Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
FLUOROURACIL (UNII: U3P01618RT) (FLUOROURACIL - UNII:U3P01618RT)
BluePoint Laboratories
INTRAVENOUS
PRESCRIPTION DRUG
Fluorouracil is indicated for the treatment of patients with: 1.1Adenocarcinoma of the Colon and Rectum 1.2Adenocarcinoma of the Breast 1.3Gastric Adenocarcinoma 1.4Pancreatic 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)].
Fluorouracil injection USP is supplied in single dose vial available in a box containing ten vials, as listed below: •NDC 68001-524-28: Vial containing 500 mg/10 mL (50 mg/mL) fluorouracil •NDC 68001-524-29: Vial containing 1 g/20 mL (50 mg/mL) fluorouracil 10 mL vials are packaged 10 vials per shelf pack with NDC 68001-524-30 20 mL vials are packaged 10 vials per shelf pack with NDC 68001-524-31 16.2 Storage Store at 20°C to 25°C (68°F 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)].
Abbreviated New Drug Application
FLUOROURACIL- FLUOROURACIL INJECTION, SOLUTION BLUEPOINT LABORATORIES ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION HIGHLIGHTS OF PRESCRIBING INFORMATIONTHESE 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) (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) (2) 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) (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 Prečítajte si celý dokument