Risperidone 4 mg – [30 tablets]

Risperidone is a selective monoaminergic antagonist, has high affinity to serotonergic 5-HT2 and dopaminergic D2 receptors, Risperidone also binds to alpha1-adrenoceptors and to a lesser extent, to H1-histaminergic and alpha2-adrenergic receptors. Risperidone has no tropism to cholinoreceptors. Risperidone reduces the productive symptomatology of schizophrenia, causes less suppression of motor activity and is less likely to induce catalepsy than classical neuroleptics. Balanced central antagonism to serotonin and dopamine probably reduces the propensity for extrapyramidal side effects and extends the therapeutic effects of the drug to include negative and affective symptoms of schizophrenia.

– Treatment of schizophrenia in adults and children 13 years of age and older;

– treatment of manic episodes associated with bipolar disorder of moderate to severe degree in adults and children from 10 years of age;

– short-term (up to 6 weeks) treatment of persistent aggression in patients with moderate to severe dementia due to Alzheimer’s disease that cannot be controlled with non-pharmacological interventions and when there is a risk of self-harm or harm to others;

– short-term (up to 6 weeks) symptomatic treatment of persistent aggression in a behavioral disorder in children 5 years of age and older with intellectual disabilities, diagnosed according to DSM-IV, where the severity of the aggression or other disruptive behavior requires pharmacological treatment. Pharmacotherapy should be part of a broader treatment program, including psychological and educational interventions. Risperidone should be prescribed by a specialist in child neurology and child psychiatry or by a physician familiar with the treatment of behavioural disorders in children and adolescents.

– Hypersensitivity to risperidone and its components;

– phenylketonuria;

– Children under 13 years of age for the treatment of schizophrenia;

– childhood under 10 years of age in the treatment of manic episodes associated with bipolar disorder.

– childhood under 5 years of age (or body weight less than 50 kg) in the treatment of persistent aggression in the structure of conduct disorder.

• Schizophrenia
• Adults
• Risperidone may be prescribed once or twice daily. The initial dose is 2 mg per day. On the second day, the dose may be increased to 4 mg per day. From then on, the dose can either be maintained at the same level or individually adjusted if necessary. Usually the optimal dose is 4 to 6 mg per day. In some cases, a slower increase in dose and lower starting and maintenance doses may be warranted. Doses above 10 mg per day have not been shown to be more effective than lower doses and may cause extrapyramidal symptoms. Because the safety of doses above 16 mg per day has not been studied, doses above this level are not recommended.
• Elderly patients.
• A starting dose of 0.5 mg per administration twice daily is recommended. The dosage may be indi- vidually increased by 0.5 mg twice daily to 1 to 2 mg twice daily.
• Children over 13 years of age
• The recommended starting dose is 0.5 mg once daily in the morning or evening. If necessary, the dose may be increased at least 24 hours later by 0.5 to 1 mg daily to the recommended dose of 3 mg daily if well tolerated. Despite the efficacy demonstrated in the treatment of schizophrenia in adolescents with doses of risperidone 1 to 6 mg daily, no additional efficacy was observed with doses greater than 3 mg daily, and side effects developed more frequently. The use of doses higher than 6 mg daily has not been studied.
• In patients with persistent somnolence, it is recommended that half of the daily dose be taken twice daily.
• There is no experience in the treatment of schizophrenia in children under 13 years of age.
• Manic episodes associated with bipolar disorder
• Adults
• The recommended starting dose of the drug is 2 mg per day in a single administration. If necessary, this dose may be increased after 24 hours at the earliest by 1 mg per day. For most patients, the optimal dose is 1 to 6 mg daily. The use of doses higher than 6 mg daily in patients with manic episodes has not been studied.
• As with any symptomatic therapy, the appropriateness of continuing treatment with risperidone should be regularly evaluated and confirmed.
• Elderly Patients.
• A starting dose of 0.5 mg per dose twice daily is recommended. The dosage may be individually increased by 0.5 mg twice daily to 1 to 2 mg twice daily. Caution is required due to limited experience with elderly patients.
• Children over 10 years of age.
• The recommended starting dose is 0.5 mg once daily in the morning or evening. If necessary, the dosage may be increased at least 24 hours later by 0.5 to 1 mg daily to a recommended dose of 1 to 2.5 mg daily if well tolerated. Although efficacy has been demonstrated in the treatment of manic episodes associated with bipolar disorder in children at doses of 0.5 to 6 mg daily, no additional efficacy was observed with doses greater than 2.5 mg daily, and side effects were more frequent. Doses higher than 6 mg daily have not been studied.
• In patients with persistent somnolence, half the daily dose twice daily is recommended.
• As with any symptomatic therapy, the appropriateness of continuing treatment with risperidone should be regularly evaluated and confirmed.
• Persistent aggression in patients with dementia due to Alzheimer’s disease
• The recommended starting dose is 0.25 mg per dose twice daily. The dosage may be increased individually to 0.25 mg twice daily, if necessary, no more often than every other day. For most patients, the optimal dose is 0.5 mg twice a day. However, some patients are indicated to take 1 mg twice a day.
• For persistent aggression in patients with dementia due to Alzheimer’s disease, risperidone should not be used for more than 6 weeks. During treatment, patients’ condition and the need for continuation of therapy should be evaluated regularly. Once patients have reached a zero dose, they may be switched to taking the drug once daily.
• Persistent aggression in the pattern of conduct disorder
• Children 5 to 18 years of age.
• For patients with a body weight of 50 kg or more, the recommended starting dose of the drug is 0.5 mg once daily. If necessary, this dose may be increased by 0.5 mg daily, no more often than every other day. For most patients, the optimal dose is 1 mg daily. However, some patients prefer to take 0.5 mg daily, while some need to increase the dose to 1.5 mg daily.
• For patients with a body weight less than 50 kg, the recommended starting dose of the drug is 0.25 mg once daily.  If necessary, this dose may be increased by 0.25 mg daily, no more often than every other day. For most patients, the optimal dose is 0.5 mg daily. For some patients, however, 0.25 mg daily is preferred, while some require an increase in dose to 0.75 mg daily.
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