Increased mortality & incidence of cerebrovascular adverse reactions (eg, stroke, transient ischemic attack) in elderly patients w/ dementia-related psychosis. Not approved for treatment of patients w/ dementia-related psychosis. Risk of NMS; tardive dyskinesia; metabolic changes eg, hyperglycemia/DM, dyslipidemia, wt gain; orthostatic hypotension; leukopenia, neutropenia, agranulocytosis; esophageal dysmotility & aspiration; pathological gambling & other compulsive behaviours; somnolence, postural hypotension, motor & sensory instability leading to falls. Use cautiously in patients w/ history of seizures or w/ conditions that lower the seizure threshold. Disruption of body's ability to reduce core body temp. May impair judgment, thinking, or motor skills. Concomitant use w/ CYP2D6 inhibitors &/or CYP3A4 inhibitors/inducers. CYP2D6 poor metabolizers. Pregnancy & lactation. Elderly. Has not been studied in childn ≤18 yr.
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