RISPERIDONE

Posology Schizophrenia Adults Risperidone Orodispersible Tablets may be given once daily 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.

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 age 18 with schizophrenia due to a lack of data on efficacy.

Manic episodes in bipolar disorder Adults Risperidone Orodispersible Tablets 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 over a range of 1 to 6 mg per day to optimize each patient’s level of efficacy and tolerability. Daily doses over 6 mg risperidone have not been investigated in patients with manic episodes.

As with all symptomatic treatments, the continued use of Risperidone Orodispersible Tablets 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. Since clinical experience in elderly is limited, caution should be exercised.

Paediatric population Risperidone is not recommended for use in children below age 18 with bipolar mania due to a lack of data on efficacy. 25 mg twice daily is recommended. 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 Orodispersible Tablets should not be used more than 6 weeks in patients with persistent aggression in Alzheimer’s dementia.

During treatment, patients must 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 once daily is recommended. 25 mg once daily not more frequently than every other day, if needed. 5 mg once daily for most patients. 75 mg once daily. As with all symptomatic treatments, the continued use of Risperidone Orodispersible Tablets must be evaluated and justified on an ongoing basis.

Risperidone Orodispersible Tablets 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 Orodispersible Tablets should be used with caution in these groups of patients. Method of administration Risperidone Orodispersible Tablets is for oral use. Food does not affect the absorption of Risperidone Orodispersible Tablets.

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) has been reported. Switching from other antipsychotics.

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

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

Risperidone Orodispersible Tablets:

Do not open the blister until ready to administer. Remove the tablet from the blister with dry hands. Immediately place the tablet on the tongue. The tablet will begin disintegrating within seconds. Water may be used if desired.

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 postmarketing experience with risperidone by frequency category estimated from Risperidone Orodispersible Tablets clinical trials.

The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1000) and very rare (< 1/10,000) Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Adverse Drug Reactions by System Organ Class and Frequency Infections and infestations Common Pneumonia, Influenza, Bronchitis, Upper respiratory tract infection, Urinary tra infection, Sinusitis, Ear infection Uncommon Viral infection, Tonsillitis, Cellulitis localized infection, Acarodermatitis, Respiratory tract infection, Cystitis, Onychomycosis, Eye infection Rare Infection Blood and lymphatic system disorders Uncommon Neutropenia, White blood cell count decreased, Anaemia, Thrombocytopenia, Haematrocrit decreased, Eosinophil count increased Rare AgranulocytosisC Immune system disorders Uncommon Hypersensitivity Rare Anaphylactic reactionC Endocrine disorders Common Hyperprolactinaemiaa Rare Inappropriate antidiuretic hormone secretion, glucose urine present Metabolism and nutrition disorders Common Increased appetite, Decreased appetite, Weight increased Uncommon Diabetes mellitus b, Hyperglycaemia, Polydipsia, Weight decreased, Anorexia, Blood cholesterol increased Rare Water intoxicationc, Hypoglycaemia, Hyperinsulinaemiac, Blood triglycerides increased Very rare Diabetic ketoacidosis Psychiatric disorders Very common Insomniad Common Anxiety, Agitation, Sleep disorder, Depression Uncommon Confusional state, Mania, Libido decreased, Nervousness, Nightmare Rare Catatonia, Somnambulism, Sleep-related eating disorder, Anorgasmia, Blunted affect Nervous system disorders Very common Sedation/ Somnolence, Parkinsonismd, Headache Common Akathisiad, Dizziness, Tremor, Dystoniad, Dyskinesiad Uncommon Tardive dyskinesia, Cerebral ischaemia, Unresponsive to stimuli, loss of consciousness, Depressed level of consciousness, Convulsiond, Syncope, Psychomotor hyperactivity, Balance disorder, Coordination abnormal, Dizzines postural, Disturbance in attention, Dysarthria, Dysgeusia, Hypoaesthesia, paraesthesia Rare Neuroleptic malignant syndrome, Diabetic coma, Cerebrovascular disorder, He titubation Eye disorders Common Vision blurred, Conjunctivitis Uncommon Ocular hyperaemia, Dry eye, Lacrimation increased, Photophobia Rare Glaucoma, Eye movement disorder, Eye rolling, Eyelid margin crusting, Flopp iris syndrome (intraoperative)C Ear and labyrinth disorders Uncommon Ear pain, Tinnitus, Vertigo Cardiac disorders Common Tachycardia Uncommon Atrial fibrillation, Atrioventricular block, Conduction disorder, Electrocardiogr QT prolonged, Bradycardia, Electrocardiogram abnormal, Palpitations Rare Sinus arrhythmia Vascular disorders Common Hypertension Uncommon Hypotension, Orthostatic hypotension, Flushing Rare Pulmonary embolism, Venous thrombosis Respiratory, thoracic and mediastinal disorders Common Dyspnoea, Epistaxis, Cough, Nasal congestion, Pharyngolaryngeal pain Uncommon Wheezing, Pneumonia aspiration, Pulmonary congestion, Respiratory disorder, Rales, Respiratory tract congestion, Dysphonia Rare Sleep apnoea syndrome, Hyperventilation Gastrointestinal disorders Common Vomiting, Diarrhoea, Constipation, Nausea, Abdominal pain, Abdominal discomfort, Dyspepsia, Dry mouth, Toothache Uncommon Dysphagia, Gastroenteritis, Faecal incontinence, Faecaloma, Flatulence Rare Intestinal obstruction, Pancreatitis, Swollen tongue, Cheilitis Very rare Ileus Skin and subcutaneous tissue disorders Common Rash, Erythema Uncommon Skin lesion, Skin disorder, Pruritus, Acne, Skin discoloration, Alopecia, Seborrhoeic dermatitis, Dry skin, Hyperkeratosis, Eczema, Urticaria Rare Drug eruption, Dandruff Very rare Angioedema Not known Stevens -Johnson syndrome/toxic epidermal necrolysis Musculoskeletal and connective tissue disorders Common Arthralgia, Back pain, Muscle spasms, Musculoskeletal pain Uncommon Blood creatine phosphokinase increased, Posture abnormal, Joint stiffness, Join swelling muscular weakness, Neck pain Rare Rhabdomyolysis Renal and urinary disorders Common Urinary incontinence Uncommon Dysuria, Urinary retention, Pollakiuria Pregnancy, puerperium and neonatal conditions Rare Drug withdrawal syndrome neonatalc Reproductive system and breast disorders Uncommon Amenorrhoea, Sexual dysfunction, Erectile dysfunction, Ejaculation disorder, Galactorrhea, Gynaecomastia, Menstrual disorderd, Vaginal discharge, Breast p Breast discomfort Rare Priapismc, Menstruation delayed, Breast engorgement, Breast enlargement, Bre discharge General disorders and administration site conditions Common Pyrexia, Fatigue, Oedemad, Asthenia, Chest pain, Pain Uncommon Face oedema, Gait abnormal, Feeling abnormal, Thirst, Chest discomfort, Chil Body temperature increased, Discomfort, Malaise Rare Hypothermia, Body temperature decreased, Drug withdrawal syndrome, Periph coldness, Indurationc Hepatobiliary disorders Uncommon Transaminases increased, Gamma-glutamyl transferase increased, Hepatic enzy increased Rare Jaundice Injury, poisoning and procedural complications Common Fall Uncommon Procedural pain a Hyperprolactinemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, anovulation, galactorrhea, fertility disorder, decreased libido, erectile dysfunction.

11% in placebo group. 43% in all risperidone-treated subjects. c Not […]

Elderly patients with dementia Increased mortality in elderly people with dementia In a meta-analysis of 17 controlled trials of atypical antipsychotics, including Risperidone Orodispersible Tablets, 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 antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.

1%; mean age 80 years, range 67-90). The increase 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 have been seen in randomised 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 Orodispersible Tablets 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 Orodispersible Tablets 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 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 Orodispersible Tablets should only be used 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 Orodispersible Tablets.

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 leukopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of Risperidone Orodispersible Tablets 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 […]

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