Universal reference book for medicines
Name of the preparation: CHLORPROTIXENE ZENTIVA (CHLORPROTHIXEN ZENTIVA)

Active substance: chlorprothixene

Type: Antipsychotic drug (antipsychotic)

Manufacturer: ZENTIVA (Czech Republic)
Composition, form of production and packaging
The tablets covered with a film cover of orange color, round, biconcave; The view of the fracture is a kernel from white to almost white.
1 tab.
Chloroprotxene hydrochloride 15 mg
Excipients: corn starch - 10 mg, lactose monohydrate - 92 mg, sucrose - 10 mg, calcium stearate - 1.5 mg, talc - 1.5 mg.
Composition of the film membrane: hypromellose 2910/5 - 2.011 mg, macrogol 6000 - 0.069 mg, macrogol 300 - 0.49 mg, talc - 1.43 mg, aluminum lacquer based on the sunset dye yellow (E110) - 1 mg.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.
The tablets covered with a film membrane from light brown to light yellow color, round, biconcave; The view of the fracture is a kernel from white to almost white.
1 tab.
Chloroprotxene hydrochloride 50 mg
Excipients: corn starch - 37.5 mg, lactose monohydrate - 135 mg, sucrose - 20 mg, calcium stearate - 3.75 mg, talc - 3.75 mg.
The composition of the film coat: hypromellose 2910/5 - 3.6594 mg, macrogol 6000 - 0.1333 mg, macrogol 300 - 0.9166 mg, talcum - 2.4194 mg, titanium dioxide - 0.3423 mg, iron oxide, yellow oxide - 0.029 mg.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Chlorprotixen is a neuroleptic, a derivative of thioxanthene. Has antipsychotic, pronounced sedative and moderate antidepressant effect.
The antipsychotic effect of chlorprotixen is associated with its blocking effect on dopamine receptors. With the blockade of these receptors, the antiemetic and analgesic properties of the drug are also associated. Chlorprotixen is able to block 5-HT 2 -receptors,? 1- adrenoreceptors, as well as H 1 -gistamine receptors, which determines its adrenoblocking antihypertensive and antihistaminic properties.
PHARMACOKINETICS
The bioavailability of chlorprotixen at oral intake is about 12%. After ingestion quickly and well absorbed. In the walls of the intestine and liver is subjected to pre-systemic metabolism. Has the effect of "first pass" 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 chlorproticene, 41% - chlorprotixene sulfoxide. T 1/2 8-12 hours.
INDICATIONS
- psychoses, including schizophrenia and manic conditions that occur with psychomotor agitation, agitation and anxiety;
- An abstinence syndrome with alcoholism and drug addiction;
- hyperactivity, irritability, agitation, confusion in elderly patients;
- behavioral disorders in children;
- Depressive conditions, neuroses, psychosomatic disorders;
- Insomnia;
pain (in combination with analgesics).
DOSING MODE
Chlorprotixen Zentiva can be used for a long time because it does not cause the development of addiction or drug dependence.
Psychoses, including schizophrenia and manic conditions
Treatment begins with 50-100 mg / day, gradually increasing the dose to achieve the optimal effect, usually up to 300 mg / day. The maintenance dose is usually 100-200 mg / day. The maximum daily intake for adults is 600 mg.
The daily dose of Chlorprothixen Zentiva is usually divided into 2-3 administrations, taking into account the expressed sedative effect of Chlorprothixen Zentiva, it is recommended to prescribe a smaller part of the daily dose in the daytime, and most in the evening.
Abstinence syndrome with 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 disappearance of manifestations of withdrawal, the dose gradually decreases. The maintenance dose of 15-45 mg / day allows to stabilize the condition, reduces the risk of developing another binge.
In elderly patients, with the presence of hyperactivity, irritability, agitation, confusion, 15-90 mg / day is prescribed. The daily dose, as a rule, is divided into 3 doses.
In children, Chlorprotixen Zentiva is prescribed at the rate of 0.5-2 mg / kg of body weight to correct behavioral disorders.
Depressive states, neuroses, psychosomatic disorders
Chlorprotixen Zentiva can be used for depression, especially when combined with anxiety, stress, as an adjunct to therapy with antidepressants or alone.
Chlorprotixen Zentiva can be prescribed for neuroses and psychosomatic disorders, accompanied by anxiety and depressive disorders up to 90 mg / day. The daily dose, as a rule, is divided into 2-3 doses.
Insomnia
For 15-30 mg in the evening for 1 h before bedtime.
Pain
The ability of Chlorprothixen Zentiva 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 of 15 to 300 mg.
SIDE EFFECT
The frequency of 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 than 1/100 , rarely from more than 1/10 000 to less than 1/1000, very rarely from less than 1/10 000, including individual reports.
From the side of the nervous system: drowsiness, fatigue, dizziness, psychomotor retardation, mild extrapyramidal hypokiaetic hypertension syndrome, akathisia (within the first 6 hours after administration), dystonic reactions persisting tardive dyskinesia (these side effects usually occur at the beginning of therapy and often disappear as it continues); rarely - malignant neuroleptic syndrome, late dystonia.
On the part of the cardiovascular system: orthostatic hypotension (especially when using Chlorprothixen Zentiva in high doses), transient tachycardia and changes in the QT interval on the electrocardiogram.
From the side of the digestive system: transient dryness of the oral mucosa; rarely - constipation, cholestatic jaundice with prolonged use, especially in high doses (more likely between 2-4 weeks of treatment).
On the part of the endocrine system: rarely - dysmenorrhea, with prolonged use in high doses - galactorrhea, gynecomastia, diabetes mellitus, decreased potency and / or libido, increased appetite, change in carbohydrate metabolism, weight gain, increased sweating, temporary at the beginning of therapy.
From the sense organs: clouding of the cornea and / or lens with possible visual impairment, paresis of accommodation at the beginning of treatment and disappearing as the therapy continues.
On the part of the organs of hematopoiesis: rarely - agranulocytosis (more likely between 4-10 weeks of treatment), single cases of transient benign leukopenia and hemolytic anemia.
Other : urinary retention, skin rash, dermatitis, photosensitivity, withdrawal syndrome, blood flushes to the face.
CONTRAINDICATIONS
- depression of the central nervous system of any origin (including caused by the intake of alcohol, barbiturates or opiates);
- Comatose conditions;
- Vascular collapse;
- pathological changes in blood;
- bone marrow suppression;
- pheochromocytoma;
- such hereditary diseases as lactose intolerance, or fructose, lactase deficiency or glucose-galactose malabsorption, sugarase / isomaltase deficiency (due to the presence of lactose and sucrose in the composition);
- children's age till 6 years;
- Hypersensitivity to the components of the drug (including phenothiazines).
With caution: with a tendency to collapse, with severe cardiovascular and respiratory insufficiency (due to acute infectious diseases, asthma or emphysema of the lungs), the risk of transient increase in blood pressure, expressed atherosclerosis of the cerebral vessels, glaucoma (including predisposition to it), peptic ulcer disease stomach and 12-colon, renal and / or hepatic insufficiency, urinary retention and the risk of urinary retention in clinical manifestations of prostatic hyperplasia, Reye's syndrome (increased risk of hepatotox Cesky influence), Parkinson's disease (may increase extrapyramidal disorders), epilepsy (possible more frequent attacks by lowering the seizure threshold), diabetes mellitus. Alcohol abuse can exacerbate CNS depression.
PREGNANCY AND LACTATION
Chlorprotixen Zentiva should not be given to pregnant women and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Chlorprotixen Zentiva should be administered with caution from renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Chlorprothixen Zentiva should be administered with caution to patients with hepatic insufficiency.
APPLICATION FOR CHILDREN
Contraindicated in children under the age of 6 years.
In children, Chlorprotixen Zentiva is prescribed at the rate of 0.5-2 mg / kg of body weight to correct behavioral disorders.
APPLICATION IN ELDERLY PATIENTS
In elderly patients, with the presence of hyperactivity, irritability, agitation, confusion, 15-90 mg / day is prescribed. The daily dose, as a rule, is divided into 3 doses.
SPECIAL INSTRUCTIONS
The use of Chlorprothixen Zentiva can lead to a false positive result when an immunobiological test of urine for pregnancy, false indices of hyperbilirubinemia, a change in the QT interval on an 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 extrapyramidal effects may occur in the first few days of treatment, but usually their frequency increases with increasing dose; may be more frequent in elderly patients and older children
Late dyskinesia at the beginning of treatment is dose-dependent, but its frequency may increase with prolonged treatment and with the achievement of the total dose; may persist after the termination of the use of thioxanthenes.
During the treatment it is necessary to perform a blood test and determine the leukocyte formula, monitor the liver function, 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.
Malignant neuroleptic syndrome may occur at any time during treatment with antipsychotic drugs, but more often it develops shortly after initiation of therapy or after the transfer of the patient from another neuroleptic, during combined treatment with other psychoactive drugs or after increasing the dose.
Although not all listed side effects are specifically associated with each thioxanthene, it is likely that they may occur when using any drug from this group.
During treatment should be refrained from taking ethanol, exposure to extremely high temperatures (the risk of heat stroke), insolation.
To avoid the development of the "withdrawal" syndrome, discontinuation of treatment should be gradual.
Impact on the ability to drive vehicles and manage mechanisms
During the administration of Chlorprothixen Zentiva, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.
OVERDOSE
Symptoms. Drowsiness, hypo- or hyperthermia, extrapyramidal symptoms, convulsions, shock, coma.
Treatment. Symptomatic and supportive. As soon as gastric lavage has to be done, the use of sorbent is recommended. Measures should be taken to maintain the respiratory and cardiovascular systems. Do not use epinephrine, tk. this can lead to a subsequent lowering of blood pressure. Seizures can be suppressed with diazepam, and extrapyramidal disorders with biperidenum.
DRUG INTERACTION
The inhibitory effect of chlorprotixen on the CNS can be enhanced by simultaneous administration with ethanol and ethanol containing preparations, anesthetics, opioid analgesics, sedatives, hypnotics, antipsychotics.
The anticholinergic effect of chlorprotixen is enhanced by the simultaneous use of M-cholinoblockers, antihistamines and anti-Parkinsonian agents. The use of chlorprotixen leads to a decrease in the threshold of convulsive activity, which requires an additional correction of the dose of antiepileptic drugs in patients with epilepsy.
The ability of chlorprotixen to block dopamine receptors decreases the effectiveness of levodopa.
Compatible with timoleptics (including amitriptyline, nortriptyline, imipramine, dozolepin).
Perhaps the emergence of extrapyramidal disorders with the simultaneous use of phenothiazines, metoclopramide, haloperidol, reserpine.
There may be a perversion of the peripheral vasoconstrictive effect caused by dopamine in high doses, epinephrine and ephedrine (the presence of alpha-adrenergic blocking action in chlorprotixen). The prescription of thioxanthenes may reduce the vasoconstrictor effect of phenylephrine.
The drug enhances the effect of antihypertensive drugs. The simultaneous use of chlorprotixen and epinephrine can lead to arterial hypotension and tachycardia.
Reduces the hypotensive effect of guanetidine due to its displacement from adrenergic neurons and inhibition of its capture by these neurons.
Quinidine causes an increased risk of side effects from the heart.
May mask the symptoms of ototoxicity (tinnitus, dizziness) of ototoxic drugs (especially antibiotics).
Due to hyperprolactinemia, a correction of the dosing regimen of bromocriptine may be required.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 25 ° C. Shelf life - 3 years.
Do not use after the expiry date printed on the package.
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