INDICATIONS AND USAGE Schizophrenia 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 ? 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 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). | ||||
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