RISPERIDONE GRINDEKS

Posology Schizophrenia Adults Risperidone Grindeks may be given once or twice daily. Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg. Subsequently, the dosage can be maintained unchanged, or further individualised, if needed.

Most patients will benefit from daily doses between 4 and 6 mg. In some patients, a slower titration phase and a lower starting and maintenance dose may be appropriate. Doses above 10 mg/day have not demonstrated superior efficacy to lower doses and may cause increased incidence of extrapyramidal symptoms.

The safety of doses above 16 mg/day has not been evaluated, and are therefore not recommended. 5 mg twice daily is recommended. 5 mg twice daily increments to 1 to 2 mg twice daily. Paediatric population Risperidone is not recommended for use in children below 18 years of age with schizophrenia due to a lack of data on efficacy.

Manic episodes in bipolar disorder Adults Risperidone Grindeks should be administered on a once daily schedule, starting with 2 mg risperidone. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day.

Risperidone can be administered in flexible doses a range of 1 to 6 mg per day to optimize the level of efficacy and tolerability for each patient. Daily doses above 6 mg risperidone have not been studied in patients with manic episodes.

As with all symptomatic treatment, the continued use of Risperidone Grindeks must be evaluated and justified on an ongoing basis. 5 mg twice daily is recommended. 5 mg twice daily increments to 1 to 2 mg twice daily. As clinical experience in elderly is limited, caution should be exercised.

Paediatric population Risperidone is not recommended for use in children below 18 years of age with bipolar mania due to a lack of data on efficacy. 25 mg of the oral solution twice daily is recommended. 25 mg. 25 mg twice daily, not more frequently than every other day, if needed.

5 mg twice daily for most patients. Some patients, however, may benefit from doses up to 1 mg twice daily. Risperidone Grindeks should not be used more than 6 weeks in patients with persistent aggression in Alzheimer’s dementia. During treatment, patients should be evaluated frequently and regularly, and the need for continuing treatment reassessed.

5 mg once daily is recommended. 5 mg once daily not more frequently than every other day, if needed. The optimum dose is 1 mg once daily for most patients. 5 mg once daily. 25 mg of the oral solution once daily is recommended. 25 mg. 25 mg once daily not more frequently than every other day, if needed.

5 mg once daily for most patients. 75 mg of the oral solution once daily. 75 mg. As with all symptomatic treatments, the continued use of Risperidone Grindeks should be evaluated and justified on an ongoing basis. Risperidone Grindeks is not recommended in children less than 5 years of age, as there is no experience in children less than 5 years of age with this disorder.

Renal and hepatic impairment Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than in adults with normal renal function. Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone.

Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment. Risperidone Grindeks should be used with caution in these patient groups.

Method of administration Risperidone Grindeks is for oral use. Food does not affect the absorption of Risperidone Grindeks. Upon discontinuation, gradual withdrawal is advised. 8). Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) have been reported.

Switching from other antipsychotics When medically appropriate, gradual discontinuation of the previous treatment while Risperidone Grindeks therapy is initiated, is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate Risperidone Grindeks therapy in place of the next scheduled injection.

The need for continuing existing anti-Parkinson medicines should be re-evaluated periodically.

The most frequently reported adverse drug reactions (ADRs) (incidence ≥10%) are: Parkinsonism, sedation/somnolence, headache and insomnia. The ADRs that appeared to be dose-related included parkinsonism and akathisia. The following are all the ADRs that were reported in clinical trials and post- marketing experience with risperidone by frequency category estimated from risperidone clinical trials.

The following terms and frequencies are applied: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Adverse drug reactions FrequencySystem Organ Class Very common Common Uncommon Rare Very rare Not known Infections and infestations pneumonia, bronchitis, upper respiratory tract infection, sinusitis, urinary tract infection, ear infection, influenza respiratory tract infection, cystitis, eye infection, tonsillitis, onychomycosis, cellulitis localised infection, viral infection, infection Adverse drug reactions FrequencySystem Organ Class Very common Common Uncommon Rare Very rare Not known acarodermatitis Blood and lymphatic system disorders neutropenia, white blood cell count decreased, thrombocytopenia, anaemia, haematocrit decreased, eosinophil count increased agranulocytosis c Immune system disorders hypersensitivity anaphylactic reaction c Endocrine disorders hyperprolactinaemia a inappropriate excretion of antidiuretic hormone, glucose is presented in the urine Metabolism and nutrition disorders weight increased, increased appetite, decreased appetite diabetes mellitus b, hyperglycaemia, polydipsia, weight decreased, anorexia, blood cholesterol increased water intoxication c, hypoglycaemia, hyperinsulinemia c, blood triglycerides increased diabetic ketoacid osis Psychiatric disorders insomnia d sleep disorder, agitation, depression, anxiety mania, confusional state, libido decreased, nervousness, nightmare catatonia, somnambul ism, sleep-related eating disorder, blunted affect, anorgasmia Nervous system disorders sedation/ somnolence, parkinsonismd, headache akathisia d, dystonia d, dizziness, dyskinesia d, tremor tardive dyskinesia, cerebral ischaemia, unresponsive to stimuli, loss of consciousness, depressed level of consciousness, convulsion d, syncope, psychomotor hyperactivity, balance disorder, coordination abnormal, postural dizziness, disturbance in attention, dysarthria, dysgeusia, hypoaesthesia, paraesthesia neuroleptic malignant syndrome, cerebrovascular disorder, diabetic coma, head titubation Adverse drug reactions FrequencySystem Organ Class Very common Common Uncommon Rare Very rare Not known Eye disorders blurred vision, conjunctivitis photophobia, dry eye, lacrimation increased, ocular hyperaemia glaucoma, eye movement disorder, eye rolling, eyelid margin crusting, floppy iris syndrome (intraoperative) c Ear and labyrinth disorders vertigo, tinnitus, ear pain Cardiac disorders tachycardia atrial fibrillation, atrioventricular block, conduction disorder, prolonged QT interval on electrocardiogram (ECG), bradycardia, abnormal ECG, palpitations sinus arrhythmia Vascular disorders hypertension hypotension, orthostatic hypotension, flushing pulmonary embolism, venous thrombosis Respiratory, thoracic and mediastinal disorders dyspnoea, pharyngolaryngeal pain, cough, epistaxis, nasal congestion aspiration pneumonia, pulmonary congestion, respiratory tract congestion, rales, wheezing, dysphonia, respiratory disorder sleep apnoea syndrome, hyperventilatio n Gastrointestinal disorders abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, dyspepsia, dry mouth, toothache faecal incontinence, faecaloma, gastroenteritis, dysphagia, flatulence pancreatitis, intestinal obstruction, swollen tongue, cheilitis ileus Skin and subcutaneous tissue disorders rash, erythema urticaria, pruritus, alopecia, hyperkeratosis, eczema, dry skin, skin discoloration, acne, seborrhoeic dermatitis, skin disorder, skin lesion drug eruption, dandruff angioedem a Stevens- Johnson syndrome/ toxic epidermal necrolysis c Musculoskeletal system and connective tissue disorders muscle spasms, musculoskeletal pain, back pain, arthralgia blood creatine phosphokinase increased, abnormal posture, joint stiffness, joint swelling, muscular weakness, neck pain rhabdomyolysis Renal and urinary disorders urinary incontinence pollakiuria, urinary retention, dysuria Pregnancy, puerperium and perinatal period neonatal drug withdrawal syndromec Adverse drug reactions FrequencySystem Organ Class Very common Common Uncommon Rare Very rare Not known Reproductive system and breast disorders erectile dysfunction, ejaculation disorder, amenorrhoea, menstrual disorderd, gynecomastia, galactorrhoea, sexual dysfunction, breast pain, breast discomfort, vaginal discharge priapismc, menstruation delayed, breast engorgement, breast enlargement, breast discharge General disorders and administration site conditions oedemad, pyrexia, chest pain, asthenia, fatigue, pain face oedema, chills, body temperature increased, abnormal gait, thirst, chest discomfort, malaise, abnormal feeling, discomfort hypothermia, body temperature decreased, peripheral coldness, drug withdrawal syndrome, indurationc Hepatobiliary disorders transaminases increased, gamma- glutamyltransferase increased, hepatic enzyme increased jaundice Injury, poisoning and procedural complications fall procedural pain a Hyperprolactinaemia can, in some cases, lead to gynaecomastia, menstrual disturbances, amenorrhoea, anovulation, galactorrhoea, fertility disorder, decreased libido, erectile dysfunction.

11% in placebo group. 43% in all […]

Elderly patients with dementia Increased mortality in elderly people with dementia In a meta-analysis of 17 controlled trials of atypical antipsychotics, including risperidone, elderly patients with dementia treated with atypical antipsychotics have an increased mortality compared to placebo.

1% for placebo-treated patients. 1). The mean age (range) of patients who died was 86 years (range 67-100). Data from two large observational studies showed that elderly people with dementia who are treated with conventional antipsychotics are also at a small increased risk of death compared with those who are not treated.

There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotics as opposed to some characteristic(s) of the patients is not clear.

1%; mean age 80 years, range 67–90 years). The increased in mortality in patients treated with furosemide plus risperidone was observed in two of the four clinical trials. Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.

No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use.

There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be carefully avoided in elderly patients with dementia.

Cerebrovascular adverse events (CVAE) An approximately 3-fold increased risk of cerebrovascular adverse events has been observed in randomized placebo-controlled clinical trials in the dementia population with some atypical antipsychotics.

2% (8/712) of patients treated with placebo. 50). The mechanism for this increased risk is not known. An increased risk cannot be excluded for other antipsychotics or other patient populations. Risperidone Grindeks should be used with caution in patients with risk factors for stroke.

The risk of CVAEs was significantly higher in patients with mixed or vascular type of dementia when compared to Alzheimer’s dementia. Therefore, patients with other types of dementias than Alzheimer’s should not be treated with risperidone.

Physicians are advised to assess the risks and benefits of the use of Risperidone Grindeks in elderly patients with dementia, taking into account risk predictors for stroke in the individual patient. Patients/caregivers should be cautioned to immediately report signs and symptoms of a potential CVAEs such as sudden weakness or numbness in the face, arms or legs, and speech or vision problems.

All treatment options should be considered without delay, including discontinuation of risperidone. Risperidone Grindeks should only be used the short-term for persistent aggression in patients with moderate to severe Alzheimer’s dementia to supplement non- pharmacological approaches which have had limited or no efficacy and when there is potential risk of harm to self or others.

Patients should be reassessed regularly, and the need for continuing treatment reassessed. Orthostatic hypotension Due to the alpha-blocking activity of risperidone, (orthostatic) hypotension can occur, especially during the initial dose-titration period.

Clinically significant hypotension has been observed post-marketing with concomitant use of risperidone and antihypertensive treatment. 2). A dose reduction should be considered if hypotension occurs. Leucopenia, neutropenia and agranulocytosis Events of leucopenia, neutropenia and agranulocytosis have been reported with antipsychotic agents including risperidone.

Agranulocytosis has been reported very rarely (<1/10,000 patients) during post-marketing surveillance. Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leucopenia/neutropenia should be monitored during the first few months of treatment and discontinuation of Risperidone Grindeks should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1 x 109/L) should discontinue Risperidone Grindeks and […]

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