FLUOROURACIL injection, solution

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Xiromed LLC

Կառավարման երթուղին:

INTRAVENOUS

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 b

Ապրանքի ամփոփագիր:

Fluorouracil injection USP is supplied in single dose vial available in a box containing ten vials, as listed below: 10 mL vials are packaged 10 vials per shelf pack with NDC 70700-186-23 20 mL vials are packaged 10 vials per shelf pack with NDC 70700-187-23 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not Freeze. 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)] .

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

FLUOROURACIL- FLUOROURACIL INJECTION, SOLUTION
XIROMED 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
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)
DOSAGE FORMS AND STRENGTHS
Injection: 500 mg in a 10 mL vial in Single dose vial (3)
1 g in a 20 mL vial in Single dose vial (3)
CONTRAINDICATIONS
None (4) (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: Altere