FLUOROURACIL injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

FLUOROURACIL (UNII: U3P01618RT) (FLUOROURACIL - UNII:U3P01618RT)

Sẵn có từ:

Ingenus Pharmaceuticals, LLC

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Fluorouracil is indicated for the treatment of patients with: None. Pregnancy Category D Risk Summary There are no adequate and well-controlled studies with fluorouracil in pregnant women. Based on its mechanism of action, fluorouracil can cause fetal harm when administered to a pregnant woman. Administration of fluorouracil to rats and mice during selected periods of organogenesis, at doses lower than a human dose of 12 mg/kg, caused embryolethality and teratogenicity. Malformations included cleft palate and skeletal defects. In monkeys, maternal doses of fluorouracil higher than an approximate human dose of 12 mg/kg resulted in abortion. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus [see Clinical Pharmacology (12.1)]. Animal Data Malformations including cleft palate, skeletal defects and deformed appendages (paws and tails) were observed when fluorouracil was administered by intraperitoneal injection t

Tóm tắt sản phẩm:

Fluorouracil injection, USP is available in two pharmacy bulk vials as follows: The 50 mL and 100 mL pharmacy bulk packages are packaged 1 vial per carton. Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. Fluorouracil is a cytotoxic drug. Follow applicable special handling and disposable procedures [see References (15)] .

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

FLUOROURACIL- FLUOROURACIL INJECTION, SOLUTION
INGENUS PHARMACEUTICALS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUOROURACIL INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUOROURACIL
INJECTION
FLUOROURACIL INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL:1962
RECENT MAJOR CHANGES
Dosage and Administration (2) 07/2016
INDICATIONS AND USAGE
Fluorouracil 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
Fluorouracil 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)
Pharmacy Bulk Package: Prepare doses for more than one patient in a
Pharmacy Admixture Service under appropriate
conditions for cytotoxic drugs. Do not inject entire contents of vial
directly into patients. Use within 4 hours of puncture
(2.7, 2.8)
DOSAGE FORMS AND STRENGTHS
Inje ction:
2.5 g in a 50 mL vial in a pharmacy bulk package
5 g in a 100 mL vial in a pharmacy bulk package (3)
CONTRAINDICATIONS
None (4)
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 early-
onset or unusually severe toxicity, which may indicate near complete
or total absence of dipyrimidine dehydrogenase
(DPD) activity. No fluoroura