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1 Indications And Usage Risperidone Orally Disintegrating Tablets Are An Atypical Antipsychotic Indicated For: • Treatment Of Schizophrenia ( 1.1 ) • As Monotherapy Or Adjunctive Therapy With Lithium Or Valproate, For The Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder ( 1.2 ) • Treatment Of Irritability Associated With Autistic Disorder ( 1.3 ) 1.1 Schizophrenia Risperidone Orally Disintegrating Tablets Are Indicated For The Treatment Of Schizophrenia. Efficacy Was Established In 4 Short-Term Trials In Adults, 2 Short-Term Trials In Adolescents (Ages 13 To 17 Years), And One Long-Term Maintenance Trial In Adults [See Clinical Studies ( 14.1 ) ]. 1.2 Bipolar Mania Monotherapy Risperidone Orally Disintegrating Tablets Are Indicated For The Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder. Efficacy Was Established In 2 Short-Term Trials In Adults And One Short-Term Trial In Children And Adolescents (Ages 10 To 17 Years) [See Clinical Studies ( 14.2 ) ]. Adjunctive Therapy Risperidone Orally Disintegrating Tablets Adjunctive Therapy With Lithium Or Valproate Is Indicated For The Treatment Of Acute Manic Or Mixed Episodes Associated With Bipolar I Disorder. Efficacy Was Established In One Short-Term Trial In Adults [See Clinical Studies ( 14.3 )]. 1.3 Irritability Associated With Autistic Disorder Risperidone Orally Disintegrating Tablets Are Indicated For The Treatment Of Irritability Associated With Autistic Disorder, Including Symptoms Of Aggression Towards Others, Deliberate Self-Injuriousness, Temper Tantrums, And Quickly Changing Moods. Efficacy Was Established In 3 Short-Term Trials In Children And Adolescents (Ages 5 To 17 Years) [See Clinical Studies ( 14.4 ) ].
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