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These highlights do not include all the information needed to use ZYPREXA safely and effectively. See full prescribing information for ZYPREXA. 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 U.S. Approval: 1996
Medication labelWhy this: Advisory · dailymed-prescription
Oral ZYPREXA is indicated for acute and maintenance treatment of Schizophrenia in adults. Monotherapy — Oral ZYPREXA is indicated for acute treatment of manic or mixed episodes associated with Bipolar I Disorder (monotherapy and in combination with lithium or valproate) and maintenance treatment of Bipolar I Disorder (monotherapy) in adults. Combination Therapy — The combination of oral ZYPREXA with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults [see Clinical Studies (14.2)]. ZYPREXA IntraMuscular is indicated for the treatment of acute agitation associated with Schizophrenia and Bipolar I Mania. “Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.” Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation [see Clinical Studies (14.3)]. When using ZYPREXA and fluoxetine in combination, also refer to the Clinical Studies section of the package insert for Symbyax. Oral ZYPREXA and fluoxetine in combination is indicated for the acute treatment of depressive episodes associated with Bipolar I Disorder in adult patients. ZYPREXA monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder. When using ZYPREXA and fluoxetine in combination, also refer to the Indications and Usage section of the package insert for Symbyax. Oral ZYPREXA and fluoxetine in combination is indicated for the acute treatment of treatment resistant depression (Major Depressive Disorder in adult patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). ZYPREXA monotherapy is not indicated for the treatment of treatment resistant depression.
- generic_name
- olanzapine
- product_names
- Olanzapine
- ndc
- 54868-4255, 0002-4112, 54868-4255-0, 54868-4255-1, 54868-4254, 0002-4115, 54868-4254-0, 54868-4254-1, 54868-5336, 0002-4116, 54868-5336-0, 54868-3941, 0002-4117, 54868-3941-0
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en