2021年奥氮平片fda说明书欧兰宁奥氮平片说明书.docx

奥氮平片fda说明书欧兰宁奥氮平片说明书
1 • Efficacy was established with Symbyax (olanzapine and HIGHLIGHTS OF PRESCRIBING INATION fluoxetine in combination) in adults; refer to the product label These highlights do not include all the ination needed to use for Symbyax. ZYPREXA safely and effectively. See full prescribing ination for ZYPREXA. ------------------------ DOSAGE AND ADMINISTRATION ----------------------- ZYPREXA (olanzapine) Tablet for Oral use ZYPREXA ZYDIS (olanzapine) Tablet, Orally Disintegrating for Oral use ZYPREXA IntraMuscular (olanzapine) Injection, Powder, For Solution for Intramuscular use Initial Approval: 1996 WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing ination for complete boxed warning. • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ZYPREXA is not approved for the treatment of patients with dementia-related psychosis. (, , ) When using ZYPREXA and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax. --------------------------- RECENT MAJOR CHANGES -------------------------- Warnings and Precautions: Metabolic Changes 12/2021 Orthostatic Hypotension MM/YYYY Hyperprolactinemia 12/2021 ---------------------------- INDICATIONS AND USAGE --------------------------- ZYPREXA® (olanzapine)