WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [ see Warnings and Precautions (5.1) ]. Quetiapine is not approved for the treatment of patients with dementia-related psychosis [ see Warnings and Precautions (5.1) ]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [ see Warnings and Precautions (5.2) ]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [ see Warnings and Precautions (5.2) ]. Quetiapine is not approved for use in pediatric patients under ten years of age [ see Use in Specific Populations (8.4) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning . Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Quetiapine tablets is not approved for elderly patients with dementia-related psychosis ( 5.1 ) Suicidal Thoughts and Behaviors Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants ( 5.2 ) Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.2 )
Adult Dosing
General dosing
DOSAGE & ADMINISTRATION · Quetiapine tablets, USP can be taken with or without food Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia-Adults 25 mg twice daily 150 to 750 mg/day 750 mg/day Schizophrenia-Adolescents (13 to 17 years) 25 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania- Adults Monotherapy or as an adjunct to lithium or divalproex 50 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania- Children and Adolescents (10 to 17 years), Monotherapy 25 mg twice daily 400 to 600 mg/day 600 mg/day Bipolar Depression-Adults 50 mg once daily at bedtime 300 mg/day 300 mg/day Geriatric Use: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly ( 2.3 , 8.5 ) Hepatic Impairment: Lower starting dose (25 mg/day) and slower titration may be needed ( 2.4 , 8.7 , 12.3 ) 2.1 Important Administration Instructions Quetiapine tablets, USP can be taken with or without food. 2.2 Recommended Dosing The recommended initial dose, titration, dose range and maximum quetiapine dose for each approved indication is displayed in Table 1.
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