Chlorprothixene, 50 mg, film-coated tablets, 30 pcs.

Release form and composition

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.

Analogs

If for some reason a person is unable to be treated with Chlorprothixene, then it can be replaced with other medications with a similar principle of action. Structural analogues of the main active substance:

• Truxal;
• Chlorprothixene Lecheva.

By pharmacological group:

• Barnetyl;
• Haloperidol;
• Zeldox;
• Aminazine;
• Galoper;
• Azaleptin;
• Betamax;
• Droperidol.

Pharmacological properties

Pharmacodynamics

Chlorprothixene is an antipsychotic, a thioxanthene derivative. It has antipsychotic, moderate antidepressant and pronounced sedative effects. The antipsychotic effect is associated with the blocking effect of chlorprothixene on dopamine receptors. The analgesic and antiemetic properties of the drug are also associated with the blockade of these receptors. Chlorprothixene is able to block α1-adrenergic receptors, 5-HT2 receptors, as well as H1-histamine receptors, which determines its adrenergic blocking hypotensive and antihistamine effect.

Pharmacokinetics

When taken orally, the bioavailability of chlorprothixene is approximately 12%. After oral administration, it is absorbed well and quickly. In the liver and intestinal walls it undergoes first-pass metabolism. Has a first pass effect through the liver.

Chlorprothixene penetrates the placental barrier and into breast milk.

Excretion is carried out by the intestines and kidneys: chlorprothixene - 29%, chlorprothixene sulfoxide - 41%.

The half-life ranges from 8 to 12 hours.

Patients' opinions

The drug "Chlorprothixene" has mixed reviews from people: some praise this medication, while others zealously criticize it. Patients for whom this remedy helped cope with depression, neuroses, and psychoses speak positively about it. The patients themselves note the fact that after treatment with Chlorprothixene, their condition improved significantly, they truly began to relax and be content with life as it is. If previously these patients could not sleep normally, then after treatment with this medicine they stop complaining of sleep problems.

However, the product "Chlorprothixene" has not only flattering reviews, but also negative ones. Some patients say that after treatment with this medication their health condition worsened. However, the mental situation has returned to normal. But at the same time, such people are dissatisfied with this medicine, because after therapy they feel unwell: they are dizzy, their eyes are cloudy, they are lethargic, tired, and have no desire to work.

Indications for use

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).

Contraindications

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.

Instructions for use of Chlorprothixene Zentiva: method and dosage

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

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.

For neurosis

When diagnosing acute or chronic neurosis, the drug is taken for 2-4 weeks. The daily dosage for the patient is usually 90 mg. It may increase or decrease depending on the therapeutic effect achieved.

Experts recommend not taking the entire daily dose at one time; it is better to divide the dose into 3 doses throughout the day at approximately equal intervals. If necessary, the doctor may cancel treatment prematurely or extend it if the desired therapeutic effect is not achieved.

Side effects

Possible adverse reactions (> 10% - very common; > 1% and < 10% - often; > 0.1% and < 1% - uncommon; > 0.01% and < 0.1% - rare; < 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.

Description

The sleeping pill Chlorprothixene is a medication characterized by neuroleptic, anticonvulsant, tranquilizing, and antipsychotic effects. It has the property of strengthening the effect of analgesic medications.

The drug begins to act 20 minutes after taking it. The active substances are absorbed very quickly. Promptly absorbed in the intestines. The maximum concentration in the blood is observed after 2-3 hours. Half-life from the body is observed after 16 hours.

The antipsychotic drug eliminates irritability and nervousness, so you can sleep peacefully. The product should be taken half an hour before bedtime.

During treatment, patients should not engage in potentially hazardous activities that require increased attention. It is also not recommended to drive vehicles during treatment.

Overdose

Main symptoms: drowsiness, hyper- or hypothermia, convulsions, coma, shock, extrapyramidal symptoms.

In case of overdose, symptomatic and supportive therapy is usually prescribed. Gastric lavage and activated charcoal should be taken as soon as possible. Activities aimed at maintaining the functioning of the cardiovascular and respiratory systems are also shown. Epinephrine should not be used as it may cause a subsequent decrease in blood pressure. Extrapyramidal disorders can be treated with biperiden, and seizures with diazepam.

special instructions

Taking the drug may lead to false indicators of hyperbilirubinemia, a false positive result when conducting an immunobiological urine pregnancy test, and a change in the QT interval on the electrocardiogram.

Alcohol abuse increases depression of the central nervous system.

The development of dystonic reactions is most often observed in children and young patients. As a rule, they appear at the beginning of therapy and may subside within 24–48 hours after stopping Chlorprothixene Zentiva.

Parkinsonian extrapyramidal effects may be observed during the first few days of treatment, but their frequency usually increases as the dose is increased; their appearance is more common in elderly patients and older children

Tardive dyskinesia at the beginning of treatment is dose-dependent, but its frequency may increase with a long course and as the total dose is reached. After discontinuation of Chlorprothixene Zentiva, the disorder may persist.

The risk of developing extrapyramidal and hypotensive reactions in adolescents is higher than in adult patients.

During the use of Chlorprothixene Zentiva, a blood test and determination of the leukocyte formula, monitoring of liver function indicators, an ophthalmological examination, as well as careful observation are required to identify early signs of tardive dystonia and dyskinesia.

The occurrence of neuroleptic malignant syndrome is possible at any time during therapy, but more often its development is observed soon after the start of taking Chlorprothixene Zentiva or after transferring the patient from another antipsychotic, during combined use with other psychoactive drugs or after increasing the dose.

It is recommended to refrain from taking ethanol, as well as exposure to insolation and extremely high temperatures.

Therapy should be discontinued gradually, this will reduce the likelihood of developing withdrawal syndrome.

Impact on the ability to drive vehicles and complex mechanisms

While taking Chlorprothixene Zentiva, patients should exercise caution when driving vehicles.

Similar medications

In terms of composition and release form, the medication described in this article has similar products. These are the Truxal and Chloroprotexen Lechiva pills. They contain the same active ingredient - chlorprothixene hydrochloride. But in terms of the achievable effect, the product has more analogues. So, you can replace the tablets that the article is devoted to with the pills “Klopiksol”, “Fluanxol”, injection solutions “Klopikslo depot”, “Fluanxol depot”, “Amizepine”. The drug "Chlorprothixene", analogues of which are also very effective, can be purchased at any pharmacy.

Drug interactions

• 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).

Doctors' opinions

Psychotherapists recommend the medicine “Chlorprothixene” to their patients. Such pills receive only positive reviews from doctors. Experts really prove that there is an effect from this drug, and it is visible. Therefore, they prescribe this medication to their patients who come to see them.

Psychotherapists also explain why some people do not like this drug and why they experience such side effects. The fact is that if a person self-medicates with Chlorprothixene tablets without a doctor’s prescription, then the effect of them can really be negative. Reading the instructions is not enough, since each patient is individual and the dosage indicated in the leaflet will not always suit him. Yes, and people have different diagnoses. Therefore, you need to consult with specialists and follow their recommendations regarding how to take the pills, in what quantity and for how long. Among patients who comply with doctor's prescriptions, the drug "Chlorprothixene" has only positive reviews.