Rispolept is an atypical highly effective antipsychotic

Effect of risperidone

The mechanism of action is caused by the effect on dopamine, serotonin, adrenergic and histamine receptors of nerve cells. Due to the fact that in many endogenous, organic mental diseases the functions of these receptor systems are changed, risperidone has a fairly broad therapeutic effect:

For productive symptoms of psychosis and schizophrenia (delusions and hallucinations), for negative ones - apathy, isolation, lack of emotions, autism.
Reduces pathologically elevated mood (mania).
Calming, anti-anxiety, hypnotic effect.
Reduces (or removes) aggressiveness, self-aggression.
Anti-suicidal action.
Reducing the pathological craving for drugs and alcohol in case of addiction.
Removes obsessive thoughts, actions and sensations.

Release form

One of the advantages of this drug is the presence of all the dosage forms necessary for psychiatrists: tablets, drops, extended-release injections (depot).
Pills

2 or 4 milligrams per package of 10,20,30,50,60 or 100 pieces

Drops

. In bottles of 30 or 100 milliliters. A special graduated pipette is included, which is used to determine the amount of a single dose to take.

Depot

. In powder form for the preparation of a long-acting intramuscular suspension. Dosages: 25, 37.5 and 50 milligrams. It is used as an intramuscular injection, which will ensure slow release and entry of the drug into the blood over 2 - 3 weeks. Produced under the name RISPOLEPT CONST.

Indications

Risperidone was originally used to treat schizophrenia and psychosis. But as experience has accumulated about the action of this medicine, the indications for its use have expanded. Currently indicated for the following diseases and conditions:

Schizophrenia
Schizotypal disorder
Organic mental disorders
Schizoid personality disorder
Manic and hypomanic states in bipolar affective disorder, schizoaffective disorder
Psychoses
Delusions: paranoia, paranoid, paraphrenia
Depressive and anxiety states, neuroses and neurosis-like conditions
Aggressiveness
Autism

The drug is recommended for adults and children over 13 years of age. At a younger age, it is prescribed by the doctor’s decision in cases where the potential risk of side and negative effects of the drug is less than the risk of worsening the condition as the disease progresses.

Rispolept oral solution 1 mg/ml, 30 ml

Release form

Oral solution

Package

30 ml

pharmachologic effect

Rispolept is an antipsychotic drug, a derivative of benzisoxazole. It also has a sedative, antiemetic and hypothermic effect.

Risperidone is a selective monoaminergic antagonist with high affinity for serotonin 5-HT2 and dopamine D2 receptors. It binds to α1-adrenergic receptors and somewhat weaker to histamine H1-receptors and α2-adrenergic receptors. Does not have tropism for cholinergic receptors.

The antipsychotic effect is due to the blockade of dopamine D2 receptors in the mesolimbic and mesocortical systems. The sedative effect is due to the blockade of adrenergic receptors in the reticular formation of the brain stem; antiemetic effect - blockade of dopamine D2 receptors in the trigger zone of the vomiting center; hypothermic effect - blockade of dopamine receptors of the hypothalamus.

Risperidone reduces the productive symptoms of schizophrenia (delusions, hallucinations), aggressiveness, automatism, causes suppression of motor activity to a lesser extent and induces catalepsy to a lesser extent than classical antipsychotics. Balanced central antagonism of serotonin and dopamine may reduce the propensity for extrapyramidal side effects and enhance the drug's therapeutic impact on negative and affective symptoms of schizophrenia.

Risperidone may cause a dose-dependent increase in plasma prolactin concentrations.

Pharmacokinetics

Suction

After oral administration, risperidone is completely absorbed from the gastrointestinal tract. Cmax in plasma is reached after 1-2 hours. Food does not affect the absorption of the drug, so Rispolept can be prescribed regardless of food intake.

Distribution

Risperidone is rapidly distributed in the body. Vd is 1-2 l/kg. In plasma, risperidone binds to albumin and alpha1-glycoprotein. Risperidone is 88% bound to plasma proteins, 9-hydroxy-risperidone is 77% bound.

Css of risperidone in the body in most patients is achieved within 1 day.

Css of 9-hydroxy-risperidone is achieved within 4-5 days. Plasma concentrations of risperidone are proportional to the dose of the drug (within therapeutic doses).

Metabolism

Risperidone is metabolized in the liver with the participation of the CYP2D6 isoenzyme with the formation of 9-hydroxy-risperidone, which has a pharmacological effect similar to risperidone. Risperidone and 9-hydroxy-risperidone constitute the active antipsychotic fraction. Another route of metabolism for risperidone is N-dealkylation.

Removal

After oral administration in patients with psychosis, T1/2 of risperidone from plasma is about 3 hours. T1/2 of 9-hydroxy-risperidone and the active antipsychotic fraction is 24 hours.

After a week of taking the drug, 70% of the dose is excreted in the urine, 14% in feces. In urine, risperidone plus 9-hydroxy-risperidone represents 35-45% of the dose. The remaining amount consists of inactive metabolites.

Pharmacokinetics in special clinical situations

In elderly patients and in patients with renal failure, higher plasma concentrations and slower elimination of risperidone were observed after a single oral dose.

In patients with liver failure, plasma risperidone concentrations did not change.

Indications

Relief of acute attacks and long-term maintenance therapy:

acute and chronic schizophrenia and other psychotic disorders with productive and negative symptoms;
affective disorders in various mental illnesses;
behavioral disorders in patients with dementia with symptoms of aggression (outbursts of anger, physical violence), disturbances in activity (agitation, delusions) or psychotic symptoms;
behavior disorders in adolescents over 15 years of age and adult patients with a reduced intellectual level or mental retardation in cases where destructive behavior (aggression, impulsivity, self-aggression) is leading in the clinical picture of the disease.

To stabilize mood in the treatment of mania in bipolar disorders (as an adjuvant therapy).

Contraindications

lactation period (breastfeeding);
hypersensitivity to the components of the drug.

The drug should be used with caution in patients with diseases of the cardiovascular system (including chronic heart failure, previous myocardial infarction, conduction disorders), dehydration, hypovolemia, cerebrovascular accident, Parkinson's disease, convulsions (including history), severe renal or hepatic failure, drug abuse or drug dependence, conditions predisposing to the development of torsade de pointes (bradycardia, electrolyte imbalance, concomitant use of drugs that prolong the QT interval), brain tumors , intestinal obstruction, in cases of acute drug overdose, in Reye's syndrome (since the antiemetic effect of risperidone can mask the symptoms of these conditions), during pregnancy, in patients under the age of 15 years (since the safety and effectiveness of the drug have not been established) .

Use during pregnancy and breastfeeding

The safety of Rispolept in pregnant women has not been studied. Rispolept can be used during pregnancy only if the positive effect justifies the possible risk. Because risperidone and 9-hydroxy-risperidone are excreted in breast milk, women using Risperidone should not breast-feed.

special instructions

The drug should be used with caution in patients with diseases of the cardiovascular system (including heart failure, myocardial infarction, cardiac muscle conduction disorders), as well as in cases of dehydration, hypovolemia or cerebrovascular disorders. In this category of patients, the dose should be increased gradually. The risk of developing orthostatic hypotension is especially increased in the initial period of dose selection. If hypotension occurs, dose reduction should be considered. When using drugs that have the properties of dopamine receptor antagonists, the occurrence of tardive dyskinesia, characterized by involuntary rhythmic movements (mainly of the tongue and/or face), was noted. There are reports that the occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. Rispolept causes the appearance of extrapyramidal symptoms to a lesser extent than classical antipsychotics. If symptoms of tardive dyskinesia occur, discontinuation of all antipsychotic medications should be considered. When using classical antipsychotics, cases of NMS have been described, which is characterized by hyperthermia, muscle rigidity, instability of autonomic functions, disturbances of consciousness and increased levels of CPK. If NMS develops, it is necessary to discontinue all antipsychotic drugs, including Rispolept. Rispolept should be prescribed with caution to patients with Parkinson's disease, since theoretically it may worsen the course of this disease. Classical antipsychotics are known to lower the seizure threshold. Considering this, Rispolept is recommended to be used with caution in patients with epilepsy. Rispolept primarily affects the central nervous system, so it should be used with caution in combination with other centrally acting drugs. During the treatment period, patients should be advised to refrain from overeating due to the possibility of weight gain.

Compound

Active substance: risperidone 1 mg;

Excipients: tartaric acid; benzoic acid; sodium hydroxide; purified water

Directions for use and doses

A. Schizophrenia Adults and children over 15 years of age. Rispolept can be prescribed once or twice a day. The initial dose of Rispolept is 2 mg per day. On the second day, the dose should be increased to 4 mg per day. From this point on, the dose can either be kept at the same level or individually adjusted if necessary. Usually the optimal dose is 4-6 mg per day. In some cases, a slower dose escalation and lower initial and maintenance doses may be justified. Doses higher than 10 mg per day have not been shown to be more effective than lower doses and may cause extrapyramidal symptoms. Due to the fact that the safety of doses above 16 mg per day has not been studied, doses above this level should not be used. Benzodiazepines can be added to Rispolept therapy if additional sedation is required. There is no information available for use in the treatment of schizophrenia in children under 15 years of age. Elderly patients. An initial dose of 0.5 mg twice daily is recommended. The dosage can be individually increased by 0.5 mg twice daily to 1-2 mg twice daily. Liver and kidney diseases. The recommended initial dose is 0.5 mg per dose 2 times a day. This dose can be gradually increased to 1-2 mg per dose twice a day. Drug abuse or drug dependence - the recommended daily dose of the drug is 2-4 mg.

B. Behavioral disorders in patients with dementia An initial dose of 0.25 mg twice daily is recommended. If necessary, the dosage can be increased individually by 0.25 mg 2 times a day, no more than every other day. For most patients, the optimal dose is 0.5 mg twice daily. However, some patients are advised to take 1 mg 2 times a day. Once the optimal dose is reached, it may be recommended to take the drug once a day.

B. Bipolar disorders with mania The recommended initial dose of the drug is 2 mg per day at a time. If necessary, this dose can be increased by 2 mg per day, no more than every other day. For most patients, the optimal dose is 2-6 mg per day.

D. Behavioral disorders in patients with mental retardation or with destructive tendencies dominating the clinical picture. Patients weighing 50 kg or more - the recommended initial dose of the drug is 0.5 mg once a day. If necessary, this dose can be increased by 0.5 mg per day, no more than every other day. For most patients, the optimal dose is 1 mg per day. However, for some patients, 0.5 mg per day is preferable, while some require an increase to 1.5 mg per day. Patients weighing less than 50 kg - The recommended starting dose of the drug is 0.25 mg once a day. If necessary, this dose can be increased by 0.25 mg per day, no more than every other day. For most patients, the optimal dose is 0.5 mg per day. However, for some patients, 0.25 mg per day is preferable, while some require an increase in dose to 0.75 mg per day. Long-term use of Rispolept in adolescents should be carried out under the constant supervision of a physician. Use in children under 15 years of age is not recommended.

Side effects

From the nervous system: insomnia, agitation, anxiety, headache, sometimes - drowsiness, fatigue, dizziness, impaired concentration, blurred vision, rarely - extrapyramidal symptoms: tremor, rigidity, hypersalivation, bradykinesia, akathisia, acute dystonia. In patients with schizophrenia - hypervolemia (either due to polydipsia or due to the syndrome of inappropriate secretion of antidiuretic hormone), tardive dyskinesia (involuntary rhythmic movements mainly of the tongue and / or face), neuroleptic malignant syndrome (hyperthermia, muscle rigidity, instability of autonomic functions, impaired consciousness and increased levels of creatine phosphokinase), thermoregulation disorders and epileptic seizures. From the digestive system: constipation, dyspepsia, nausea or vomiting, abdominal pain, increased activity of liver enzymes, dry mouth, hypo- or hypersalivation, anorexia, increased appetite, increased or decreased body weight. From the cardiovascular system: orthostatic hypotension, reflex tachycardia, increased blood pressure. During treatment with Rispolept, the development of strokes has been described, mainly in elderly patients with predisposing factors. From the hematopoietic organs: neutropenia, thrombocytopenia. From the endocrine system: galactorrhea, gynecomastia, menstrual irregularities and amenorrhea. In very rare cases, hyperglycemia and exacerbation of pre-existing diabetes mellitus in patients have been reported. From the genitourinary system: priapism, erectile dysfunction, ejaculation disorders, anorgasmia, urinary incontinence. Allergic reactions: rhinitis, rash, angioedema, photosensitivity. From the skin: dry skin, hyperpigmentation, itching, seborrhea. Other: arthralgia

Drug interactions

Taking into account the fact that Rispolept® primarily affects the central nervous system, it should be used with caution in combination with other centrally acting drugs and alcohol.

Rispolept® reduces the effectiveness of levodopa and other dopamine agonists.

Clozapine reduces the clearance of risperidone.

When using carbamazepine, a decrease in the concentration of the active antipsychotic fraction of Rispolept in plasma was observed. Similar effects may be observed with other liver enzyme inducers.

Phenothiazines, tricyclic antidepressants and some beta-blockers may increase plasma concentrations of risperidone, but this does not affect the concentration of the active antipsychotic fraction.

Fluoxetine may increase plasma concentrations of risperidone, but to a lesser extent the concentration of the active antipsychotic fraction.

When Rispolept is used together with other drugs that are highly bound to plasma proteins, no clinically significant displacement of any drug from the plasma protein fraction is observed.

Antihypertensive drugs - the severity of the decrease in blood pressure increases with risperidone.

Overdose

Symptoms: represent the already known pharmacological effects of the drug in an enhanced form - drowsiness, sedation, tachycardia, arterial hypotension, extrapyramidal symptoms. Up to 360 mg of the drug has been reported. The data obtained suggest a wide range of drug safety. In rare cases, an overdose has been associated with prolongation of the QT interval.

In case of acute overdose during combination therapy, the possibility of involvement of the effects of several drugs in the symptoms should be analyzed.

Treatment: an open airway should be achieved and maintained to ensure adequate oxygen supply and ventilation, gastric lavage (after intubation, if the patient is unconscious) and the administration of activated charcoal along with a laxative. ECG monitoring should be started immediately to identify possible arrhythmias.

There is no specific antidote; appropriate symptomatic therapy must be carried out. Arterial hypotension and vascular collapse should be treated with IV fluid infusions and/or sympathomimetic drugs. If acute extrapyramidal symptoms develop, anticholinergic drugs should be prescribed. Constant medical observation and monitoring should be continued until symptoms of intoxication disappear.

Storage conditions

The drug should be stored at a temperature of 15° to 30°C.

Best before date

3 years

Conditions for dispensing from pharmacies Dispensed with a doctor's prescription

Possible product names

Rispolept 0.001/ml 30ml solution d/v approx
Rispolept 0.001/ml 30ml bottle d/v approx
Rispolept 1mg/ml 30ml
Rispolept 1 mg/ml solution for oral administration 30 ml bottle. x1 b m (r)
Rispolept solution internally 1 mg/ml 30 ml No. 1

Use during pregnancy and breastfeeding

There are no absolute contraindications to taking risperidone during pregnancy and lactation. However, due to the lack of special research in this direction, use during pregnancy is allowed only in cases described by the following formulation: when the benefits of taking it for the pregnant woman outweigh the potential risks to the fetus.

Due to the fact that risperidone passes into breast milk, it is recommended to transfer the child to artificial nutrition for the period of treatment of a breastfeeding mother.

Instructions for use RISPOLEPT®

In case of schizophrenia, at the beginning of treatment with Rispolept, it is recommended to gradually discontinue previous therapy if clinically justified. At the same time, if patients are transferred from depot therapy with antipsychotic drugs, it is recommended to start Rispolept therapy instead of the next scheduled injection. The need to continue current antiparkinsonian drug therapy should be periodically assessed.

Due to the alpha-adrenergic blocking effect of Rispolept, orthostatic hypotension may occur, especially during the initial dose selection period. If arterial hypotension occurs, dose reduction should be considered. In patients with diseases of the cardiovascular system, as well as in cases of dehydration, hypovolemia or cerebrovascular disorders, the dose should be increased gradually.

There are reports that the occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. Rispolept is less likely to cause extrapyramidal symptoms than classic antipsychotics. If signs and symptoms of tardive dyskinesia occur, discontinuation of all antipsychotic medications should be considered.

In case of development of NMS, characterized by hyperthermia, muscle rigidity, instability of autonomic functions, disturbances of consciousness and increased CPK levels, it is necessary to discontinue all antipsychotic drugs, including Rispolept.

When carbamazepine and other liver enzyme inducers are discontinued, the dose of Rispolept should be reduced.

During treatment with Rispolept, patients should be advised to refrain from overeating due to the possibility of weight gain.

Use in pediatrics

Data on the safety and effectiveness of Rispolept in children under 15 years of age

are absent, so prescribing the drug to this category of patients is not recommended. Long-term use of Rispolept in adolescents should be carried out under the constant supervision of a physician.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, until individual sensitivity to the drug is determined, patients should avoid driving vehicles and other activities that require high concentration and speed of psychomotor reactions.

Side effects

The drug is usually well tolerated. According to clinic doctors, it is one of the well-tolerated antipsychotics. In approximately 10% of cases, the following side effects are possible.

Increased muscle tone, restlessness, trembling, feeling of stiffness, “extrapyramidal syndrome,” parkinsonism. To prevent these phenomena, correctors may be additionally prescribed: trihexyphenidyl (Cyclodol), biperiden (Akineton, Mendylex, Bezac), amantadine (PK-Merz), etc.
Headache.
Insomnia.

Rare but unpleasant side effects include metabolic (metabolic) disorders: weight gain and the development of diabetes. As a rule, such effects develop in persons predisposed to this.

Therefore, to avoid them, it is recommended to conduct an examination with blood tests before starting therapy to exclude an increase in glucose and prolactin in the blood.

Rispolept®

Use in elderly patients with dementia

Increased mortality in older patients with dementia

Elderly patients with dementia treated with atypical antipsychotics experienced increased mortality compared with placebo in studies of atypical antipsychotics, including risperidone. When using risperidone in this population, the incidence of death was 4.0% for patients taking risperidone compared with 3.1% for placebo. The mean age of patients who died was 86 years (range, 67–100 years). Data collected from two large observational studies show that older patients with dementia treated with typical antipsychotic medications also have a slightly increased risk of death compared with patients not treated. At present, insufficient data have been collected to accurately assess this risk. The reason for the increase in this risk is also unknown. Also unknown is the extent to which the increased mortality may be attributable to antipsychotic drugs rather than to the characteristics of this patient population.

Combined use with furosemide

In elderly patients with dementia, there was an increased mortality rate when taking furosemide and oral risperidone concomitantly (7.3%, mean age 89 years, range 75-97 years) compared with the risperidone alone group (3.1%, mean age 84 years , range 70-96 years) and the furosemide-only group (4.1%, mean age 80 years, range 67-90 years). An increase in mortality in patients taking risperidone with furosemide was observed in 2 of 4 clinical studies. Concomitant use of risperidone with other diuretics (mainly low-dose thiazide diuretics) was not associated with an increase in mortality.

No pathophysiological mechanisms have been established to explain this observation. However, special care should be taken when prescribing the drug in such cases. Before prescribing, the risk/benefit ratio must be carefully assessed. There was no increase in mortality in patients taking other diuretics concomitantly with risperidone. Regardless of treatment, dehydration is a common risk factor for mortality and should be carefully monitored in older patients with dementia.

In elderly patients with dementia, an increase in cerebrovascular adverse events (acute and transient cerebrovascular accidents), including patient deaths (mean age 85 years, range 73-97 years) was observed with risperidone compared with placebo.

Cardiovascular effects

In placebo-controlled clinical trials, an approximately 3-fold increased risk of cerebrovascular side effects was observed in patients with dementia taking certain atypical antipsychotic drugs. Pooled data from 6 placebo-controlled studies involving primarily elderly patients with dementia (age >65 years) demonstrate that cerebrovascular adverse events (serious and non-serious) occurred in 3.3% (33/1009) of patients treated with risperidone. and in 1.2% (8/712) of patients receiving placebo. The risk ratio was 2.96 (1.34, 7.50) with a 95% confidence interval. The mechanism by which this risk increases is unknown. An increased risk cannot be excluded for other antipsychotic drugs, as well as for other patient populations. Rispolept® should be used with caution in patients with risk factors for stroke.

The risk of cerebrovascular side effects is much higher in patients with mixed or vascular dementia compared to patients with Alzheimer's dementia. Therefore, patients with any type of dementia other than Alzheimer's should not take risperidone.

Physicians should assess the risk/benefit ratio of using Rispolept® in elderly patients with dementia, taking into account the precursors of stroke risk individually for each patient.

Patients and caregivers should be cautioned to immediately report signs and symptoms of cardiovascular events, such as sudden weakness or stiffness/numbness in the face, legs, arms, as well as difficulty speaking and vision problems. All possible treatment options should be considered, including discontinuation of risperidone.

Rispolept® should only be used for the short-term treatment of persistent aggression in patients with moderate to severe Alzheimer's dementia, as an adjunct to non-pharmacological treatments when they are ineffective or of limited effectiveness, and when there is a risk of harm to the patient himself or herself to other persons.

Patients' condition and the need for continued risperidone therapy should be continually assessed.

Orthostatic hypotension

Risperidone has alpha-blocking activity and may therefore cause orthostatic hypotension in some patients, especially during initial dose titration. Clinically significant hypotension has been observed in the post-marketing period when used concomitantly with antihypertensive drugs. Rispolept® should be used with caution in patients with known cardiovascular disease (eg, heart failure, myocardial infarction, cardiac conduction disorders, dehydration, hypovolemia or cerebrovascular disease). Appropriate dose adjustment is also necessary. It is recommended to evaluate the possibility of dose reduction if hypotension occurs.

Tardive dyskinesia and extrapyramidal disorders

Drugs with dopamine receptor antagonist properties can cause tardive dyskinesia, which is characterized by rhythmic involuntary movements, mainly of the tongue and/or facial muscles. The occurrence of extrapyramidal symptoms is a risk factor for the development of tardive dyskinesia. If a patient experiences objective or subjective symptoms indicating tardive dyskinesia, the advisability of discontinuing all antipsychotic drugs, including Rispolept®, oral solution, should be considered.

Neuroleptic malignant syndrome (NMS)

Antipsychotics, including risperidone, may cause neuroleptic malignant syndrome (NMS), which is characterized by hyperthermia, muscle rigidity, instability of autonomic nervous system function, depression of consciousness, and increased serum concentrations of creatine phosphokinase. Myoglobinuria (rhabdomyolysis) and acute renal failure may also occur in patients with NMS. If a patient experiences objective or subjective symptoms of NMS, all antipsychotic drugs, including Rispolept®, must be immediately discontinued.

Parkinson's disease and dementia with Lewy bodies

Antipsychotic medications, including Rispolept®, should be prescribed with caution to patients with Parkinson's disease or dementia with Lewy bodies. Both groups of patients have an increased risk of developing neuroleptic malignant syndrome and increased sensitivity to antipsychotic drugs (including dullness of pain sensitivity, confusion, postural instability with frequent falls and extrapyramidal symptoms). Parkinson's disease may worsen when taking risperidone.

Hyperglycemia and diabetes mellitus

Hyperglycemia, diabetes mellitus, and exacerbation of existing diabetes mellitus were observed during treatment with Rispolept®. It is likely that weight gain prior to treatment is also a predisposing factor. Very rarely, ketoacidosis and rarely, diabetic coma can occur. 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.

Weight gain

During treatment with Rispolept®, a significant increase in body weight was observed. It is necessary to monitor patients' body weight.

Hyperprolactinemia

Based on the results of tissue culture studies, it has been suggested that the growth of breast tumor cells may be stimulated by prolactin. Although clinical and epidemiological studies have not shown a clear association between hyperprolactinemia and antipsychotic drug use, caution should be exercised when prescribing risperidone to patients with a history of this. Rispolept® should be used with caution in patients with existing hyperprolactinemia and in patients with possible prolactin-dependent tumors.

Prolongation of the QT interval

QT prolongation has been observed very rarely during post-marketing surveillance. As with other antipsychotics, caution should be exercised when prescribing Rispolept® to patients with known cardiovascular diseases, family history of QT interval prolongation, bradycardia, electrolyte imbalance (hypokalemia, hypomagnesemia), as this may increase the risk of an arrhythmogenic effect; and when used together with drugs that prolong the QT interval.

Convulsions

Rispolept® should be used with caution in patients with a history of seizures or other medical conditions that may lower the seizure threshold.

Priapism

Priapism may occur with risperidone due to alpha-blocking effects.

Body temperature regulation

Antipsychotic drugs are associated with such undesirable effects as disruption of the body's ability to regulate temperature. Caution should be exercised when prescribing Rispolept® to patients with conditions that may contribute to an increase in core body temperature, such as intense physical activity, dehydration, exposure to high external temperatures, or concomitant use of drugs with anticholinergic activity.

Venous thromboembolism

Cases of venous thromboembolism have been reported with the use of antipsychotic drugs. Since patients taking antipsychotic drugs are often at risk of developing venous thromboembolism, all possible risk factors should be identified before and during treatment with Rispolept®, and preventive measures should be taken.

Children and teenagers

Before prescribing Rispolept® to children or adolescents with mental retardation, their condition must be carefully assessed for the presence of physical or social causes of aggressive behavior, such as pain or inadequate demands of the social environment.

The sedative effect of risperidone should be carefully monitored in this population due to the possible effect on learning ability. Changing the timing of risperidone administration may improve control of the effects of sedation on attention in adolescents and children. Risperidone use was associated with mean increases in body weight and body mass index. Height changes in longitudinal studies were within expected age-related norms. The effects of long-term use of risperidone on sexual development and growth have not been fully studied.

Due to the possible impact of prolonged hyperprolactinemia on growth and sexual development in children and adolescents, regular clinical assessment of hormonal status should be carried out, including measurement of height, weight, monitoring of sexual development, menstrual cycle and other possible prolactin-dependent effects.

During treatment with risperidone, regular monitoring for the presence of extrapyramidal symptoms and other movement disorders should be carried out.