One 15mg tablet contains: active substance – chlorprothixene hydrochloride 15 mg
Excipients: corn starch 10,000mg; lactose monohydrate 92,000mg; sucrose 10,000mg; calcium stearate 1,500mg; talc 1,500mg
The composition of the film shell: hypromellose 2910/5 – 2.011mg; macrogol 6000 – 0.069mg; macrogol 300 – 0.490; talc 1,430mg; Sanset yellow FCF, E 110 – 1,000mg
Chlorprothixene is rapidly absorbed in the gastrointestinal tract, its effect after oral administration occurs within 30 minutes. Binds to plasma proteins (over 99%). Chlorprothixene crosses the placental and blood-brain barrier and is excreted in breast milk in small amounts. The half-life is 8-12 hours. Metabolized in the liver, metabolites have no neuroleptic activity, excreted in feces and urine
Chlorprothixene is a neuroleptic derived from thioxanthene. It has antipsychotic and pronounced sedative effects. Possesses moderate antidepressant properties, has anticholinergic and adrenergic blocking effects
The antipsychotic effect of chlorprothixene is associated with its blocking effect on dopamine receptors. The antiemetic and analgesic properties of the drug are also associated with the blockade of these receptors. Chlorprothixene is able to block 5-HT2 -receptors, a1-adrenergic receptors, as well as H1 -histamine receptors, which determines its adrenolytic, hypotensive and antihistamine effects
Indications for use
Chlorprothixene is intended for use in adults, adolescents and children over the age of 6 years.
– psychoses, including schizophrenia and manic states, proceeding with psychomotor agitation, agitation and anxiety
– depressive conditions
– sleep disorders
– psychosomatic disorders (including dermatoses accompanied by persistent itching)
– with increased motor activity, irritability, agitation, behavioral disorders in elderly patients
– psychosomatic, neurotic and behavioral disorders in children
Method of administration and dosage
The dosage regimen of the drug Chlorprothixene is determined individually, depending on the type and severity of the disease, the therapeutic effect. Usually, at the beginning of the course of treatment, the drug is prescribed for adults at a dose of 30-45 mg (2-3 tablets) 3-4 times a day, for children and elderly patients, the drug is prescribed at a dose of 15-30 mg (1-2 tablets) 3-4 times a day. day or at a dose of 50 mg (1 tablet) 3-4 times a day. Given the pronounced sedative effect of the drug, it is recommended to prescribe most of the daily dose in the evening.
The course of treatment should be started with a low dose of the drug, gradually increasing it in the future, until a therapeutic effect is obtained. The daily dose of the drug in adults should not exceed 600 mg.
When the drug is discontinued, the dose should be reduced gradually. A quick cessation of the course of treatment with the drug, even after a few weeks, may manifest itself as vomiting, increased sweating, headache, insomnia, and anxiety.
Chlorprothixene should be taken with or after a meal, the tablets should be swallowed whole with a glass of water or milk
Chlorprothixene is usually well tolerated. The likelihood of side effects increases with prolonged use of high doses of the drug, as well as in children and the elderly.
– At the beginning of the course of treatment, increased fatigue, motor retardation, orthostatic hypotension are possible
– in rare cases, there are effects associated with anticholinergic action – dry mouth, tachycardia, hot flashes, impaired accommodation, constipation, urinary disorders
– disorders of the hematopoietic organs in the form of changes in the picture of peripheral blood (agranulocytosis, leukocytosis, leukopenia, hemolytic anemia),
– yellowness of the skin
– allergic reactions in the form of skin rashes and itching, increased photosensitivity, photodermatitis
– changes in the endocrine status in the form of amenorrhea, galactorrhea, gynecomastia, disorders of carbohydrate metabolism, weakening of potency and libido
– increased appetite with an increase in body weight, impaired thermoregulation
– paradoxical reactions in the form of a state of excitement, agitation, irritability
– hypersensitivity to chlorprothixene or thioxanthenes
– poisoning with drugs with a depressing effect on the central nervous system
– coma of any etiology
– children under 6 years old
– use of the drug during pregnancy and lactation
The depressing effect of chlorprothixene on the central nervous system can be enhanced when taken simultaneously with ethanol and drugs containing ethanol, anesthetics, opioid analgesics, sedatives, hypnotics, antipsychotics.
The anticholinergic effect of chlorprothixene is enhanced by the simultaneous use of anticholinergics, antihistamines and antiparkinsonian drugs.
The drug enhances the effect of antihypertensive drugs.
The simultaneous use of chlorprothixene and epinephrine can lead to arterial hypotension and tachycardia.
The use of chlorprothixene leads to a decrease in the seizure threshold, which requires additional dose adjustment of antiepileptic drugs.
The ability of chlorprothixene to block dopamine receptors reduces the effectiveness of levodopa.
The appearance of extrapyramidal disorders is possible with the simultaneous use of phenothiazines, metoclopramide, haloperidol, reserpine.
With the simultaneous use of chlorprothixene and bromocriptine, the dose of the latter should be adjusted, taking into account the possibility of chlorprothixene to increase the concentration of prolactin in the serum.
Particular care should be taken when prescribing Chlorprothixene to patients prone to alcoholism and drug addiction; patients with myasthenia gravis, angle-closure glaucoma; in patients with epilepsy, parkinsonism, with severe atherosclerosis of the cerebral vessels, with a tendency to collapse, with severe cardiovascular and respiratory failure, hematopoietic disorders, with severe liver and kidney dysfunction, diabetes mellitus, prostatic hypertrophy, as well as debilitated patients and the elderly.
Care should be taken to prescribe the drug in the treatment of electroshock, the simultaneous use of drugs with a depressing effect on the central nervous system.
The use of chlorprothixene can lead to a false positive result during an immunobiological urine test for pregnancy, a false increase in the level of bilirubin in the blood, a change in the level of the QT interval on the electrocardiogram.
During treatment with Chlorprothixene, it is recommended to refrain from drinking alcohol, avoid increased insolation, as well as extremely high or low temperature exposure.
Influence of the medicinal product on the ability to drive vehicles
Taking the drug Chlorprothixene has a negative effect on activities that require a high speed of mental and physical reactions, for example: driving vehicles, servicing cars, working at heights, etc.
Taking the drug in a single dose of 2.5-4 g or more can be fatal; in children, this dose is 4 mg / kg of body weight.
In case of an overdose (intoxication) with the drug, the following symptoms are possible: drowsiness, confusion, coma, respiratory failure, arterial hypotension, tachycardia, fever, miosis. With relief of signs of intoxication, convulsions, hyperactivity, hematuria are possible.
If signs of overdose (intoxication) appear with the drug, it is necessary to flush the stomach, do not induce vomiting, as this can lead to aspiration of vomit, take activated charcoal, saline laxatives, ensure adequate breathing, urgently consult a doctor.
Treatment is symptomatic, against the background of monitoring the indicators of vital body functions. It is necessary to provide adequate breathing, appropriate correction of body temperature, control and correction of blood pressure. Epinephrine should not be used because of the risk of paradoxical arterial hypotension.
In a dry place at a temperature of +10 to + 25 ° C.
Keep out of the reach of children!
Expiration date – 3 years
Do not use after the expiration date printed on the package.