Invega coated pills prolonged 3mg N28
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Active ingredients
Paliperidone
Release form
Pills
Pharmacological effect
Absorption is high, but at a slow rate. When taking the drug simultaneously with food, bioavailability increases by 25%, Cmax increases by 25% and Tmax decreases. In humans, when taking sertraline at a dose of 50 to 200 mg 1 time / day for 14 days, Cmax was reached 4.5-8.4 hours after taking . Cmax and AUC are proportional to the dose in the range of 50-200 mg of sertraline 1 time / day for 14 days, thus revealing the linear nature of the pharmacokinetic dependence. The distribution of plasma protein binding is about 98%. Accordingly, the final T1 / 2 is observed approximately twice the cumulation of the drug before the onset equilibrium concentrations after 1 week of treatment (receiving a dose of 1 time / day). Metabolism Sertralin undergoes active biotransformation during the first passage through the liver. The main metabolite found in plasma, N-desmethyl sertraline, is significantly inferior (about 20 times) to sertraline in in vitro activity and is actually not active on in vivo depression models. Sertralin and N-desmethyl sertraline are actively biotransformed. Excretion of Sertralin T1 / 2 in young and older men and women is 22-36 hours. T1 / 2 N-desmethylsertraline varies from 62-104 hours. Metabolites are excreted in faeces and urine in equal amounts. Only a small part of the drug (less than 0.2%) is excreted in the urine unchanged. Pharmacokinetics in special clinical situations The pharmacokinetic profile in adolescents and elderly patients is not significantly different from that in patients aged 18 to 65 years. It is shown that sertralin pharmacokinetics in children with OCD, it is similar to that in adults (although sertraline is slightly more active in children). However, given the lower body weight in children (especially at the age of 6-12 years), it is recommended to use the drug in a lower dose in order to avoid excessive plasma levels. In patients with cirrhosis of the liver, the T1 / 2 of the drug and AUC are increased compared with those of healthy people.
Indications
Mechanism of action Paliperidone is a centrally acting dopamine D2 receptor antagonist, which also has a high antagonism against serotonin 5-HT2A receptors. In addition, paliperidone is an antagonist of alpha1 and alpha2-adrenergic receptors and H1-histamine receptors. Paliperidone does not have an affinity for cholinergic, muscarinic, and beta1- and beta2-adrenergic receptors.The pharmacological activity of (+) and (-) - enantiomers of paliperidone is the same in qualitative and quantitative terms. The antipsychotic action is due to the blockade of the D2-dopaminergic receptors of the mesolimbic and mesocortical system. It causes less suppression of motor activity and to a lesser extent induces catalepsy than classical antipsychotics (neuroleptics). A balanced central antagonism to serotonin and dopamine may reduce the propensity for extrapyramidal side effects and extend the therapeutic effect of the drug to cover the negative and productive symptoms of schizophrenia. sleep structure: reduces the latent period before falling asleep, reduces the number of awakenings after falling asleep, increases the overall telnost sleep, increases sleep time and improves sleep quality index. Has an antiemetic effect, may cause an increase in the concentration of prolactin in the blood plasma.
Contraindications
Inside, pills should be swallowed whole with a liquid, they should not be chewed, divided into parts or crushed. Schizophrenia Adults (over 18 years old). The recommended dose in adults is 6 mg 1 time per day, in the morning, regardless of the meal. A gradual increase in the initial dose is not required. In some patients, lower or higher doses cause a therapeutic effect within the recommended range of 3–12 mg once a day. There is a general tendency to enhance the effect when using large doses of the drug. If an increase in the dose is necessary, it is recommended to increase the dose by 3 mg per day at intervals of more than 5 days. Teenagers (12-17 years). The recommended dose in adolescents is 3 mg 1 time per day, in the morning, regardless of the meal. A gradual increase in the initial dose is not required. In some patients, higher doses within the recommended range of 6–12 mg once a day cause a therapeutic effect. Increasing the dose is possible only after a clinical revaluation, with an increase in the dose of 3 mg per day at intervals of more than 5 days. Schizoaffective disorders Adults (over 18 years old). The recommended dose in adults is 6 mg 1 time per day, in the morning. A gradual increase in the initial dose is not required.In some patients, lower or higher doses cause a therapeutic effect within the recommended range of 6–12 mg once a day. Increasing the dose, if necessary, should be carried out only after assessing the clinical condition of the patient. If an increase in the dose is necessary, it is recommended to increase the dose by 3 mg / day at intervals of more than 4 days. Maintenance therapy in patients with schizoaffective disorders has not been studied. Patients with impaired liver function. Patients with a weak or moderate degree of liver dysfunction do not require a dose reduction. The use of Invega in patients with severely impaired liver function has not been studied. Patients with impaired renal function. For patients with mild renal impairment (Cl creatinine ≥50, but <80 ml / min), the recommended starting dose is 3 mg 1 time per day. This dose can be increased to 6 mg 1 time per day after assessing the patient's condition and taking into account the tolerability of the drug. For patients with moderate or severe renal impairment (creatinine Cl ≥10, but <50 ml / min), the recommended dose is 3 mg 1 time per day. The use of the drug Invega in patients with Cl creatinine <10 ml / min has not been studied, and therefore it is not recommended to prescribe the drug to these patients. Older patients. For elderly patients with normal renal function (Cl creatinine ≥80 ml / min), the same doses are recommended as for adult patients with normal renal function. However, in elderly patients, renal function may be reduced, and in this case, the dose of the drug should be selected in accordance with the renal function in a particular patient (see "Patients with impaired renal function"). Caution must be exercised when using the drug in elderly patients with dementia due to an increased risk of stroke. The efficacy and safety of the drug Invega in patients over 65 years with schizoaffective disorders has not been studied. Children and adolescents. The efficacy and safety of the drug Invega for the treatment of schizophrenia in children under 12 years of age has not been studied. The efficacy and safety of the drug Invega for the treatment of schizoaffective disorders in patients younger than 18 years has not been studied. Specific groups of patients It is not recommended to change the dose of paliperidone depending on gender,age and on whether the patient smokes or not. Transferring patients for treatment with other antipsychotics There are currently no systematically collected data on the transfer of patients from treatment with paliperidone to treatment with other antipsychotics. Pharmacodynamics and pharmacokinetics of different antipsychotic drugs are not the same, and therefore doctors should closely monitor the condition of patients when transferring them from one antipsychotic drug to another.
Precautionary measures
Contraindicated in patients with hypersensitivity to paliperidone, risperidone, as well as any auxiliary ingredient of the drug. Dysphagia and narrowing of the gastrointestinal lumen (possibility of obstruction). Invega pills are not deformed and almost do not change their shape in the gastrointestinal tract, and therefore they should not be prescribed to patients with a strong narrowing of the lumen of the gastrointestinal tract (pathological or iatrogenic), as well as to patients who suffer from dysphagia or who are hard to swallow pills. There are rare reports of gastrointestinal obstruction symptoms associated with the ingestion of non-deformable dosage forms with controlled release of the active substance. Paliperidone also applies to such dosage forms, and therefore it can be prescribed only to those patients who can swallow pills whole. Older patients with dementia. The efficacy and safety of paliperidone have not been evaluated in elderly patients with dementia. A meta-analysis of 17 placebo-controlled studies showed that elderly patients with dementia who received atypical antipsychotics, such as risperidone, aripiprazole, olanzapine, and quetiapine, showed a higher mortality rate compared to patients who received placebo. Placebo-controlled studies, in which elderly patients with dementia participated, demonstrated an increased incidence of cerebrovascular undesirable effects (strokes and transient ischemic attacks), incl. fatalities in patients who received some atypical antipsychotics, including risperidone, aripiprazole, and olanzapine, compared with patients who received placebo. Parkinson’s disease and dementia with Lewy bodies.Physicians should carefully weigh possible risks and potential benefits when prescribing antipsychotics, including paliperidone, to patients suffering from Parkinson's disease or dementia with Lewy bodies, since such patients may have an increased risk of developing anti-psychotic malignant syndrome (MND) or increased sensitivity to antipsychotic drugs. Manifestations of this hypersensitivity include, in addition to extrapyramidal symptoms, confusion, dullness of reactions and postural hypotension with frequent falls.
Use during pregnancy and lactation
Malignant Neuroleptic Syndrome It is known that antipsychotic drugs, including paliperidone, can cause malignant neuroleptic syndrome (NNS), which is characterized by hyperthermia, muscle rigidity, instability of the autonomic nervous system function, depression of consciousness, as well as an increase in serum creatine phosphors, as well as an increase in the serum of the SPF, as well as an increase in serum concentration Myoglobinuria (rhabdomyolysis) and acute renal failure may also occur in patients with NNS. When an objective or actor appears in a patient In general, the objective and subjective symptoms of paliperidone overdose are enhanced pharmacological effects of this drug, i.e. drowsiness and sedation, tachycardia and hypotension, prolongation of the QT interval and extrapyramidal symptoms. Bidirectional tachycardia and ventricular fibrillation were observed with an overdose of oral paliperidone. In acute overdose, it is necessary to consider the possibility of the toxic action of several drugs. In assessing the therapeutic needs of the patient and the effectiveness of stopping the overdose, remember that Invega is a drug with a prolonged release of the active substance. There is no specific antidote for paliperidone. It is necessary to implement generally accepted supporting measures. A good airway, adequate oxygenation and ventilation should be ensured and maintained. It is necessary to immediately organize monitoring of cardiovascular activity (ECG monitoring in order to identify possible arrhythmias).Hypotension and collaptoid states are treated by intravenous injection of plasma-substituting solutions and / or sympathomimetic agents. In certain situations, gastric lavage (after intubation, if the patient is unconscious), the introduction of activated charcoal and laxatives are indicated. If severe extrapyramidal symptoms occur, m-anticholinergic blockers should be administered. Monitoring of the patient’s condition and monitoring of basic physiological functions must be continued until the overdose of the overturning symptoms of the NNS is completely eliminated. All antipsychotic drugs, including paliperidone, should be immediately canceled. predominantly tongue and / or facial muscles. If a patient develops objective or subjective symptoms indicating late dyskinesia, it is necessary to consider the advisability of stopping all antipsychotic drugs, including paliperidone. QT interval and joint use with drugs that extend the QT interval. Hyperglycemia and diabetes mellitus When treated with Invega on Luda hyperglycemia, diabetes mellitus, and exacerbation of existing diabetes mellitus. Establishing the relationship between the use of atypical antipsychotics and glucose metabolism disorders is complicated by an increased risk of developing diabetes in patients with schizophrenia and the prevalence of diabetes in the general population. Given these factors, the relationship between the use of atypical antipsychotic drugs and the development of side effects associated with hyperglycemia is not fully established. In patients with an established diagnosis of diabetes mellitus, glucose levels should be regularly monitored. Patients with risk factors for diabetes mellitus (for example, obesity, a family history of diabetes) must undergo fasting blood glucose monitoring at the beginning of treatment and periodically during treatment.All patients should be clinically monitored for symptoms of hyperglycemia and diabetes mellitus. Patients who develop hyperglycemia symptoms with atypical antipsychotics should undergo a control of blood glucose levels. In some cases, the symptoms of hyperglycemia disappeared when stopping atypical antipsychotics, but some patients require antidiabetic treatment, despite discontinuing the suspected drug. Increasing body weight With atypical antipsychotics, a significant increase in body weight was observed. It is necessary to control the body weight of patients. Hyperprolactinemia Like other D2-dopamine receptor antagonists, paliperidone increases the level of prolactin and this increase persists throughout the entire dose of the drug. The effect of paliperidone is comparable to that of risperidone, a drug with the greatest influence on the level of prolactin among other antipsychotic drugs. Hyperprolactinemia, regardless of etiology, can suppress the expression of GnRH (gonadotropin-releasing hormone) of hypothamus, which leads to a decrease in the secretion of gonadotropins, which leads to a decrease in the secretion of gonadotropins, which leads to a decrease in the secretion of gonadotropins. This, in turn, can suppress reproductive function, weakening sexual steroidogenesis in women and men. Galactorrhea, amenorrhea, gynecomastia, and impotence were reported in patients taking drugs that increase the level of prolactin. Prolonged hyperprolactinemia associated with hypogonadism can lead to a decrease in bone density in women and in men. Studies in tissue cultures in vitro have shown that about one third of breast cancer cases in humans are prolactin-dependent. This should be considered when prescribing drugs that increase the level of prolactin in patients with previously diagnosed breast cancer. Clinical and epidemiological studies conducted to date have shown no association between atypical antipsychotic drugs and the formation of tumors in humans. However, the available data is too limited to draw final conclusions. Orthostatic hypotension Paliperidone has alpha-blocking activity and therefore may cause orthostatic hypotension in some patients.Paliperidone should be used with caution in patients with cardiovascular diseases (for example, heart failure, heart attack or myocardial ischemia, cardiac muscle conduction disturbances), cerebrovascular diseases, as well as conditions that promote arterial hypotension (for example, dehydration, hypovolemia, and antihypertensive drugs) ). Regulation of body temperature. An undesirable effect is attributed to antipsychotic drugs as a violation of the body's ability to regulate t mperaturu. Care must be taken when prescribing paliperidone in patients with conditions that may contribute to an increase in internal body temperature, which include intense physical exertion, dehydration, exposure to high external temperatures, or simultaneous use of drugs with anticholinergic activity. Anti-emetic effect In pre-clinical studies, the anti-emetic effect of paliperidone was detected. This effect, if it occurs in humans, can mask the objective and subjective symptoms of overdosing of certain drugs, as well as diseases such as intestinal obstruction, Reye's syndrome and brain tumors. PrimismPreparations with alpha-adreno-blocking effects can cause priapism. In post-marketing studies of paliperidone, there have been reports of the development of priapism. Suicidal attempts The possibility of suicidal attempts is characteristic of mental illness, therefore, therapy of patients with high risk must be carried out under close observation. In these cases, the drug Invega should be discharged in the minimum number of pills to reduce the risk of overdose. Leukopenia, neutropenia, agranulocytosis Leukopenia, neutropenia and agranulocytosis were observed with the use of antipsychotic drugs, including the use of the drug Invega. Agranulocytosis was observed very rarely during post-marketing observations. Patients with a clinically significant decrease in the number of leukocytes in history or drug-dependent leukopenia / neutropenia are recommended to have a complete blood count during the first months of therapy, discontinuation of treatment with Invega should be considered at the first clinically significant decrease in the number of leukocytes in the absence of other possible causes.Patients with clinically significant neutropenia are advised to be monitored for fever or symptoms of infection and to begin treatment immediately when such symptoms occur. Patients with severe neutropenia (absolute neutrophil count less than 1 × 109 / L) should discontinue use of the drug Invega until the leukocyte count normalizes. Venous thromboembolism Venous thromboembolism has been observed with the use of antipsychotic drugs. Since patients taking antipsychotic drugs often have a risk of developing venous thromboembolism, all possible risk factors should be identified before and during treatment with Invega and preventive measures should be taken. Intraoperative flabby iris syndrome (ISDR) was observed during surgery. about the presence of cataracts in patients receiving therapy with drugs from the α1 -adrenoreceptor antagonist group. IDDR increases the risk of organ complications Om vision, during and after surgery. The doctor performing this operation should be informed in advance that the patient has been taking or is currently taking medications that have α1-adrenoreceptor antagonist activity. The potential benefit of abolishing therapy with α1-adrenoreceptor antagonists before surgery has not been established, and should be evaluated with regard to the risks associated with the abolition of antipsychotic therapy.
Dosage and administration
Schizophrenia, incl. in the phase of exacerbation in adults, prevention of exacerbations of schizophrenia in adults, treatment of schizophrenia in adolescents aged 12 to 17 years, therapy of schizoaffective disorders: as monotherapy or as part of combination therapy with antidepressants and / or mood adjustments in adult patients
Side effects
Caution should be exercised when co-administering Invega with drugs that prolong the QT interval. Effect of paliperidone on other drugs Paliperidone is not likely to be involved in clinically significant pharmacokinetic interactions with drugs that are metabolized by cytochrome P450 isoenzymes.In vitro studies using human liver microsomes have shown that paliperidone does not cause significant inhibition of bioprevals of drugs that are metabolized by cytochrome P450 isoenzymes, including CYP1A4, CYP2A6, CYP2C8 / 9/10, CYP2D6, CYP2E1, CYP3A4 and CYP3A3 Based on this, there is no reason to assume that paliperidone will inhibit to a clinically significant extent the clearance of drugs that are metabolized by these enzymes. In in vitro studies, paliperidone did not induce the activity of CYP1A2, CYP2C19 or CYP3A4 isoenzymes. At high concentrations, paliperidone is a weak inhibitor of P-glycoprotein. No in vivo data, clinical significance is unknown. Considering the fact that paliperidone acts primarily on the central nervous system, it should be used with caution in combination with other drugs of central action and with alcohol. Paliperidone can neutralize the effects of levodopa and other dopamine agonists. Due to the ability of paliperidone to cause orthostatic hypotension, an additive effect may occur when using the drug simultaneously with other drugs that cause orthostatic hypotension. The pharmacokinetic interaction of paliperidone and lithium is unlikely. Simultaneous administration of the Inveg drug at a dosage of 12 mg 1 times / day and sodium pills of prolalpropro spondroeon spondroaxies 500-2000 mg 1 time per day) does not affect the pharmacokinetics of valproate. In clinical studies in patients taking a constant dose of valproate, the concentration of valproate in the blood plasma did not differ from that for patients who took Invega with a dose of 3–15 mg in combination with valproate. CYP2C9, CYP2C19 and CYP3A5. This indicates a low probability of its interaction with inhibitors or inducers of these enzymes. In vitro studies revealed a minimal involvement of CYP2D6 and CYP3A4 isoenzymes in paliperidone metabolism, however, there is no evidence that these isoenzymes play a significant role in the metabolism of paliperidone in vitro or in vivo. In vitro studies have shown that paliperidone is a substrate of P-glycoprotein. Paliperidone is metabolized in a limited manner by the CYP2D6 isoenzyme.In a study on adult volunteers, the interaction of paliperidone with paroxetine, a potential inhibitor of the CYP2D6 isoenzyme, showed no clinically significant change in the pharmacokinetics of paliperidone. The combined use of paliperidone with 200 mg of carbamazepine twice a day caused a decrease in Cmax and AUC of paliperidone by approximately 37%. This decrease is due to a 35% increase in paliperidone clearance as a result of carbamazepine induction of renal P-glycoprotein. A slight decrease in the amount of the drug excreted unchanged suggests that when combined, carbamazepine has a negligible effect on CYP metabolism or paliperidone bioavailability. When prescribing carbamazepine, the dose of paliperidone should be overestimated and increased if necessary. Conversely, when carbamazepine is canceled, the dose of paliperidone should be overestimated and reduced if necessary. Paliperidone, which is a cation at physiological pH values, is excreted mainly in unchanged form by the kidneys; moreover, about half of the excretion falls on filtration and about half on active secretion. The use of paliperidone simultaneously with trimethoprim, which is known to inhibit active renal transport of cationic drugs, did not affect the pharmacokinetics of paliperidone. When administering the drug Inwegav at the same time, 12 mg once-daily and 2-fold pills of 500 mg of 1 mg per day) there was an increase in Cmax and AUC of paliperidone by 50%. Consideration should be given to reducing the dose of the drug Invega while administering valproate on the basis of the patient's clinical evaluation. Simultaneous use of paliperidone and risperidone has not been the subject of scientific research. Paliperidone is the active metabolite of risperidone, and therefore with simultaneous use of paliperidone and risperidone, an increase in blood levels of paliperidone is possible.
Overdose
The undesirable effects observed in patients are listed below. The frequency of adverse effects was classified as follows: very often (≥10%); often (≥1 and <10%); infrequently (≥0.1 and <1%); rarely (≥0.01 and <0.1%) and very rarely (<0.01%). Infections: often - upper respiratory tract infections, nasopharyngitis; infrequently - urinary tract infections, acrodermatitis, bronchitis, inflammation of the subcutaneous fat,cystitis, ear infections, flu, onychomycosis, pneumonia, respiratory tract infections, sinusitis, tonsillitis. On the immune system: infrequent - anaphylactic reaction, hypersensitivity. On the side of the hematopoietic and lymphatic system: infrequent - anemia, hematocrit reduction, neutropenia, reduced white blood cell count ; rarely thrombocytopenia; very rarely - agranulocytosis. From the endocrine system: infrequently - hyperprolactinemia; very rarely - inadequate secretion of ADH. In terms of metabolism and nutrition: infrequently - increased activity of CPK, anorexia, hyperglycemia; rarely - diabetes, hypoglycemia, water intoxication; very rarely - diabetic ketoacidosis. Psychiatric disorders: often - insomnia (including initial and moderate insomnia), mania; infrequently - nightmares, sleep disturbances, depression. For the nervous system: very often - headache; often - akathisia, dystonia, dysarthria, increased muscle tone, parkinsonism, sedation, drowsiness, tremor, drooling; infrequently - cerebrovascular disorders, postural dizziness, dyskinesia, convulsions, fainting, attention disorder, hypesthesia, loss of consciousness, paresthesia, psychomotor hyperactivity, tardive dyskinesia, hypokinesia, opistotonus. , muscle rigidity, instability of the function of the autonomic nervous system, depression of consciousness, increased activity of CK, myoglobinuria, rhabdomyolysis, acute renal failure atochnostyu.So the organs of vision: rarely - conjunctivitis, dry eye, photophobia, lacrimation; with an unknown frequency - flabby iris syndrome (intraoperative). On the part of the organ of hearing and labyrinth disturbances: rarely - pain in the ears, vertigo, tinnitus. On the side of the CAS: infrequently - bradycardia, heartbeat, AV blockade, conduction disturbance, changes in ECG, increased QT interval, ischemia, hot flashes, increased blood pressure, decreased blood pressure; rarely - atrial fibrillation; very rarely - deep vein thrombosis, pulmonary embolism. On the side of the digestive tract: often - nausea, diarrhea, constipation, discomfort in the upper abdomen,dyspepsia, increased appetite; infrequently - decreased appetite, inflammation of the lips, dysphagia, fecal incontinence, small bowel obstruction, flatulence, gastroenteritis, tongue swelling, toothache, dysgeusia; very rarely - pancreatitis, intestinal obstruction. From the liver and biliary tract: very rarely - jaundice. From the respiratory system: rarely - pain in the pharyngeal-guttural area, nasal congestion, cough, shortness of breath, hyperventilation of the lungs, breathing breathing; rarely - sleep apnea syndrome. From the side of the musculoskeletal and connective tissue: often - myalgia, musculoskeletal pain; infrequently - muscle spasms, back pain, arthralgia, stiffness in the joint, joint swelling, muscle weakness, neck pain. On the side of the skin and subcutaneous tissues: rarely - rash, itching, acne, dry skin, eczema, erythema, seborrheic dermatitis, skin discoloration; rarely - angioedema, alopecia. From the kidneys and urinary tract: infrequently - dysuria, pollakiuriuria, urinary incontinence, urinary retention. From the genitals and breast: rarely - decreased libido, anorgasmia, nipple discharge, erectile dysfunction, gynecomas, erectile dysfunction, gynecomas, erectile dysfunction, gynecomas, erectile dysfunction. changes in the menstrual cycle, sexual dysfunction, vaginal discharge, impaired ejaculation, engorgement of the mammary glands; very rarely - priapism. Effect on the course of pregnancy, postpartum and perinatal conditions: very rarely - withdrawal syndrome in newborns. Others: often - an increase in body weight; infrequently - weight loss, chills, swelling of the face, gait disturbance, edema (including generalized, peripheral, mild), increased body temperature, fever, thirst; very rarely - hypothermia. Laboratory tests: infrequently - an increase in the activity of GGT, an increase in the activity of liver enzymes, an increase in the activity of transaminases, an increase in the concentration of cholesterol in the blood, an increase in the concentration of triglycerides in the blood. Information on dose-related side effects is shown in Tables 1 and 2. Table 1 Side effects reported in ≥2% of adult patients with schizophrenia receiving Invega in clinical studies. Organ system / side effects 3 mg 1 time per day,% 6 mg 1 time per day,% 9 mg once a day,% 12 mg once a day,% Placebo,% Nervous system headache 11 12 14 14 12 dizziness 6 5 4 5 4 extrapiramide disorders * 5 2 7 7 2 drowsiness 5 3 7 5 3 acacia 4 3 8 10 4 tremor 3 3 4 3 3 hypertension 2 1 4 3 1 distony 1 1 4 4 1 sedative effect 1 5 3 4 1 sinus arrhythmia 2 1 1 <1 0 orthostatic hypotension 2 1 2 4 1 Gastrointestinal disturbances vomiting 2 3 4 5 5 dry mouth 2 3 1 3 1bol in the upper abdomen 1 3 2 2 1 hypersal ivation 0 <1 1 4 <1 General disorders of asthenia 2 <1 2 2 1 fatigue 2 1 2 2 1 Table 2 Side effects reported in ≥2% of adolescents 12–17 years old with schizophrenia receiving Invega in clinical studies Organ system / side effects 1, 5 mg 1 time a day,% 3 mg 1 time a day,% 6 mg 1 time a day,% 12 mg 1 time a day,% Placebo,% From the side of the cardiovascular system tachycardia0 6 9 6 0 On the part of the visual organs, blurred visual perception0 0 0 3 0 Gastrointestinal disorders dry mouth 0 0 0 3 2 hyper salivation 2 6 2 0 0 current of tongue 0 0 0 3 0 pitch 0 6 11 3 10 General disorders of asthenia 0 0 2 3 0 fatigue 4 0 2 3 0 Infections nasopharyngitis 4 0 4 0 2 Laboratory tests weight gain 7 6 2 3 0 On the side of the nervous system, akathisia 4 6 11 17 0 verbose 2 6 2 3 0 extrapyramidal disorders 9 4 4 14 4 years 0 0 3 0 drowsiness 9 13 20 26 4 parish of tongue 0 0 03 0 Disruption of the psyche anxiety 0 0 9 9 On the side of the genital organs and the mammary gland, amenorrhea 0 6 0 0 0 galactorrhea 0 0 4 0 0 on the side of the respiratory system 0 * Extrapyramidal disorders include: oculogy crisis, muscular rigidity, musculoskeletal p gidnost, stiffness in the neck, torticollis, trismus, bradykinesia, cogwheel rigidity, dyskinesia, dystonia, extrapyramidal disorder,