1 INDICATIONS AND USAGE
Olanzapine is an atypical antipsychotic indicated:
As oral formulation for the:
Treatment of schizophrenia. ( )
1.1
Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( )
14.1
Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( )
1.2
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. ( )
14.2
Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( )
1.2
Efficacy was established in two 6-week clinical trials in adults ( ). Maintenance efficacy has not been systematically evaluated.
14.2
As Olanzapine and Fluoxetine in Combination for the:
Treatment of depressive episodes associated with bipolar I disorder. ( )
1.5
Efficacy was established with Symbyax* (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax*.
1.1 Schizophrenia
olanzapine is indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial
deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents .
Oral
[see Clinical Studies ( )]
14.1
.
When
[see Warnings and Precautions ( , )]
5.5
5.6
describing the use of olanzapine orally disintegrating tablets in pediatric patients with schizophrenia is approved for Eli Lilly and Companys olanzapine drug product labeling. However, due to Eli Lilly and Companys marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Information
1.2 Bipolar I Disorder (Manic or Mixed Episodes)
Oral olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Efficacy was established in three clinical trials in adult patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one monotherapy maintenance trial
deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents .
Oral olanzapine is indicated for the treatment of manic or mixed episodes associated with bipolar I disorder as an adjunct to lithium or valproate. Efficacy was established in two 6-week clinical trials in adults. The effectiveness of adjunctive therapy for longer-term use has not been systematically evaluated in controlled trials .
Monotherapy
[see Clinical Studies ( )]
14.2
.
When
[see
Warnings and Precautions ( , )]
5.5
5.6
describing the use of olanzapine orally disintegrating tablets in pediatric patients with bipolar 1 disorder is approved for Eli Lilly and Companys olanzapine drug product labeling. However, due to Eli Lilly and Companys marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Information
Therapy to Lithium or Valproate
Adjunctive
[see Clinical Studies ( )]
14.2
1.3 Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder
on treating pediatric patients with schizophrenia and bipolar 1 disorder is approved for Eli Lilly and Companys olanzapine drug product labeling. However, due to Eli Lilly and Companys marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Information
1.5 Olanzapine and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder
Oral olanzapine and fluoxetine in combination is indicated for the treatment of depressive episodes associated with bipolar I disorder, based on clinical studies in adult patients. When using olanzapine and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax*.
Olanzapine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.