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 pose a threat to himself or others. Short-term (up to 6 weeks) symptomatic treatment of severe aggression in the course of behavioral disorders in adolescents and children from 5 years of age with reduced intellectual performance or mentally handicapped, diagnosed according to DSM-IV criteria, in which intensification of aggression and other destructive behaviors requires treatment; pharmacotherapy should be an integral part of a comprehensive treatment program, including psychosocial and educational activities; It is recommended that Risperidone be prescribed by a specialist in child neurology and a psychiatrist 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 of risperidone. The preparation contains lactose.

An antipsychotic drug - a selective monoaminergic antagonist. It has high affinity for 5-HT receptors₂-serotonin and D₂-dopaminergicznego. It also binds to the α receptors₁-renergic and less with H-receptors₁-histamines and α-receptors₂-adrenergicznymi. It does not show affinity for cholinergic receptors. It works for positive symptoms of schizophrenia and probably also for negative symptoms. Risperidone is completely absorbed after oral administration. The maximum concentration in plasma reaches within 1-2 h. In the majority of patients, the steady state concentration is reached within 1 day and the concentration of 9-hydroxyrisperidone in 4-5 days. Risperidone binds to plasma proteins (with albumin and acid alpha₁-glycoprotein) in 88%, while 9-hydroxy-sporidone in 77%. Risperidone is metabolised by cytochrome P450 2D6 to 9-hydroxy Risperidone, which has similar pharmacological activity to risperidone. Together, they form the active antipsychotic fraction. Risperidone is also metabolised by the N-dealkylation process. After oral administration in patients with T psychosis_0,5 risperidone in the elimination phase is about 3 hours. In all patients, T_0,5 9-hydroxyryperidone in the elimination phase and the active antipsychotic fraction is 24 hours. After 1 week after oral administration 70% of the dose is excreted in the urine and 14% in the faeces. In the urine, risperidone and 9-hydroxyseripidone together account for 35-45% of the dose. The remainder is inactive metabolites.

Hypersensitivity to risperidone or to 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. 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.

The safety of the medicine during pregnancy has not been established. It should not be used during pregnancy unless clearly necessary. Reversible extrapyramidal symptoms have been observed in newborns after risperidone in women in the last trimester of pregnancy - therefore proper observation of newborns is necessary. 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, discomfort in the stomach, involuntary urination, rash, erythema, joint pain, back pain, limb pain, increased appetite, reduced appetite, pneumonia, influenza, inflammation bronchi, 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, ECG changes, increased blood Glucose, increased transaminases, decreased white blood cell count, elevated body temperature, increased eosinophil count, decreased hemoglobin, increased blood creatine kinase, atrial block -cellular, bundle branch block, atrial fibrillation, sinus bradycardia, palpitations, anemia, thrombocytopenia, lack of response to stimuli, loss of consciousness, syncope, decreased level of consciousness, cerebrovascular events, 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, aspiration pneumonia, pulmonary congestion, breathing disorders, flopping, respiratory congestion, dysphonia, difficulty swallowing, gastritis, faecal incontinence, fecal incontinence, painful urination, urinary incontinence, pollakiuria, angioneurotic edema, changes cutaneous, skin disorders, pruritus, acne, skin discoloration, alopecia, seborrheic dermatitis, dry skin, hyperkeratosis, muscle weakness, muscle pain, neck pain, joint swelling, abnormal posture, stiffness of the joints, chest-muscle pain , anorexia, excessive thirst, sinusitis, viral infection, ear infection, tonsillitis, cellulitis, otitis media, eye infection, local infection, mite dermatitis, respiratory infection, cystitis, onychomycosis, hypotension no, orthostatic hypotension, sudden redness (depth 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, ejaculatory disorders, galactorrhea, 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, swelling of the lips , red dandruff, dandruff, rhabdomyolysis, inadequate antidiuretic hormone secretion, chronic otitis media, generalized edema, hypothermia, withdrawal syndrome (nausea, vomiting, sweating and insomnia, may also recurrent psychotic symptoms and involuntary movements such as akathisia, dystonia and dyskinesia), feeling cold in the extremities, jaundice, lack of orgasm, blunting feelings. Very rare: diabetic ketoacidosis. Not known: agranulocytosis, water intoxication, venous thromboembolism (including pulmonary embolism, deep vein thrombosis), anaphylactic reaction, priapism. Side effects associated with the class of drugs: QT prolongation, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, sudden death, cardiac arrest,torsade de pointes. In elderly patients with dementia, transient ischemic attacks and cerebrovascular events have been observed; at the rate of at least two-fold higher than in other adult populations, urinary tract infection, peripheral edema, lethargy and cough were observed. In children (5 to 17 years) the following side effects have been reported with a frequency ≥ 5% and more than twice the corresponding frequency in adults: drowsiness / sedation, fatigue, headache, increased appetite, vomiting, upper respiratory tract infection, 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 day 2 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 may 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, not 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. Do not use the drug for more 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. As with other drugs used symptomatically, the continuation of risperidone therapy should be verified and justified by the current state of the patient.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.
The preparation can be taken regardless of meals.