Index of drugs

Treatment of schizophrenia. Treatment of moderate to severe manic episodes in the course of bipolar disorder. Short-term treatment (up to 6 weeks) 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 pose a threat to himself or others. Short-term symptomatic (up to 6 weeks) treatment of severe aggression in behavioral disorders in children from 5 years of age and youth with intellectual performance below the average or mentally impaired, diagnosed according to DSM-IV criteria, in which aggression and other destructive behaviors require pharmacological treatment ; pharmacotherapy should be an integral part of a comprehensive therapeutic program, including psychosocial and educational activities; It is recommended that Risperidone be prescribed by a specialist physician in the field of pediatric neurology and pediatric and adolescent psychiatry or a doctor specializing in the treatment of behavioral disorders in children and adolescents.

1 tabl powl. contains 1 mg, 2 mg, 3 mg or 4 mg risperidone; Table. contain lactose. 1 ml of solution contains 1 mg risperidone.

An antipsychotic drug - a selective monoaminergic antagonist. It is characterized by high affinity to serotoninergic 5-HT2 and dopaminergic D2 receptors. It also binds to α-1-adrenergic receptors and, with less affinity, to histaminergic H1 receptors and α-2-adrenergic receptors. It does not show affinity for cholinergic receptors. Despite the fact that risperidone is a strong antagonist of D2 receptors, which alleviates the symptoms of schizophrenia, it causes less catalepsy and to a lesser extent, it limits motor activity 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 C_max after 1-2 h. Food has no significant effect on the absorption of the drug. It is metabolised by CYP2D6 to 9-hydroxyrisperidone with similar pharmacological properties to risperidone. Risperidone and 9-hydroxyperidone form an active antipsychotic fraction. Risperidone is 90% bound to plasma proteins and 77% to 9-hydroxy scisidone. T_0,5 risperidone is about 3 h, 9-hydroxyrisperidone and the active antipsychotic fraction - 24 h. During the week since administration, 70% of the dose is excreted in the urine and 14% in the faeces.

Hypersensitivity to the components of the preparation.

In elderly patients with dementia, using atypical antipsychotics (including risperidone), increased mortality and an increased incidence of cerebrovascular accidents were observed. Caution should be exercised in patients with risk factors for stroke. The risk of adverse cerebrovascular events was significantly higher in patients with mixed or vascular dementia compared to patients with Alzheimer's dementia - patients with other types of dementia than 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. If you experience unwanted cerebrovascular symptoms, such as sudden weakness or numbness of the face, hands or legs, or speech or vision problems, all treatment options should be considered immediately, including discontinuation of risperidone therapy. 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.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, family history of QT prolongation, bradycardia, electrolyte disturbances (hypokalaemia or hypomagnesaemia) and in patients concomitantly treated with other QT prolonging agents because risperidone may increase the risk of arrhythmia; 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) in patients receiving α-receptor antagonists₁-adrenergic (including risperidone), before the cataract surgery, the ophthalmologist should be informed about the use of risperidone now or in the past; the possible benefits of discontinuation of α-blocking drugs prior to cataract surgery have not been established, and this should be weighed against the risk of discontinuing antipsychotic therapy. 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. During treatment with 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, tablets should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

The safety of the medicine during pregnancy has not been established. It should not be used during pregnancy unless clearly necessary. Newborns exposed to risperidone during the third trimester of pregnancy are at risk for extrapyramidal disorders and / or withdrawal symptoms of varying severity and duration after delivery. If you need to stop treatment during pregnancy, do not stop your treatment suddenly.Risperidone and 9-hydroxy sugar are excreted in human milk - the benefits of breastfeeding should be weighed against the potential risk to the baby.

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 disorders. Uncommon: prolongation of the ECG QT interval, ECG changes, hyperglycaemia, transaminase elevation, decreased white blood cell count, elevated body temperature, increased eosinophils, decreased hemoglobin, increased blood creatine phosphokinase in the blood, atrioventricular block, leg block His bundle, atrial fibrillation, sinus bradycardia, palpitations, anemia, thrombocytopenia, no response to stimuli, loss of consciousness, fainting, depressed level of consciousness, cerebrovascular accident, transient ischemic attack, dysarthria, attention disorders, excessive drowsiness, dizziness after changes 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, thrombosis pneumonia, pulmonary congestion, breathing disorders, rales, congestion, dysphonia, difficulty swallowing, gastritis, faecal incontinence, fecal incontinence, painful urination, urinary incontinence, pollakiuria, angioneurotic edema, skin changes, impaired skin, pruritus, acne, skin discoloration, alopecia, seborrheic dermatitis, dry skin, hyperkeratosis, muscle weakness, muscle pain, neck pain, joint swelling, abnormal posture, stiffness of the joints, muscular-osteochondral pain, anorexia, excessive thirst, sinusitis, viral infection, otitis, tonsillitis, cellulitis, otitis media, eye infection, local infection, dermatitis, respiratory tract infection, cystitis, onychomycosis, hypotension, orthostatic hypotension, sudden redness of the face, swelling of the face, gait disturbance, abnormal frame of mind, slowing, flu-like illness, thirst, chest discomfort, chills, hypersensitivity reactions, amenorrhea, sexual dysfunction, erectile dysfunction, ejaculation disorders, galactorrhea, gynecomastia, menstruation, 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, swelling of the lips , red dandruff, dandruff, rhabdomyolysis, inadequate antidiuretic hormone secretion, chronic otitis media, generalized edema, hypothermia, withdrawal syndrome, feeling 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, withdrawal symptoms in newborns, 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 and children.In elderly people with dementia has been reported ischemic attacks and cerebrovascular events and more frequent cases of urinary tract infections, peripheral edema, lethargy and cough. Children were more likely to experience drowsiness and / or sedation, tiredness, headache, increased appetite, vomiting, upper respiratory tract infection, nasal congestion, 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. During clinical trials, a statistically significant increase in the number of cases of weight gain in the risperidone group was found. After the sudden withdrawal of psychotic drugs used in high doses, withdrawal symptoms have been very rarely reported, including: nausea, vomiting, hyperhidrosis and insomnia; Psychotic symptoms and involuntary movements (such as akathisia, dystonia and dyskinesia) may also occur.

Orally.Schizophrenia. Adults: the drug can be administered once or twice a day. Treatment should start at a dose of 2 mg a day. The dose can be increased on the second day to 4 mg a day. From this moment, the dose may remain unchanged or individually adjusted. The average, optimal therapeutic dose is 4-6 mg per 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 increase the incidence of extrapyramidal symptoms. The safety of doses greater than 16 mg / day has not been studied - their use is not recommended. In the elderly, the recommended starting dose is 0.5 mg 2 times a day. 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: drug should be administered once a day. The initial dose is 2 mg. If necessary, the dose should be increased by 1 mg, not more often than once a day. The effectiveness of the drug was demonstrated at a dose of 1-6 mg per day. The safety of using doses greater than 6 mg per day for the treatment of manic episodes has not been studied. In the elderly, the recommended starting dose is 0.5 mg 2 times a day. 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 recommended starting dose is 0.25 mg 2 times a day. If necessary, the dose may be increased by 0.25 mg 2 times a day, no more often than every other day. The optimal dose for most patients is 0.5 mg 2 times a day. Some patients may, however, require doses of up to 1 mg 2 times a day. The preparation should not be used longer than 6 weeks; Patients should be regularly and frequently assessed when considering the need for continued treatment.Behavioral disorders in children and adolescents from 5 to 18 years of age. People with mc. ≥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, not more often than every other day. The optimal dose for most patients is 1 mg once a day; however, in the treatment of some patients the drug is effective at a dose of 0.5 once a day and in others at a dose of 1.5 mg once a day. People with mc. <50 kg: the recommended starting dose is 0.25 mg once a day. If necessary, the dosage can be individually modified by increasing the dose by 0.25 mg per day, not more often than every other day. The optimal dose for most patients is 0.5 mg once a day; however, some patients may need a dose of 0.25 mg once a day, some - 0.75 mg once a day.Special groups of patients. In patients with impaired liver or kidney function, regardless of the indication, the initial dose and subsequent doses should be halved and the dose should be increased more slowly.Way of giving. The preparation can be taken regardless of meals. The tablets can be divided into halves. The solution can be diluted with mineral water, orange juice or black coffee.