【警告】
低或不存在二嘧啶脱氢酶活性患者严重或致命不良反应的风险增加：患有急性早孕或异常严重毒性的患者停用或永久停用氟尿嘧啶，这可能表明双嘧啶脱氢酶几乎完全或完全缺失（ DPD）活动。 在没有DPD活性的患者中，没有证明氟尿嘧啶剂量是安全的。（5.1）
心脏毒性：氟尿嘧啶可引起心脏毒性，包括心绞痛，心肌梗塞/缺血，心律失常和心力衰竭。 保留氟尿嘧啶用于心脏毒性。（5.2）
高氨血症性脑病：氟尿嘧啶开始后72小时内可发生改变的心理状态，精神错乱，定向障碍，昏迷或共济失调，血氨水平升高。 扣留氟尿嘧啶并开始氨化治疗。（5.3）
【INDICATIONS AND USAGE】
Adrucil (fluorouracil injection) is a nucleoside metabolic inhibitor indicated for the treatment of patients with
---Adenocarcinoma of the Colon and Rectum (1.1)
---Adenocarcinoma of the Breast (1.2)
---Gastric Adenocarcinoma (1.3)
---Pancreatic Adenocarcinoma (1.4)
【DOSAGE AND ADMINISTRATION】
Adrucil is recommended for administration either as an intravenous bolus or as an intravenous infusion. (2.1)
See Full Prescribing Information for dose individualization (2.1) and dose modifications due to adverse reactions (2.6)
See Full Prescribing Information for recommended doses of fluorouracil for adenocarcinoma of the colon and rectum (2.2) and for recommended doses of fluorouracil as a component of a chemotherapy regimen for adenocarcinoma of the breast (2.3), gastric adenocarcinoma (2.4), pancreatic adenocarcinoma (2.5)
Prepare dose in a Pharmacy Admixture Service under appropriate conditions for cytotoxic drugs. (2.7)
【WARNINGS AND PRECAUTIONS】
Increased Risk of Serious or Fatal Adverse Reactions in Patients with Low or Absent Dipyrimidine Dehydrogenase Activity: Withhold or permanently discontinue fluorouracil in patients with evidence of acute earlyonset or unusually severe toxicity, which may indicate near complete or total absence of dipyrimidine dehydrogenase (DPD) activity. No fluorouracil dose has been proven safe in patients with absent DPD activity. (5.1)
Cardiotoxicity: Fluorouracil can cause cardiotoxicity, including angina, myocardial infarction/ischemia, arrhythmia, and heart failure. Withhold fluorouracil for cardiac toxicity. (5.2)
Hyperammonemic Encephalopathy: Altered mentalstatus, confusion, disorientation, coma, or ataxia with elevated serum ammonia level can occur within 72 hours of initiation of fluorouracil. Withhold fluorouracil and initiate ammonialowering therapy. (5.3)
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