Olanzapine API

Mechanism of Action

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.

Indication

ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:

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.
• Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance 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 evaluation 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 evaluated.

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 disorder.
• Efficacy was established with Symbyax (olanzapine and fluoxetine in combination); refer to the product label for Symbyax.
• Treatment of treatment resistant depression.
• Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.