Composition
1 film-coated tablet contains:
Active ingredient:
Chlorprothixen hydrochloride 50 mg,
Auxiliary substances:
corn starch – 37.5 mg,
lactose monohydrate-135 mg,
sucrose-20 mg,
calcium stearate-3.75 mg,
talc-3.75 mg.
Composition of the film shell:
hypromellose 2910/5 – 3.6594 mg, macrogol 6000-0.1333 mg, macrogol 300-0.9166 mg, talc-2.4194 mg, titanium dioxide-0.3423 mg, iron oxide yellow dye-0.029 mg
Pharmacological action
Antipsychotic agent (neuroleptic), a derivative of thioxanthene. It has antipsychotic, antidepressant, sedative, antiemetic effects, has alpha-adrenoblocking activity.
It is believed that the antipsychotic effect is associated with the blockade of postsynaptic dopamine receptors in the brain. The antiemetic effect is associated with the blockade of the chemoreceptor trigger zone of the medulla oblongata.
The sedative effect is caused by an indirect weakening of the activity of the reticular system of the brain stem. Inhibits the release of most hypothalamic and pituitary hormones.
However, as a result of blocking the prolactin-inhibiting factor, which inhibits the release of prolactin from the pituitary gland, the concentration of prolactin increases.
In terms of chemical structure and pharmacological properties, thioxanthenes are similar to piperazine derivatives of phenothiazine.
Indications
Psychosis and psychotic States, accompanied by anxiety, fear, psychomotor agitation, aggressiveness, including depressive-paranoid, circular of schizophrenia, with a simple sluggish schizophrenia with psychopathic and neurotic symptoms with other mental disorders,
encephalopathy, traumatic brain injury (in combination therapy), delirium tremens; sleep disorders in somatic diseases;
the need for long-term therapy the state of excitation and anxiety, psychosomatic, neurotic and behavioral disorders in children;
whooping cough, spastic conditions in the gastrointestinal tract;
premedication;
medicine, accompanied by persistent itching;
allergic reactions.
Use during pregnancy and lactation
Chlorprothixen should not, if possible, be prescribed to pregnant women and during breastfeeding.
Contraindications
- hypersensitivity to the components of Chlorprothixen;
- depression of the central nervous system of any origin (including caused by alcohol, barbiturates or opiates);
- comatose states;
- vascular collapse;
- diseases of the hematopoietic organs;
- pheochromocytoma.
Side effects
Drowsiness, tachycardia, dry mouth, excessive sweating, difficulty accommodating. These side effects, which usually occur at the beginning of therapy, often disappear as it continues.
Orthostatic hypotension may occur, especially when Chlorprothixen is used in high dosages.
Dizziness, dysmenorrhea, skin rashes, constipation are rare. Extrapyramidal symptoms are particularly rare.
Isolated cases of reduced seizure threshold, transient benign leukopenia and hemolytic anemia are described.
With prolonged use, especially in high doses, may occur: cholestatic jaundice, galactorrhea, gynecomastia, decreased potency and / or libido, increased appetite, weight gain.
Interaction
The depressing effect of Chlorprothixen on the central nervous system may be enhanced when taken simultaneously with ethanol and ethanol-containing drugs, anesthetics, opioid analgesics, sedatives, sleeping pills, and neuroleptics.
The anticholinergic effect of Chlorprothixen is enhanced by the simultaneous use of anticholinergic, antihistamines and antiparkinsonian agents.
The drug enhances the effect of antihypertensive agents.
Concomitant use of Chlorprothixen and epinephrine may lead to hypotension and tachycardia. The use of Chlorprothixen leads to a decrease in the threshold of convulsive activity, which requires additional dose adjustment of antiepileptic drugs in patients with epilepsy.
The ability of Chlorprothixen to block dopamine receptors reduces the effectiveness of levodopa.
Extrapyramidal disorders may occur with the simultaneous use of phenothiazines, metoclopramide, haloperidol, and reserpine.
How to take, course of use and dosage
Psychoses, including schizophrenia and manic states.
Treatment begins with 50-100 mg / day, gradually increasing the dose until the optimal effect is achieved, usually up to 300 mg / day. In some cases, the dose may be increased to 1200 mg / day. The maintenance dose is usually 100-200 mg / day. The daily dose of Chlorprothixen Zentiv is usually divided into 2-3 doses, given the pronounced sedative effect of Chlorprothixen Zentiv, it is recommended to prescribe a smaller part of the daily dose in the daytime, and most of it in the evening.
Hangover withdrawal syndrome in alcoholism and drug addiction.
The daily dose, divided into 2-3 doses, is 500 mg. The course of treatment usually lasts 7 days. After the withdrawal symptoms disappear, the dose is gradually reduced. A maintenance dose of 15-45 mg / day helps to stabilize the condition, reduces the risk of developing another binge.
In elderly patients with hyperactivity, irritability, agitation, confusion,15-90 mg/day is prescribed. The daily dose is usually divided into 3 doses.
In children, to correct behavioral disorders, Chlorprothixen Zentiva is prescribed at the rate of 0.5-2 mg/kg of body weight.
Depressive states, neuroses, psychosomatic disorders.
Chlorprothixen Zentiva can be used for depression, especially when combined with anxiety, tension, as an adjunct to antidepressant therapy, or on its own. Chlorprothixen Zentiva can be prescribed for neurosis and psychosomatic disorders accompanied by anxiety and depressive disorders up to 90 mg / day. The daily dose is usually divided into 2-3 doses. Since taking Chlorprothixen Zentiva does not cause the development of addiction or drug dependence, it can be used for a long time.
Insomnia. 15-30 mg in the evening 1 hour before bedtime.
Pain. The ability of Chlorprothixen Zentiv to potentiate the action of analgesics can be used in the treatment of patients with pain. In these cases, Chlorprothixen Zentiva is prescribed together with analgesics in doses from 15 to 300 mg.
Overdose
Symptoms. Drowsiness, hypo-or hyperthermia, extrapyramidal symptoms, convulsions, shock, coma.
Treatment. Symptomatic and supportive treatment.
Gastric lavage should be performed as soon as possible, and the use of a sorbent is recommended.
Measures should be taken to maintain the functioning of the respiratory and cardiovascular systems.
Do not use epinephrine, as this can lead to a subsequent decrease in blood pressure.
Seizures can be stopped with diazepam, and extrapyramidal disorders with biperiden.
Special instructions
Chlorprothixen should be used with caution in patients suffering from epilepsy, parkinsonism, severe cerebral vascular atherosclerosis, a tendency to collapse, severe cardiovascular and respiratory failure, severe liver and kidney dysfunction, diabetes mellitus, and prostatic hypertrophy.
The use of Chlorprothixen can lead to a false positive result during an immunobiological test of urine for pregnancy, a false increase in the level of bilirubin in the blood, a change in the QT interval on the electrocardiogram.
During treatment with the drug, it is recommended to refrain from drinking alcoholic beverages, avoid increased sun exposure.
Influence on the ability to drive motor vehicles and manage mechanisms
Taking Chlorprothixen has a negative impact on activities that require a high rate of mental and physical reactions (for example, driving vehicles, servicing machines, working at heights, etc. ).
Storage conditions
In a dark place, at a temperature not exceeding 25°C.
Shelf
life is 3 years.
Active ingredient
Chlorprothixen
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
Purpose
For adults as prescribed by a doctor, for children as prescribed by a doctor
Indications
Schizophrenia, Mental disorders, Manic-depressive psychosis, Insomnia, Neurosis, Depression, Hangover
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