Risperidone indications

List of indications
Schizophrenia Bipolar mania Irritability associated with autistic disorder
 * Monotherapy
 * Combination therapy

Schizophrenia
Risperidone is indicated for the treatment of schizophrenia. The efficacy of Risperidone in schizophrenia was established in short-term (6- to 8-weeks) controlled trials of schizophrenic inpatients. The efficacy of Risperidone in delaying relapse was demonstrated in schizophrenic patients who had been clinically stable for at least 4 weeks before initiation of treatment with Risperidone or an active comparator and who were then observed for relapse during a period of 1 to 2 years. Nevertheless, the physician who elects to use Risperidone for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Return to top

Monotherapy
Risperidone is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder. The efficacy of Risperidone was established in two placebo-controlled trials (3-week) with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features. Return to top

Combination therapy
The combination of Risperidone with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder. The efficacy of Risperidone in combination with lithium or valproate was established in one placebo-controlled (3-week) trial with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features. The effectiveness of Risperidone for longer-term use, that is, for more than 3 weeks of treatment of an acute episode, and for prophylactic use in mania, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use Risperidone for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient. Return to top

Irritability associated with autistic disorder
Risperidone is indicated for the treatment of irritability associated with autistic disorder in children and adolescents, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods. The efficacy of Risperidone was established in two 8-week, placebo controlled trials in children and adolescents (aged 5 to 16 years) who met the DSM-IV criteria for autistic disorder. The benefit of maintaining patients with irritability associated with autistic disorder on therapy with Risperidone after achieving a responder status for an average duration of about 140 days was demonstrated in a controlled trial. Physicians who elect to use Risperidone for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient. Return to top