Increased risk of death in elderly patients w/ dementia-related psychosis. Not approved for treatment of dementia-related psychosis. Discontinue treatment at 1st sign of decline in WBC, in absence of other causative factors; in patients w/ severe neutropenia (ANC <1,000/mm
3). Consider drug discontinuation if signs & symptoms of tardive dyskinesia appear. NMS characterized by hyperthermia, muscle rigidity, autonomic instability, altered consciousness & elevated serum creatine phosphokinase levels. Increased sensitivity to extrapyramidal effects, & association w/ irreversible cognitive decompensation or death in patients w/ Lewy body dementia or Parkinson's disease dementia. Leukopenia, neutropenia & agranulocytosis. Dyslipidemia. Wt gain. Regularly monitor patients w/ DM for worsening of glucose control. Elevation of prolactin levels (hyperprolactinemia). History of seizures or w/ conditions that lower seizure threshold, eg, Alzheimer's dementia. Patients w/ CV (eg, heart failure, history of MI, ischemia, or conduction abnormalities) & cerebrovascular disease, or predisposing conditions to hypotension (eg, dehydration, hypovolemia, & antihypertensive treatment). Frequently monitor CBC during the 1st few mth of therapy in patients w/ pre-existing low WBC or history of drug induced leukopenia/neutropenia. Carefully monitor & promptly treat fever or other symptoms or signs of infection in patients w/ neutropenia. Closely supervise high-risk patients w/ inherent psychotic illness for possible suicide attempts. Monitor wt; orthostatic vital signs in patients vulnerable to hypotension. Avoid grapefruit & grapefruit juice. Potential to impair judgment, thinking or motor skills. Neonates exposed to antipsychotics during the 3rd trimester of pregnancy are at risk for extrapyramidal &/or w/drawal symptoms following delivery. Pregnancy & lactation. Ped <13 yr. Elderly ≥65 yr.
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