Teva Pharmaceuticals USA
Product Description: ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).
Status: Ongoing
City: 霍舍姆
State: PA
Country: US
Voluntary/Mandated: Voluntary: Firm Initiated
最初公司Notification:
Distribution Pattern: Nationwide.
Classification: 课上我
Product Quantity: 6001 vials
召回原因: 颗粒物质的存在:发现漂浮在溶液中的硅酮橡胶和氟尿嘧啶晶体
召回启动日期: 20150724
Report Date: 20150902

Adrucil

Adrucil

Adrucil Recall

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Questions & Answers

副作用和不良反应

(see boxed WARNING)

THE DAILY DOSE OF ADRUCIL INJECTION IS NOT TO EXCEED 800 MG. IT IS RECOMMENDED THAT PATIENTS BE HOSPITALIZED DURING THEIR FIRST COURSE OF TREATMENT.

ADRUCIL should be used with extreme caution in poor risk patients with a history of high-dose pelvic irradiation or previous use of alkylating agents, those who have a widespread involvement of bone marrow by metastatic tumors or those with impaired hepatic or renal function.

Rarely, unexpected, severe toxicity (e.g., stomatitis, diarrhea, neutropenia and neurotoxicity) associated with 5-fluorouracil has been attributed to deficiency of dipyrimidine dehydrogenase activity. A few patients have been rechallenged with 5-fluorouracil and despite 5-fluorouracil dose lowering, toxicity recurred and progressed with worse morbidity. Absence of this catabolic enzyme appears to result in prolonged clearance of 5-fluorouracil.

怀孕
Teratogenic Effects
怀孕Category D

Fluorouracil may cause fetal harm when administered to a pregnant woman. Fluorouracil has been shown to be teratogenic in laboratory animals. Fluorouracil exhibited maximum teratogenicity when given to mice as single intraperitoneal injections of 10 to 40 mg/kg on day 10 or 12 of gestation. Similarly, intraperitoneal doses of 12 to 37 mg/kg given to rats between days 9 and 12 of gestation and intramuscular doses of 3 to 9 mg given to hamsters between days 8 and 11 of gestation were teratogenic. Malformations included cleft palates, skeletal defects and deformed appendages, paws and tails. The dosages which were teratogenic in animals are 1 to 3 times the maximum recommended human therapeutic dose. In monkeys, divided doses of 40 mg/kg given between days 20 and 24 of gestation were not teratogenic.

There are no adequate and well-controlled studies with fluorouracil in pregnant women. While there is no evidence of teratogenicity in humans due to fluorouracil, it should be kept in mind that other drugs which inhibit DNA synthesis (例如据报道,甲氨蝶呤和氨基酮蛋白在人类中是致畸的。应该建议育儿潜力的妇女,以避免怀孕。如果在妊娠期间使用药物,或者如果患者在服用药物的同时怀孕,则应讲述患者对胎儿的潜在危害。氟尿嘧啶只有在潜在利益对胎儿的潜在风险证明妊娠期时才会使用。

Combination Therapy

Any form of therapy which adds to the stress of the patient, interferes with nutrition or depresses bone marrow function will increase the toxicity of fluorouracil.

法律问题

There is currently no legal information available for this drug.

FDA安全警报

目前没有用于此药物的FDA安全警报。

制造商警告

目前还没有生产informa的警告tion available for this drug.

FDA标记更改

There are currently no FDA labeling changes available for this drug.

Uses

ADRUCIL Injection is effective in the palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas.

History

目前没有这种药物没有毒品历史。

Other Information

Adrucil®(氟尿嘧啶注射,USP)抗肿瘤抗体粘土,是静脉内施用的无菌,非膨动式可注射溶液。每10毫升含有500mg氟尿嘧啶;用氢氧化钠将pH调节至约9.2。

Chemically, fluorouracil, a fluorinated pyrimidine, is 5-fluoro-2,4 (1H,3H)-pyrimidinedione. It is a white to practically white crystalline powder which is sparingly soluble in water. The molecular weight of fluorouracil is 130.08 and the structural formula is:

Chemical Structure

分子式:C.4H3FN2O2

Adrucil Manufacturers


  • Teva肠外药品,Inc。
    Adrucil (Fluorouracil) Injection [Teva Parenteral Medicines, Inc.]
  • Teva肠外药品,Inc。
    Adrucil (Fluorouracil) Injection [Teva Parenteral Medicines, Inc.]

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