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Fluanxol pills 1 mg 50 pcs

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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.

special instructions

Contraindications: Hypersensitivity to flupentixol or any of the excipients (including known hypersensitivity to phenothiazines), hereditary galactose intolerance and / or fructose, lack lactase deficiency sucrase and isomaltase, impaired absorption of glucose and galactose, the vascular collapse, depression of any consciousness origin (including caused by alcohol, barbiturates or opioids), coma, children age (up to 18 years) .With caution: organic diseases brain, mental retardation, convulsive disorders, severe liver failure, hypokalemia, hypomagnesemia and genetic susceptibility to such conditions, history of cardiovascular diseases (risk of transient blood pressure reduction), including prolongation of the QT interval, bradycardia <50 beats per minute , recent acute myocardial infarction, decompensated heart failure, arrhythmia, risk factors for stroke, glaucoma (and predisposition to it), ulcerative bo gastric and duodenal ulcer disease, opioid and alcohol dependence (CNS depression may increase), pheochromocytoma, leukopenia, respiratory failure associated with acute infectious diseases, asthma or emphysema, lung cancer (increased extrapyramidal disorders, imbalance), an inoperable mode, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, an inoperable, anesthetic, adrenaline, anesthesia, heart failure with clinical manifestations (risk of urinary retention), Reye syndrome (increased risk of hepatotoxic action), pregnancy, breastfeeding period. It is not recommended to prescribe to patients in a state of psychomotor agitation a dose of the drug up to 25 mg / day, since the activating effect of Fluanxol can exacerbate these symptoms. When you receive any neuroleptics, there is the possibility of the development of a malignant neuroleptic syndrome (hyperthermia, muscle rigidity, episodes of loss of consciousness, instability of the autonomic nervous system). The risk increases when using stronger drugs.In patients with existing psychoorganic syndrome, dementia and dependence on opiates and / or alcohol, the incidence of death is higher. Treatment: Stop taking neuroleptics. Prescribe symptomatic and fortifying therapy. The use of dantrolene and bromocriptine is recommended. Symptomatology may persist for more than a week after discontinuation of oral neuroleptics and longer when using depot forms. As well as other neuroleptics flupentiksol it is necessary to appoint with care to patients with a psychoorganic syndrome, convulsive frustration and heavy dysfunction of a liver. It is not recommended to assign patients with highly excitable or hyperactive patients doses up to 25 mg / day, since the activating effect of the drug may worsen the patient's condition. If the patient received tranquilizers or neuroleptics with a sedative effect, they should be canceled gradually. Like other psychotropic drugs, flupentixol can change the concentration of insulin and glucose in the blood, which may require correction of the doses of hypoglycemic drugs in patients with diabetes. With long-term therapy, especially with high doses, it is necessary to conduct a careful monitoring, periodically assessing the condition of patients, in order to decide on the possibility of reducing the maintenance dose. Like other drugs belonging to the therapeutic class of neuroleptics, flupentixol can cause a prolongation of the QT interval. Continuously prolonged QT intervals may increase the risk of malignant arrhythmias. Therefore, flupentixol should be used with caution in patients with hypokalemia, hypomagnesemia, and a genetic predisposition to such conditions and in patients with a history of cardiovascular disease, such as prolongation of the QT interval, significant bradycardia (<50 beats per minute) recently undergoing acute myocardial infarction decompensated heart failure or arrhythmia. Concurrent use with other antipsychotics should be avoided. Depression is associated with an increased risk of suicidal thoughts, personal injury and suicide (suicidal acts). This risk persists until the onset of severe remission.Since there may be no improvement during the first few weeks of therapy or even a longer period of time, patients should be kept under constant observation until their condition improves. General clinical practice shows that an increased risk of suicide is possible in the early stages of recovery. Other mental conditions for which flupentixol is prescribed may also be associated with an increased risk of suicidal events and events. In addition, these conditions can be a comorbid condition in relation to a depressive episode. When treating patients with other mental disorders, the same precautions should be observed as in the treatment of patients with a depressive episode. Patients with a history of suicidal behavior, or patients with a significant level of reflection on suicidal topics prior to treatment, are more at risk of suicidal thoughts or suicide attempts, so they should be closely monitored during treatment. Meta-analysis of placebo-controlled clinical trials of antidepressants with the participation of adult patients with mental disorders showed that when taking antidepressants in patients younger than 25 years old there is an increased risk of suicidal behavior compared with taking placebo. Drug treatment of these patients and, in particular, patients with a high risk of suicide should be accompanied by careful observation, especially at an early stage of treatment and with dose changes. Patients (and those caring for patients) should be warned about the need to control any manifestations of clinical deterioration, suicidal behavior or thoughts, as well as unusual changes in behavior, and seek medical advice immediately when these symptoms appear. Cases of the development of venous thromboembolism have been reported while receiving antipsychotics. Due to the fact that patients under treatment with neuroleptics are often at risk of developing venous thromboembolism, before and during treatment with flupentixol, it is necessary to determine the risk factors for developing venous thromboembolism and take precautions. Older patients. Cerebrovascular adverse reactions.In a randomized, placebo-controlled clinical trial of the use of some atypical antipsychotics in patients with dementia, there was a 3-fold increase in the risk of cerebrovascular unwanted reactions. The mechanism for such an increase in risk is unknown. Increased risk cannot be ruled out when other antipsychotics are used in other groups of patients. Caution should be taken with flupentixol in patients at risk for stroke. Increased mortality in elderly patients with dementia. The data from two large observational studies have shown that elderly patients with dementia who took antipsychotics showed a slight increase in the risk of death compared with patients who did not take antipsychotics. There is no sufficient data to accurately assess the magnitude of the risk and the reasons for its increase. Fluanxol is not registered for the treatment of behavioral disorders in patients with dementia. Auxiliary substances. The pills contain lactose monohydrate. Patients with rare hereditary intolerance to galactose, lactase deficiency or impaired absorption of glucose and galactose should not take this drug. Tablets also contain sucrose. Patients with rare hereditary fructose intolerance, impaired absorption of glucose and galactose or deficiency sucrase and isomaltase should not take this drug.

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