DrugsLevel 4 LocalisationS5SOL · TAB · FCT · ODTEML

Risperidone

BenzisoxazoleAtypical antipsychotic

Indications

Registered South African indications:

Acute and chronic schizophrenic psychoses and related psychosis in which positive symptoms (hallucinations, delusions, thought disturbances, hostility and suspiciousness) and/or the negative symptoms (blunted affect, emotional and social withdrawal, poor speech) are prominent (fct, odt, sol)
- Also alleviates affective symptoms associated with schizophrenia. In patients who have shown an initial treatment response, risperidone is also effective in maintaining the clinical improvement (fct, odt, sol)
Mania in bipolar disorder. These episodes are characterised by symptoms such as elevated, expansive or irritable mood, inflated self-esteem, decreased need for sleep, pressured speech, racing thoughts, distractibility, or poor judgment, including disruptive or aggressive behaviours (odt, sol)
Behavioural disturbances in patients with dementia in whom symptoms such as aggressiveness, activity disturbances or psychotic symptoms are prominent (fct)
Conduct and other disruptive behaviour disorders in children (aged 5-12 years), with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g., aggression, impulsivity and self-injurious behaviours) are prominent (fct, odt, sol)

Contraindications (ZA)

Registered South African contraindications

Hypersensitivity to the active ingredient or any of its excipients
Conduct and other disruptive behaviour disorders in children, risperidone is contraindicated in children under 5 years of age as efficacy and safety in these children have not been demonstrated
Parkinson’s disease and Lewy body dementia
Pregnancy (fct, tab)
Breastfeeding (fct, tab)

Warnings & precautions

Pregnancy (odt, sol)
Breastfeeding (odt, sol)
Renal impairment
Hepatic impairment
Elderly
Orthostatic hypotension
Cardiovascular disease
History of leukopenia and neutropenia
Parkinson's disease
Dementia with Lewy Bodies
Diabetes mellitus
History or family history of QT prolongation
History of seizures
Risk factors for venous thromboembolism
Cataract surgery
Paediatrics
Galactose intolerance
Lapp lactase deficiency
Glucose-galactose malabsorption

Adult dosage (ZA)

Forms avail. in SA and covered in this monograph: fct, tab, odt, sol

South African registered indications and dosages

Schizophrenia

Oral (fct, tab, odt, sol): Initial: 2mg/day in 1-2 divided doses; Day 2: May be increased to 4mg/day; Then: Dosage can be maintained unchanged, or further individualised, if needed; Most patients benefit from daily doses of 4-8mg/day; Doses >6mg/day (when admin. twice daily) are associated with more extrapyramidal symptoms and other adverse effects and are not recommended; In some patients, particularly with first episode acute psychosis, a slower titration phase and a lower starting and maintenance dose may be appropriate; Doses >10mg/day have not been shown to be superior in efficacy to lower doses and may cause an increased incidence of side effects such as extrapyramidal symptoms; Dosages >10mg/day should only be considered if the benefits outweigh the risk; Max. total daily dose: 16mg/24hrs

A benzodiazepine may be added to risperidone if additional sedation is required

Behavioural disturbances with dementia

Oral (fct, tab): 0.25mg, twice daily; Dosage can be individually adjusted by increments of 0.25mg, twice daily not more frequently than every other day, if needed; Optimum dose: 0.5mg, twice daily, for most patients; Some patients, may benefit from doses up to 1mg, twice daily; Once patients have reached their target dose, a once-daily dosing regimen can be considered

The continued use of risperidone must be evaluated and justified on an ongoing basis

Oral (fct, tab): Can be taken with or without food

Mania in bipolar disorders

Oral (odt, sol): Initial: 2-3mg, once daily; Titrate by 1mg/day at intervals no less than 24hrs, if needed; Efficacy was demonstrated in flexible doses over a range of 1-6mg/day

Continued use of risperidone must be evaluated and justified on an ongoing basis

Oral (odt, sol): For oral use. Food does not affect the absorption of risperidone

Switching from other antipsychotics to risperidone
When medically appropriate, gradual discontinuation of the previous treatment, while risperidone therapy is initiated, is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate risperidone therapy in place of the next scheduled injection. The need for continuing existing anti-Parkinson medications should be re-evaluated periodically

Paediatric dosage (ZA)

Paed. forms avail. in SA and covered in this monograph: fct, tab, odt, sol

South African registered indications and dosages

Schizophrenia

Oral (fct, tab)

Younger than 15 years: Not established for use

Conduct and other disruptive behaviour disorders

Oral (fct, tab, odt, sol)

Younger than 5 years old: Contraindicated
Between 5-12 years old: <50kg: Initial: 0.01mg/kg, once daily is recommended; Dosage can be individually adjusted by increments of 0.01mg/kg, once daily not more frequently than every other day, if needed; Recommended maintenance dose: 0.02-0.04mg/kg, once daily; Mean dose: 0.03mg/kg, once daily

The continued use of risperidone must be evaluated and justified on an ongoing basis

Oral (fct, tab, odt, sol): Can be taken with or without food

Oral (odt): Experience is lacking in bipolar mania in children and adolescents less than 18 years of age