Increased mortality in elderly patients w/ dementia-related psychosis. Increased incidence of cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities. May worsen depression &/or emergence of suicidal ideation & behaviour or unusual changes in behaviour in patients w/ major depressive disorder. Patient w/ depressive symptoms should be adequately screened for bipolar disorder prior to initiating treatment w/ antidepressants. Neuroleptic malignant syndrome. Consider discontinuation if signs & symptoms of tardive dyskinesia appear. Identify all possible risk factors for venous thromboembolism before & during treatment. Hyperglycemia & DM (monitor patient for worsening of glucose control). Wt gain. Patients w/ known CV disease (history of MI or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease or conditions which would predispose patients to hypotension (dehydration, hypovolemia & treatment w/ antihypertensives). Perform a complete blood count & monitor patients w/ history of clinically significant low WBC/ANC or drug-induced leukopenia/neutropenia during the 1st few mth of therapy. Discontinue in patients w/ severe neutropenia (ANC <1,000/mm3
). Pathological gambling & other compulsive behaviours. History of seizures or those w/ a lowered seizure threshold. Patients who will be experiencing conditions which may contribute to an elevation in core body temp & those at risk for aspiration pneumonia. Dysphagia. Close supervision of high-risk suicidal patients. Avoid overheating & dehydration. Patients w/ sleep apnoea or risk factors for developing sleep apnoea. May affect ability to drive or operate machinery. Pregnancy & lactation. Not approved for use in treating depression in paed population. Not approved for treatment in patients w/ psychosis associated w/ Alzheimer's disease.