FLUOROURACIL injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Fresenius Kabi USA, LLC

INN (국제 이름):

FLUOROURACIL

구성:

FLUOROURACIL 50 mg in 1 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Fluorouracil is indicated for the treatment of patients with: • Adenocarcinoma of the Colon and Rectum • Adenocarcinoma of the Breast • Gastric Adenocarcinoma • Pancreatic Adenocarcinoma 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, skele

제품 요약:

Fluorouracil injection, USP is supplied as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. DO NOT FREEZE. Retain in carton until time of use. Fluorouracil injection, USP, is a cytotoxic drug. Follow applicable special handling and disposable procedures [see References (15)]. The container closure is not made with natural rubber latex.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

FLUOROURACIL- FLUOROURACIL INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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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
RX ONLY
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)
Adenocarcinoma of the Breast (1)
Gastric Adenocarcinoma (1)
Pancreatic Adenocarcinoma (1)
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)
DOSAGE FORMS AND STRENGTHS
Injection: 500 mg in a 10 mL vial, 1 g in a 20 mL vial (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 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: Alt