Chlorprothixene Zentiva instructions for use

Russian name

Chlorprothixenum
(

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Chlorprothixeni)

(Z)-3-(2-Chloro-9H-thioxanthene-9-ylidene)-N,N-dimethyl-1-propanamine (and as hydrochloride)

Pharmacological group of the substance Chlorprothixene

Release form and composition

1 film-coated tablet contains chlorprothixene 15 or 50 mg; 10 pcs in a blister, 3 blisters in a box.

The dosage form of Chlorprothixene Zentiva is film-coated tablets: round, biconvex, orange (15 mg each) or light brown to light yellow (50 mg each); the color of the kernel at the break is from almost white to white (in a cardboard pack there are 3 or 5 contour strip packs of 10 pcs.).

Composition of 1 tablet:

• active substance: chlorprothixene hydrochloride – 15 or 50 mg;
• auxiliary components (15/50 mg): corn starch – 10/37.5 mg; lactose monohydrate – 92/135 mg; sucrose – 10/20 mg; calcium stearate – 1.5/3.75 mg; talc – 1.5/3.75 mg;
• shell (15/50 mg): hypromellose 2910/5 – 2.011/3.659 4 mg; macrogol 6000 – 0.069/0.133 3 mg; macrogol 300 – 0.49/0.916 6 mg; talc – 1.43/2.419 4 mg; aluminum varnish based on sunset yellow dye (E110) – 1/0 mg; titanium dioxide – 0.342 3 mg.

Chlorprothixene Zentiva

One of the most effective, powerful antipsychotic drugs is Chlorprothixene Zentiva. This effective remedy comes in several forms and is considered a thioxanthene derivative. With its help you can cope with mild or serious mental disorders, nervous breakdowns, insomnia, the consequences of chronic alcoholism and other pathologies. To achieve the maximum positive result from Chlorprothixene therapy, you must strictly follow the recommendations of your doctor and adhere to the instructions for use of the drug.

Composition and release form

Most pharmacies sell the antipsychotic drug in several dosage forms. More common are convex orange (15 mg) or brown (50 mg) film-coated Chlorprothixene tablets. They are produced in blisters of 10 pieces - one package contains 50 tablets. The main active component is chlorprothixene hydrochloride, additional substances: sucrose, talc, lactose monohydrate, corn starch, calcium stearate. The antipsychotic can be in the form of oral drops or an injection solution (1/2 ml ampoules, 10 or 100 pieces per package).

Pharmacological properties

The medication has a neuroleptic (slows down the central nervous system), antipsychotic, sedative (tranquilizing), hypotensive effect. The drug Chlorprothixene also provides antiemetic, anticonvulsant and analgesic effects. In addition to this, it has the ability to increase the level of initiative, speed of thinking, and eliminate feelings of fatigue in unusual conditions.

The neuroleptic works well at blocking dopamine receptors, the mesolimbic and mesocortical systems (in other words, it relieves a person from delusional states and hallucinations). The medication also has antiemetic, adrenergic blocking, and antihistamine properties. The active ingredient of the drug is absorbed from the intestines, and its maximum amount in the blood serum is reached after two hours. The metabolites do not exhibit neuroleptic activity and are excreted from the body in urine and feces.

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Indications for use

A medication with antipsychotic effects has a number of indications. According to the instructions, the main conditions and diseases treated with Chlorprothixene are:

• sleep disturbances (one-time or regular);
• depression;
• disruptions in children's behavioral reactions;
• severe form of psychosis (manic attacks, schizophrenia);
• brain injuries;
• the likelihood of miscarriage, premature labor;
• attacks of vomiting, spasms of the gastrointestinal tract;
• anxiety;
• diseases of a somatic nature, the symptoms of which are itchy skin, neuroses;
• sclerosis;
• confusion, irritability in older people;
• encephalopathy;
• preparation for general anesthesia;
• acclimatization period;
• neurotic conditions, characterized by anxiety, fear, aggressive behavior;
• pain (neuroleptic enhances the effect of analgesics);
• severe, convulsive cough;
• withdrawal reaction (hangover) caused by regular use of alcohol and/or drugs;
• neurotic dermatosis, which causes itching;
• An antipsychotic drug is used in psychotherapeutic intervention.

Terms and conditions of storage

Indications for Chlorprothixene Zentiva are the following conditions and diseases:

• insomnia;
• psychoses, including manic states and schizophrenia, accompanied by psychomotor agitation, anxiety and agitation;
• depressive states, neuroses, psychosomatic disorders;
• withdrawal syndrome in alcoholism and drug addiction;
• behavioral disorders in children;
• confusion, hyperactivity, agitation, irritability in elderly patients;
• pain (in combination with analgesics).

Absolute:

• bone marrow suppression;
• pathological changes in the blood;
• pheochromocytoma;
• lactose or fructose intolerance, glucose-galactose malabsorption or lactase deficiency, isomaltase/sucrase deficiency (Chlorprothixene Zentiva contains lactose and sucrose);
• depression of the central nervous system of any origin (including those associated with the intake of alcohol, opiates or barbiturates);
• vascular collapse;
• comatose states;
• age up to 6 years;
• individual intolerance to the components of the drug, including phenothiazines.

Relative (Chlorprothixene Zentiva is prescribed under medical supervision):

• tendency to collapse;
• diabetes;
• glaucoma (including the presence of a predisposition to its occurrence);
• urinary retention and the risk of its development in clinical manifestations of prostatic hyperplasia;
• renal/liver failure;
• Reye's syndrome;
• Parkinson's disease (associated with increased extrapyramidal disorders);
• severe cardiovascular and respiratory failure associated with acute infectious diseases, asthma or emphysema (there is a high risk of a transient increase in blood pressure);
• severe cerebral atherosclerosis;
• peptic ulcer of the stomach and duodenum;
• epilepsy (associated with the likelihood of increased seizures as a result of a lowered seizure threshold);
• pregnancy and lactation period.

Store at temperatures up to 25 °C. Keep away from children.

Shelf life – 3 years.

Dispensed by prescription.

Hypersensitivity; poisoning with central nervous system depressants (including alcohol), coma, vascular collapse, pheochromocytoma, diseases of the hematopoietic organs, pregnancy, breastfeeding, children (up to 6 years).

Psychoses, incl. schizophrenia, depressive states during menopause, states of excitation associated with fear and tension, discirculatory encephalopathy, traumatic brain injuries, delirium tremens, sleep disturbances in anxiety states; psychosomatic, neurotic disorders in children; in patients with burns; dermatoses with persistent itching.

Absolute: hypersensitivity, poisoning with drugs that depress the central nervous system (including alcohol), coma of any etiology.

Relative: epilepsy, parkinsonism, tendency to collapse, severe dysfunction of the kidneys, liver, heart and breathing, closed-angle glaucoma, myasthenia gravis, pregnancy, lactation (breastfeeding should be avoided), old age.

In a dry place, at a temperature of 10–25 °C.

Keep out of the reach of children.

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3 years.

Do not use after the expiration date stated on the package.

Overdose

Symptoms Drowsiness, hypo- or hyperthermia, extrapyramidal symptoms, convulsions, shock, coma.

Treatment. Symptomatic and supportive. Gastric lavage should be performed as quickly as possible, and the use of a sorbent is recommended. Measures should be taken to maintain the functioning of the respiratory and cardiovascular systems. Adrenaline should not be used because this may lead to a subsequent decrease in blood pressure. Seizures can be treated with diazepam, and extrapyramidal disorders with biperiden.

Synonyms of nosological groups

Side effects of the substance Chlorprothixene

Extrapyramidal disorders, increased fatigue, headache, dry mouth, orthostatic hypertension, tachycardia, accommodation disturbances, blurred vision, constipation, urinary disorders, jaundice, amenorrhea, galactorrhea, gynecomastia, changes in libido, carbohydrate metabolism disorders, increased appetite, weight gain , agranulocytosis, leukopenia, photosensitivity, photodermatitis, withdrawal syndrome (with sudden cessation of treatment).

Possible adverse reactions ({amp}gt; 10% - very often; {amp}gt; 1% and {amp}lt; 10% - often; {amp}gt; 0.1% and {amp}lt; 1% – infrequently; {amp}gt; 0.01% and {amp}lt; 0.1% – rare; {amp}lt; 0.01% – very rare):

• cardiovascular system: orthostatic hypotension (especially when using high doses of Chlorprothixene Zentiva), transient changes in the QT interval on the electrocardiogram and tachycardia;
• nervous system: dizziness, increased fatigue, drowsiness, psychomotor retardation, mild extrapyramidal hypokinetic-hypertensive syndrome, akathisia (during the first 6 hours after administration), dystonic reactions, persistent tardive dyskinesia (disturbances usually appear at the beginning of therapy and often as it continues disappear on their own); rarely - tardive dystonia, neuroleptic malignant syndrome;
• endocrine system: rarely – dysmenorrhea; with long-term use of high doses of Chlorprothixene Zentiva - galactorrhea, diabetes mellitus, gynecomastia, decreased potency/libido, increased sweating, changes in carbohydrate metabolism, increased appetite, weight gain;
• digestive system: xerostomia (transient); rarely - constipation, cholestatic jaundice (with a long course, especially with the use of high doses, the development of a disorder is most likely between 2 and 4 weeks of therapy);
• hematopoietic organs: rarely – agranulocytosis (the disorder most often develops at 4–10 weeks of treatment); in isolated cases - transient benign leukopenia and hemolytic anemia;
• sensory organs: clouding of the lens/cornea with possible visual impairment, accommodation paresis (occurs at the beginning of treatment and disappears as Chlorprothixene Zentiva continues to be taken);
• others: skin rash, urinary retention, dermatitis, flushing, withdrawal syndrome, photosensitivity.

From the nervous system and sensory organs: increased fatigue, dizziness, psychomotor retardation, mild extrapyramidal hypokinetic-hypertensive syndrome, akathisia (within the first 6 hours after administration), dystonic reactions, persistent tardive dyskinesia, opacification of the cornea and/or lens with possible impairment vision, accommodation paresis; rarely - neuroleptic malignant syndrome, tardive dystonia.

From the cardiovascular system and blood (hematopoiesis, hemostasis): orthostatic hypotension, tachycardia, change in the QT interval on the ECG; rarely - agranulocytosis (more likely between 4-10 weeks of treatment), leukopenia, hemolytic anemia.

From the gastrointestinal tract: dryness of the oral mucosa, constipation, cholestatic jaundice (more likely between 2–4 weeks of treatment).

From the genitourinary system: urinary retention, dysmenorrhea, decreased potency and/or libido.

Allergic reactions: skin rash, dermatitis, photosensitivity.

Other: withdrawal syndrome, flushing, galactorrhea, gynecomastia, increased appetite, changes in carbohydrate metabolism, weight gain, increased sweating.

Chlorprothixene Zentiva instructions for use

Active ingredient Chlorprothixene Dosage form: film-coated tablets

Composition: Each film-coated tablet, 15 mg, contains: active substance chlorprothixene hydrochloride - 15 mg; excipients core: corn starch - 10 mg, lactose monohydrate - 92 mg, sucrose - 10 mg, calcium stearate - 1.5 mg, talc - 1.5 mg; film coating: hypromellose 2910/5 - 2.011 mg, macrogol 6000 - 0.069 mg, macrogol 300 - 0.49 mg, talc - 1.43 mg, aluminum varnish based on sunset yellow dye (E 110) - 1 mg. Each film-coated tablet, 50 mg, contains: active substance - chlorprothixene hydrochloride - 50 mg; excipients core: corn starch 37.5 mg, lactose monohydrate - 135 mg, sucrose - 20 mg, calcium stearate - 3.75 mg, talc - 3.75 mg; film coating: 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 dye yellow oxide - 0 .0290 mg.

Description: 15 mg tablets: round, biconvex, orange film-coated tablets. Fractured appearance: the core is white to almost white. 50 mg tablets: round, biconvex, film-coated tablets from light brown to light yellow. Fractured appearance: the core is white to almost white.

Pharmacotherapeutic group: antipsychotic (neuroleptic)

ATX: N05AF03

Pharmacodynamics: Chlorprothixene is an antipsychotic, a thioxanthene derivative. It has antipsychotic, pronounced sedative and moderate antidepressant 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, α1-adrenergic receptors, as well as Hi-histamine receptors, which determines its adrenergic blocking hypotensive and antihistamine actions.

Pharmacokinetics: The bioavailability of chlorprothixene when taken orally is about 12%. After oral administration, it is quickly and well absorbed. It undergoes first-pass metabolism in the intestinal walls and liver. Has a “first pass” effect through the liver. Penetrates through the placental barrier and into breast milk. It is excreted by the kidneys and intestines, mostly in the form of metabolites: when taking a daily dose of 300 mg - about 29% in the form of chlorprothixene, 41% - chlorprothixene sulfoxide. The half-life is 8-12 hours.

Indications: - psychoses, including schizophrenia and manic states, occurring with psychomotor agitation, agitation and anxiety; - withdrawal syndrome in alcoholism and drug addiction - hyperactivity, irritability, agitation, confusion in elderly patients; — behavioral disorders in children; — depressive states, neuroses, psychosomatic disorders; - insomnia; - pain (in combination with analgesics).

Contraindications: Hypersensitivity to the components of the drug (including phenothiazines). Central nervous system (CNS) depression of any origin (including those caused by alcohol, barbiturates or opiates), coma, vascular collapse, pathological changes in the blood, bone marrow depression, pheochromocytoma, hereditary diseases such as lactose or fructose intolerance, lactase deficiency or glucose-galactose malabsorption, sucrase/isomaltase deficiency (due to the presence of lactose and sucrose in the composition), children under 6 years of age. With caution: with a tendency to collapse, with severe cardiovascular and respiratory failure (due to acute infectious diseases, asthma or emphysema), the risk of a transient increase in blood pressure (BP), severe cerebral atherosclerosis, glaucoma (including a predisposition to it ), peptic ulcer of the stomach and duodenum, renal and/or liver failure, urinary retention and the risk of urinary retention in clinical manifestations of prostatic hyperplasia, Reye's syndrome (increased risk of hepatotoxicity), Parkinson's disease (possibly increased extrapyramidal disorders), epilepsy (possible increased frequency of attacks as a result of a decrease in the seizure threshold), diabetes mellitus. Alcohol abuse can enhance CNS depression.

Pregnancy and lactation: Chlorprothixene should not be prescribed to pregnant women or during breastfeeding.

Method of administration and dosage: Chlorprothixene Zentiva can be used for a long time because it does not cause addiction or drug dependence. 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. The maintenance dose is usually 100-200 mg/day. The maximum daily dose for adults is 600 mg. The daily dose of Chlorprothixene Zentiva is usually divided into 2-3 doses, given the pronounced sedative effect of Chlorprothixene Zentiva, it is recommended to prescribe a smaller part of the daily dose in the daytime, and the larger part in the evening. 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 symptoms of withdrawal disappear, the dose is gradually reduced. A maintenance dose of 15-45 mg/day allows you to stabilize the condition and reduces the risk of developing another binge. In elderly patients In the presence of 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, Chlorprothixene Zentiva is prescribed at the rate of 0.5-2 mg per 1 kg of weight. Depressive states, neuroses, psychosomatic disorders Chlorprothixene Zentiva can be used for depression, especially when combined with anxiety, tension, as an addition to antidepressant therapy or independently. Chlorprothixene Zentiva can be prescribed for neuroses and psychosomatic disorders accompanied by anxiety and depressive disorders up to 90 mg/day. The daily dose is usually divided into 2-3 doses. Insomnia 15-30 mg in the evening 1 hour before bedtime. Pain The ability of Chlorprothixene Zentiva to potentiate the action of analgesics can be used in the treatment of patients with pain. In these cases, Chlorprothixene Zentiva is prescribed together with analgesics in doses of 15 to 300 mg.

Side effects: The frequency of the adverse reactions listed below was determined according to the following (World Health Organization classification): very often - more than 1/10, often - from more than 1/100 to less than 1/10, infrequently - from more than 1/1000 to less 1/100, rarely - from more than 1/10000 to less than 1/1000, very rarely - from less than 1/10000, including individual messages. From the nervous system: drowsiness, increased fatigue, dizziness, psychomotor retardation, mild extralyramide hypokinetic-hypertensive syndrome, akathisia (within the first 6 hours after administration), dystonic reactions, persistent tardive dyskinesia (these side effects usually occur at the beginning of therapy and often disappear as it continues); rarely - neuroleptic malignant syndrome, tardive dystonia. From the cardiovascular system: orthostatic hypotension (especially when using Chlorprothixene Zentiva in high doses), transient tachycardia and changes in the QT interval on the electrocardiogram. From the digestive system: transient dryness of the oral mucosa; rarely - constipation, cholestatic jaundice with long-term use, especially in high doses (more likely between 2-4 weeks of treatment). From the endocrine system: rarely - dysmenorrhea, with long-term use in high doses - galactorrhea, gynecomastia, diabetes mellitus, decreased potency and/or libido, increased appetite, changes in carbohydrate metabolism, weight gain, increased sweating, which occurs temporarily at the beginning of therapy. From the senses: clouding of the cornea and/or lens with possible visual impairment, accommodation paresis at the beginning of treatment and disappearing as therapy continues. From the hematopoietic organs: rarely - agranulocytosis (more likely between 4-10 weeks of treatment), isolated cases of transient benign leukopenia and hemolytic anemia. Other: urinary retention, skin rash, dermatitis, photosensitivity, flushing syndrome.

Overdose: Symptoms: Drowsiness, hypo- or hyperthermia, extrapyramidal symptoms, convulsions, shock, coma. Treatment: Symptomatic and supportive. Gastric lavage should be performed as quickly as possible; the use of activated carbon is recommended. Measures should be taken to maintain the functioning of the respiratory and cardiovascular systems. Epinephrine should not be used because this may lead to a subsequent decrease in blood pressure. Seizures can be treated with diazepam, and extrapyramidal disorders with biperiden.

Interaction: The inhibitory effect of chlorprothixene on the central nervous system can be enhanced when taken simultaneously with ethanol and ethanol-containing drugs, anesthetics, opioid analgesics, sedatives, hypnotics, and antipsychotics. The anticholinergic effect of chlorprothixene is enhanced by the simultaneous use of M-cholinergic blockers, antihistamines and antiparkinsonian drugs. The use of chlorprothixene leads to a decrease in the threshold of convulsive activity, which requires additional adjustment of the dose of antiepileptic drugs in patients with epilepsy. The ability of chlorprothixene to block dopamine receptors reduces the effectiveness of levodopa. Compatible with thymoleptics (including amitriptyline, nortriptyline, imipramine, dosulepin). Extrapyramidal disorders may occur with the simultaneous use of phenothiazines, metoclopramide, haloperidol, and reserpine. It is possible to distort the peripheral vasoconstrictor effect caused by dopamine in high doses, epinephrine and ephedrine (chlorprothixene has an alpha-adrenergic blocking effect). Pre-administration of thioxanthenes may reduce the vasoconstrictor effect of phenylephrine. The drug enhances the effect of antihypertensive drugs. The simultaneous use of chlorprothixene and epinephrine can lead to arterial hypotension and tachycardia. Reduces the hypotensive effect of guanethidine due to its displacement from adrenergic neurons and inhibition of its uptake by these neurons. Quinidine increases the risk of cardiac side effects. May mask symptoms of ototoxicity (tinnitus, dizziness) of ototoxic drugs (especially antibiotics). Due to hyperprolactinemia, adjustment of the bromocriptine dosage regimen may be required.

Special instructions: The use of Chlorprothixene Zentiva can lead to a false positive result when conducting an immunobiological urine pregnancy test, false indicators of gilerbilirubinemia, and a change in the QT interval on the electrocardiogram. Dystonic reactions are most common in children and young patients; usually appear early in the course of treatment and may subside within 24-48 hours after cessation of treatment. Parkinsonian extralyramide effects may be observed in the first few days of treatment, but their frequency usually increases with increasing dose; may be more common in older patients and older children Tardive dyskinesia at the beginning of treatment is dose-dependent, but its frequency may increase with long-term treatment and as the total dose is reached; may persist after discontinuation of thioxanthenes. During the treatment period, it is necessary to conduct a blood test and determine the leukocyte formula, monitor liver function indicators, ophthalmological examination, as well as careful observation to identify early signs of tardive dyskinesia and dystonia. The likelihood of hypotensive and extrapyramidal reactions in adolescents is higher than in adults. Neuroleptic malignant syndrome can occur at any time during treatment with antipsychotic drugs, but more often it develops soon after the start of therapy or after transferring the patient from another antipsychotic drug, during combination treatment with other psychoactive drugs, or after an increase in dose. Although not all of the side effects listed are specifically associated with each thioxanthene, it is possible that they may occur with any drug in this group. During treatment, you should refrain from taking ethanol, exposure to extremely high temperatures (risk of heat stroke), and insolation. To avoid the development of withdrawal syndrome, it is necessary to stop treatment gradually.

Impact on the ability to drive vehicles. Wed and fur.: While taking the drug Chlorprothixene Zentiva, care should be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form/dosage: Film-coated tablets 15 mg, 50 mg.

Packaging: 10 tablets in a PVC/A1 blister. 3 or 5 blisters along with instructions for use in a cardboard box.

Storage conditions: At a temperature not exceeding 25 °C. Keep out of the reach of children.

Shelf life: 3 years. Do not use after the expiration date stated on the package.

Conditions for dispensing from pharmacies: By prescription

Manufacturer: ZENTIVA, ks

Interaction

• ethanol and ethanol-containing drugs, anesthetics, opioid analgesics, sedatives, hypnotics, antipsychotics: the inhibitory effect of chlorprothixene on the central nervous system is enhanced;
• antiepileptic drugs (in patients with epilepsy): the threshold of convulsive activity is reduced (additional dose adjustment is required);
• m-cholinergic blockers, antihistamines and antiparkinsonian drugs: the anticholinergic effect of chlorprothixene is enhanced;
• phenothiazines, metoclopramide, haloperidol, reserpine: extrapyramidal disorders may occur;
• levodopa: its effectiveness decreases;
• phenylephrine: vasoconstrictor effect may be reduced;
• dopamine (in high doses), epinephrine and ephedrine: peripheral vasoconstrictor effect may be perverted;
• epinephrine: hypotension and tachycardia may develop;
• antihypertensive drugs: their effect is enhanced;
• quinidine: the risk of adverse reactions from the heart increases;
• guanethidine: the hypotensive effect is reduced;
• bromocriptine: hyperprolactinemia may develop, which requires adjustment of the dosage regimen;
• ototoxic drugs (especially antibiotics): chlorprothixene may mask symptoms of ototoxicity (in the form of tinnitus, dizziness).

Enhances the effect of drugs that depress the central nervous system, incl. alcohol.

The inhibitory effect of chlorprothixene on the central nervous system may be enhanced when used simultaneously with general anesthetics, narcotic analgesics, sedatives, hypnotics, other neuroleptics, as well as with ethanol and ethanol-containing drugs. The anticholinergic effect is enhanced by the simultaneous use of anticholinergic, antihistamine and antiparkinsonian drugs.

Cross-drug interactions

The suppressive effect of the drug on the central nervous system is enhanced when taken together with alcohol, ethanol-containing medications, anesthesia, narcotic painkillers, sedative and hypnotic drugs, and antipsychotics.

M-anticholinergic agents can enhance the anticholinergic effect of Chlorprothixene. The same thing happens when taken together with antihistamines and antiparkinsonian drugs. Since the active substance Chlorprothixene reduces the level of convulsive activity, dosage adjustment of antiepileptic drugs is required during therapy.

Chlorprothixene is not recommended to be taken simultaneously with Levodopa, as it reduces its effectiveness.

Taking with Phenothiazine, Metoclopramide, Rezprpine or Haloperidol increases the risk of extrapyramidal disorders.

Chlorprothixene has an alpha-adrenergic blocking effect, so when combined with Epinephrine or Ephedrine, it can distort peripheral vasoconstriction.

Chlorprothixene potentiates the effect of drugs with a hypotensive effect. Simultaneous use may contribute to arterial hypotension and tachycardia.

When combining Chlorprothixene with Bromocriptine, hyperprolactinemia may develop, so dosage adjustment of the latter medication is necessary.

Pharmacology

It has antiserotonin, cholinergic and adrenolytic activity. Blocks dopamine receptors in polyneuronal synapses of the brain (relieves the productive symptoms of psychosis - delusions and hallucinations), as well as in the nigrostriatal zone and tubuloinfundibular region (which causes extrapyramidal disorders). Binds histamine, serotonin, alpha-adrenergic and cholinergic receptors in the central nervous system, inhibits the trigger zone of the vomiting center.

When taken orally, it is quickly absorbed. The action occurs within 20 minutes. Subjected to first-pass metabolism (in the intestinal walls and liver); due to the “first pass” effect, plasma concentrations are always lower than with intramuscular administration. Penetrates through the placental barrier and into breast milk. It is excreted by the kidneys and intestines, primarily in the form of metabolites (at a daily dose of 300 mg - about 29% as chlorprothixene, 41% as chlorprothixene sulfoxide). T1/2 is 8–12 hours.

Directions for use and doses

Orally, during or after meals, without chewing, with water. The dosage regimen is determined individually. Typically for adults: 30–50 mg 3–4 times daily. Treatment begins with low doses, then the dose is gradually increased until signs of the disease disappear. Most of the dose is usually given at night. The daily dose for adults should not exceed 600 mg.

Children: 15–30 mg 3–4 times a day.

Chlorprothixene Zentiva is intended for oral administration. Long-term therapy is possible, since the drug does not cause addiction or drug dependence.

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Recommended dosage regimen:

• psychoses, including manic states and schizophrenia: initial daily dose – 50–100 mg. The dose is gradually increased until the optimal effect is achieved, usually 300 mg. The average maintenance dose is 100 to 200 mg per day. Maximum – 600 mg per day. Usually the daily dose is divided into 2-3 doses, the smaller part should be taken in the daytime, the larger part in the evening;
• withdrawal syndrome for drug addiction and alcoholism: daily dose - 500 mg in 2-3 doses. Duration of use – 7 days. After the condition improves, the dose is gradually reduced. The maintenance daily dose ranges from 15 to 45 mg. Taking Chlorprothixene Zentiva allows you to stabilize your condition and reduce the likelihood of developing another binge;
• hyperactivity, irritability, agitation, confusion in elderly patients: from 15 to 90 mg per day in 3 divided doses;
• behavioral disorder in children: 0.5–2 mg/kg;
• neuroses, depressive states, psychosomatic disorders: daily dose – 90 mg in 2-3 doses;
• insomnia: 15–30 mg 60 minutes before bedtime;
• pain (in combination with analgesics): 15–300 mg per day.

Indications for use of Chlorprothixene

According to the instructions, Chlorprothixene is effective for:

• behavioral disorders in children;
• insomnia;
• psychoses, including manic states and schizophrenia, accompanied by anxiety, psychomotor agitation and agitation;
• for psychosomatic disorders, neuroses, depressive states;
• irritability, hyperactivity, confusion, agitation in older people;
• for pain (the medicine is used as one of the components of combination therapy);
• with hangover withdrawal syndrome, with alcoholism and drug addiction.

Precautions for the substance Chlorprothixene

It is recommended to stop treatment by gradually reducing the dosage. During therapy, you should avoid drinking alcohol, exposure to extreme temperatures, insolation, and potentially hazardous activities that require increased attention and speed of psychomotor reactions.

It is recommended to stop treatment by gradually reducing the dose. During therapy, you should avoid drinking alcohol, exposure to extreme temperatures, insolation, and potentially hazardous activities that require increased attention and speed of psychomotor reactions.

Restrictions on use

Diseases of the cardiovascular system (risk of transient increase in blood pressure), severe cerebral atherosclerosis, glaucoma (including predisposition to it), tendency to collapse, peptic ulcer of the stomach and duodenum; respiratory distress associated with acute infectious diseases, asthma or emphysema, urinary retention, Parkinson's disease (increased extrapyramidal effects), prostatic hyperplasia with clinical manifestations (risk of urinary retention), Reye's syndrome (increased risk of hepatotoxicity), epilepsy (in as a result of a decrease in the seizure threshold, an increase in seizures is possible), diabetes mellitus, severe impairment of liver and/or kidney function.

special instructions

To avoid unwanted side effects from taking an antipsychotic and not to aggravate the condition, you must adhere to the special instructions described in the instructions:

1. Treatment with Chlorprothixene in any dosage form may affect the correct results of immunobiological urine pregnancy tests and blood tests to detect bilirubin levels.
2. It is recommended to avoid activities that require high speed of physical and psychomotor reactions during therapy.
3. Long-term use of antipsychotics is addictive and dependent, which will not give positive results from treatment.
4. According to the instructions, you should be less likely to be exposed to direct sunlight and avoid sun exposure.
5. During therapy with Chlorprothixene, blood pressure may increase or decrease. This likelihood is higher in adolescent children.
6. When using the medicine, it is recommended to regularly take tests for kidney and liver function.
7. The drug is prescribed with extreme caution to patients with epilepsy, diabetes mellitus, parkinsonism, cerebral atherosclerosis, people with mental retardation, respiratory and cardiovascular failure, impaired functioning of the liver and kidneys, and a tendency to collapse.

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