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ZYPREXA(olanzapine) tablet

2015-01-29 19:29:58 来源: 作者: 【大中小】浏览:313次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

See full prescribing information for complete boxed warning.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ZYPREXA is not approved for the treatment of patients with dementia-related psychosis. (5.1, 5.14, 17.2)
When using ZYPREXA and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.

INDICATIONS AND USAGE

ZYPREXA® (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)
- Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)
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)
- Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)
Medication therapy for pediatric patients with schizophrenia or bipolarI disorder should be undertaken only after a thorough diagnostic eva luation and with careful consideration of the potential risks. (1.3)
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 eva luated.

As ZYPREXA IntraMuscular for the:

Treatment of acute agitation associated with schizophrenia and bipolarI mania. (1.4)
- Efficacy was established in three 1-day trials in adults. (14.3)

As ZYPREXA 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.
Treatment of treatment resistant depression (major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). (1.6)
- Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.