Risperidone tablets are indicated for:
treatment of schizophrenia and other psychiatric disorders, including maintenance therapy in patients who have responded to therapy, in order to prevent relapse of the disease; treatment of manic episodes in bipolar disorders (adjunctive therapy in combination with normotensives as initial treatment or as monotherapy for a period of up to 12 weeks); short-term treatment of pronounced aggression or severe psychiatric symptoms in patients with dementia when there is a threat of harm to themselves or others; symptomatic treatment of defiant oppositional disorders or other social behavior disorders in children, adolescents and adults with below average mental development or mental retardation who have manifestations of destructive behavior (impulsivity, autoaggression); symptomatic treatment of autistic disorders in children aged 5 years and older, in whom symptoms range from hyperactivity to irritability (including aggression, self-harm, anxiety and pathological cyclic actions).
Composition
One tablet contains 2 mg of risperidone.
Excipients: lactose, sodium lauryl sulfate, microcrystalline cellulose, corn starch, magnesium stearate, colloidal silicon dioxide; shell: polyvinyl alcohol, macrogol, titanium dioxide (E 171), talc, sunset yellow FCF dye (E 110).
Contraindication
Hypersensitivity to the active ingredient or to any excipient in the preparation.
Method of application
Usual dose: The drug can be used once or twice a day, doses greater than 8 mg should be divided into two doses (morning and evening).
Schizophrenia (adults under 65 years of age)
The drug can be prescribed once or twice a day. The dose should be started with 2 mg of the drug per day, on the second day the dose can be increased to 4 mg. After that, the dose can be maintained unchanged or, if necessary, continue individual dose adjustment. For most patients, the recommended dose is 4-6 mg per day. Some patients may require a gradual increase in dose or a reduced initial dose. The maximum daily dose is 10 mg. Doses above 10 mg per day have not shown high efficacy compared to lower doses, but they may cause extrapyramidal symptoms. Since the safety of doses exceeding 16 mg per day has not been studied, doses above this level should not be used.
Schizophrenia (elderly patients - over 65 years old)
The recommended starting dose is 0.5 mg twice daily. If necessary, the dose may be increased to 1-2 mg twice daily in 0.5 mg twice daily increments. If additional sedation is required, a benzodiazepine may be used concomitantly.
Manic episodes in bipolar disorder (children over 10 years of age and adults)
The recommended initial dose is 2 mg once a day, in the evening. The dose can be individually increased by adding one mg/day no more often than every 24 hours. The recommended dose range is from 2 to 6 mg per day. As with other types of symptomatic treatment, with long-term use of this drug, it is necessary to periodically review the dose and adjust it throughout the course of therapy. There is no data on the effectiveness of the drug in the treatment of acute bipolar mania lasting more than 12 weeks. If "Rispetril" is used in combination with normostimulants, therapy can be stopped earlier, since the onset of the effect of the treatment can be expected in the first weeks of therapy. Even after the first response to treatment, the possibility of recurrence of depressive symptoms should be taken into account due to the peculiarities of the course of the disease and the side effects of the drugs used for treatment, including this drug.
Short-term treatment of severe aggression or severe psychiatric symptoms in patients with dementia
The recommended initial dose is 0.25 mg twice daily. If necessary, the dose can be increased by increasing the dose by 0.25 mg twice daily not more often than every other day. For most patients, the optimal dose is 0.5 mg twice daily. However, for some patients, the effective dose can be increased to one mg twice daily. Once the optimal dose is reached, the possibility of taking the daily dose once a day can be considered. Cancellation of treatment with this drug should occur no later than three months after the start of therapy, therapy can be resumed only if behavioral disorders reappear.
Symptomatic treatment of social behavior disorders or aggressive behavior (patients with body weight > 50 kg)
The recommended starting dose is 0.5 mg once daily. If necessary, the dose should be adjusted by adding 0.5 mg once daily no more than every other day. The optimal dose for most patients is 1 mg once daily. However, for some patients, no more than 0.5 mg once daily is sufficient to achieve a positive effect, while others may require 1.5 mg once daily.
The recommended initial dose is 0.25 mg once daily. If necessary, the dose can be adjusted by adding 0.25 mg once daily no more than every other day. The optimal dose for most patients is 0.5 mg once daily. However, for some patients, no more than 0.25 mg once daily is sufficient to achieve a positive effect, while others may require 0.75 mg once daily. As with other types of symptomatic treatment, long-term use of this drug should be periodically reviewed and adjusted throughout the course of therapy.
Autism
Children from 5 years of age: the dose should be selected individually, depending on the patient's condition and clinical response.
Patients weighing <50 kg: the recommended starting dose is 0.25 mg once daily; from the fourth day the dose can be increased by 0.25 mg; the dose should be maintained at 0.5 mg and the clinical response assessed on day 14; dose increases of 0.25 mg at two-week intervals should be considered only in patients with insufficient clinical response.
Patients weighing ≥ 50 kg: the recommended starting dose is 0.5 mg once daily; from the fourth day the dose can be increased by 0.5 mg; the dose should be maintained at 1 mg and the clinical response assessed on day 14; a dose increase of 0.5 mg at two-week intervals can be considered only for patients with insufficient clinical response.
Application features
Pregnant women
Risperidone is not recommended for use during pregnancy unless clearly necessary. If it is necessary to stop treatment with this drug during pregnancy, this should not be done abruptly.
In animal studies, risperidone and 9-hydroxyrisperidone were excreted in breast milk. There are observations that risperidone and 9-hydroxyrisperidone may also be excreted in breast milk in small quantities. In individual cases, 4.3% of the dose administered by the mother as the active antipsychotic fraction of the active substance was detected in breast milk. If necessary, breastfeeding should be discontinued.
Children
The drug is used for the symptomatic treatment of social behavior disorders, oppositional defiant disorder or other social behavior disorders, as well as autistic behavior disorders in children aged 5 years and older.
Drivers
The drug may have a minor or moderate influence on the ability to drive and use machines due to potential effects on the nervous system and visual organs. During treatment, it is recommended to refrain from driving or operating machinery until the individual sensitivity of patients to the drug is known.
Overdose
Symptoms
The signs and symptoms of overdose observed are known adverse drug reactions manifested in an intensified form: drowsiness and sedation, tachycardia and hypotension, as well as extrapyramidal symptoms. QT prolongation and convulsions have been reported in cases of overdose. Flickering has been reported in association with overdose of risperidone in combination with paroxetine. In the event of acute overdose, the possibility of multiple drug interactions should be considered.
Treatment
A patent airway should be established and maintained to ensure adequate ventilation and oxygenation. Gastric lavage (after intubation if the patient is unconscious) and activated charcoal with a laxative should be considered no later than one hour after ingestion. Cardiovascular monitoring, including continuous ECG recording for possible arrhythmias, is indicated. There is no specific antidote for the drug. Therefore, appropriate supportive measures should be taken. Hypotension and vascular collapse should be treated with measures such as intravenous fluids and/or sympathomimetics. Anticholinergics should be administered in the event of acute extrapyramidal symptoms. Close medical observation and monitoring should be continued until the patient recovers.
Side effects
The most common adverse reactions reported are parkinsonism, headache, and insomnia.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 5 years.
