FDA 블랙박스 경고: QUETIAPINE FUMARATE

블랙박스 경고

Quetiapine fumarate (QUETIAPINE FUMARATE) — REMEDYREPACK INC.

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 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 ) 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

약물 상호작용

7 DRUG INTERACTIONS Concomitant Use of Strong CYP3A4 Inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g. ketoconazole, ritonavir) ( 7.1 , 12.3 ) Concomitant Use of Strong CYP3A4 Inducers: Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7 to 14 days) of potent CYP3A4 inducers (e.g. phenytoin, rifampin, St. John's wort) ( 2.6 , 7.1 , 12.3 ) Discontinuation of Strong CYP3A4 Inducers: Reduce quetia

주의사항

이 정보는 FDA 공공 데이터를 기반으로 하며, 의사/약사의 전문적 판단을 대체하지 않습니다.