Active substancePericiazinePericiazine
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  • Neuleptil®
    solution inwards 
  • Neuleptil®
    capsules inwards 
  • Periciazine
    capsules inwards 
    R-PHARM, CJSC     Russia
  • Dosage form: & nbspTOthe apsules.
    Composition:

    One capsule contains:

    5 mg

    10 mg

    20 mg

    Active substance:


    Periciazine

    Excipients:

    5.0 mg

    10.0 mg

    20.0 mg

    Calcium hydrogen phosphate dihydrate

    139.0 mg

    278.0 mg

    556.0 mg

    Croscarmellose sodium

    4.5 mg

    9.0 mg

    18.0 mg

    Magnesium stearate

    1.5 mg

    3.0 mg

    6.0 mg

    Capsule shell:




    hard gelatin capsule: body: titanium dioxide - 2%, gelatin - up to 100%; cover: dye azorubin - 0.0328%, dye sunset yellow - 0.219%, titanium dioxide - 2%, gelatin - up to 100%

    48 mg



    hard gelatin capsule: body: dye quinoline yellow - 0.9197%, titanium dioxide - 1.3333%, dye sunset yellow - 0.0044%, gelatin - up to 100%; cover: dye quinoline yellow - 0.9197%, titanium dioxide - 1.3333% dye sunset yellow - 0.0044%, gelatin - up to 100%


    76 mg


    hard gelatin capsule: body: titanium dioxide - 2%, gelatin - up to 100%; cover: dye crimson [Ponzo 4R] - 1.36%, iron dye oxide red - 0.85%; titanium dioxide - 2.5%, gelatin - up to 100%



    96 mg

    Description:

    Capsules 5 mg - hard gelatin capsule size 3 with a white body and an orange cover. Capsules contain a yellow powder.

    Capsules 10 mg - hard gelatin capsules of size 1 with a body and a lid of yellow color. Capsules contain a yellow powder.

    Capsules 20 mg - Hard gelatin capsules of size No. 0 with a white body and a red cover. Capsules contain a yellow powder.
    Pharmacotherapeutic group:antipsychotic agent (antipsychotic)
    ATX: & nbsp

    N.05.A.C.01   Periciazine

    Pharmacodynamics:

    Pericyiazine is a neuroleptic from the group of piperidine derivatives of phenothiazine, antidophaminergic activity of which causes the development of therapeutic antipsychotic (without stimulating component), as well as antiemetic and hypothermic effects of the drug. However, the development of its side effects (extrapyramidal syndrome, motor disorders and hyperprolactinemia) is also associated with antidopaminergic activity.

    Moderate antidopaminergic activity of pericyazine has a moderate antipsychotic effect with moderate manifestation of extrapyramidal disorders. Due to the blocking effect of pericyazine on adrenoreceptors of the reticular formation of the brainstem and central histamine receptors, the drug has a distinct sedative effect,which can also be a desirable clinical effect, especially with angry-irritable and angry types of affect, and a decrease in aggressiveness is not accompanied by the appearance of lethargy and inhibition. Compared with chlorpromazine pericyazine has a more pronounced antiserotonin, antiemetic and central sedative effect, but less pronounced antihistamine action.

    Pericyzine reduces aggressiveness, excitability, disinhibition, due to which it is effective in behavior disorders. Because of the normalizing influence on behavior pericyazine was called the "behavior corrector."

    Blockade of peripheral H1-gistaminovyh receptors determines the antiallergic effect of the drug. Blockade of peripheral adrenergic structures is manifested by its hypotensive effect. In addition, the drug has cholinolytic activity.

    Pharmacokinetics:

    After oral administration pericyazine is well absorbed, however, like other phenothiazine derivatives, it undergoes intensive pre-systemic metabolism in the intestine and / or liver, so after its intake, the concentration of unchanged pericyazine in the plasma is lower than for the / m administration and varies widely.

    After ingestion of 20 mg of pericyazine, the maximum plasma concentration is reached within 2 hours and is 150 ng / ml (410 nmol / l).

    The connection with plasma proteins is 90%. Periciazine intensively penetrates into the tissues, as it easily passes through the histohematological barriers, including through the blood-brain barrier.

    Most of the periciazine is metabolized in the liver by hydroxylation and conjugation. The metabolites released from the bile can be reabsorbed in the intestine. The half-life period of pericyazine is 12-30 hours; elimination metabolites is even more prolonged. Conjugated metabolites are displayed with urine, and the rest of the drug and its metabolites - with bile and calves.

    In elderly patients, metabolism and the excretion of phenothiazines slows down.
    Indications:

    - Acute psychotic disorders;

    - Chronic psychotic disorders, such as schizophrenia, chronic non-schizophrenic delusional disorders: paranoid delusional disorders, chronic hallucinatory psychoses (for the treatment and prevention of relapses);

    - Anxiety, psychomotor agitation, aggressive or dangerous impulsive behavior (as an additional drug for short-term treatment of these conditions).

    Contraindications:

    - Hypersensitivity to pericyiazine and / or other ingredients of the drug;

    - Closed-angle glaucoma;

    - Retention of urine against the background of diseases of the prostate;

    - Agranulocytosis in history;

    - Porphyria in the anamnesis;

    - Concomitant therapy with dopaminergic agonists: levodopa, amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, pyribenidyl, pramipexole, quinagolide, ropinirole, except for their use in patients with Parkinson's disease (see section "Interaction with other drugs");

    - Vascular insufficiency (collapse);

    - Acute poisoning with substances depressing the central nervous system or coma;

    - Heart failure;

    - Pheochromocytoma;

    - Myasthenia gravis is severe pseudo-paralytic (Erba-Goldflem disease);

    - Children's age (up to 18 years).

    Carefully:

    - In patients with predisposing factors for the development of ventricular arrhythmias (patients with cardiovascular disease, congenital elongated interval QT, bradycardia, hypokalemia, hypomagnesemia, starvation and / or alcoholism, receiving concomitant therapy with drugs capable of lengthening the interval QT and / or cause a pronounced bradycardia of less than 55 beats per minute, slow intracardiac conduction, or alter the electrolyte composition of the blood), since phenothiazine antipsychotics in very rare cases may cause lengthening of the interval QT (this effect depends on the dose) and increase the risk of developing severe ventricular arrhythmias, including a bidirectional ventricular "pirouette" tachycardia that can be life threatening (sudden death);

    - In patients with renal and / or hepatic insufficiency (risk of cumulation of the drug);

    - In elderly patients (there is an increased predisposition to the development of postural hypotension, excessive hypotensive and sedative effects, the development of extrapyramidal disorders, hyperthermia in hot and hypothermia in cold weather, constipation, paralytic intestinal obstruction and urinary retention in prostate diseases, there is a risk of accumulation of the drug due to decreased liver and kidney function);

    - Patients with cardiovascular diseases (due to the danger for them of possible hypotensive and quinidine-like effects, the ability of the drug to cause tachycardia);

    - In elderly patients with dementia (increased risk of death);

    - In patients with risk factors for stroke (elderly patients with dementia had a triple increase in the incidence of stroke);

    - In patients with risk factors for venous and thromboembolic complications (see "Side effect", "Special instructions");

    - In patients with epilepsy who do not receive adequate anticonvulsant therapy (neuroleptics from the phenothiazine group reduce the threshold of convulsive alertness);

    - In patients with Parkinson's disease;

    - In patients with hyperthyroidism (increased risk of agranulocytosis with pericyazine in combination with drugs for the treatment of hyperthyroidism);

    - Patients with changes in the blood picture (increased risk of developing leukopenia or agranulocytosis);

    - In patients with breast cancer (the possibility of progression of the disease due to increased prolactin levels in the blood);

    - In patients with diabetes mellitus, patients with risk factors for developing diabetes (requires careful monitoring of the concentration of glucose in the blood because of the possibility of developing hyperglycemia or reducing glucose tolerance).

    Pregnancy and lactation:

    Pregnancy

    It is desirable to maintain the mental health of the mother during pregnancy in order to prevent decompensation. If medication is needed to maintain mental balance, then it must begin and continue at effective doses throughout the entire pregnancy.

    Studies of the teratogenic effect of pericyazine in humans have not been conducted, there is no evidence of the effect of pericyazine during pregnancy on the development of the fetal brain, but the analysis of pregnancies that occurred against the background of pericyazine showed no specific teratogenic effects. Thus, the risk of teratogenic action of the drug, if it exists, is insignificant.

    The appointment of pericyazine in pregnancy is possible, but each time it is necessary to compare the benefits for the mother with the risk for the fetus.It is advisable to limit the duration of the drug during pregnancy.

    The following disorders have been reported in neonates whose mothers received antipsychotics, phenothiazine derivatives, during the third trimester of pregnancy (follow-up data after the drug was released on the market):

    • respiratory disorders of varying severity (from tachypnea to respiratory failure), bradycardia and lowering blood pressure, especially common if the mother at the same time took other medications (such as psychotropic drugs and drugs with atropine-like effect);
    • symptoms associated with atropine-like effects of phenothiazine derivatives, such as meconium intestinal obstruction, feeding difficulties, bloating, tachycardia;
    • neurological disorders, such as extrapyramidal disorders (including tremor and muscle hypertonia), drowsiness, agitation;
    • delay in the retreat of meconium.

    It is recommended that medical supervision of children born to mothers who take pericyazine, and, if necessary, conduct appropriate treatment for them.

    If possible, at the end of pregnancy, it is desirable to reduce doses of pericyazine and antiparkinsonian drugs that correct it, capable of potentiating the atropine-like effect of neuroleptics. The neonates should monitor the state of the nervous system and the function of the gastrointestinal tract.

    Breastfeeding period

    Due to the lack of data on the penetration of the drug into breast milk, it is not recommended to breast-feed while taking the drug.

    Dosing and Administration:

    Periciasin, capsules 5 mg, 10 mg and 20 mg is intended for oral administration adult patients.

    Children should use other dosage forms of the drug (see the section "Contraindications").

    The dosage regimen varies considerably depending on the indications and the patient's condition. Doses of the drug must be selected individually. If the patient's condition allows, then treatment should start with low doses, which then can gradually increase. Always use the lowest effective dose.

    The daily dose should be divided into 2 or 3 doses and most of the dose should always be taken in the evening.

    In adults, the daily dose can range from 30 mg to 100 mg.

    The maximum daily dose is 200 mg.

    Treatment of acute and chronic psychotic disorders

    The initial daily dose is 60-80 mg (divided into 2-3 doses). The daily dose may be increased by 20 mg per week until the optimal effect is achieved (on average, up to 100 mg per day).

    In exceptional cases, the daily dose may increase to 200 mg.

    Correction of behavioral disorders

    The initial daily dose is 10-30 mg.

    Treatment of elderly patients

    Doses are reduced by 2-4 times.

    Side effects:

    The undesirable reactions, the occurrence of which may or may not depend on the amount of the dose taken, are listed below, and in the latter case, be a consequence of the increased individual sensitivity of the patient.

    Disorders from the central nervous system

    - Sedation or drowsiness, more pronounced at the beginning of treatment and usually passing in a few days;

    - Apathy, anxiety, mood changes;

    - In some cases, paradoxical effects are possible: insomnia, agitation, sleep inversion, increased aggressiveness and increased psychotic symptoms;

    - Extrapyramidal disorders (often occurring when using the drug in high doses):

    - acute dystonia or dyskinesia (spasmodic torticollis, oculogic crises, trisus, etc.), usually occurring within 4 days after starting treatment or increasing the dose;

    - Parkinsonism, which often develops in elderly patients and / or after long-term treatment (during weeks or months), is partially eliminated in the appointment of central m-holinoblockers and manifests itself with one or more of the following symptoms: tremor (very often the only manifestation of parkinsonism) , rigidity, akinesia in combination with or without muscle hypertension;

    - late dystonia or dyskinesia, usually (but not always) arising from long-term treatment and / or use of the drug in high doses, and capable of arising even after cessation of treatment (central m-cholinoblockers do not cause any impairment if they occur);

    - akathisia, usually observed after taking high initial doses.

    Inhibition of respiration (possibly in patients with predisposing factors to the development of respiratory depression, for example, in patients receiving other drugs that can depress respiration, in senile patients, etc.).

    Violation of the autonomic nervous system

    Effects due to blockade of m-cholinergic receptors (dry mouth, paresis of accommodation, urinary retention, constipation, paralytic intestinal obstruction).

    Violation of the cardiovascular system

    - Decrease in blood pressure, usually postural arterial hypotension (more often occurs in elderly patients and patients with a decrease in the volume of circulating blood, especially at the beginning of treatment and when using high initial doses);

    - Arrhythmias, including atrial rhythm disturbances, atrioventricular blockade, ventricular tachycardia, including potentially fatal ventricular "pirouette" tachycardia, more likely to occur with high doses (see "With caution," "Interaction with other drugs," "Special instructions ");

    - ECG changes, usually minor: lengthening of the interval QT, segment depression ST, the appearance of a prong U and changes in the T wave;

    - With the use of neuroleptics, there have been cases of venous thromboembolic complications, including pulmonary embolism (sometimes fatal) and cases of deep vein thrombosis (see "Special instructions").

    Endocrine and metabolic disorders (often occurring when using the drug in high doses)

    - Hyperprolactinemia, which can lead to amenorrhea, galactorrhea, gynecomastia, impotence, frigidity;

    - Weight gain;

    - Thermoregulation disorders;

    - Hyperglycemia, a decrease in glucose tolerance.

    Skin and allergic reactions

    - Allergic skin reactions, skin rash;

    - Bronchospasm, laryngeal edema, angioedema, hyperthermia and other allergic reactions;

    - Photosensitivity (more often when using the drug in high doses);

    - Skin sensitization (see "Special instructions").

    Hematologic disorders

    - Leukopenia (observed in 30% of patients receiving high doses of antipsychotics);

    - Agranulocytosis, the development of which does not depend on the dose, and which can occur either immediately or after two to three months of leukopenia.

    Ophthalmic disorders

    Brownish deposits in the anterior chamber of the eye, pigmentation of the cornea and lens due to accumulation of the drug, usually not affecting the eyesight (especially when using high doses of drugs from the group of phenothiazine derivatives for a long time).

    From the liver and biliary tract

    Cholestatic jaundice and liver damage, mostly of cholestatic or mixed type, requiring discontinuation of the drug.

    Other (General disorders)

    - Malignant neuroleptic syndrome, potentially fatal syndrome, which can occur when all neuroleptics are taken and manifests itself as hyperthermia, muscle rigidity, vegetative disorders (pallor, tachycardia, unstable arterial pressure, increased sweating, shortness of breath) and impaired consciousness up to coma. The emergence of a malignant neuroleptic syndrome requires the immediate cessation of treatment with neuroleptics. Although this effect of pericyazin and other neuroleptics is associated with idiosyncrasy, there are predisposing factors for its occurrence, such as dehydration or organic lesions of the brain;

    - Positive serological test for the presence of antinuclear antibodies, without clinical manifestations of lupus erythematosis;

    - Very rarely: priapism;

    - Nasal congestion;

    - Very rarely: the development of withdrawal syndrome with a sharp discontinuation of treatment with high doses of pericyazine, manifested by nausea, vomiting,insomnia and the possibility of exacerbation of the underlying disease or development of extrapyramidal disorders;

    - Single cases of sudden death, possibly caused by cardiac causes (see "Special instructions"), as well as unexplained cases of sudden death were noted in patients taking neuroleptics of the phenothiazine series.

    Overdose:

    Symptoms

    Symptoms of an overdose of phenothiazines include CNS depression, progressing from drowsiness to coma with areflexia. Patients with initial manifestations of intoxication or intoxication of moderate severity may experience anxiety, confusion, agitation, an excited or delirious state. Other manifestations of an overdose include lowering blood pressure, tachycardia, ventricular arrhythmias, ECG changes, collapse, hypothermia, pupil constriction, tremor, muscle twitching, spasm or muscle rigidity, convulsions, dystonic movements, muscle hypotension, difficulty swallowing, respiratory depression, apnea, cyanosis. Also, the appearance of polyuria leading to dehydration, and severe extrapyramidal dyskinesias.

    Treatment

    Treatment should be symptomatic and conducted in a specialized department where it is possible to monitor the functions of the respiration and cardiovascular system and continue it until the overdose phenomena are completely eliminated.

    If after taking the drug it took less than 6 hours, then you should wash the stomach or aspirate its contents. The use of emetics is contraindicated because of the risk of aspiration of vomit due to inhibition and / or extrapyramidal disorders. It is possible to use activated carbon. There is no specific antidote.

    Treatment should be aimed at maintaining vital body functions.

    With a decrease in blood pressure, the patient must be moved to a horizontal position with raised legs. Infusion intravenous fluid injection was shown. If the administration of fluid is insufficient to eliminate hypotension, it is possible to administer norepinephrine, dopamine or phenylephrine. The introduction of epinephrine is contraindicated.

    With hypothermia, it is possible to wait for its independent resolution, except for cases when the body temperature drops to a level at which the development of cardiac arrhythmias is possible (i.e., up to 29.4 ° C).

    Ventricular or supraventricular tachyarrhythmias usually respond to restoring normal body temperature and eliminating hemodynamic and metabolic disorders. With the preservation of life-threatening rhythm disturbances, antiarrhythmics may be required. Avoid the use of lidocaine and, if possible, long-acting antiarrhythmic drugs.

    With CNS and respiratory depression, the patient may need to be transferred to artificial lung ventilation and antibiotic therapy to prevent pulmonary infections.

    Severe dystonic reactions usually respond to intramuscular or intravenous administration of procyclidine (5-10 mg) or orfenadrine (20-40 mg). Seizures can be cured by intravenous diazepam.

    In extrapyramidal disorders intramuscularly used anticholinergic anti-Parkinsonics.

    Interaction:

    Contraindicated combinations

    - With dopaminergic agonists (levodopa, amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole) in patients without Parkinson's disease - mutual antagonism between dopaminergic agonists and pericyazin.

    Do not treat treatment of neuroleptic-induced extrapyramidal disorders with dopaminergic agonists (decrease or loss of neuroleptic activity) - in this case, the use of anticholinergic antiparkinsonian agents is more evident.

    Unsupported combinations

    - With dopaminergic agonists (levodopa, amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole) in patients with Parkinson's disease - mutual antagonism between dopaminergic agonists and pericyazin. Dopaminergic agonists can exacerbate psychotic disorders. If patients with Parkinson's disease who are receiving dopaminergic agonists require treatment with an antipsychotic, then they should be abolished by gradually lowering the doses (sudden withdrawal of dopaminergic agonists may increase the risk of developing a neuroleptic malignant syndrome). When using periciazine together with the drug levodopa use the lowest effective doses of both drugs;

    - With alcohol - potentiation of the sedative effect caused by pericyazine;

    - With amphetamine, clonidine, guanethidine - the effect of these drugs decreases with simultaneous admission with neuroleptics;

    - With sultopride, an increased risk of ventricular arrhythmias, in particular ventricular fibrillation.

    Combinations of medicines requiring caution when used

    - With drugs that can increase the interval QT (antiarrhythmics IA and III class, moxifloxacin, erythromycin, methadone, mefloquine, sertindole, tricyclic antidepressants, lithium salts, cisapride and others) - an increased risk of arrhythmias (see "Contraindications", "With caution");

    - With thiazide diuretics, the risk of arrhythmias increases, due to the possibility of developing electrolyte disorders (hypokalemia, hypomagnesemia);

    - With antihypertensive drugs, especially alpha-adrenoblockers - an increase in hypotensive action and the risk of development of orthostatic hypotension (additive effect). For clonidine and guanethidine,"Interaction with other medicinal products", "Not recommended combinations of drugs";

    - With other drugs that have an inhibitory effect on the CNS: morphine derivatives (analgesics, antitussives), barbiturates, benzodiazepines, nonbenzodiazepine anxiolytics, hypnotics, antipsychotics, antidepressants with sedative effectamitriptyline, doxepin, mianserin, mirtazapine, trimipramine), histamine blockers H1-receptors with sedative effect, antihypertensive agents of central action, baclofen, thalidomide, pizotifenom - the danger of additional oppressive effects on the central nervous system, respiratory depression;

    - With tricyclic antidepressants, MAO inhibitors, maprotiline - an increased risk of developing a malignant neuroleptic syndrome, it is possible to increase and prolong the duration of sedative and anticholinergic effects;

    - With atropine and other anticholinergics, as well as drugs with anticholinergic action (imipramine antidepressants, anticholinergic antiparkinsonian drugs,disopyramide) - the possibility of cumulating undesirable effects associated with cholinolytic action, such as urinary retention, constipation, dry mouth, heat stroke, etc., as well as reducing the antipsychotic effect of neuroleptics;

    - With beta-blockers - the risk of developing hypotension, especially orthostatic (additive effect), and the risk of developing irreversible retinopathy, arrhythmia and tardive dyskinesia;

    - With hepatotoxic drugs - increased risk of hepatotoxic action;

    - With lithium salts - reduced absorption in the gastrointestinal tract, increased rate of excretion Li+, increased severity of extrapyramidal disorders; early signs of intoxication Li+ (nausea and vomiting) may be masked by the antiemetic effect of phenothiazines;

    - With alpha and beta adrenostimulators (epinephrine, ephedrine) - reducing their effects, perhaps a paradoxical reduction in blood pressure;

    - With antithyroid drugs - increased risk of agranulocytosis;

    - With apomorphine - a decrease in the emetic effect of apomorphine, an increase in its inhibitory effect on the central nervous system;

    - With hypoglycemic drugs - when combined with neuroleptics, hypoglycemic action may decrease, which may require an increase in their doses.

    Combinations of drugs, in the application of which there is interaction, which should be taken into account

    - With antacids (salts, oxides and hydroxides of magnesium, aluminum and calcium) - a decrease in the absorption of pericyazine in the gastrointestinal tract. If possible, the interval between taking antacids and pericyazine should be at least two hours;

    - With bromocriptine, an increase in the plasma concentration of prolactin when taking pericyazine interferes with the effects of bromocriptine;

    - With the means to reduce appetite (with the exception of fenfluramine) - reducing their effect.

    Special instructions:

    When taking pericyazine, it is recommended to regularly monitor the composition of peripheral blood, especially if there is a fever or infection (the possibility of developing leukopenia and agranulocytosis). In case of significant changes in peripheral blood (leukocytosis, granulocytopenia), treatment with pericyazine should be discontinued.

    Malignant neuroleptic syndrome - in case of unexplained fever, treatment with pericyazine should be discontinued, as it may be a manifestation of a malignant neuroleptic syndrome,early manifestations of which can also be the emergence of vegetative disorders (such as excessive sweating, instability of the pulse and blood pressure).

    During the treatment, alcohol and alcohol-containing drugs should not be taken, as in this case, the potentiation of the sedative effect leads to a decrease in the reaction, which can be dangerous for persons driving vehicles and mechanisms (see "Interaction with other drugs").

    Due to the ability of the drug to reduce the threshold of convulsive readiness, when taking pericyazin by patients with epilepsy, they should be followed by a thorough clinical and, if possible, electroencephalographic observation.

    Except in special cases, pericyazine should not be used in patients with Parkinson's disease (see "Contraindications" and "Interaction with other medicines").

    Neuroleptics of the group of phenothiazine derivatives can dose-dependently lengthen the interval QT, which, as is known, can increase the risk of developing severe ventricular rhythm disturbances, including a life-threatening bidirectional "pirouette" ventricular tachycardia.The risk of their occurrence increases with the presence of bradycardia, hypokalemia and with lengthening of the interval QT (congenital or acquired under the influence of drugs that increase the duration of the interval QT). Before the appointment of therapy with neuroleptics, if the patient's condition allows, and during treatment with the drug, the presence of factors predisposing to the development of these severe arrhythmias (bradycardia less than 55 beats per minute, hypokalemia, hypomagnesemia, retardation of intraventricular conduction and congenital elongated interval QT or an elongated interval QT when using other drugs that extend the interval QT) (see "With caution", "Side effect").

    In the case of abdominal and abdominal distention accompanied by pericyazin, a necessary examination should be made to exclude intestinal obstruction, since the development of this side effect requires the necessary urgent measures.

    Particularly careful monitoring of the condition of patients and adherence to special care is required when prescribing pericyazine and other neuroleptics to elderly patients,patients with cardiovascular diseases, patients with hepatic and renal insufficiency, elderly patients with dementia and patients with risk factors for stroke (see "With caution").

    In randomized clinical trials, compared with some atypical antipsychotics with placebo performed in elderly patients with dementia, there was a triple increase in the risk of developing cerebrovascular complications. The mechanism of this increased risk of developing cerebrovascular complications is not known. It can not be ruled out that this risk increases with other neuroleptics or when neuroleptics are taken by patients in other groups, so pericyazine should be used with caution in patients with risk factors for stroke.

    In elderly patients with psychoses associated with dementia, in the treatment of antipsychotic drugs, there was an increased risk of death. An analysis of 17 placebo-controlled trials (average duration of 10 weeks) showed that the majority of patients who received atypical antipsychotics had a 1.6-1.7 times greater risk of death than patients who received a placebo.In a typical placebo-controlled clinical trial in patients receiving the active drug (neuroleptic) patients at the end of a 10-week course of treatment, the mortality was 4.5% against 2.6% in patients receiving placebo. Although the causes of death in clinical studies with atypical antipsychotics varied, most of the causes of death were either cardiovascular (eg, heart failure, sudden death), or infectious (eg, pneumonia) by nature. Observational studies have confirmed that, similar to treatment with atypical antipsychotics, treatment with typical neuroleptics can also increase mortality. The extent to which an increase in mortality may be due to the administration of an antipsychotic drug, rather than to some features of patients, is not clear.

    When using antipsychotic drugs, there have been cases of venous thromboembolic complications, sometimes fatal. therefore pericyazine should be used with caution in patients with risk factors for venous thromboembolic complications (see "Side effect").

    There was reported the development of hyperglycemia and a decrease in glucose tolerance in patients taking pericyazine. Patients with an established diagnosis of diabetes mellitus or with risk factors for its development who start treatment with pericyazine during the treatment should monitor the concentration of glucose in the blood (see "Side effect").

    In connection with the possibility of developing withdrawal syndrome with a sharp discontinuation of treatment with high doses of pericyazine (see "Side effect"), the drug should be phased out when used in high doses.

    In connection with the possibility of developing photosensitization, patients receiving pericyazine, it should be recommended to avoid being exposed to direct sunlight.

    Due to the fact that in persons who often treat phenothiazines, in very rare cases, the development of contact sensitization of the skin to phenothiazines is possible, direct contact of the drug with the skin should be avoided.

    In pediatric practice, it is advisable to use pericyazine in other dosage forms, for example as a solution for oral administration.

    Effect on the ability to drive transp. cf. and fur:

    It is necessary to inform patients, especially those who are drivers of vehicles or persons working with other mechanisms, about the possibility of drowsiness and reaction in connection with taking the drug, especially at the beginning of treatment, since the disturbance of psychomotor reactions can be potentially dangerous when driving vehicles and work with mechanisms.

    Form release / dosage:

    Capsules, 5 mg, 10 mg and 20 mg.

    Packaging:

    10 capsules per circuit cell packaging made of polyvinylchloride film EP-73 according to GOST 25250-88 or produced by Bilkea Recech GmbH, Germany and foils of aluminum printed lacquered according to GOST 745-2003.

    For 5 contour mesh packages together with the instruction for use, they are placed in a pack of boxboard in accordance with GOST 7933-89 or imported, approved for use in the Russian Federation.

    The packets are placed in a group package. Group packing and transport packaging in accordance with GOST 17768-90.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.
    Shelf life:2 years.
    Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-003560
    Date of registration:12.04.2016
    Date of cancellation:2021-04-12
    The owner of the registration certificate:R-PHARM, CJSC R-PHARM, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspR-PHARM, JSC R-PHARM, JSC Russia
    Information update date: & nbsp16.06.2016
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