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Fluanxol 3 Mg 50 Tablets ingredient Flupentixol
FLUANXOL ® 3 mg Coated Tablet
Flupentixol dihydrochloride 3.504 mg
(Equivalent to 3 mg flupentixol)
It contains yellow iron oxide and sugar.
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Flupentixol is a thioxanthene derivative with pronounced antipsychotic, anxiolytic and activating effects. The antipsychotic effects of neuroleptics are usually associated with blocking effects of dopaminergic receptors; blocking of these receptors can also cause chain changes in other neurotransmitter systems.
Flupentixol does not induce sedation at low and moderate doses (up to 25 mg / day). However, at higher doses, a non-specific sedative effect occurs. Flupentixol also has significant anxiolytic effect at all doses.
Flupentixol should be used at doses higher than 3 mg per day in order to have significant effect on hallucinations, paranoid delusions and other psychotic symptoms. The antipsychotic effect is increased by increasing the dose. Flupentixol brings apathetic, depressed, self-withdrawn, and poorly motivated patients into a more cautious, more shared, and more active social relationship with their inhibitory (antioxidant and activating) and general mood-enhancing effects.
After oral administration of Flupentixol the bioavailability is approximately 40% and reaches serum peak concentrations within 4 hours. Flupentixol passes the placental barrier in small quantities and is again released into the milk in low amounts.
Metabolites lack neuroleptic activity. The excretion is largely in the feces and some in the urine.
Its biological half-life is 35 hours.
It is especially indicated for acute and idiopathic treatment of schizophrenia and other psychoses with symptoms of apathy, anger, depression and withdrawal accompanied by hallucinations, delusions and distress symptoms.
Acute alcohol, barbiturate and opiate poisonings are contraindicated in coma. It should not be applied in excitable or overactive patients, as the active effect of the drug may exacerbate such properties.
It should not be used in patients with severe depression who may require electroconvulsive therapy or be hospitalized.
Warnings / Precautions:
Fluanxol should be administered with caution in cases of advanced hepatic, convulsive or cardiovascular disease, as well as severe respiratory diseases, renal insufficiency and Parkinson's disease. In cases where the sedative effect is being treated with prominent neuroleptics, the dose of this neuroleptic should be reduced and reduced when Fluanxol therapy begins. Patients who are treated on long-term and especially high doses should be carefully monitored and evaluated periodically for reassessment of the administration dose.
Doses up to 25 mg / day may not be recommended for excitable or overactive patients due to an activating effect.
As with other psychotropics, flupenthixol can alter insulin and glucose levels. For this reason, antidiabetic therapy may need to be adjusted in diabetic patients.
Antipsychotics may cause QT prolongation in flupentixol as well as other medicines in the therapeutic class. Persistence QT interval extension may increase malignant arrhythmia risk. Therefore, flupentixol should be used with caution in susceptible individuals (those with hypokalemia, hypomagnesemia, or genetic predisposition) and with a history of QT prolongation, marked bradycardia (<50 beats per minute), recent history of myocardial infarction, noncompensated heart failure or cardiac arrhythmia. Simultaneous treatment with other antipsychotics should be avoided (see Drug Interactions and Other Interactions).
Antipsychotic medications and venous thromboembolism (VTE) cases have been reported. Since the risk factors for VTE are often found in patients treated with antipsychotics, all possible risk factors for VTE should be identified before and during treatment with flupentixol and preventive measures should be taken.
Elderly patients should receive the lowest treatment dose.
In randomized, placebo-controlled clinical trials, it was observed that the dementia population using some atypical antipsychotics had an approximately 3-fold increase in the risk of cerebrovascular adverse events. The mechanism of this risk increase is unknown. The risk increase can not be ignored in other antipsychotics and other patient populations. Flupentixol should be used with caution in patients at risk of stroke.
Increased mortality in elderly people with dementia
The data from two broad observational studies show that demented elderly people treated with antipsychotics have a small risk of mortality
increase. There is not enough data to give a precise estimate of the exact size of the raisins, and the reason for the increased risk is unknown.
Flupentixol is not licensed in the treatment of dementia-related behavioral disorders.
Neuroleptic malignant syndrome is an uncommon but potentially fatal neuroleptic condition. The main indications of neuroleptic malignant syndrome are hyperthermia, muscle stiffness and fluctuating consciousness as well as autonomic dysfunction (lahab blood pressure, tachycardia, diaphoresis). In addition to the necessity of immediate interruption of the neuroleptic drug, general supportive measures and symptomatic treatment are essential.
The tablets contain lactose monohydrate. Patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption problem should not use this drug.
Tablets also contain sucrose. Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency problems should not use this drug.
Warning for pregnancy and lactation periods:
Fluanxol is preferably not given during pregnancy and lactation.
Use in children is not recommended.
Effects on Vehicle Use and Operation of a Machine:
As the use of cars and other motor vehicles may be affected during treatment, care must be taken as far as the determination of the individual's response to treatment is concerned.
Side Effects / Adverse Effects:
Neurological: Extrapyramidal symptoms may occur during treatment with Fluanxol, especially in the early stages of treatment. In most cases these side effects can be controlled in a satisfactory manner by reducing the dose and / or by antiparkinson drugs. However, routine antiparkinson drug prophylaxis is not recommended. Tardive dyskinesia can occur very rarely in long-term treatments. Antiparkinson drugs do not cure these symptoms. It is recommended to reduce the dose and, if possible, discontinue treatment.
Psychic: Transient insomnia can be seen, especially when the fluoxetine is applied to sedative neuroleptics. A sedative effect may occur at high doses.
Autonomic and cardiovascular: Such side effects are very rare in the therapeutic dose range.
Liver: Liver function tests may temporarily detect slight increases in liver function tests.
Frequencies were taken from literature and spontaneous reports. The frequencies are defined as follows:
It is very common (≥1 / 10), diffuse (≥1 / 100 to <1/10), uncommon (≥1 / ), very infrequent (<1/10 000), or unknown (not predictable from available data).
Common Tachycardia, palpitations Cardiac disorders
QT prolongation in sparse electrocardiogram Blood and lymph system disorders
Spontaneous thrombocytopenia, neutropenia, leukopenia, agranulocytosis
Very common Somnolans, akathisia, hyperkinesia, hypokinesia
Common Tremor, dystonia, dizziness, headache
Uncommon - rare Tardive dyskinesia, dyskinesia, parkinsonism, speech impairment, convulsions Nervous system disorders
Very rare Neuroleptic malignant syndrome
Common aphasia, visual anomalies
Eye disorders Not common
Oculography (circular movement of the eye) Respiratory, thoracic and mediastinal disorders
Very common Oral installation
Common salivation, constipation, vomiting, dyspepsia, diarrhea Gastrointestinal disorders
Not common Abdominal pain, nausea, gas Kidney and urinary system disorders
Common Voiding Disorders, urinary retention
Common hyperhidrosis, pruritus Skin and subcutaneous tissue disorders
Not common Rash, photosensitivity reaction, dermatitis.
Musculoskeletal disorders, connective tissue and bone disorders
Not common Muscle rigidity Endocrine disorders
Common appetite increase, weight gain
Lack of appetite Metabolism and nutritional disorders
Sparse hyperglycaemia, impaired glucose tolerance
Not common Hypotension, hot pressure Vascular disorders
Very rare venous thromboembolism General disorders and disorders related to the application zone
Common Asthenia, fatigue Immune system disorders
Rare Hypersensitivity, anaphylactic reaction
Not common Abnormalities as a result of liver function tests Hepato-biliary disorders
Very rare Jaundice
Uncommon Ejaculation disorder, erectile dysfunction Reproductive system and breast disorders
Rare Jinekomasti, galactore, amenore
Commonly insomnia, depression, nervousness, agitation, decreased libido Psychiatric disorders
Unconventional Confusion status As with other medications included in the antipsychotics therapeutic group, QT prolongation, ventricular arrhythmia-ventricular fibrillation, ventricular tachycardia, Torsade de Pointes and unexplained sudden death cases have been reported rarely for flupentixol (see Warnings / Precautions).
Sudden interruption of flupentixol may cause withdrawal symptoms. The most common symptoms are nausea, vomiting, anorexia, diarrhea, rhinorrhea, sweating, myalgia, paresthesia, insomnia, restlessness, anxiety and agitation. Patients may also experience vertigo, consecutive temperature and cold sensations and tremor. The symptoms usually start from day 1 to day 4 after the drug is given and decrease within 7 to 14 days.
WHEN YOU EXPECT AN UNEXPECTED EFFECT, WE APPLY TO A DOCTOR.
Drug Interactions and Other Interactions:
Fluanxol may enhance the sedative effect of alcohol at high doses, the effects of barbiturates and other central nervous system depressants. Fluanxol should not be administered with drugs that have guanethidine or similar effects, as they may block antihypertensive effects. Fluanxol may reduce the effects of levodopa and adrenergic drugs and concomitant use with metoclopramide and piperazine may cause exacerbation of extrapyramidal symptoms.
The combined use of neuroleptics with lithium increases the risk of neurotoxicity.
Tricyclic antidepressants and neuroleptics mutually inhibit each other's metabolism.
QT interval durations due to antipsychotic treatment may be further exacerbated by the simultaneous application of other drugs known to prolong QT interval significantly. Simultaneous administration of these drugs should be avoided. The classes related to this include the following:
• class Ia and III antiarrhythmics (eg quinidine, amiodarone, sotalol, dofetilide)
• some antipsychotics (eg thioridazine)
• some macrolides (eg erythromycin)
• some antihistamines (eg terfenadine, astemizole)
• some quinolone antibiotics (eg gatifloxacin, moxifloxacin)
The above list is not exhaustive and should be avoided from other medications known to prolong QT interval (eg, cisapride, lithium).
Drugs known to degrade electrolyte balance (hypokalaemia), such as thiazide diuretics, and drugs known to increase plasma concentrations of flupentixol should be used with caution as they increase the risk of QT prolongation and malignant arrhythmias (see Warnings / Precautions).
Usage Shape and Dose:
Dosage should be adjusted individually according to the condition of the patient. Dependence is usually given in the morning as a single dose.
Adults: As a general rule, treatment should be started with a low dose and dose should be increased until an optimal effect is achieved.
The daily dose is 3-9 mg twice a day (1-3 tablets, morning and evening), maximum 18 mg (6 tablets) per day. It is recommended that treatment initiation and dosage increase be performed under close observation.
Elderly illness should begin with a dose half recommended for adults.
Dose Excession and Treatment:
Symptoms: Drowsiness, coma, extrapyramidal symptoms, convulsions, hypotension, shock, hypo or hyperthermia. Changes in electrocardiography, QT prolongation, Torsade de Pointes, cardiac arrest, and ventricular arrhythmia have been reported when taken in overdose with known medicinal effects.
Treatment: Symptomatic and supportive. Gastric lavage should be done as soon as possible and activated charcoal applied. Necessary precautions should be taken to support respiratory and cardiovascular systems. Adrenalin should not be used because it can lower blood pressure even more. The resulting convulsions should be treated with diazepam, and extrapyramidal symptoms with biperiden.
Store at room temperature below 25 ° C.
Commercial Presentation Shape and Packing Material:
In plastic packaging of 50 tablets.
Other pharmaceutical dosage forms available in the market include:
Fluanxol Depot 20 mg / ml, i.m. Injectable 1ml, 1 ampoules in boxes