Increased mortality in elderly patients w/ dementia-related psychosis. Not for dementia-related psychosis. Suicidal thoughts & behaviors. Closely monitor high-risk patients for possible suicidal attempt. Cerebrovascular AR including stroke in elderly patients w/ dementia-related psychosis. Patients w/ known CV disease, family history of QT prolongation, electrolyte imbalance, or concomitant use w/ drugs that prolong QT interval; recent history of MI or unstable CV disease. Identify all possible risk factors for venous thromboembolism prior to & during treatment. Risk of NMS. Discontinue use if NMS is suspected; signs & symptoms of tardive dyskinesia appear; at the 1st sign of clinically significant decline in WBC in absence of other causative factors; in patients w/ ANC <1,000/mm
3. Metabolic changes including hyperglycemia, DM, dyslipidemia & body wt gain. Assess fasting plasma glucose prior or soon after the initiation of treatment & periodically monitor during long-term treatment. Regularly monitor for worsening of glucose control in patients w/ DM or risk for DM. Monitor fasting lipid profile & wt gain at baseline & periodically during treatment. Risk for pathological gambling & other compulsive behaviors. Carefully monitor patients w/ prior history of impulse-control disorders. Reduce dose or discontinue use if compulsive behaviors develops. Perform CBC frequently during the 1st few mth of therapy in patients w/ pre-existing low WBC/ANC or history of drug-induced leukopenia/neutropenia. Monitor patients w/ clinically significant neutropenia for fever or other symptoms or signs of infection & treat promptly if such symptoms or signs occur. Orthostatic hypotension & syncope. Monitor orthostatic vital signs in patients who are at risk for developing hypotension (eg, elderly, patients w/ dehydration, hypovolemia, treatment w/ antihypertensives), known CV disease including history of MI, ischemic heart disease, heart failure or conduction abnormalities, & cerebrovascular disease. May cause somnolence, postural hypotension, motor & sensory instability which may lead to falls & fractures or other injuries; seizures in patients w/ history or conditions that lower the seizure threshold. Perform complete fall risk assessments when initiating treatment & recurrently for patients on long-term therapy. May disrupt the body's ability to reduce core body temp. Patients on conditions that may contribute to 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. Dysphagia. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. CYP2D6 poor metabolizers. Minor to moderate influence on the ability to drive & use machines, impair judgement or thinking due to potential nervous system effects eg, sedation & dizziness. Hepatic & renal impairment. Pregnancy & lactation. Risk for extrapyramidal &/or w/drawal symptoms in neonates whose mothers are exposed to treatment during the 3rd trimester of pregnancy. Ped patients. Elderly ≥65 yr.
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