The mechanism of action of olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug’s efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. The mechanism of action of olanzapine in the treatment of acute manic or mixed episodes associated with bipolar I disorder is unknown.

As oral formulation for the:
• Treatment of schizophrenia.
• Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial.
• Adolescents (ages 13-17): Efficacy was established in one 6­ week trial in patients with schizophrenia . The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. See package insert for complete information.

See package insert for complete information.

Most common adverse reactions (≥5% and at least twice that for placebo) associated with: Oral Olanzapine Monotherapy:
• Schizophrenia (Adults) – postural hypotension, constipation, weight gain, dizziness, personality disorder, akathisia.
• Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.

• None with ZYPREXA monotherapy.
• When using ZYPREXA and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax®.
• When using ZYPREXA in combination with lithium or valproate, refer to the Contraindications section of the package inserts for those products.

• Elderly Patients with Dementia-Related Psychosis: Increased risk of death and increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack).
• Suicide: The possibility of a suicide attempt is inherent in schizophrenia and in bipolar I disorder, and close supervision of high-risk patients should accompany drug therapy; when using in combination with fluoxetine, also refer to the Boxed Warning and Warnings and Precautions sections of the package insert for Symbyax.
• Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring.
• Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain. See package insert for complete information.