2022年奥氮平片fda说明书欧兰宁奥氮平片说明书.docx

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1 • Efficacy was established with Symbyax (olanzapine and HIGHLIGHTS OF PRESCRIBING INATIONtenance treatment of bipolar I disorder. • Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. • Adolescents (ages 13-17): Efficacy was established in one 3­ week trial in patients with manic or mixed episodes associated with bipolar I disorder . The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. • Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic uation and with careful consideration of the potential risks. • Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. • Efficacy was established in two 6-week clinical trials in adults . Maintenance efficacy has not been systematically uated. As ZYPREXA IntraMuscular for the: • Treatment of acute agitation associated with schizophrenia and bipolar I mania. • Efficacy was established in three 1-day trials in adults. As ZYPREXA and Fluoxetine in Combination for the: • Treatment of depressive episodes associated with bipolar I disor