In patients with a manic or mixed episode of bipolar disorder, olanzapine demonstrated superior efficacy to placebo and valproate semisodium divalproex in reduction of manic symptoms over 3 weeks.
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The stated frequencies of adverse reactions represent the proportion of individuals who experiencedat least oncea treatment-emergent adverse reaction of the type listedA reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluationThe reported reactions do not include those reaction terms that were so general as to be uninformativeReactions listed elsewhere in labeling may not be repeated belowIt is important to emphasize thatalthough the reactions occurred during treatment with olanzapinethey were not necessarily caused by itThe entire label should be read to gain a complete understanding of the safety profile of olanzapine.
Cerebrovascular effects includingstroke and transient ischemic attack resulting in death reported.
Olanzapine can be given without regards for meals as absorption is not affected by foodGradual tapering of the dose should be considered when discontinuing olanzapine.
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the clinical consequences are likely to be limited, but clinical monitoring is recommended and an increase of olanzapine dose may be considered if necessary see section 4.