Fluanxol pills 1mg, 50pcs

Composition

1 coated tablet contains:

Active ingredient:

flupentixol dihydrochloride, 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 (E 172).

The pharmacological action

of Fluanxol is neuroleptic.

Blocks serotonin (S-HT2) dopamine (D1, D2) receptors.

Pharmacodynamics

It has pronounced antipsychotic and anxiolytic properties, anti-autistic and activating components.

Pharmacokinetics

It is absorbed quickly enough. Bioavailability is about 40%. Cmax is reached in 3-6 hours.

It passes through the GBI placental barrier, and is found in small amounts in breast milk.

It forms inactive metabolites in the liver. It is excreted in the faeces, partially in the urine. T 1/2 — 35 h.

Indications

In medium doses (4-40 mg / day): psychotic states with a predominance of hallucinatory-paranoid symptoms and thinking disorders, accompanied by apathy, anergy and autism.

In high doses (40-150 mg / day): acute and chronic psychoses, including schizophrenia, resistant to therapy, alcohol withdrawal syndrome.

Use during pregnancy and lactation

The use of Fluanxol during pregnancy and lactation (breastfeeding) is possible only in cases where the intended benefit of therapy for the mother exceeds the potential risk to the fetus.

Newborns whose mothers took antipsychotics in the third trimester of pregnancy or during childbirth may show signs of intoxication, such as lethargy, tremor, and excessive excitability. In addition, these newborns have a low Apgar score.

Breast-feeding is permitted during treatment with Fluanxol if it is clinically necessary. In such cases, it is recommended to monitor the condition of the newborn, especially in the first 4 weeks after birth.

Contraindications

Hypersensitivity, severe toxic depression of the central nervous system and comatose states of any etiology, impaired liver and kidney function, neuroleptic malignant syndrome, central hyperthermia and toxic agranulocytosis in the anamnesis, Parkinsonism, acute febrile conditions, pregnancy, breast-feeding (stop for the duration of treatment).

Side effects

The frequency of side effects and their severity are most pronounced at the beginning of treatment, and decrease with the continuation of therapy.

From the nervous system: drowsiness, dizziness, headache, tremor, akathisia, Parkinsonism, hypokinesia, dystonia; infrequently-attention disorders, extrapyramidal disorders (mainly muscle rigidity and hyperkinesis), dyskinesia, amnesia, convulsive disorders, late dystonia.

From the side of mental activity: insomnia, nervousness, agitation; infrequently-decreased libido, depression, confusion.

From the cardiovascular system: infrequently-palpitations, orthostatic hypotension.

Hematopoietic disorders: rarely-granulocytopenia, agranulocytosis (more likely between 4 and 10 weeks of treatment), leukopenia, hemolytic anemia.

From the side of the visual organs: impaired accommodation, opacity of the cornea and / or lens with possible visual impairment; infrequently-oculohiric crisis.

From the digestive system: dry mouth, digestive disorders (including constipation, diarrhea, dyspepsia, nausea), increased salivation, vomiting, cholestatic jaundice (more likely between 2 and 4 weeks of treatment).

Metabolic disorders and eating disorders: infrequently-decreased appetite, increased appetite.

From the respiratory system: infrequently-shortness of breath.

From the endocrine system: dysmenorrhea, gynecomastia, diabetes mellitus, decreased potency, changes in carbohydrate metabolism, hot flashes.

From the urinary system: infrequently-urinary retention, painful urination.

Allergic reactions: infrequently-pruritus, dermatitis, skin rash, photosensitization, increased sweating.

Musculoskeletal and connective tissue disorders: infrequently-arthralgia.

From the reproductive system: infrequently-erectile dysfunction, galactorrhea.

From the body as a whole: weakness, asthenia; infrequently – weight gain.

There are data on the development of neuroleptic malignant syndrome (NMS). The main symptoms of NMS are hyperthermia, muscle rigidity and impaired consciousness in combination with dysfunction of the autonomic nervous system (labile blood pressure, tachycardia, increased sweating). In addition to immediate discontinuation of antipsychotic medications, general supportive measures and symptomatic treatment are essential.

Patients undergoing long-term treatment may develop tardive dyskinesia. Antiparkinsonian medications do not eliminate its symptoms and may worsen them. It is recommended to reduce the dose or, if possible, discontinue treatment.

For persistent akathisia, benzodiazepines or propranolol may be useful.

There are isolated reports of the development of minor transient changes in the indicators of functional liver tests. When taking flupentixol, the following side effects that occur with other antipsychotics have also been reported: in rare cases, prolongation of the QT interval, ventricular (ventricular) arrhythmia – ventricular fibrillation, ventricular tachycardia, sudden death and the development of paroxysms of ventricular tachycardia (Torsade de Pointes).

Interaction

When used concomitantly, Fluanxol may increase the sedative effect of ethanol, barbiturates and other drugs that have a depressing effect on the central nervous system.

Fluanxol should not be used in conjunction with guanethidine and drugs with a similar effect, because neuroleptics can weaken their hypotensive effect.

When used concomitantly, Fluanxol may reduce the effectiveness of levodopa and other adrenergic agents.

When Fluanxol is co-administered with metoclopramide and piperazine, the risk of extrapyramidal disorders increases. Fluanxol should not be mixed with other fluids for injection.

How to take, course of use and dosage

For the treatment of depressive and anxiety disorders, the initial dose of the drug for oral use is 1 mg 1 time / day in the morning or 500 mcg 2 times/day. In the absence of a satisfactory therapeutic effect, the dose can be increased to 2 mg/day after 1 week. The daily dose, ranging from 2 mg to 3 mg, should be divided into several doses. If there is no therapeutic effect when using Fluanxol at a maximum dose of 3 mg / day for 1 week, the drug should be discontinued.

In the treatment of psychotic states, the dose is set individually, depending on the patient’s condition. The initial daily dose is 3-15 mg in 2-3 divided doses. If necessary, the dose can be increased to 20-30 mg / day. The maximum daily dose is 40 mg. For maintenance therapy, the drug is used in a dose of 5-20 mg 1 time/day in the morning.

Overdose

Symptoms:  possible drowsiness, hyper-or hypothermia, extrapyramidal disorders, seizures, hypotension, shock, coma.

Treatment:  conduct symptomatic and supportive therapy. If the drug is taken orally, it is necessary to flush the stomach as soon as possible, and it is recommended to take a sorbent. Measures should be taken to maintain the functioning of the respiratory and cardiovascular systems. Do not use epinephrine (epinephrine), as this may lead to a subsequent decrease in blood pressure. Seizures can be treated with diazepam, and extrapyramidal symptoms can be treated with biperiden.

Special instructions

With concomitant treatment of diabetes mellitus, the appointment of Fluanxol may require an adjustment of the insulin dose.

If the patient has previously been treated with antipsychotics or sedative tranquilizers, they should be discontinued gradually. With long-term therapy, especially with the use of high doses of Fluanxol, it is necessary to carefully monitor and periodically assess the condition of patients.

During pregnancy, Fluanxol should only be used if the intended benefit to the mother outweighs the potential risk to the fetus. Newborns whose mothers took antipsychotic medications in the last trimester of pregnancy or during labor may experience signs of intoxication, such as lethargy, tremors, and excessive excitability. In addition, these newborns have a low Apgar score.

Breast-feeding is permitted during treatment with Fluanxol if it is clinically necessary. However, it is recommended to monitor the condition of the newborn, especially in the first 4 weeks after birth.

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Tablets

Storage conditions

Store at a temperature not exceeding 30°C.

Shelf

life is 3 years.

Active ingredient

Flupentixol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Neurosis, Mental Disorders, Depression, Schizophrenia