Loading…
RISPERIDONE STERANCO is a brand name for Risperidone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Risperidone Steranco is indicated for the treatment of schizophrenia. Risperidone Steranco is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders. Risperidone is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Schizophrenia Adults Risperidone Steranco 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 Steranco 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 Steranco 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 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 Steranco 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.
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 clinical trials.
The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 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 ReactionSystem Organ Class Frequency Very Common Common Uncommon Rare Very Rare Not known Infections and infestation s pneumonia, bronchitis, upper respiratory tract infection, sinusitis, urinary tract infection, ear infection, influenza respiratory tract infection, cystitis, eye infection, tonsillitis, onychomycosi s, cellulitis localised infection, viral infection, acarodermatiti s infection Blood and lymphatic system disorders neutropenia, white blood cell count decreased, thrombocytop enia, anaemia, haematocrit decreased, eosinophil count increased agranulo cytosis c Immune system disorders hypersensitivit y anaphyla ctic reactionc Endocrine disorders Hyperpro lactinaemia a inapprop riate antidiure tic hormone secretion , glucose urine present Metabolis m and nutrition disorders weight increased, increased appetite, decreased appetite diabetes mellitus b, hyperglycaemi a, polydipsia, weight decreased, anorexia, blood cholesterol increased water intoxicat ion c, hypogly caemia, hyperins ulinaemi a c, blood triglycer ides increase d diab etic keto acid osis Psychiatri c disorders insomni a d sleep disorder, agitation, depression, anxiety mania, confusional state, libido decreased, nervousness, nightmare catatonia , somnam bulism, sleeprelate d eating disorder, blunted affect, anorgas mia Nervous system disorders sedation/ somnole nce, parkinso nism d, headach e 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, dizziness postural, disturbance in attention, dysarthria, dysgeusia, hypoaesthesia, paraesthesia neurolep tic maligna nt syndrom e, cerebrov ascular disorder, diabetic coma, head titubatio n Eye disorders vision blurred, conjunctiviti s photophobia, dry eye, lacrimation increased, ocular hyperaemia glaucom a, eye moveme nt disorder, eye rolling, eyelid margin crusting, floppy iris syndrom e (intraope rative) c Ear and labyrinth disorders vertigo, tinnitus, ear pain Cardiac disorders tachycardia atrial fibrillation, atrioventricula r block, conduction disorder, electrocardiog ram QT prolonged, bradycardia, electrocardiog ram abnormal, palpitations sinus arrhythmi a Vascular disorders hypertension hypotension, orthostatic hypotension, flushing pulmona ry embolis m, venous thrombo sis Respirator , thoracic and mediastina disorders y l dyspnoea, pharyngolary ngeal pain, cough, epistaxis, nasal congestion pneumonia aspiration, pulmonary congestion, respiratory tract congestion, rales, wheezing, dysphonia, respiratory disorder sleep apnoea syndrom e, hyperve ntilation Gastro intestinal disorders abdominal pain, abdominal discomfort, vomiting, nausea, constipation, diarrhoea, dyspepsia, dry mouth, toothache faecal incontinence, faecaloma, gastroenteritis, dysphagia, flatulence pancreat itis, intestina l obstructi on, swollen tongue, cheilitis ileu s Skin and sub cutaneous tissue disorders rash, erythema urticaria, pruritus, alopecia, hyperkeratosis , eczema, dry skin, skin discolouration, acne, seborrhoeic dermatitis, skin disorder, skin lesion drug eruption, dandruff angi oed ema Stevens - Johnso n syndro me/ toxic epider mal necrolsi s c Musculo skeletal and connective tissue disorders muscle spasms, musculoskel etal pain, back pain, arthralgia blood creatine phosphokinase increased, posture abnormal, joint stiffness, joint swelling muscular weakness, neck pain rhabdom yolysis Renal and urinary disorders urinary incontinence pollakiuria, urinary retention, dysuria Pregnancy , Puerperiu , and neonatal conditions m drug with drawal syndrom e neonatal c Reproduct ive system and breast disorders erectile dysfunction, ejaculation disorder, amenorrhoea, menstrual disorder d, gynaecomastia , galactorrhoea, sexual dysfunction, breast pain, breast discomfort, vaginal discharge priapismc , menstrua tion delayed, breast engorge ment, breast enlargem ent, breast discharge General disorders and admini stration site conditions oedema d, pyrexia, chest pain, asthenia, fatigue, pain face oedema, chills, body temperature increased, gait abnormal, thirst, chest discomfort, malaise, feeling abnormal, discomfort hypother mia, body temperat ure decrease d, periphera l coldness, drug withdraw al syndrom e, induratio n c Hepato biliary disorders transaminases increased, gamma- glutamyltrans ferase increased, hepatic enzyme increased jaundice Injury, poisoning and procedura l complicati ons fall procedural pain a Hyperprolactinaemia can in some cases lead to gynaecomastia, menstrual disturbances, amenorrhoea, anovulation, galactorrhoea, fertility disorder, decreased libido, erectile dysfunction.
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 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.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Risperidone in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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. As with all symptomatic treatments, the continued use of Risperidone Steranco must be evaluated and justified on an ongoing basis. Risperidone Steranco 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 Steranco should be used with caution in these groups of patients.
Method of administration Risperidone Steranco is for oral use. Food does not affect the absorption of risperidone. 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 Steranco therapy is initiated is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate Risperidone Steranco therapy in place of the next scheduled injection.
The need for continuing existing anti-Parkinson medicines should be re-evaluated periodically.
11% in placebo group. 43 % in all risperidone-treated subjects. c Not observed in risperidone clinical studies but observed in post-marketing environment with risperidone. d Extrapyramidal disorder may occur: Parkinsonism (salivary hypersecretion, musculoskeletal stiffness, […]
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 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 Steranco 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 Steranco should only be used short term for persistent aggression in patients with moderate to severe Alzheimer’s dementia to supplement nonpharmacological 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 therapy and discontinuation of risperidone 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 × 109/L) should discontinue Risperidone Steranco and have their WBC followed until […]