Increased risk of death in elderly patients w/ dementia-related psychosis. Not approved for the treatment of patients w/ dementia-related psychosis. Increased incidence of cerebrovascular adverse reactions (eg, stroke, transient ischemic attack) including fatalities. NMS, tardive dyskinesia. Patients diagnosed w/ DM should be monitored regularly for worsening of glucose control; patients w/ risk factors for DM (eg, obesity, family history of diabetes); dyslipidemia. Monitor wt regularly. Intense urges, particularly for gambling & the inability to control urges while on therapy; orthostatic hypotension; risk factors for leukopenia/neutropenia including pre-existing low WBC/ANC & history of drug-induced leukopenia/neutropenia. Perform CBC frequently in patients w/ history of a clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia. Complete fall risk assessments when initiating treatment & recurrently for patients on long-term therapy. Patients w/ a history of seizures or w/ conditions that lower the seizure threshold; conditions which may contribute to an elevation in core body temp (eg, exercising strenuously, exposure to extreme heat, receiving concomitant medication w/ anticholinergic activity or being subject to dehydration); at risk for aspiration pneumonia. May impair judgment, thinking, or motor skills; thus, avoid operating hazardous machinery, including automobiles. Pregnancy & lactation. Childn <18 yr. Elderly.
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