Increased risk of death & higher incidence of cerebrovascular adverse reactions in elderly patients w/ dementia-related psychosis. Not approved for the treatment of patients w/ dementia-related psychosis. Increased risk of suicidal thoughts & behavior in ped & young adults. Monitor patients for clinical worsening & emergence of suicidal thoughts & behaviors, especially during the initial few mth of drug therapy & at times of dosage changes. Reports of neuroleptic malignant syndrome; immediately discontinue treatment if suspected. Tardive dyskinesia can develop; consider drug discontinuation if signs & symptoms appear. Associated w/ metabolic changes, including hyperglycemia, dyslipidemia, & body wt gain. Patients w/ an established diagnosis of DM should be monitored regularly for worsening of glucose control. Patients w/ risk factors for DM (eg, obesity, family history of diabetes) should undergo fasting blood glucose testing at the beginning of & periodically during treatment. Elevation of prolactin levels (hyperprolactinemia). Reports of leukopenia/neutropenia during treatment. Patients w/ a pre-existing low WBC or a history of drug-induced leukopenia/neutropenia should have their CBC monitored frequently during the 1st few mth of therapy; discontinue treatment at the 1st sign of decline in WBC in the absence of other causative factors. May cause orthostatic hypotension & syncope. May cause somnolence, postural hypotension, motor & sensory instability, leading to falls &, consequently, fractures or other injuries. Use w/ caution in patients w/ a history of seizures or w/ conditions that lower the seizure threshold eg, Alzheimer's dementia. Disruption of body's ability to reduce core body temp. Can increase the risk of developing a manic or hypomanic episode, particularly in patients w/ bipolar disorder. Associated w/ esophageal dysmotility & aspiration. Use w/ caution in patients at risk for aspiration pneumonia. Increased sensitivity to antipsychotic medication in patients w/ Parkinson's disease or dementia w/ Lewy bodies. Caution w/ concomitant use of moderate CYP3A4 inhibitors or inducers. Avoid grapefruit & grapefruit juice. Carefully evaluate patients for history of drug abuse; observe carefully for signs of Latuda misuse or abuse. Potential to impair judgment, thinking or motor skills. Patients w/ moderate or severe renal or hepatic impairment. Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal &/or w/drawal symptoms following delivery. Pregnancy & lactation.
20-mg tab No established efficacy in the treatment of mania associated w/ bipolar disorder.
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