FLUOROURACIL injection, solution

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Fresenius Kabi USA, LLC

INN (Международно Name):

FLUOROURACIL

Композиция:

FLUOROURACIL 50 mg in 1 mL

Начин на приложение:

INTRAVENOUS

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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, skeletal

Каталог на резюме:

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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

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
PHARMACY BULK PACKAGE - NOT FOR DIRECT INFUSION
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)
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)
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
Injection: 2.5 g in a 50 mL vial and 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