Vraylar

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor for clinical worsening or behavior changes in all patients. Discontinue immediately if neuroleptic malignant syndrome is suspected; treat appropriately. Tardive dyskinesia. Diabetes. Monitor for hyperglycemia, hyperlipidemia; do fasting blood glucose and lipids testing initially and during therapy. Monitor for weight gain, extrapyramidal symptoms, akathisia; consider reducing dose or discontinuing. Pre-existing low WBC or ANC, or history of leukopenia/neutropenia; monitor CBCs during 1^st few months of treatment; discontinue if WBCs decline or ANC <1000/mm³. Hypovolemia. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Cardio- or cerebrovascular disease. Monitor HR and BP. History of seizures. Strenuous exercise. Exposure to extreme heat. Risk for aspiration. Reevaluate periodically. Severe hepatic or renal impairment: not recommended. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3^rd-trimester pregnancy). Pregnancy. Nursing mothers.

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor for clinical worsening or behavior changes in all patients. Discontinue immediately if neuroleptic malignant syndrome is suspected; treat appropriately. Tardive dyskinesia. Diabetes. Monitor for hyperglycemia, hyperlipidemia; do fasting blood glucose and lipids testing initially and during therapy. Monitor for weight gain, extrapyramidal symptoms, akathisia; consider reducing dose or discontinuing. Pre-existing low WBC or ANC, or history of leukopenia/neutropenia; monitor CBCs during 1^st few months of treatment; discontinue if WBCs decline or ANC <1000/mm³. Hypovolemia. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Cardio- or cerebrovascular disease. Monitor HR and BP. History of seizures. Strenuous exercise. Exposure to extreme heat. Risk for aspiration. Reevaluate periodically. Severe hepatic or renal impairment: not recommended. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3^rd-trimester pregnancy). Pregnancy. Nursing mothers.