risperidone
risperidone is listed in the FDA National Drug Code directory with 50 NDC codes, marketed under brand names including risperidone, RISPERDAL M-TAB, UZEDY. Available dosage forms: tablet, film coated, tablet, orally disintegrating, injection, suspension, extended release, solution, injection, suspension.
Drug Details
- Generic Name
- risperidone
- Brand Names
- risperidone, RISPERDAL M-TAB, UZEDY, Risperidone, RISPERDAL CONSTA, RISPERDAL
- Application Number
- ANDA078040
- Sponsor
- Major Pharmaceuticals
- NDC Codes
- 50
- Dosage Forms
- TABLET, FILM COATED, TABLET, ORALLY DISINTEGRATING, INJECTION, SUSPENSION, EXTENDED RELEASE, SOLUTION, INJECTION, SUSPENSION, KIT, POWDER, TABLET
- Routes
- ORAL, SUBCUTANEOUS, INTRAMUSCULAR
- Active Ingredients
- RISPERIDONE
Indications and Usage
1 INDICATIONS AND USAGE Risperidone is 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 is 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 is 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 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 is 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)] .