1 INDICATIONS AND USAGE
1.1 SchizophreniaOral ZYPREXA is indicated for acute and maintenance treatment of
Schizophrenia in adults.
1.2 Bipolar I Disorder (Manic or Mixed
Episodes)
Monotherapy
Oral ZYPREXA is
indicated for acute treatment of manic or mixed episodes associated with
BipolarI Disorder (monotherapy and in combination with lithium or valproate)
and maintenance treatment of BipolarI Disorder (monotherapy) in adults.
Combination Therapy
The
combination of oral ZYPREXA with lithium or valproate is indicated for the
short-term treatment of acute manic or mixed episodes associated with BipolarI
Disorder in adults [see Clinical Studies (14.2)].
1.3 ZYPREXA IntraMuscular: Agitation Associated with
Schizophrenia and BipolarI ManiaZYPREXA IntraMuscular is indicated for the treatment of acute
agitation associated with Schizophrenia and BipolarI Mania. Psychomotor
agitation is defined in DSM-IV as excessive motor activity associated with a
feeling of inner tension. Patients experiencing agitation often manifest
behaviors that interfere with their diagnosis and care, e.g., threatening
behaviors, escalating or urgently distressing behavior, or self-exhausting
behavior, leading clinicians to the use of intramuscular antipsychotic
medications to achieve immediate control of the agitation [see Clinical Studies (14.3)].
1.4 ZYPREXA and Fluoxetine in Combination: Depressive
Episodes Associated with BipolarI Disorder
When using ZYPREXA and
fluoxetine in combination, also refer to the Clinical Studies section of the
package insert for Symbyax.
Oral ZYPREXA and fluoxetine in
combination is indicated for the acute treatment of depressive episodes
associated with BipolarI Disorder in adult patients.
ZYPREXA monotherapy is not
indicated for the treatment of depressive episodes associated with BipolarI
Disorder.
1.5 ZYPREXA and Fluoxetine in Combination: Treatment
Resistant Depression
When using ZYPREXA and
fluoxetine in combination, also refer to the Indications and Usage section of
the package insert for Symbyax.
Oral ZYPREXA and fluoxetine in
combination is indicated for the acute treatment of treatment resistant
depression (Major Depressive Disorder in adult patients who do not respond to 2
separate trials of different antidepressants of adequate dose and duration in
the current episode).
ZYPREXA monotherapy is not
indicated for the treatment of treatment resistant depression.
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 evaluation 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
evaluated.
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.