1 INDICATIONS AND USAGE
Olanzapine Tablets, USP are 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 bipolarI disorder and maintenance treatment of bipolarI disorder. (1.2)
Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolarI 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 bipolarI disorder. (1.2)
Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.
As olanzapine tablets and fluoxetine in combination for the:
Treatment of depressive episodes associated with bipolarI 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 Tablets,USP are 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. [see Clinical Studies (14.1)].
When 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 [see Warnings and Precautions (5.5, 5.6)].
Information describing the use of olanzapine tablets and 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.
1.2 Bipolar I Disorder (Manic or Mixed Episodes)
Monotherapy
Olanzapine Tablets,USP are indicated for the acute treatment of manic or mixed episodes associated with bipolarI disorder and maintenance treatment of bipolarI 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. [see Clinical Studies (14.2)].
When 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 [see Warnings and Precautions (5.5, 5.6)].
Information describing the use of olanzapine tablets and olanzapine orally disintegrating tablets in pediatric patients with bipolar I 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.
Adjunctive Therapy to Lithium or Valproate
Olanzapine Tablets,USP are indicated for the treatment of manic or mixed episodes associated with bipolarI 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 [see Clinical Studies (14.2)].
1.3 Special Considerations in Treating Pediatric Schizophrenia and BipolarI Disorder
Information on treating pediatric patients with schizophrenia and bipolar I 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.
1.5 Olanzapine tablets and Fluoxetine in Combination: Depressive Episodes Associated with BipolarI Disorder
Olanzapine tablets and fluoxetine in combination is indicated for the treatment of depressive episodes associated with bipolarI disorder, based on clinical studies in adult patients. When using olanzapine tablets and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax.
Olanzapine tablets monotherapy is not indicated for the treatment of depressive episodes associated with bipolarI disorder.