Rispolept konsta powder for the preparation of suspensions of intramuscularly prolonged action 50mg vial N1
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Active ingredients
Risperidone
Release form
Powder
Composition
1 bottle contains: Active substance: risperidone - 50 mg. Auxiliary substances: copolymer of lactic and glycolic acids - 619 mg (per 1 g of microgranules). Solvent: carmellose sodium 40 mPa.s - 22.5 mg, polysorbate 20 - 1 mg, sodium hydrogen phosphate dihydrate - 1.27 mg, anhydrous citric acid - 1 mg, sodium chloride - 6 mg, sodium hydroxide - 0.54 mg, water d / and - up to 1 ml.
Pharmacological effect
Risperidone is a selective monoaminergic antagonist. It has a high affinity for serotonergic 5-HT2 receptors and dopaminergic D2 receptors. In addition, risperidone binds to alpha1-adrenergic receptors and, to a lesser extent, to H1-histaminergic and alpha2-adrenergic receptors. Risperidone does not bind to cholinergic receptors. Despite the fact that risperidone is a powerful antagonist of D2 receptors, thanks to which it improves the positive symptoms of schizophrenia, this drug, compared to typical neuroleptics, to a lesser extent inhibits locomotor activity and less often causes catalepsy. Thanks to a balanced central antagonism against serotonin and dopamine receptors, risperidone is less likely to cause extrapyramidal side effects and has a therapeutic effect on the negative and affective symptoms of schizophrenia.
Pharmacokinetics
Risperidone is metabolized by a CYP2D6 isoenzyme to 9-hydroxyrisperidone, which has the same pharmacological activity as risperidone itself. Risperidone and 9-hydroxyrisperidone form an active antipsychotic fraction. Another route of metabolism of risperidone is N-dealkylation. In fast metabolizers, the clearance of the active antipsychotic fraction and risperidone is 5.0 and 13.7 l / h, respectively, and in weak metabolizers, 3.2 and 3.3 l / h, respectively. General characteristics of risperidone after injection to patients of the drug Rispolept Konsta With a single intramuscular injection of the drug Rispolept Konsta, the release profile of risperidone consists of a small initial phase (less than 1% of the dose), followed by an interval of 3 weeks. After intramuscular injection, the main release of risperidone begins after 3 weeks, is maintained from week 4 to week 6, and decreases to week 7. In this regard, the patient should take an additional antipsychotic drug during the first 3 weeks after the start of treatment with the drug Rispolept Konsta.The combination of risperidone release profile and dosing regimen (intramuscular injection once every two weeks) ensures that therapeutic concentrations of risperidone are maintained in plasma. Therapeutic concentrations persist until the 4th – 6th week after the last injection of the drug Rispolept Konst. The elimination phase is completed approximately 7–8 weeks after the last injection. Risperidone is completely absorbed from the suspension Rispolept Konsta. Risperidone is rapidly distributed in body tissues. The volume of distribution is 1–2 l / kg. In plasma, risperidone binds to albumin and alpha1-acid glycoprotein. The relationship with plasma proteins of risperidone is 90%, and 9-hydroxyrisperidone - 77%. After intramuscular injections of the drug Rispolept Konst in doses of 25 or 50 mg once every two weeks, the average values of the minimum and maximum plasma concentrations of the active antipsychotic fraction are 9.9–19.2 ng / ml and 17.9–45 to 5 ng / ml, respectively. With this dosing regimen, risperidone pharmacokinetics is linear. In long-term use (12 months) in patients who were administered the drug Rispolept Konst in doses of 25–50 mg once every two weeks, cumulation of risperidone was not observed. A single dose study of the oral form of risperidone showed higher plasma concentrations and a reduced clearance of the active antipsychotic fraction by 30% in elderly patients and 60% in patients with renal insufficiency. Plasma risperidone concentrations in patients with hepatic insufficiency were normal, but the mean value of the free fraction in plasma increased by 35%.
Indications
Treatment and prevention of schizophrenia and schizoaffective disorders.
Contraindications
Lactation period (breastfeeding). Children and adolescents up to 18 years. Hypersensitivity to the drug Rispolept Konst. Because of the alpha-adrenergic blocking activity of risperidone, patients may experience orthostatic hypotension, especially during the initial period of treatment, and therefore risperidone should be used with caution in patients with cardiovascular diseases (for example, heart failure, myocardial infarction, impaired cardiac muscle / for example , AV blockade, dehydration, hypovolemia, or cerebrovascular disorders). In such patients, the dose should be increased gradually. With the continuation of clinically significant hypotension, it is necessary to evaluate the risk / benefit indicator of further treatment with Rispolept Konst.Care must be taken when prescribing Rispoleppe Konsta to patients with Parkinson's disease (since, theoretically, risperidone can exacerbate the disease), as well as patients with epilepsy.
Precautionary measures
With caution Use with caution in the following conditions: - diseases of the cardiovascular system (chronic heart failure, myocardial infarction, cardiac muscle conduction disturbances) - dehydration and hypovolemia - cerebral circulation disorders - Parkinson's disease - convulsions and epilepsy (including history) - severe renal failure - liver failure - drug abuse or drug dependence - conditions that predispose to development ahikardii type pirouette (bradycardia, electrolyte imbalance, concomitant drugs, prolonging the interval QT) - brain tumor, intestinal obstruction, acute drug overdose cases, Reye's syndrome (antiemetic effect of risperidone may mask symptoms of these states) - pregnancy.
Use during pregnancy and lactation
Pregnancy: There are no data on the safety of risperidone in pregnant women. In animal experiments, risperidone did not have a direct toxic effect on the reproductive system, but caused some indirect effects mediated through prolactin and the central nervous system. None of the studies had risperidone teratogenic effects. If a woman took antipsychotics (including Rispolept) in the third trimester of pregnancy, newborns are at risk of extrapyramidal disorders and / or withdrawal symptoms of varying severity. These symptoms may include agitation, hypertension, hypotension, tremor, drowsiness, respiratory disorders and feeding disorders. The drug Rispolept Konsta can be used during pregnancy only in cases where the potential benefits to a woman outweigh the possible risk to the fetus. Lactation: In animal experiments, risperidone and 9-hydroxyrisperidone are excreted in milk. It was also found that risperidone and 9-hydroxyrisperidone are excreted in human milk. Therefore, women taking rispolept Konsta should not breastfeed.
Dosage and administration
Konsta's rispolept is injected 1 time in 2 weeks deeply in / m using a sterile needle attached to the syringe. Injections should be made alternately in the right and left buttocks. The drug can not be administered in / in! Adults Rispole Konst administered at a dose of 25 mg / m 1 every 2 weeks. Some patients need higher doses - 37.5 mg or 50 mg. The maximum dose should not exceed 50 mg 1 time in 2 weeks. Within 3 weeks after the first injection of the drug, Rispolept Konsta (that is, prior to the onset of the drug), the patient should take an effective antipsychotic agent. The dose of the drug can be increased no more than 1 time in 4 weeks. The effect of such a dose increase should be expected no earlier than 3 weeks after the first injection of the increased dose. Elderly patients, the recommended dose is 25 mg / m 1 time in 2 weeks. Within 3 weeks after the first injection of the drug, Rispolept Konsta (that is, prior to the onset of the drug), the patient should take an effective antipsychotic agent. Currently, there is no data on the use of the drug Rispolept Konst in patients with impaired liver or kidney function. If it is nevertheless necessary to use Rispolepta Konst in this category of patients, then in the first week it is recommended to take orally 500 μg of risperidone 2 times / day in the form of pills or solution for the reception Inside. During the second week, the patient can take 1 mg 2 times / day or 2 mg 1 time / day. If the patient is well tolerated by an oral dose of at least 2 mg, then he can be injected in / m 25 mg of the drug Rispolept Konsta 1 time in 2 weeks.
Side effects
Konsta's rispolept in therapeutic doses causes the following adverse events: Often (more than 1/100) - an increase in body weight (by 2.7 kg or more over 1 year), depression, increased fatigue and extrapyramidal symptoms. While taking the drug Rispolept Konsta (in doses up to 50 mg), the frequency of extrapyramidal symptoms is similar to that in patients who received placebo. Rarely (more than 0.1 / 100) - weight gain, irritability, sleep disturbances, apathy, decreased concentration , tardive dyskinesia, seizures, neuroleptic malignant syndrome, visual disturbances, hypotension, tachycardia, syncope, skin rash, pruritus, peripheral edema,reaction at the injection site. Symptoms of hyperprolactinemia, such as non-birth-related lactation, amenorrhea, gynecomastia, menstrual disorders, impaired sexual function, impaired ejaculation, decreased libido and impotence. Hematological disorders increase or decrease in the number of leukocytes or platelets, increased activity of hepatic enzymes .In addition, the following adverse effects are possible: insomnia, agitation, anxiety, headache, constipation, abdominal pain, rhinitis, urinary incontinence, priapism, drowsiness, heads whirling, dyspepsia, nausea, vomiting, disturbances in thermoregulation, and hypervolemia caused by polydipsia or the syndrome of inadequate secretion of ADH. During treatment with the drug Rispolept Konsta sometimes there are violations of cerebral circulation. When treating with drug Rispolept Konsta, hyperglycemia or worsening of the course of diabetes is very rarely observed.
Overdose
When risperidone parenteral dosage forms are used, overdose is less likely than when oral forms are used (film-coated pills and oral solution), and therefore information regarding oral forms is presented here. Symptoms: The symptoms observed in overdose are exacerbated by known pharmacological effects. They include sedation, drowsiness, tachycardia, lowering blood pressure and extrapyramidal disorders. A prolongation of the QT interval and convulsions was observed. Bidirectional ventricular tachycardia was observed while taking an increased dose of oral risperidone and paroxetine. In case of overdose, the possibility of involving several drugs should be considered. Treatment: provide and maintain airway, adequate oxygenation and ventilation. It is necessary to monitor the function of the cardiovascular system, which should include continuous monitoring of the ECG to detect possible arrhythmias. Rispolept has no specific antidote, and therefore treatment should be aimed at maintaining the function of the central nervous system and cardiovascular system, and detoxification therapy should also be carried out. For severe extrapyramidal symptoms, anticholinergic drugs should be administered.Medical surveillance and monitoring must continue until signs of overdose disappear.
Interaction with other drugs
The drug interactions Rispolept Konsta with other drugs have not been systematically evaluated. Interaction data presented in this section is based on studies of the oral form of the drug Rispolept. Pharmacodynamic-related interactions: Central-acting drugs and alcohol: Konsta's rispolept increases the severity of the inhibitory effect on the central nervous system of opioid analgesics, hypnotics, anxiolytics, tricyclic antidepressants, general anesthetics, and alcohol. Levodopa and dopamine receptor agonists Rispolept Konsta may weaken the effect of levodopa and other dopamine receptor agonists. If necessary, simultaneous use, especially in patients with end-stage Parkinson's disease, should be prescribed the minimum effective dose of each of the drugs. Antihypertensive drugs: Clinically significant hypotension occurs when co-administered with risperidone and antihypertensive drugs. Drugs that increase the interval QT: Care must be taken in the combined use of the drug Rispolept Konst with drugs that increase the interval QT, such as antiarrhythmic agents (quinidine, disopyramide, procainamide, propafenone, amiodarone, sotalol), tricyclic antidepressants (amitriptyline), tetracyclic antidepressants ( maprotiline), some antihistamines, other antipsychotics, some antimalarials (quinine, mefloquine), drugs, challenges ayuschimi electrolyte imbalance (hypokalemia, hypomagnesemia), bradycardia and drugs that inhibit the metabolism of risperidone in the liver. Paliperidone: Since paliperidone is an active metabolite of risperidone, caution should be exercised with the simultaneous use of Xseplion and risperidone or paliperidone orally for a long period of time. Data on the safety of the drug Xeplion and other antipsychotics are limited.The interactions associated with the pharmacokinetics of risperidone are mainly metabolized by the isoenzyme CYP2D6 and to a lesser extent CYP3A4. Both risperidone and its active metabolite 9-hydroxyrisperidone are substrates of P-glycoprotein (P-GP). Substances that alter the activity of CYP2D6, or substances that strongly inhibit or induce the activity of CYP3A4 and / or P-GP, can affect the pharmacokinetics of risperidone and the active antipsychotic fraction. Strong inhibitors of CYP2D6. Combined use of the drug Rispolept Konsta with a strong inhibitor of CYP2D6 can increase the concentration of risperidone in plasma, but to a lesser extent the active antipsychotic fraction. Higher doses of a strong inhibitor of CYP2D6 may increase the concentration of risperidone and the active antipsychotic fraction (for example, paroxetine, see below). It is expected that other inhibitors of CYP2D6, such as quinidine, may affect plasma concentration of risperidone in a similar manner. With the simultaneous use of paroxetine, quinidine or another strong CYP2D6 inhibitor, especially at higher doses, the dose of the drug Rispolept Konsta should be adjusted. CYP3A4 and / or P-GP inhibitors: Co-administration of the drug Rispolept Konst with a strong inhibitor of CYP3A4 and / or P-GP can significantly increase plasma concentrations of risperidone and the active antipsychotic fraction. With the simultaneous use of itraconazole or another strong inhibitor of CYP3A4 and / or P-GP, the dose of the drug Rispolept Konsta should be adjusted. Inductors CYP3A4 and / or P-GP Combined use of the drug Rispolept Konst with a strong inducer CYP3A4 and / or P-GP can reduce the plasma concentration of risperidone and the active antipsychotic fraction. With the simultaneous use of carbamazepine or another strong inducer of CYP3A4 and / or P-GP, the dose of the drug Rispolept Konst should be adjusted. The degree of induction can vary in time with the achievement of the maximum effect up to 2 weeks after administration and a decrease in induction up to 2 weeks after discontinuation of the drug. Drugs, strongly binding to plasma proteins: When used together with drugs that have a high binding capacity to plasma proteins, there is no clinically significant displacement of the drug from plasma proteins. With simultaneous use should refer to the instructions for use of the appropriate drug and, if necessary, adjust the dose of the drugs.Antibacterial drugs: Erythromycin, a moderate CYP3A4 inhibitor and a P-GP inhibitor, does not alter the pharmacokinetics of risperidone and the active antipsychotic fraction. Rifampicin, a strong inducer of CYP3A4 and P-GP, reduces the plasma concentration of the active antipsychotic fraction. Donepezil and galantamine, substrates of CYP2D6 and CYP3A4, do not have a clinically significant effect on the pharmacokinetics of risperidone and the active antipsychotic fraction. Antiepileptic drugs Carbamazepine, a strong inducer of CYP3A4 and P-GP, reduces the plasma content of the active antipsychotic fraction risperidone. A similar effect is observed with the use of phenytoin and phenobarbital, which are also inducers of CYP3A4 and P-GP. Topiramate moderately reduces the bioavailability of risperidone, but not the active antipsychotic fraction. This interaction is not considered clinically significant. Risperidone has no clinically significant effect on the pharmacokinetics of valproic acid or topiramate. Antifungal drugs: Itraconazole, a strong inhibitor of CYP3A4 and P-GP, at a dose of 200 mg / day increases the plasma concentration of the active antipsychotic fraction by about 70% when using risperidone at a dose of 2 to 8 mg / day. Ketoconazole, a strong inhibitor of CYP3A4 and P-GP, at a dose of 200 mg / day, increases the concentration of risperidone in plasma and decreases the concentration of 9-hydroxyrisperidone in plasma. Antipsychotic drugs: Phenothiazines may increase the concentration of risperidone in plasma, but to a lesser extent, the concentration of the active antipsychotic fraction. Aripiprazole, substrate CYP2D6 and CYP3A4: risperidone does not affect the pharmacokinetics of aripiprazole and its active metabolite, dihydroaripiprazole. Antiviral drugs Protease inhibitors: no official research data available. Since ritonavir is a potent CYP3A4 inhibitor and a weak CYP2D6 inhibitor, ritonavir and protease inhibitors enhanced by ritonavir can lead to an increase in the concentration of risperidone and the active antipsychotic fraction. Beta-blockers Some beta-blockers may increase the concentration of risperidone in plasma, but not the active antipsychotic fraction. Verapamil, a moderate CYP3A4 and P-GP inhibitor of slow calcium channel blockers, increases the concentration of risperidone and the active antipsychotic fraction in plasma. Cardiac glycosides: Risperidone has no clinically significant effect on digoxin pharmacokinetics. Diuretics: Seesection “Specific Instructions” on the increased mortality of elderly patients with dementia with the combined use of furosemide and oral forms of risperidone. Gastrointestinal drugs: H2 receptor antagonists: cimetidine and ranitidine, which are weak inhibitors of CYP2D6 and CYP3A4, increase the bioavailability of risperidone, but minimally affect the concentration of the active antipsychotic fraction. Lithium preparations: Risperidone has no clinically significant effect on the pharmacokinetics of lithium preparations. Serotonin reuptake inhibitors and tricyclic antidepressants: Fluoxetine, a potent CYP2D6 inhibitor, increases plasma plasma risperidone concentration, but affects the concentration of the active antipsychotic fraction to a lesser extent. Paroxetine, a potent inhibitor of CYP2D6, increases plasma plasma concentration of risperidone, but at doses up to 20 mg / day, the concentration of the active antipsychotic fraction is less affected. However, higher doses of paroxetine may increase the concentration of the active antipsychotic fraction of risperidone. Tricyclic antidepressants can increase the plasma concentration of risperidone, but do not affect the concentration of the active antipsychotic fraction. Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction. Sertralin is a weak inhibitor of CYP2D6, and fluvoxamine is a weak inhibitor of CYP3A4. At doses up to 100 mg / day, sertraline and fluvoxamine do not have a clinically significant effect on the concentration of the active antipsychotic fraction of risperidone. However, the use of doses higher than 100 mg / day can lead to an increase in the concentration of risperidone and the active antipsychotic fraction.
special instructions
In patients who have not previously received risperidone, it is recommended to determine the tolerability of oral dosage forms of risperidone, before starting treatment with Rispolept Konsta. Use in elderly patients with dementia: The use of the drug Rispolept Konsta has not been studied in elderly patients with dementia, as it is not indicated for this group of patients. The drug Dispo Konsta is not intended for the treatment of behavioral disorders associated with dementia. Increased mortality in elderly patients with dementia: In elderly patients with dementia, treatment with atypical antipsychotics showed increased mortality compared with the placebo group in a meta-analysis of 17 controlled studies of atypical antipsychotics, including oral risperidone.In placebo-controlled studies of oral risperidone for this population, the death rate was 4.0% for patients taking risperidone, compared with 3.1% for the placebo group. The average age of deceased patients is 86 years (range 67–100 years). The data collected from two extensive observational studies show that elderly patients with dementia who are being treated with typical antipsychotic drugs also have a slightly increased risk of death compared with patients not undergoing treatment. Not enough data is currently collected to accurately assess this risk. Unknown and the reason for the increase in this risk. Nor is the degree to which the increase in mortality may be applicable to antipsychotic drugs, and not to the characteristics of this group of patients. Concurrent use with furosemide: Older patients with dementia experienced increased mortality while taking furosemide and risperidone orally (7.3%, mean age 89 years, range 75-97 years) compared with the group taking only risperidone (3.1%, mean age 84 years, a range of 70-96 years) and a group that took only furosemide (4.1%, average age 80 years, range 67-90 years). An increase in the mortality of patients taking risperidone with furosemide was observed in 2 of 4 clinical trials. The combined use of risperidone with other diuretics (mainly with thiazide diuretics in small doses) was not accompanied by an increase in mortality. There is no established pathophysiological mechanisms explaining this observation. However, special care should be taken when prescribing the drug in such cases. Before an appointment, it is necessary to carefully evaluate the risk / benefit ratio. No increase in mortality was found in patients who simultaneously took other diuretics with risperidone. Regardless of treatment, dehydration is a common risk factor for mortality and should be carefully monitored in elderly patients with dementia. Cerebrovascular Adverse Events: In placebo-controlled clinical studies in patients with dementia who were taking some atypical antipsychotics, there was an increase in the risk of cerebrovascular adverse events by about 3 times.Combined data from 6 placebo-controlled studies, which included mostly elderly patients with dementia (age over 65 years), demonstrate that cerebrovascular adverse events (serious and not serious) occurred in 3.3% (33/1009) of the patients taking risperidone and in 1.2% (8/712) patients taking placebo. The risk ratio was 2.96 (1.34, 7.50) with a confidence interval of 95%. The mechanism to increase the risk is unknown. Increased risk is not excluded for other antipsychotic drugs, as well as for other patient populations. Konsta's rispolept should be used with caution in patients with risk factors for stroke. Orthostatic hypotension: Risperidone has alpha-adrenergic blocking activity, and therefore may cause orthostatic hypotension in some patients, especially at the beginning of therapy. Clinically significant hypotension was observed in the post-marketing period with combined use with antihypertensive drugs. Risperidone must be used with caution in patients with known cardiovascular diseases (for example, heart failure, myocardial infarction, conduction disturbances, dehydration, hypovolemia, or cerebrovascular disease). It is recommended to carefully evaluate the benefit / risk ratio when assessing the possibility of continuing therapy with the drug Rispolepept Konsta. Blood disorders (leukopenia, neutropenia and agranulocytosis): Cases of leucopenia, neutropenia and agranulocytosis have been reported with antipsychotics, including Rispolept Konsta. During post-registration observation, very rare cases of agranulocytosis have been reported (less than 1/10000 patients). During the first few months of treatment, patients should be monitored with a clinically significant decrease in the number of white blood cells or leukopenia or neutropenia caused by medication, in history. The possibility of discontinuation of the drug Rispolept Konst should be considered when the first signs of a clinically significant reduction in the number of white blood cells in the absence of other causative factors appear. The condition of patients with clinically significant neutropenia for fever or other signs or symptoms of infection should be carefully monitored, and treatment of such conditions should begin immediately.Discontinue use of the drug Rispolept Konst in patients with severe neutropenia (neutrophil count is less than 1 × 109 / l) and monitor the number of white blood cells before recovery. Late dyskinesia and extrapyramidal disorders Preparations with dopamine receptor antagonist properties can cause tardive dyskinesia, which is characterized by rhythmic involuntary movements, mainly of the tongue and / or mimic muscles. The occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. If a patient develops objective or subjective symptoms indicating late dyskinesia, it is necessary to consider the advisability of canceling all antipsychotic drugs. Malignant neuroleptic syndrome (NNS): Antipsychotics, including risperidone, can cause malignant neuroleptic syndrome (NNS), which is characterized by hyperthermia, muscle rigidity, instability of the autonomic nervous system function, depression of consciousness, and also an increase in serum creatine phosphine concentration in serum. Myoglobinuria (rhabdomyolysis) and acute renal failure may also occur in patients with NNS. When a patient has symptoms of NMS, it is necessary to immediately cancel all antipsychotics, including rispolept Konsta. Parkinson's disease and dementia with Lewy bodies: The prescription of antipsychotic drugs, including Rispolept Konst, for patients with Parkinson’s disease or dementia with Lewy bodies, should be done with caution, because both groups of patients have an increased risk of developing an antipsychotic malignant syndrome and increased sensitivity to antipsychotic drugs (including dulling pain sensitivity, confusion, postural instability with frequent falls and extrapyramidal symptoms). When taking risperidone may worsen the course of Parkinson's disease. Hypersensitivity Reactions: Although the tolerability of oral forms of risperidone should be checked before initiating therapy with Rispolept's drug, very rare cases of anaphylactic reactions occurring during post-registration use in patients who have previously tolerated oral forms of risperidone have been reported.In the event of hypersensitivity reactions, it is necessary to discontinue the use of the drug Rispolept Konsta, to take the necessary supporting clinical measures and to monitor the condition of the patients until the symptoms disappear. Hyperglycemia and diabetes mellitus When treated with the drug Rispolept Konst, hyperglycemia, diabetes mellitus and exacerbation of existing diabetes were observed. It is likely that a pre-treatment increase in body weight is also a predisposing factor. Ketoacidosis can occur very rarely and diabetic coma rarely. All patients should be clinically monitored for symptoms of hyperglycemia (such as polydipsia, polyuria, polyphagia and weakness). Patients with diabetes mellitus should be regularly monitored for worsening glucose control. An increase in body weight During treatment with the drug Rispolept Konsta, a significant increase in body weight was observed. It is necessary to monitor the body weight of patients. Hyperprolactinemia: Hyperprolactinemia is a common undesirable reaction when treated with risperidone. It is recommended to determine the concentration of prolactin in the blood of patients with signs of hyperprolactinemia (for example, gynecomastia, menstrual disorders, anovulation, impaired fertility, decreased libido, erectile dysfunction, galactorrhea). Based on the results of tissue culture studies, it has been suggested that cell growth in breast tumors can be stimulated by prolactin. Despite the fact that clinical and epidemiological studies have not revealed a clear link between hyperprolactinemia and antipsychotic drugs, caution should be exercised when prescribing risperidone in patients with a history of complications. The drug Konsta's Ipo should be used with caution in patients with existing hyperprolactinemia and in patients with possible prolactin-dependent tumors. QT interval lengthening: The QT interval lengthening was very rarely observed in the post-marketing observation period. As with other antipsychotics, care should be taken when prescribing the drug Rispolept Konsta to patients with known cardiovascular diseases,lengthening of the QT interval in family history, bradycardia, electrolyte imbalance (hypokalemia, hypomagnesaemia), as this may increase the risk of an arrhythmogenic effect; and when used together with drugs that extend the QT interval. Seizures: Konsta's rispole should be used with caution in patients with a history of seizures or other medical conditions in which the seizure threshold can be reduced. Priapism: Priapism may occur when using risperidone because of alpha-adreno-blocking effects.