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Active ingredient

1 pill contains:

Active substance:


Risperidone

1 mg / 2 mg / 3 mg / 4 mg

Therapeutic indications

  • Treatment of schizophrenia in adults and children from 13 years.
  • Treatment of manic episodes associated with bipolar disorder, moderate and severe in adults and children from 10 years.
  • Short-term (up to 6 weeks) treatment of ongoing aggression in patients with dementia due to Alzheimer's disease, moderate and severe, not amenable to non-pharmacological methods of correction, and if there is a risk of the patient being injured to himself or others.
  • Short-term (up to 6 weeks) symptomatic treatment of ongoing aggression in the structure of behavioral disorder in children aged 5 years with mental retardation, diagnosed according to DSM-IV criteria, in which, due to the severity of aggression or other destructive behavior, medical treatment is required. Pharmacotherapy should be part of a comprehensive treatment program, including psychological or educational activities. Risperidone should be prescribed by a specialist in child neurology and child psychiatry, or by a physician familiar with the treatment of behavioral disorders in children and adolescents.

Dosage and administration

Schizophrenia

Adults

Drug Torendoâ can be applied 1 or 2 times a day. Initial dose of Torendoâ makes 2 mg / days. On the second day, the dose should be increased to 4 mg / day. From this point on, the dose can either be maintained at the same level, or individually adjusted if necessary. Usually the optimal dose is 4-6 mg / day. In some cases, a slower dose increase and lower initial and maintenance doses may be justified.

Doses above 10 mg / day do not show a higher efficacy compared with smaller doses and may cause the appearance of extrapyramidal symptoms. Due to the fact that the safety of doses above 16 mg / day has not been studied, doses above this level should not be used.

Elderly patients

The recommended initial dose of 0.5 mg per dose 2 times a day. The dose can be individually increased by 0.5 mg 2 times a day to 1-2 mg 2 times a day.

Children from 13 years

An initial dose of 0.5 mg per dose is recommended once a day, in the morning or in the evening. If necessary, the dosage can be increased no less than 24 hours by 0.5-1 mg per day to the recommended dose of 3 mg per day with good tolerance. Despite the effectiveness demonstrated in treating schizophrenia in adolescents with doses of 1–6 mg per day, no additional efficacy was observed at doses above 3 mg per day, and higher doses caused more side effects. The use of doses higher than 6 mg per day has not been studied. Patients who have sustained drowsiness, it is recommended to take half the daily dose 2 times a day.

Manic related episodes with bipolar disorder, moderate to severe

Adults

Recommended starting dose of Torendo® - 2 mg once a day. If necessary, this dose can be increased by at least 24 hours at 1 mg per day. For most patients, the optimal dose is 1-6 mg per day. The use of doses higher than 6 mg per day in patients with manic episodes has not been studied. As with any other symptomatic therapy, the feasibility of continuing treatment with Torendo® should be regularly evaluated and validated.

Elderly patients

The recommended initial dose is 0.5 mg per dose, 2 times a day. The dose can be individually increased by 0.5 mg 2 times a day to 1-2 mg 2 times a day. Experience with elderly patients is limited, caution should be exercised.

Children from 10 years

An initial dose of 0.5 mg per dose is recommended once a day, in the morning or in the evening. If necessary, the dosage can be increased no less than 24 hours by 0.5-1 mg per day to the recommended dose of 1-2.5 mg per day with good tolerability. Despite the effectiveness demonstrated in the treatment of manic episodes associated with bipolar disorder, in children with doses of 0.5-6 mg per day, no additional efficacy was observed at doses above 2.5 mg per day, and higher doses caused more side effects. The use of doses higher than 6 mg per day has not been studied. Patients who have sustained drowsiness, it is recommended to take half the daily dose 2 times a day.

Nonstop aggression in n patients with dementia due to Alzheimer's disease, moderate and severe

The recommended initial dose is 0.25 mg per dose, 2 times a day. If necessary, an individual dose increase of 0.25 mg 2 times a day with an interval of at least 1 day is possible. For most patients, the optimal dose is 0.5 mg 2 times a day. In some patients, however, the effective dose may be 1 mg 2 times a day. Drug Torendo® should not be used for more than 6 weeks with ongoing aggression in patients with dementia due to Alzheimer's disease. During treatment with Torendo® frequent and regular assessment of the patient’s condition is necessary to decide whether to continue therapy.

Continuous aggression in the structure of the behavior disorder

Children from 5 to 18 years

Patients weighing 50 kg or more - the recommended initial dose of the drug Torendo® - 0.5 mg once a day. If necessary, this dose can be increased by 0.5 mg 1 time per day no less than 24 hours. For most patients, the optimal dose is 1 mg 1 time per day. However, for some patients, it is preferable to take 0.5 mg per day, while some require an increase in dose to 1.5 mg per day.

Patients with a body weight less than 50 kg - the recommended initial dose of the drug - 0.25 mg 1 time per day. If necessary, this dose can be increased by 0.25 mg 1 time per day no less than 24 hours. For most patients, the optimal dose is 0.5 mg 1 time per day.However, for some patients, it is preferable to take 0.25 mg per day, while some require an increase in dose to 0.75 mg per day. As with any other symptomatic therapy, the feasibility of continuing treatment with Torendo® should be regularly evaluated and validated. Use in children under 5 is not recommended due to lack of data.

Special patient groups

Impaired renal and hepatic function

In patients with impaired renal function, the ability of elimination of the active antipsychotic fraction is reduced compared with other groups of patients. In patients with impaired liver function, an increased concentration of the free fraction of risperidone is observed in the blood plasma.

The initial and maintenance dose in accordance with the indications should be reduced by 2 times, increasing the dose in patients with impaired liver and kidney function should be slower.

Drug Torendo® should be used with caution in this category of patients.

Contraindications

  • Hypersensitivity to risperidone and other components of the drug.

Carefully

  • Cardiovascular diseases (chronic heart failure, previous myocardial infarction, cardiac muscle conduction disturbances);
  • Dehydration and hypovolemia;
  • Disorders of cerebral circulation;
  • Parkinson's disease;
  • Convulsions (including history);
  • Severe renal or hepatic impairment;
  • Drug abuse or drug dependence;
  • Conditions predisposing to the development of tachycardia of the “pirouette” type (bradycardia, electrolyte imbalance, concomitant medication, prolonging the QT interval);
  • Brain tumor, intestinal obstruction, cases of acute drug overdose, Reye's syndrome (the antiemetic effect of risperidone may mask the symptoms of these conditions);
  • Risk factors for venous thromboembolism;
  • Disease diffuse calf levy;
  • Use in elderly patients with cerebrovascular dementia;
  • Pregnancy.

Precautions and special instructions for use

Use in older students with dementia

Increased mortality in elderly patients with dementia

According to the results of a meta-analysis of clinical studies in elderly patients with dementia who used atypical antipsychotics, there was an increase in mortality compared with the placebo group. Mortality in patients receiving risperidone or placebo was 4.0% and 3.1%, respectively. The average age of the deceased patients was 86 years (range 67–100 years). According to two extensive observational studies in elderly patients with dementia, treatment with typical antipsychotic drugs shows a slight increase in the risk of death compared with that in patients not receiving treatment.Not enough data is currently collected to accurately estimate the indicated 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.

Simultaneous management with furosemide

While taking Furosemide and risperidone orally, elderly patients with dementia experienced increased mortality (7.3%, mean age 89 years, range 75-97 years) compared with the group taking only risperidone (3.1%, mean age 84 years, the range of 70-96 years) and the group that took only furosemide (4.1%, the average age of 80 years, the range of 67-90 years). An increase in mortality with the use of furosemide simultaneously with risperidone was noted in 2 out of 4 clinical studies. The simultaneous 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 using the drug in such cases. Before use, it is necessary to carefully evaluate the risk / benefit ratio. No increase in mortality was found in patients who simultaneously took other diuretics at the same time as risperidone. Regardless of therapy, dehydration is a common risk factor for mortality and should be carefully controlled in elderly patients with dementia.

Cerebrovascular undesirable phenomena

In placebo-controlled clinical trials in patients with dementia who were taking some atypical antipsychotics, there was an increase in the risk of cerebrovascular side effects by about 3 times. A summary of 6 placebo-controlled studies that included mostly elderly patients with dementia (over 65 years of age) showed that cerebrovascular side effects (serious and not serious) occurred in 3.3% (33/1 009) of patients taking risperidone, and 1.2% (81712) of 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 with other antipsychotic drugs or in other patient populations cannot be ruled out. Drug Torendo® should be used with caution in patients with stroke risk factors.

The risk of developing cerebrovascular adverse events in patients with mixed or vascular dementia was significantly higher than in patients with dementia due to Alzheimer's disease. Therefore, risperidone should not be used in patients with dementia of any type other than dementia due to Alzheimer's disease.

It is necessary to evaluate the risk / benefit ratio before using Torendo® in elderly patients with dementia, given the risk factors for stroke in a particular patient.Patients and caregivers should be informed about the immediate notification to the doctor about possible manifestations of cerebrovascular disorders (such as sudden weakness or immobility / insensitivity in the face, legs, arms, and speech and visual impairment). The necessary treatment measures should be taken immediately, including the cancellation of risperidone.

Drug Torendo® can only be used for short-term treatment of ongoing aggression in patients with dementia due to Alzheimer's disease, moderate and severe, as an adjunct to non-pharmacological methods of correction, if they are ineffective or have limited effectiveness, and when there is a risk of harm to the patient himself or others .

It is necessary to constantly evaluate the patient's condition and the need to continue therapy with risperidone.

Orthodynamics

Due to the a-adrenergic blocking effect of risperidone, some patients may develop orthostatic hypotension, especially during the initial dose selection period. Cases of clinically significant arterial hypotension with simultaneous use of risperidone with antihypertensive drugs in the post-marketing period are described. Drug Torendo® must be used with caution in patients with cardiovascular diseases (for example, chronic heart failure, myocardial infarction, cardiac muscle conduction disturbances, dehydration, hypovolemia, or cerebrovascular diseases). A corresponding dose adjustment is also required.It is recommended to evaluate the possibility of reducing the dose in case of arterial hypotension.

Leukopenia, neuropathy and agranulocytosis

Cases of leukopenia, neutropenia and agranulocytosis have been described with the use of antipsychotics, including with the use of the drug Torendo®.

Agranulocytosis was observed very rarely (1/10000 patients) during post-registration observation. Patients with a clinically significant decrease in the number of leukocytes or drug-induced leukopenia / neutropenia in history should be monitored for the first few months after the start of therapy, and when the first signs of a clinically significant decrease in the number of leukocytes appear, in the absence of other causative factors, treatment should be stopped.

Patients with clinically significant neutropenia should be closely monitored for fever or other symptoms of infection, and should immediately begin treatment if these symptoms occur. Patients with severe neutropenia (absolute neutrophil count <1 x 109/ l) must stop taking Torendo® until recovery of leukocyte count.

Late dyskinesia / extrapyramidal symptoms

Therapy with dopamine receptor antagonists 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, consideration should be given to the advisability of withdrawing all antipsychotic drugs, including Torendo®.

Malignant Neurological Syndrome (ZNS)

With antipsychotic medication, it is possible to develop NNS characterized by hyperthermia, muscle stiffness, instability of the autonomic nervous system, depression of consciousness and increased plasma plasma creatine phosphokinase concentration, as well as myoglobinuria (rhabdomyolysis) and acute renal failure . If a patient develops objective or subjective symptoms of MNS, all antipsychotic drugs, including Torendo, should be immediately discontinued.®.

Parkinson's disease and dementia with Levi's little bodies

The use of antipsychotic drugs, including the drug Torendo®, in patients with Parkinson’s disease or dementia with Lewy bodies, it should be carried out with caution, since both groups of patients have an increased risk of developing NNS and increased sensitivity to antipsychotic drugs (including dullness of pain, confusion, postural instability with frequent