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Description
Fluanxol coated pills are an antipsychotic drug of the thioxanthenes group. The antipsychotic action of neuroleptics is associated with blockade of dopamine receptors, as well as, possibly, blockade of 5-HT (5-hydroxytryptamine) receptors. The antipsychotic effect of flupentixol begins to appear as soon as the daily dose of 3 mg is prescribed and its severity increases with increasing dose. Flupentiksol has a pronounced anxiolytic effect. The drug has disinhibiting (anti-anthracistic and activating) properties, helps to revitalize patients, increases their interpersonal skills and facilitates social adaptation. In small and medium doses (up to 25 mg per day), flupentixol does not have a sedative effect, however, when prescribing the drug in a dose of more than 25 mg / day, a sedative effect may develop. When taking small doses (up to 3 mg / day), flupentixol has an antidepressant effect.
Active ingredients
Flupentixol
Release form
Pills
Composition
The active substance is flupentixol dihydrochloride 1.168 mg, which corresponds to 1 mg of flupentixol. Auxiliary substances - lactose monohydrate, potato starch, gelatin, talc, magnesium stearate. Shell - gelatin, sucrose, sucrose powder, iron oxide yellow (E172), polishing Capol 1295 wax (a mixture of white beeswax and carnauba wax).
Indications
At a dose of up to 3 mg / day. Depression of mild to moderate severity, combined with anxiety, asthenia and lack of initiative. Chronic neurotic disorders with anxiety, depression and apathy. Psychosomatic disorders with asthenic manifestations. At a dose of 3 mg / day or more. Schizophrenia and schizophrenia-like psychosis with a predominance of hallucinatory symptoms, delusions and thinking disorders, also accompanied by apathy, anergy, decreased mood and autism.
Precautionary measures
Before use, consult with your doctor. The drug is available on prescription.
Use during pregnancy and lactation
Pregnancy During pregnancy Fluanxol should be used only if the intended benefit to the mother outweighs the potential risk to the fetus. Newborns exposed to antipsychotics (including flupentixol) during the third trimester of pregnancy are at risk of developing adverse reactions, including extrapyramidal symptoms and / or withdrawal symptoms, which can vary in severity and duration after delivery.There were cases of arousal, increased and decreased muscle tone, tremor, drowsiness, respiratory distress, and eating disorders. Therefore, newborns should be carefully monitored. Animal studies have shown the presence of reproductive toxicity. Breastfeeding Considering the fact that flupentiksol in small concentrations is present in breast milk, it is unlikely to be able to have a negative effect on the child in the case of prescribing the drug to the mother in therapeutic doses. The dose administered orally to the child’s body is less than 0.5% of the daily maternal dose, adjusted for body weight. During treatment with Fluanxol, it is allowed to continue breastfeeding, if it is considered clinically necessary. However, it is recommended to monitor the condition of the newborn, especially in the first 4 weeks after birth.
Dosage and administration
Tablets are taken by mouth: swallow with water. Depression. Neurotic disorders. Psychosomatic disorders. Initially, 1 mg daily as a single morning dose or 0.5 mg twice a day. After a week with insufficient therapeutic effect, the dose may be increased to 2 mg per day. A daily dose of more than 2 mg and up to 3 mg should be divided into several doses. Elderly patients: the recommended daily dose is 0.5-1.5 mg. The reaction of patients to Fluanxol usually occurs within 2-3 days. If the effect of the maximum dose (3 mg per day) is not observed within a week, then the drug should be discontinued. Schizophrenia and schizophrenia-like psychosis. Doses of the drug should be selected individually depending on the patient's condition. As a rule, small doses should initially be applied, which are then rapidly increased to the optimum depending on the clinical effect. The initial daily dose - 3-15 mg - is divided into 2-3 doses. If necessary, the dose can be increased to 20-30 mg per day. The maximum daily dose is 40 mg. Conventional maintenance therapy is 5–20 mg per day. Maintenance dose can be administered once a day in the morning. Elderly patients: lower doses are recommended. The duration of therapy depends on the nature of the disease. Therapy of chronic psychosis can last several years.Reduced renal function: Fluankol can be administered in normal doses to patients with reduced kidney function. Reduced liver function: patients with reduced liver function should be given a lower dose, and if possible, monitor the concentration of flupentixol in the blood serum.
Side effects
Most adverse reactions are dose-dependent. The frequency of occurrence of adverse reactions and their intensity are most pronounced in the early stages of treatment and decrease as therapy continues. During treatment with flupentixol and immediately after discontinuation of therapy, cases of appearance of suicidal thoughts and suicidal behavior were noted. Extrapyramidal disorders may occur, especially in the early stages of treatment. In most cases, these undesirable reactions are successfully controlled by lowering the dose and / or using antiparkinsonian drugs. However, the routine use of antiparkinsonian drugs for the prevention of adverse reactions is not recommended. They do not facilitate the manifestations of tardive dyskinesia and may worsen them. A dose reduction or, if possible, discontinuation of flupentixol therapy is recommended. Benzodiazepines or propranolol may be useful in persistent akathisia. Information on the incidence of adverse reactions is presented on the basis of literature data and spontaneous reports. Frequency is indicated as: very often (1/10), often (from 1/100 to <1/10), infrequently (from 1/1000 to <1/100), rarely (from 1/10000 to <1/1000) , very rarely (<1/10000), or unknown (cannot be estimated based on existing data). Blood and lymphatic system disorders: rarely - thrombocytopenia, neutropenia, granulocytopenia, agranulocytosis, leukopenia, hemolytic anemia. Immune system disorders: rarely - hypersensitivity, anaphylactic reactions. Endocrine disorders: rarely - hyperprolactinemia, dysmenorrhea, diabetes, reduced potency, changes in carbohydrate metabolism. Metabolism and nutrition disorders: often - increase in appetite, increase in body weight, infrequently - loss of appetite, rarely - hyperglycemia, impaired glucose tolerance. Mental disorders: often - insomnia, depression, nervousness, agitation, decreased libido, infrequently - confusion, it is not known - suicidal thoughts, suicidal behavior.Nervous system disorders: very often - drowsiness, akathisia, hyperkinesia, hypokinesia, often - dizziness, headache, tremor, dystonia, attention disorder, from rarely to rarely - tardive dyskinesia, dyskinesia, parkinsonism, speech disorders, convulsive disorders, very rarely - neuroleptic malignant syndrome. Violations on the part of the organ of vision: often - disturbance of accommodation, blurred vision, infrequently - involuntary movement of the eyeballs. Heart disturbances: often - tachycardia, feeling of heartbeat, rarely - prolongation of the QT interval on the electrocardiogram. Violations of the vessels: infrequently - lowering blood pressure, "hot flashes", very rarely - venous thromboembolism. Disturbances from the respiratory system, organs of the chest and mediastinum: often - shortness of breath. Disorders of the gastrointestinal tract: very often - dry mouth, often - constipation, diarrhea, dyspepsia, increased salivation, vomiting, rarely - abdominal pain, nausea, flatulence. Disorders of the liver and biliary ducts: infrequently - changes in laboratory parameters of liver function, very rarely - jaundice. Violations of the skin and subcutaneous tissues: often - itching, sweating, infrequently - dermatitis, skin rash, photosensitization. Disorders of the musculoskeletal and connective tissues: often - myalgia, infrequently - muscular rigidity. Disturbances from the kidneys and urinary tract: often - urinary retention, urination disorder. Pregnancy, postpartum and perinatal conditions: unknown - neonatal withdrawal syndrome. Violations of the genital organs and the breast: infrequently - erectile dysfunction, ejaculation disorders, rarely - gynecomastia, galactorrhea, amenorrhea. General disorders and disorders at the injection site: often - weakness, asthenia. As with the use of other antipsychotic drugs while taking flupentixol, the following adverse reactions were also reported: in rare cases, prolongation of the QT interval, ventricular arrhythmias — fibrillation and tachycardia, sudden death, and Torsade des Pointes polymorphic ventricular tachycardia. Abrupt discontinuation of flupentixol may be accompanied by the appearance of "cancellation" reactions.The most common symptoms are nausea, vomiting, anorexia, diarrhea, rhinorrhea, sweating, myalgia, paresthesia, insomnia, nervousness, anxiety and agitation. Patients may also experience dizziness, sensations of heat and cold, and tremor. Symptoms, as a rule, begin within 1 - 4 days after cancellation and decrease within 7 - 14 days.
Overdose
Symptoms: drowsiness, coma, movement disorders, convulsions, shock, hyperthermia / hypothermia. With an overdose, simultaneously with taking medications that affect cardiac activity, ECG changes, prolongation of the QT interval, development of Torsade des Pointes, cardiac arrest, and ventricular arrhythmia have been reported. Treatment. Symptomatic and supportive. Gastric lavage should be performed as soon as possible, the use of activated carbon is recommended. Measures should be taken to support the activity of the respiratory and cardiovascular systems. Do not use epinephrine (adrenaline), because this can lead to a subsequent lowering of blood pressure. Seizures can be stopped by diazepam, and movement disorders biperidenom.
Interaction with other drugs
Fluanxol can enhance the sedative effect of alcohol, the effect of barbiturates and other CNS depressants. Fluanxol should not be prescribed together with guanethidine or similarly acting drugs because of the possible weakening of the hypotensive effect of these agents. The simultaneous use of neuroleptics and lithium increases the risk of neurotoxicity. Tricyclic antidepressants and antipsychotics mutually inhibit each other's metabolism. Fluanxol can reduce the effect of levodopa and the action of adrenergic drugs. Simultaneous use with metoclopramide and piperazine increases the risk of extrapyramidal disorders. An increase in the QT interval, characteristic of antipsychotic therapy, can be enhanced while taking drugs that prolong the QT interval: class I and Class III antiarrhythmic drugs (quinidine, amiodarone, sotalol, dofetilide), some antipsychotics (thioridazine), and some antibiotics – macrolides (erythromycin) and quinolone antibiotics (gatifloxacin, moxifloxacin), some antihistamines (terfenadine, astemizole), as well as cisapride, lithium, and other medicines, increased ivayuschih interval QT. It is necessary to avoid simultaneous administration of Fluanxol and the above mentioned drugs.Fluanksol should be prescribed with caution simultaneously with drugs that cause electrolyte disturbances (thiazide and thiazide-like diuretics), and drugs that can increase the concentration of flupentixol in the blood plasma, because of the possible increase in the risk of prolonged QT interval and the occurrence of life-threatening arrhythmias.