ZYPREXA SUMMARY
ZYPREXA (olanzapine) is a psychotropic agent that belongs to the thienobenzodiazepine class.
ZYPREXA is indicated for the following:
SCHIZOPHRENIA
Oral ZYPREXA is indicated for the treatment of schizophrenia.
The efficacy of ZYPREXA was established in short-term (6-week) controlled trials of schizophrenic inpatients (see CLINICAL PHARMACOLOGY).
The effectiveness of oral ZYPREXA at maintaining a treatment response in schizophrenic patients who had been stable on ZYPREXA for approximately 8 weeks and were then followed for a period of up to 8 months has been demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use ZYPREXA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
BIPOLAR DISORDER
Acute Monotherapy
-- Oral ZYPREXA is indicated for the treatment of acute mixed or manic episodes associated with Bipolar I Disorder.
The efficacy of ZYPREXA was established in two placebo-controlled trials (one 3-week and one 4-week) with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features (see CLINICAL PHARMACOLOGY).
Maintenance Monotherapy
-- The benefit of maintaining bipolar patients on monotherapy with oral ZYPREXA after achieving a responder status for an average duration of two weeks was demonstrated in a controlled trial (see Clinical Efficacy Data under CLINICAL PHARMACOLOGY). The physician who elects to use ZYPREXA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
Combination Therapy
-- The combination of oral ZYPREXA with lithium or valproate is indicated for the short-term treatment of acute manic episodes associated with Bipolar I Disorder.
The efficacy of ZYPREXA in combination with lithium or valproate was established in two placebo-controlled (6-week) trials with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features (see CLINICAL PHARMACOLOGY).
AGITATION ASSOCIATED WITH SCHIZOPHRENIA AND BIPOLAR I MANIA
ZYPREXA IntraMuscular is indicated for the treatment of agitation associated with schizophrenia and bipolar I 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.
The efficacy of ZYPREXA IntraMuscular for the treatment of agitation associated with schizophrenia and bipolar I mania was established in 3 short-term (24 hours) placebo-controlled trials in agitated inpatients with schizophrenia or Bipolar I Disorder (manic or mixed episodes) (see CLINICAL PHARMACOLOGY).
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