Health Vidya

Adults Risperidone tablets are indicated for the acute and maintenance treatment of schizophrenia [see Clinical Studies (14.1)]. Adolescents Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with schizophrenia. Pediatric use information for the treatment of pediatric patients with schizophrenia, 13 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products. Monotherapy - Adults Risperidone tablets are indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in Adults [see Clinical Studies (14.2)]. Due to Janssen Pharmaceuticals Corporation’s marketing exclusivity rights, this drug product is not labeled for use in pediatric patients with bipolar mania. Pediatric use information for the treatment of pediatric patients with bipolar mania, 10 to 17 years of age, is approved for Janssen Pharmaceuticals Corporation’s risperidone drug products. Combination Therapy – Adults 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 [see Clinical Studies (14.3)]. Pediatrics Risperidone tablets are indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods [see Clinical Studies (14.4)].