Adults: Schizophrenia: pms-RISPERIDONE (risperidone) is indicated for the acute treatment and maintenance treatment of schizophrenia and related psychotic disorders. In controlled clinical trials, risperidone was found to improve both positive and negative symptoms of schizophrenia.
Risperidone has been shown to be effective in maintaining clinical improvement during long-term therapy (1 year).
Severe Dementia of the Alzheimer type - Symptomatic management of aggression and psychotic symptoms: pms-RISPERIDONE is indicated for the short-term symptomatic management of aggression or psychotic symptoms in patients with severe dementia of the Alzheimer type unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. Other behavioural disturbances seen in this patient population as well as disease stage remained unaffected by risperidone treatment (see Pharmacology: Clinical Trials under Actions).
Physicians are advised to assess the risks and benefits of the use of pms-RISPERIDONE in elderly patients with dementia of the Alzheimer type, taking into account risk predictors for stroke or existing cardiovascular comorbidities in the individual patient (see Recommended Dose and Dosage Adjustment: Adults: Severe Dementia of the Alzheimer Type under Dosage & Administration; Use in Elderly: Use in Geriatric Patients with Dementia under Precautions; Clinical Trial Adverse Drug Reactions: Elderly Patients with Severe Dementia and Cerebrovascular Adverse Events (CVAEs) in Elderly Patients with Dementia under Adverse Reactions).
Bipolar Disorder - Mania: pms-RISPERIDONE is indicated as monotherapy for the acute management of manic episodes associated with Bipolar I disorder.
The efficacy of risperidone in the treatment of acute bipolar mania was established in three 3-week, placebo-controlled trials. The safety and effectiveness of risperidone for long-term use, and for prophylactic use in bipolar disorder have not been evaluated. Physicians who elect to use pms-RISPERIDONE for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient (see Recommended Dose and Dosage Adjustment: Adults: Bipolar Mania under Dosage & Administration).
Geriatrics (> 65 years of age): See Increased Mortality in Elderly Patients with Dementia under Warnings; Use in Elderly: Use in Geriatric Patients with Dementia under Precautions.
Pediatrics (< 18 years of age): The safety and efficacy of risperidone in children under the age of 18 have not been established and its use is not recommended.