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Tablet
Files
Risperidone
Strength: 2mg
Count: 60
NDC
42291-911-60
Class
Rx
Brand Name
Risperdal
Imprint Code
r;2
Color(s)
Orange
Shape
ROUND (biconvex)
Score
no score
Case Count
NA
Inactive Ingredients
lactose anhydrous, NF, microcrystalline cellulose, NF, magnesium stearate, NF, and pregelatinized starch, NF. Tablets of 2 mg. also contain hypromellose, macrogol, FD&C Yellow #6 Aluminum Lake and Titanium Dioxide.
Indications and Usage
1.1 Schizophrenia Risperidone 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. 1.2 Bipolar Mania Monotherapy Risperidone 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). Adjunctive Therapy Risperidone 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. 1.3 Irritability Associated with Autistic Disorder Risperidone 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).
