or irregular beating of the heart (palpitations); Tremor, twisting or repetitive movements or abnormal postures due to sustained muscle contractions (dystonia), dizziness, headache; Difficulties focusing on objects near to the eye (accommodation disorder), vision abnormalities; Difficulty breathing or painful breathing (dyspnoea); Increased saliva secretion (salivary hypersecretion), constipation, vomiting, digestive problems or discomfort centered in the upper abdomen (dyspepsia), diarrhoea; Urination disorder (micturition disorder), lack of ability to urinate (urinary retention); Increased sweating (hyperhidrosis), itching (pruritus); Muscle pain (myalgia); Increased appetite, increased weight; Fatigue, weakness (asthenia); Sleeplessness (insomnia), depression, nervousness, agitation, decreased sexual drive (libido decreased).
Uncommon (in more than 1 out of 1,000 and less than 1 out of 100 persons): Jerky movements (dyskinesia), parkinsonism, speech disorder, convulsion; Circular movement of the eye (oculogyration); Abdominal pain, nausea, flatulence; Rash, skin reaction due to sensitivity to light (photosensitivity reaction), eczema or inflammation of the skin (dermatitis); Muscle rigidity; Decreased appetite; Low blood pressure (hypotension), hot flush; Red or sore skin where the Fluanxol Depot injection was given; Abnormal liver function tests; Sexual disturbance (delayed ejaculation, problems with erection); State of confusion.
Rare (more than 1 out of 10,000 and less than 1 out of 1,000 persons): Low blood platelet count (thrombocytopenia), low white blood platelet count (neutropenia), reduced white blood cell count (leukopenia), bone marrow poisoning (agranulocytosis); Increased level of prolactin in the blood (hyperprolactinaemia); High blood sugar (hyperglycaemia), abnormal glucose tolerance; Over-sensitivity (hypersensitivity), acute systemic and severe allergic reaction (anaphylactic reaction); Development of breasts in men (gynaecomastia), excessive milk production (galactorrhoea), lack of menstrual periods (amenorrhoea).
As with other medicines that work in a way similar to flupentixol decanoate (the active ingredient of Fluanxol Depot), rare cases of the following side effects have been reported: QT prolongation (slow heart beat and change in the ECG); Irregular heart beat (ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia); Torsades de Pointes (a special kind of irregular heart beat).
In rare cases irregular heart beats (arrhythmias) may have resulted in sudden death.
Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If the patient notices any of these symptoms the patient should seek medical advice immediately.
In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.
Drug Interactions
Fluanxol: Combinations requiring precautions for use: Flupentixol may enhance the sedative effect of alcohol and the effects of barbiturates and other CNS depressants.
Neuroleptics may increase or reduce the effect of antihypertensive drugs; the antihypertensive effect of guanethidine and similar acting compounds is reduced.
Concomitant use of neuroleptics and lithium increases the risk of neurotoxicity.
Tricyclic antidepressants and neuroleptics mutually inhibit the metabolism of each other.
Flupentixol may reduce the effect of levodopa and the effect of adrenergic drugs.
Concomitant use of metoclopramide and piperazine increase the risk of extrapyramidal disorder.
Increases in the QT interval related to antipsychotic treatment may be exacerbated by the co-administration of other drugs known to significantly increase the QT interval. Co-administration of such drugs should be avoided. Relevant classes include: class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide); some antipsychotics (e.g. thioridazine); some macrolides (e.g. erythromycin); some antihistamines (e.g. terfenadine, astemizole); some quinolone antibiotics (e.g. gatifloxacin, moxifloxacin).
The mentioned list is not exhaustive and other individual drugs known to significantly increase QT interval (e.g. cisapride, lithium) should be avoided.
Drugs known to cause electrolyte disturbances such as thiazide diuretics (hypokalemia) and drugs known to increase the plasma concentration of flupentixol should also be used with caution as they may increase the risk of QT prolongation and malignant arrhythmias (see Precautions).
Fluanxol Depot: Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
Tell the doctor if the patient is taking any of the following medicines: Tricyclic antidepressant medicines; Guanethidine and similar medicines (used to lower the blood pressure); Barbiturates (medicines that make the patient feel drowsy); Medicines used to treat epilepsy; Levodopa and similar medicines (used to treat Parkinson's disease); Metoclopramide (used in the treatment of gastro-intestinal disorders); Piperazine (used in the treatment of roundworm and threadworm infections); Medicines that cause a disturbed water or salt balance (too little potassium or magnesium in the blood); Medicines known to increase the concentration of Fluanxol Depot in the blood.
The following medicines should not be taken at the same time as Fluanxol Depot: Medicines that change the heartbeat (quinidine, amiodarone, sotalol, dofetilide, erythromycin, terfenadine, astemizole, gatifloxacin, moxifloxacin, cisapride, lithium); Other antipsychotic medicines.
Fluanxol Depot with alcohol: Fluanxol Depot may increase the sedative effects of alcohol making the patient drowsier. It is recommended not to drink alcohol during treatment with Fluanxol Depot.
Caution For Usage
Fluanxol: Incompatibilities: Not applicable.
Special precautions for disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Fluanxol Depot: Do not throw away any medicines via wastewater or household waste.
Ask the pharmacist how to throw away medicines that no longer of use. These measures will help to protect the environment.
Storage
Fluanxol: Shelf life: 3 years.
Do not store above 30°C.
Fluanxol Depot: Keep Fluanxol Depot ampoules/vials in the box, so they are protected from light.
MIMS Class
ATC Classification
N05AF01 - flupentixol ; Belongs to the class of thioxanthene derivatives antipsychotics.
Presentation/Packing
Fluanxol: FC tab 3 mg (round, slightly biconvex, ochre, marked FI) x 100's.
Fluanxol Depot: Inj 40 mg/2 mL (amp, clear, colourless or pale-yellow liquid) x 10's.
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