Treatment of endogenous and organic psychoses with states of agitation and aggressiveness, anxiety and insomnia in neuroses and psychosomatic disorders, alcohol psychoses. The drug for use in pre-medication surgery to calm the patient and reduce neurovegetative reactions and to prevent post-operative emesis.
Composition:
1 tabl powl. contains 15 mg or 50 mg of chlorprotixene hydrochloride. The preparation (core of the tablet) contains lactose and sucrose.
Action:
Thioxanthen derivative with antipsychotic activity. The mechanism of action consists in blocking postsynaptic dopaminergic receptors in the brain and blocking α-adrenergic receptors and inhibiting the release of the majority of hypothalamic and pituitary hormones. The drug increases the concentration of prolactin as a result of blocking prolactinatin. Unlike other thioxanthene derivatives, chlorprothixene has a pronounced sedative effect because it inhibits the stimuli that flow into the reticular system of the brainstem. It also acts anti-emetically by inhibiting chemoreceptors in the spinal cord. It is quickly absorbed from the gastrointestinal tract and its effects appear within 30 minutes. It penetrates the blood-brain barrier, has a large volume of distribution in the body. It binds to plasma proteins in> 99%. It is extensively metabolised in the liver and excreted as metabolites in the urine and faeces. T0,5 is 8-12 h. The drug penetrates the placental barrier and is excreted into breast milk in small amounts.
Contraindications:
Hypersensitivity to chlorprotixene, thioxanthene derivatives or other components of the preparation. Impaired haemopoiesis, abnormalities in the blood picture. Depression o.u.n. (including depression o.u.n. running in poisoning with drugs or alcohol). Comatose states. Circulatory collapse. Children <6 years.
Precautions:
Particularly cautiously used in patients with severe hepatic, cardiovascular or respiratory disorders (eg with pneumonia, asthma, emphysema), narrow-angle glaucoma, myasthenia gravis, diabetes, prostatic hyperplasia (increased risk of urinary retention), mental retardation, epilepsy (the drug lowers the seizure threshold), fainting tenderness, Parkinson's disease (exacerbation of extrapyramidal symptoms), exposed to extreme temperatures, the elderly, alcoholism, overuse medicines with inhibitory effects on the c (risk of increased inhibitory effect) and during electroconvulsive therapy. When using the drug in children there is an increased risk of hepatotoxic effects with the symptoms of Reye's syndrome. It is not recommended for use in children and adolescents under 18 years of age - insufficient studies on efficacy and safety. In patients with hypersensitivity to phenothiazine derivatives, there is a risk of hypersensitivity to thioxanthene derivatives. Venous thromboembolism (VTE) events have been reported with the use of antipsychotics. Patients using these drugs often have acquired risk factors for venous thromboembolism. All possible VTE risk factors should be evaluated and appropriate preventive measures should be taken before and during the treatment. Elderly patients with dementia, using antipsychotics, have a slightly increased risk of death compared to patients who do not take these medicines; the cause of this increased risk is not known. The drug is not intended for the treatment of behavioral disorders associated with dementia. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose. Due to the sucrose content, the preparation should not be used in patients with fructose intolerance, sucrase-isomaltase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
During pregnancy, use only if the anticipated benefits to the mother outweigh the potential risk to the fetus. Breastfeeding during the use of the preparation is not recommended.
Side effects:
The risk of developing side effects increases with prolonged use of high doses. It is also greater in children and elderly patients. Common: drowsiness, headache, dizziness, tachycardia, orthostatic hypotension, constipation, fatigue, weight gain. Uncommon: dystonia, akathisia, extrapyramidal symptoms, dry mouth. Rarely: hypersensitivity reactions, apathy, increased anxiety, epileptic seizures, accommodation disorders, nasal congestion, nausea, dermatitis (rarely exfoliative), hypersensitivity to light, pruritus, erythema, eczema, thermoregulatory disorders of the body. Very rare: impairment of haemopoiesis (leukopenia, hemolytic thrombocytopenia, thrombocytopenic purpura, pancytopenia, eosinophilia, agranulocytosis), hyperglycemia, neuroleptic malignant syndrome - NMS (in case of symptoms of intestinal rhinitis, the preparation should be immediately discontinued and symptomatic treatment should be initiated in the ICU unit or in the anesthesiology department and resuscitation), tardive dyskinesia, retinitis pigmentosa, deposits in the lens, corneal deposits (the above-mentioned eye disorders occur in the case of long-term treatment with high doses), cardiac arrest, bradycardia, asthma, laryngeal edema, cholestatic jaundice (against the background of immunopathology), lupus-like syndrome, excessive uric acid excretion in urine, menstrual disorders, gynecomastia, galactorrhea, increased prolactin in the blood. Not known: events of venous thromboembolism, including cases of pulmonary embolism and deep vein thrombosis, priapism, discontinuation of the newborn. In rare cases, it is also possible to experience excessive excitement, especially in manic or schizoaffective patients (in such cases it is advisable to convert chlorprotixene to another neuroleptic).
Dosage:
Orally. Adults. Neurosis: usually 15 mg 1-3 times a day. Psychotic disorders: usually 50-100 mg 2-4 times a day. The daily dose should be divided so that the higher dose is given before going to sleep.