FDA 블랙박스 경고: TRAZODONE HYDROCHLORIDE

블랙박스 경고

Trazodone Hydrochloride (TRAZODONE HYDROCHLORIDE) — AvKARE

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . Trazodone hydrochloride tablets are not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ) Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) Trazodone is not approved for use in pediatric patients ( 8.4 )

약물 상호작용

7 DRUG INTERACTIONS CNS Depressants: Trazodone hydrochloride tablets may enhance effects of alcohol, barbiturates, or other CNS depressants ( 7 ). CYP3A4 Inhibitors: Consider trazodone hydrochloride tablets dose reduction based on tolerability ( 2.5 , 7 ). CYP3A4 Inducers: Increase in trazodone hydrochloride tablets dosage may be necessary ( 2.5 , 7 ). Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels ( 7 ). Warfarin: Monitor for increased or decreased prothrombin tim

주의사항

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