Fluanxol, 1 mg 50 pcs

Fluenxol is neuroleptic.

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

Pharmacodynamics

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

Pharmacokinetics

It is absorbed fairly quickly. Bioavailability is about 40%. Cmax is reached after 3-6 hours.

Passes through the HEB and placental barrier, in small amounts found in breast milk.

In the liver it forms inactive metabolites. It is excreted in the feces, partially in the urine. T1/2 is 35 hours.

Indications

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

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

Active ingredient

Composition

1 coated tablet contains:

flupentixol dihydrochloride, which corresponds to 1 mg of flupentixol;

Auxiliary substances:

Lactose monohydrate,

Potato starch,

How to take, the dosage

For therapy of depressive and anxiety disorders, the initial oral dose is 1 mg once daily in the morning or 500 mcg twice daily. In the absence of a satisfactory therapeutic effect after 1 week, the dose may be increased to 2 mg/day.

The daily dose of 2 mg to 3 mg should be divided into several doses. If there is no therapeutic effect when using Fluanksol at a maximum dose of 3 mg/day for 1 week, the drug should be discontinued.

In therapy 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 doses. If necessary, the dose may 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 once daily in the morning.

Interaction

When used concomitantly, Fluanxol may increase the sedative effect of ethanol, barbiturates and other CNS depressant drugs.

Fluanksol should not be used with guanethidine and agents with similar effects because neuroleptics may decrease their hypotensive effect.

Concomitant use of Fluanxol may decrease the effectiveness of levodopa and other adrenergic agents.

Concomitant use of Fluanksol with metoclopramide and piperazine increases the risk of extrapyramidal disorders.

Fluanksol should not be mixed with other fluids for injection.

Special Instructions

In concomitant treatment of diabetes mellitus, administration of Fluxol may require adjustment of the insulin dose.

If the patient has previously been treated with neuroleptics or tranquilizers with sedative effects, their administration should be stopped gradually.
During long-term therapy, especially with high doses of Fluxol, close monitoring and periodic evaluation of the patients’ condition is necessary.

In pregnancy, Fluanksol should be used only if the anticipated benefit to the mother exceeds the potential risk to the fetus.
Neonates whose mothers have taken neuroleptic agents in the last trimester of pregnancy or during delivery may show signs of intoxication, such as lethargy, tremors, and overexcitability. In addition, such newborns have a low Apgar score.

Breastfeeding is allowed during treatment with Fluanxol if clinically necessary. However, it is recommended that the condition of the newborn be monitored, especially in the first 4 weeks after birth.

During treatment, it is necessary to refrain from driving and engaging in potentially hazardous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

Hypersensitivity, severe toxic CNS depression and coma of any etiology, hepatic and renal dysfunction, malignant neuroleptic syndrome, central hyperthermia and toxic agranulocytosis in anamnesis, parkinsonism, acute fever states, pregnancy, breast-feeding (stop the treatment).

Side effects

The incidence and severity of side effects are most pronounced at the beginning of treatment, decreasing as therapy continues.

Nervous system disorders: somnolence, dizziness, headache, tremor, akathisia, parkinsonism, hypokinesia, dystonia; rarely – attention disorders, extrapyramidal disorders (mainly muscle rigidity and hyperkinesis), dyskinesia, amnesia, seizure disorders, tardive dystonia.

Psychiatric disorders: insomnia, nervousness, agitation; infrequently – decreased libido, depression, confusion.

Cardiovascular system: infrequent palpitations, orthostatic hypotension.

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

Visual organs: accommodation disorder, corneal and/or lens opacity with possible visual impairment; infrequent – oculogyric crisis.

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

Metabolic disorders and eating disorders: infrequent – decreased appetite, increased appetite.

Respiratory system disorders: infrequent – shortness of breath.

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

Urinary system disorders: infrequent urinary retention, painful urination.

Allergic reactions: infrequent itching, dermatitis, skin rash, photosensitization, increased sweating.

Muscular system and connective tissue disorders: infrequent – arthralgia.

Reproductive system disorders: infrequent – erectile dysfunction, galactorrhea.

With the body in general: weakness, asthenia; infrequent – weight gain.

There are data about development of malignant neuroleptic syndrome (MNS). The main symptoms of MNS are hyperthermia, muscle rigidity and impaired consciousness combined with autonomic nervous system dysfunction (labile blood pressure, tachycardia, increased sweating). In addition to immediate discontinuation of neuroleptics, the use of general supportive measures and symptomatic treatment is essential.

Patients on long-term treatment may develop tardive dyskinesia. Antiparkinsonian medications do not eliminate its symptoms and may exacerbate them. Dose reduction or, if possible, discontinuation of treatment is recommended.

In persistent akathisia, benzodiazepines or propranololol may be helpful.

There have been isolated reports of minor transient changes in liver function tests.

The following side effects have also been reported with flupentixol when taking other neuroleptics: prolongation of the QT interval, ventricular arrhythmias – ventricular fibrillation, ventricular tachycardia, sudden death and development of paroxysms of ventricular tachycardia (Torsade de Pointes) in rare cases.

Overdose

Symptoms:susceptibility, hyper- or hypothermia, extrapyramidal disorders, seizures, arterial hypotension, shock, coma may occur.

Treatment:Symptomatic and supportive therapy is carried out. In case of ingestion of the drug it is necessary to wash the stomach as soon as possible, sorbent administration is recommended. Measures should be taken to maintain respiratory and cardiovascular system activity. Adrenaline (epinephrine) should not be used, as it may lead to a subsequent decrease in BP. Seizures can be controlled with diazepam and extrapyramidal symptoms can be controlled with biperiden.

Pregnancy use

The use of Fluanksol in pregnancy and during lactation (breastfeeding) is possible only if the estimated benefit of therapy to the mother exceeds the potential risk to the fetus.

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

Breastfeeding is allowed during treatment with Fluanxol if it is clinically recognized as necessary. In such cases, it is recommended that the condition of the newborn be monitored, especially in the first 4 weeks after birth.