Index of drugs

Treatment of schizophrenia. 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 handicapped, diagnosed according to DSM-IV criteria, in which aggression and other destructive behaviors require treatment pharmacology; 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; tablets contain lactose.

An antipsychotic drug - a selective monoaminergic antagonist. It has high affinity for 5-HT serotoninergic receptors₂ and dopaminergic D₂. It also binds to the α receptors₁-adrenergic and, to a lesser extent, histaminergic H₁ and α₂-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, reaching C_max after 1-2 h of administration. The food does not affect absorption. It is metabolised by CYP2D6 to 9-hydroxy Risperidone, which has similar pharmacological effects as risperidone. Risperidone, together with 9-hydroxy-prideconide, forms an active antipsychotic fraction. T_0,5 risperidone is 3 h, 9-hydroxyrisperidone and antipsychotic active fraction - 24 h. The drug is excreted in 70% in the urine and approx. 14% in the faeces.

Hypersensitivity to the active substance or to any of the excipients.

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 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. 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), 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. Extrapyramidal symptoms and other movement disorders should be monitored regularly. 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.

The safety of risperidone during pregnancy has not been established. The drug 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 intensity and duration after delivery (effects of agitation, hypotonia, hypertension, tremor, drowsiness, breathing difficulties and difficulty in taking food) - therefore newborns should be carefully monitored. 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 (in some cases leading to gynecomastia, menstrual disorders, amenorrhea, mlekhotoku), 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, arthralgia, back pain, leg pain, increased or decreased appetite, pneumonia, influenza, bronchitis, upper respiratory tract infections, urinary tract infections, fever, fatigue, peripheral edema, weakness, chest pain, anxiety, agitation, sleep disorders. Uncommon: prolongation of the ECG QT interval, ECG changes, increased blood Glucose, increased transaminases, decreased white blood cell count, elevated body temperature, increased eosinophils, decreased hemoglobin, increased CPK activity in the blood, atrioventricular block , bundle branch block, atrial fibrillation, sinus bradycardia, palpitations, anemia, thrombocytopenia, lack of response to stimuli, loss of consciousness, fainting, decreased level of consciousness, cerebrovascular accident, transient ischemic attack, dysarthria, attention disorders, excessive drowsiness, dizziness after a change in body position, disturbance of balance, 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 , zach pneumonia, pulmonary congestion, breathing disorders, wheezing, respiratory congestion, dysphonia, difficulty swallowing, gastritis, fecal incontinence, fecal incontinence, painful urination, urinary incontinence, pollakiuria, angioneurotic edema, skin changes, disorders 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 infections, local infections, dermatitis, respiratory tract infections, cystitis, onychomycosis, hypotension, orthosis hypotension tachitis, 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, m akatotoxicity, Gynecomastia, menstrual disorders, vaginal discharge, confusion, mania, decreased libido, apathy, nervousness. Rarely: decreased body temperature, 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, rhabdomyolysis, inadequate 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, anaphylactic reaction, priapism, neonatal withdrawal syndrome, venous thromboembolism (including pulmonary embolism and deep vein thrombosis). There is a risk of intraoperative flaccid iris syndrome (IFIS) during cataract surgery in patients receiving risperidone.Additional side effects reported for parenterally administered risperidone in the form of long-acting injections but not reported for oral risperidone: weight loss, increased GGT, increased liver enzymes, bradycardia, neutropenia, paraesthesia, convulsions, blepharospasm, dizziness, toothache, tongue contraction, eczema, buttock pain, lower respiratory tract infection, infection, gastritis and intestinal abscess, fall, hypertension, pain, depression. Side effects associated with the drug class: QT prolongation, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest and ventricular tachycardiatorsade de pointes. Side effects were more common in elderly patients with dementia and in children. Transient ischemic attacks and cerebrovascular accidents as well as more frequent cases of urinary tract infection, peripheral edema, lethargy and cough have been reported in elderly subjects with dementia. Children were more likely to experience drowsiness and / or sedation, fatigue, headache, increased appetite, vomiting, upper respiratory tract infections, nasal congestion, abdominal pain, dizziness, cough, fever, tremors, diarrhea and involuntary urination.

Orally. If another antipsychotic medication is changed to risperidone, the previously used medicine should be gradually withdrawn. In the event of a change in the treatment of deposition of antipsychotic drugs to therapy with the preparation, it should be started by replacing the planned injection. Periodically, the need to continue administering anti-Parkinsonian medications should be considered.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. Do not use in the treatment of schizophrenia and manic episodes in the course of bipolar disorder in children and adolescents <18 years (no data on the effectiveness of treatment). Do not use in the treatment of behavioral disorders in children <5 years (no data on efficacy and safety in this indication in this age group).Way of giving. The drug can be taken regardless of meals. The tablets can be divided into halves.