Index of drugs

The drug is indicated for the treatment of schizophrenia. The drug is indicated for the treatment of moderate to severe manic episodes in the course of bipolar disorder. Short-term (up to 6 weeks) treatment of persistent aggression in patients with moderate to severe Alzheimer's dementia, non-reacting to non-pharmacological methods and when there is a risk that the patient will be a threat to himself or others. Short-term symptomatic (up to 6 weeks) treatment of persistent aggression in the course of behavioral disorders in children from 5 years of age and youth with intellectual efficiency below the average or mentally impaired, diagnosed according to DSM - IV criteria, in which aggression and other destructive behaviors require treatment therapy. Pharmacotherapy should be an integral part of a comprehensive therapeutic program, including psychotic and educational activities. It is recommended that Risperidone be prescribed by a specialist physician in the field of child neurology and child and adolescent psychiatry or a doctor specializing in the treatment of behavioral disorders in children and adolescents.

1 tabl powl. contains 0.5 mg, 1 mg, 2 mg, 3 mg or 4 mg risperidone. The tablets contain lactose. 1 ml of solution contains 1 mg risperidone.

An antipsychotic drug - a selective monoaminergic antagonist with moderate properties. It is characterized by high affinity for 5-HT serotonergic receptors₂ and dopaminergic D₂. It also binds to the α receptors₁-adrenergic and with a lower affinity, histaminergic H-receptors₁ and α receptors₂-adrenergicznymi. It does not bind to cholinergic receptors. Despite the fact that risperidone is a potent D-receptor antagonist₂, soothing the symptoms of schizophrenia, to a lesser extent, it limits motor activity and induces catalepsy rather than classical neuroleptics. Balanced central antagonistic activity on serotonergic and dopaminergic receptors may reduce the likelihood of extrapyramidal side effects and extend the therapeutic effect to negative and affective disorders in the course of schizophrenia. After oral administration, risperidone is completely absorbed from the gastrointestinal tract, reaching a maximum blood concentration after 1-2 hours. The presence of food does not affect the absorption of the drug. The steady state of risperidone is reached within 1 day and 9-hydroxyrisperidone within 4-5 days. The degree of binding to plasma proteins is 90% for risperidone and 77% for 9-hydroxyrisperidone. Risperidone is metabolised by the CYP2D6 isoenzyme to 9-hydroxy Risperidone, which has similar pharmacological properties as risperidone. Risperidone and 9-hydroxyperidone form an active antipsychotic fraction. T_0,5 risperidone is about 3 h, 9-hydroxyrisperidone and the active antipsychotic fraction - 24 h. 70% of the dose is excreted in the urine and 14% in the faeces.

Hypersensitivity to risperidone or any of the excipients.

In elderly patients with dementia treated with Furosemide and risperidone, greater mortality was observed compared to patients who received either risperidone alone or furosemide alone; co-administration of risperidone with other diuretics (mainly thiazide in low doses) was not associated with similar observations. Take special care and consider the risks and benefits before deciding on using risperidone with potent diuretics. In elderly patients with dementia, using atypical antipsychotics (including risperidone), increased mortality and an increased incidence of cerebrovascular accidents were observed. Risperidone should be used with caution in patients with risk factors for stroke. The risk of adverse cerebrovascular events was significantly greater in patients with mixed or vascular dementia compared to patients with Alzheimer's dementia - patients with other types of dementia than those of Alzheimer's should not be treated with risperidone. The benefit-risk ratio of elderly patients with dementia should be evaluated, taking into account individual risk factors for stroke. Patients or caregivers should be advised to immediately report the signs and symptoms of potential adverse events related to cerebral vessels, such as sudden weakness or numbness of the face, arms or legs as well as speech or visual impairment.Immediately, all therapeutic options should be considered, including discontinuation of risperidone therapy. When prescribing risperidone to patients with Lewy dementia or Parkinson's disease, the risk / benefit ratio should be considered, due to the risk of parkinsonism and neuroleptic malignancy, as well as increased sensitivity to antipsychotic drugs (manifested by confusion, consciousness, instability of posture with frequent falls). Caution in patients with cardiovascular disease (eg heart failure, myocardial infarction, conduction disorders, dehydration, hypovolaemia, cerebrovascular disease) - if hypotension should be considered, a dose reduction of risperidone should be considered; with diabetes or risk factors for the development of diabetes (regularly control glycaemia); with an interview for potentially prolactin-dependent tumors (eg breast cancer) and in patients with previously diagnosed hyperprolactinemia or prolactin-dependent tumors; with cardiovascular diseases, a family history of QT prolongation, bradycardia, electrolyte disturbances (hypokalaemia or hypomagnesaemia), because the drug may increase the risk of arrhythmia and in patients treated concomitantly with other drugs prolonging the QT interval; with a history of convulsions or other conditions that may lower the seizure threshold; in patients at risk of increasing their basic body temperature (eg, those who exercise extensively, exposed to extremely high temperatures, taking concomitant medications with anticholinergic or dehydrated agents); with kidney or liver failure; Elderly. Because of the frequent acquired risk factors for the development of venous thromboembolism in patients treated with antipsychotics, risk factors should be determined before and during treatment and appropriate preventive measures should be taken. Due to the risk of intraoperative flaccid iris syndrome (IFIS), an ophthalmologist should be informed about the use of risperidone now or in the past before cataract surgery; a cautious approach to the procedure is recommended; If the IFIS team is suspected, it may be necessary to take measures to stop the iris before falling out during the procedure. Before rissperidone is recommended for children and adolescents with behavioral disorders, a thorough analysis of the physical and social causes of aggressive behavior should be performed. The sedative effects of risperidone in this population should be closely observed, due to the possible impact on learning ability; Changing the time of administration of risperidone may reduce the effect of sedation on concentration. The long-term effect of risperidone on sexual maturation and physical development in children and adolescents is not known - the risk of hyperprolactinemia should be taken into account; a regular clinical assessment of the endocrine state of the patient should be carried out, including measurements of height, weight, sexual maturation, control of the occurrence of menstruation and other potential prolactin-related activities. When using risperidone, extrapyramidal symptoms and other movement disorders should be monitored regularly. Do not use in the treatment of schizophrenia and manic episodes in the course of bipolar disorder in children and adolescents under 18 years (no data on the effectiveness of treatment). Do not use in the treatment of behavioral disorders in children under the age of 5 years (no data on the efficacy and safety of use in this indication in this age group). Risperidone should be discontinued in the event of tardive dyskinesia or symptoms of a neuroleptic malignant syndrome. Due to the lactose content, the drug should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose. Due to the content of sunset yellow, 2 mg tablets can cause allergic reactions.

It should not be used during pregnancy unless clearly necessary. If risperidone should be discontinued, treatment should not be interrupted abruptly. Reversible extrapyramidal symptoms were observed in newborns whose mothers used risperidone in the third trimester of pregnancy, and the condition of the newborn should be monitored.Risperidone and 9-hydroxyseripide are excreted in breast milk in small amounts, therefore the benefit of breastfeeding should be weighed against the potential risk to the child.

Very often: parkinsonism, headache, insomnia. Common: increased prolactin in the blood, weight gain, tachycardia, akathisia, dizziness, tremor, dystonia, drowsiness, sedation, lethargy, dyskinesia, blurred vision, shortness of breath, nosebleeds, cough, nasal congestion, sore throat and larynx; vomiting, diarrhea, constipation, nausea, abdominal pain, indigestion, dry mouth, stomach discomfort, involuntary urination, rash, erythema, joint pain, back pain, limb pain, increased or decreased appetite, pneumonia, influenza, bronchitis , upper respiratory tract infection, urinary tract infection, fever, fatigue, peripheral edema, asthenia, chest pain, anxiety, agitation, sleep disturbances. Uncommon: prolongation of the ECG QT interval, aberrant ECG, hyperglycaemia, transaminase elevation, decrease in white blood cell count, increase in body temperature, increase in eosinophils, decrease in hemoglobin, increase in creatine phosphokinase in the blood, atrioventricular block, block bundle branches, atrial fibrillation, sinus bradycardia, palpitations, anemia, thrombocytopenia, lack of response to stimuli, loss of consciousness, fainting, depressed level of consciousness, cerebrovascular accident, transient ischemic attack, dysarthria, attention disorders, excessive drowsiness, dizziness after a change in body position, balance disorders, tardive dyskinesia, speech disorders, coordination disorders, hypoaesthesia, conjunctivitis, eye congestion, discharge from the eyes, eye swelling, dry eye, increased tearing, photophobia, ear pain, tinnitus, wheezing Chronic pneumonia, lung congestion, breathing disorders, rales, respiratory congestion, dysphonia, difficulty swallowing, gastritis, fecal incontinence, fecal incontinence, painful urination, urinary incontinence, pollakiuria, angioneurotic edema, skin lesions , skin disorders, pruritus, acne, skin discoloration, alopecia, seborrheic dermatitis, dry skin, hyperkeratosis, muscle weakness, muscle pain, neck pain, swollen joints, incorrect posture, stiff arthritis, chest-muscle pain, anorexia, excessive thirst, sinusitis, viral infection, otitis, tonsillitis, cellulitis, eye infection, otitis media, local infection, dermatitis, respiratory tract infection, cystitis, onychomycosis, hypotension, hypotension ort recent, sudden redness of the face, swelling of the face, gait disturbance, abnormal frame of mind, slowing, flu-like illness, thirst, chest discomfort, chills, hypersensitivity, lack of menstruation, sexual dysfunction, erectile dysfunction, ejaculation disorders, galactorrhea, gynecomastia, menstrual disorders, vaginal discharge, confusion, mania, decreased libido, apathy, nervousness. Rare: body temperature depression, granulocytopenia, neuroleptic malignant syndrome, diabetic coma, cerebrovascular disorders, cerebral ischemia, motion disorders, decreased visual acuity, eye drops, glaucoma, sleep apnea syndrome, hyperventilation, intestinal obstruction, pancreatitis, lip swelling , red dandruff, dandruff, decay of striated muscles, inappropriate secretion of antidiuretic hormone, chronic otitis media, generalized edema, hypothermia, withdrawal syndrome, feeling of cold in the extremities, hypersensitivity to the drug, jaundice, lack of orgasm, blunting feelings. Very rare: diabetic ketoacidosis. Not known: agranulocytosis, water intoxication, venous thromboembolic disease (including pulmonary embolism and deep vein thrombosis), anaphylactic reaction, priapism. There is a risk of intraoperative flaccid iris syndrome (IFIS) during cataract surgery in patients receiving risperidone. Side effects were more common in elderly patients with dementia and children.Transient ischemic attacks and cerebrovascular events as well as more frequent cases of urinary tract infections, peripheral edema, lethargy and cough have been reported in elderly patients with dementia. In children, the following were more common: drowsiness and / or sedation, tiredness, headache, increased appetite, vomiting, upper respiratory tract infection, nasal edema, abdominal pain, dizziness, cough, fever, tremors, diarrhea and involuntary urination. Side effects that have been reported for antipsychotics with QT prolongation: ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest, ventricular tachycardiatorsade de pointes. After the sudden discontinuation of psychotic drugs used in high doses, withdrawal symptoms have been very rarely reported, including nausea, vomiting, hyperhidrosis and insomnia, and psychotic symptoms and involuntary movements (such as akathisia, dystonia and dyskinesias) may also occur.

Orally.Schizophrenia. Adults: initially 2 mg per day, on the second day of treatment the dose can be increased to 4 mg per day, and then the dose may remain unchanged or, if necessary, individually adjusted. The optimal therapeutic dose is 4-6 mg per day. The drug can be administered 1 or 2 times a day. Slower dose adjustments and lower initial and maintenance doses may be indicated in some patients. Doses higher than 10 mg per day are not more effective, but may cause extrapyramidal symptoms. Do not use doses higher than 16 mg a day, due to lack of tests. In elderly patients, the starting dose is 0.5 mg 2 times a day, then the dose can be individually adjusted and increased by 0.5 mg 2 times a day to a dose of 1-2 mg 2 times a day.Manic episodes in the course of bipolar disorder. Adults: initially 2 mg once a day, if necessary, increase the dose by 1 mg once a day, not more often than every 24 hours. The maximum daily dose is 6 mg. In elderly patients, the starting dose is 0.5 mg 2 times a day, then the dose can be individually adjusted and increased by 0.5 mg 2 times a day to a dose of 1-2 mg 2 times a day.Persistent aggression in patients with moderate to severe Alzheimer's dementia. The starting dose is 0.25 mg 2 times a day, if necessary, the dose can be individually increased by 0.25 mg 2 times a day, not more often than every other day. The optimal dose is 0.5 mg 2 times a day. Some patients may require 1 mg 2 times a day. The preparation should not be used for more than 6 weeks.Behavioral disorders. Children and adolescents 5-18 years old. ≥50 kg: initially 0.5 mg once a day, if necessary, the dose can be adjusted individually by increasing it by 0.5 mg once a day, not more often than every other day. The optimal dose is 1 mg once a day (0.5-1.5 mg once a day). Children and adolescents 5-18 years old. <50 kg: initially 0.25 mg once a day, if necessary, increase the dose by 0.25 mg a day, not more often than every other day. The optimal dose is 0.5 mg once a day (0.25-0.75 mg once a day).
In patients with impaired liver or kidney function, the starting dose and subsequent doses should be halved and the dose should be increased more slowly.
If it is medically warranted, it is recommended to gradually withdraw the previously used medication when starting treatment with the preparation. When changing the therapy with antipsychotic medications in the form of depot for treatment with the preparation, it is recommended to start treatment with the preparation with the replacement of the Next planned injection. Periodically, the need to continue administering anti-Parkinsonian medications should be considered.
The tablets can be divided into halves. The solution may be diluted with mineral water, orange juice or black coffee.