Approval of risperidone in the USA for use by adolescents with schizophrenia or bipolar mania extends treatment options for these young patients
Recent approval of risperidone by the U.S. Food and Drug
Administration for use by adolescents with schizophrenia or bipolar mania extends
treatment options for these young patients.
The approval is for use of risperidone as treatment for
schizophrenia in patients age 13 to 17 years and for the short-term treatment
of bipolar mania associated with manic or mixed episodes of bipolar I disorder
in children and adolescents age 10 to17 years.
Regulators based approval on studies involving more than
430 adolescents, ages 13 to 17 years, in treatment of schizophrenia and 160 children
and adolescents, ages 10 to 17 years, for short-term treatment of bipolar mania
associated with manic or mixed episodes of bipolar I disorder.
Current indications for risperidone use in the USA are
for adults with schizophrenia, for treatment of manic symptoms of acute manic
or mixed episodes associated with bipolar I disorder, for treatment of irritability
associated with autistic disorder in pediatric patients age 5 to16 years, for
treatment of schizophrenia in adolescents ages 13 to 17 years and for short-term
treatment of bipolar mania associated with bipolar I disorder in children and
adolescents ages 10 to 17 years.
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