Index of drugs

Treatment of schizophrenia; acute and chronic schizophrenic psychoses and other psychotic diseases that are dominated by positive symptoms (such as hallucinations, delusions, thinking disorders, hostility, suspiciousness) and / or negative symptoms (such as blanching affect, emotional and social withdrawal, depleted speech). Risperidone alleviates affective symptoms (such as depression, guilt, anxiety) associated with schizophrenia. Risperidone is also effective in maintaining the clinical improvement obtained in the continued treatment of patients who have responded to initial treatment. Treatment of mania in bipolar disorder. These episodes are characterized by symptoms such as elevated, expansive or irritable mood, overstated self-esteem, reduced need for sleep, compulsive speech, overworked thoughts, bad attention or distorted judgment, including disturbing order or aggressive behavior. Treatment of behavioral disorders and other destructive disorders in children, adolescents and adults with mental retardation, in which destructive behaviors are dominant (eg aggression, impulsiveness and behaviors leading to self-mutilation) and when nonpharmacological psychosocial therapy does not bring the desired effect.

1 tabl powl. contains 1 mg, 2 mg, 3 mg or 4 mg of risperidone.

An antipsychotic drug - a selective monoaminergic antagonist. It has high affinity for 5-HT serotoninergic receptors₂ and dopaminergic D receptors₂. Risperidone is also associated with α receptors₁-adrenergic and, to a lesser extent, H histaminergic receptors₁ and α receptors₂-adrenergicznymi. It does not show affinity for cholinergic receptors. Despite the fact that risperidone is a potent D-receptor antagonist₂, which is associated with a beneficial effect on the prodromal symptoms of schizophrenia, to a lesser extent, it limits motor activity and induces catalepsy rather than classical neuroleptics. Balanced central antagonistic activity on serotoninergic and dopaminergic receptors may reduce the likelihood of extrapyramidal side effects and extend the therapeutic impact on negative symptoms and affective disorders that occur in the course of schizophrenia. After oral administration, risperidone is completely absorbed from the gastrointestinal tract and reaches its maximum concentration in the blood within 1-2 hours. Food does not affect the absorption of the drug. Risperidone is partially metabolised to 9-hydroxy Risperidone, which has similar pharmacological properties to risperidone. Risperidone and 9-hydroxyperidone form an active (antipsychotic) drug fraction. Risperidone is also metabolised by the N-dealkylation process. Risperidone in blood plasma is 88% bound to proteins, and 9-hydroxy-sporidone is 77% bound. After oral administration to patients with psychosis T_0,5 risperidone is about 3 h, T_0,5 9-hydroxyrisperidone is 24 hours. Within one week of taking the drug, 70% of the dose is excreted in the urine and 14% in the faeces. In elderly patients and patients with impaired renal function, increased blood levels of risperidone and slower elimination of risperidone were observed.

Hypersensitivity to risperidone or other ingredients of the preparation.

In elderly patients with dementia, caution should be exercised and the risks and benefits of concomitant administration of risperidone and Furosemide or other strong diuretics should be considered. Risperidone is not recommended for the treatment of behavioral symptoms of dementia due to the increased risk of cerebrovascular adverse effects (including strokes and transient ischemic attacks). The treatment of acute psychosis in patients with a history of dementia should be short-lived and under the supervision of a specialist. It is recommended to assess the risk of cerebrovascular adverse reactions in patients with a history of stroke or transient ischemic attacks.Other risk factors for cerebrovascular disease, including hypertension, diabetes, smoking, and atrial fibrillation, should also be considered. Use cautiously in prolactin-dependent tumors. If orthostatic hypotension occurs, dose reduction should be considered. Caution should be exercised in patients with cardiovascular disease, including those with QT prolongation (the dose should be increased gradually) and when risperidone is used together with other medicines that may prolong the QT interval. If signs and symptoms of tardive dyskinesia appear, discontinue treatment with any antipsychotic medication. Caution should be exercised when using risperidone in patients with Parkinson's disease because the medicine may worsen its symptoms. In patients with diabetes or risk factors for the development of diabetes, appropriate clinical observation is recommended. Caution should be exercised in the treatment of patients with epilepsy and in patients with impaired renal and hepatic function. There is no experience in the use of the drug in schizophrenia in children under 15 years. There is no experience regarding manic episodes in bipolar affective disorder in children and adolescents under 18 years of age. In the treatment of behavioral disorders and destructive behavior, there is no experience in the use of the drug in children under the age of 5 years. Due to the lactose content, patients with rare hereditary galactose intolerance, Lapp lactase deficiency or impaired absorption of Glucose and galactose should not use the preparation.

The safety of risperidone during pregnancy has not been established. It should only be used during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus. Women taking the product should not breastfeed.

Common (≥1 / 100, <1/10): sleep disturbances, agitation, anxiety, headache. Uncommon (≥1 / 1000, <1/100): edema, slight decrease in the number of neutrophils and / or thrombocytes in the blood, weight gain, drowsiness, fatigue, dizziness, impaired concentration, tardive dyskinesia, neuroleptic malignant syndrome, convulsions, blurred vision, orthostatic hypotension, reflex tachycardia, constipation, indigestion, nausea, vomiting, abdominal pain, increased liver enzymes in the blood, rhinitis, rash and other allergic reactions, incontinence, water intoxication due to excessive thirst or insufficient secretion antidiuretic hormone, erectile dysfunction (including priapism), ejaculation disorders, orgasmic disorders, body temperature disturbances and dose-dependent increases in prolactin levels in the blood that can lead to mellitus, gynecomastia, menstrual disorders and amenorrhea. Very rare (<1 / 10,000): hyperglycemia or worsening of existing diabetes. Extra-pyramidal symptoms were observed after high doses. During the treatment, there were cerebrovascular adverse events, including strokes and transient ischemic attacks. After the sudden discontinuation of antipsychotic drugs used at high doses, discontinuation symptoms, including nausea, vomiting, hyperhidrosis and insomnia, have been reported very rarely. There may also be relapses of psychotic symptoms and movement disorders (akathisia, dystonia, dyskinesias).

Orally.Schizophrenia. Adults: the product can be administered once or twice a day. The initial dose is 2 mg a day. The dose can be increased on the second day to 4 mg a day. Then the dose may remain unchanged or be individually adjusted to your needs. Usually, the optimal therapeutic dose is 4-6 mg per day. In some patients, a slower dose increase, a lower initial and maintenance dose may be indicated. Doses higher than 10 mg per day are not more effective, but may cause extrapyramidal symptoms. The safety of doses greater than 16 mg / day has not been studied - these should not be used. In the event that an additional sedative effect is indicated, benzodiazepine derivatives may be administered with risperidone. In elderly patients, the recommended starting dose is 0.5 mg 2 times a day. Depending on the need, this dose can be increased gradually by 0.5 mg 2 times a day to a dose of 1-2 mg 2 times a day.Bipolar disorder, manic episode. Adults: The starting dose is 2 mg per day.If necessary, the dose may be increased, however, by no more than 1 mg every 24 hours. The maintenance dose is usually 2-6 mg per day. Elderly patients are advised to have a lower maintenance dose and a slower dose increase.Disorders of behavior and destructive behavior. Adults (> 50 kg): The recommended starting dose is 0.5 mg once a day. If necessary, the dosage can be individually adjusted by increasing the dose by 0.5 mg once a day, every other day. The optimal dose for most patients is 1 mg once a day; however, some patients may require doses of 0.5-1.5 mg once a day. Children> 5 years and adolescents (<50 kg): The recommended starting dose is 0.25 mg once a day. If necessary, the dosage can be individually adjusted by increasing the dose by 0.25 mg once a day, every other day. The optimal dose for most patients is 0.5 mg once a day; however, some patients may require doses of 0.25-0.75 mg once a day.
Patients with impaired liver and kidney function: the starting dose is 0.5 mg 2 times a day. The dose can be individually increased by 0.5 mg 2 times a day to a dose of 1-2 mg 2 times a day. Change from treatment with other antipsychotics: if there are medical indications, it is recommended to gradually discontinue the previous treatment with the introduction of treatment with the preparation. When changing the treatment of the deposition of neuroleptic drugs to risperidone therapy, start by replacing it with the Next scheduled injection. Periodically, the need to continue anti-Parkinson's therapy should be assessed.