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Risperdal

[Risperidone]

The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient ncrease. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.

Antipsychotic treatment, itself, however, may suppress ( or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.
Given these considerations, RISPERDAL ® ( risperidone) should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that ( 1) is known to respond to antipsychotic drugs, and ( 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient treated on RISPERDAL ® , drug discontinuation should be considered. However, some patients may require treatment with RISPERDAL ® despite the presence of the syndrome.

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Cerebrovascular Adverse Events, Including Stroke, in Elderly Patients With Dementia Cerebrovascular adverse events ( e. g. , stroke, transient schemic attack) , including fatalities, were reported in patients ( mean age 85 years; range 73-97) n trials of risperidone in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher ncidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. RISPERDAL ® is not approved for the treatment of patients with dementia-related psychosis.

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