FLUOROURACIL injection, solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Accord Healthcare, Inc.

DCI (Dénomination commune internationale):

FLUOROURACIL

Composition:

FLUOROURACIL 50 mg in 1 mL

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Fluorouracil injection USP is a colorless to faint yellow, aqueous solution supplied in single dose vial available in a box containing ten vials, as listed below: NDC 16729-276-03 : one vial containing 500 mg/10 mL (50 mg/mL) fluorouracil NDC 16729-276-68 : one box with ten vials, containing 500 mg/10 mL (50 mg/mL) fluorouracil NDC 16729-276-05 : one vial containing 1 g/20 mL (50 mg/mL) fluorouracil NDC 16729-276-67 : one box with ten vials, containing 1 g/20 mL (50 mg/mL) fluorouracil Note: Although Fluorouracil solution may discolor slightly during storage, the potency and safety are not adversely affected. Also available as follows: Pharmacy Bulk packages NDC 16729-276-11 : one box with one vial, containing 2.5 g/50 mL (50 mg/mL) fluorouracil NDC 16729-276-38 : one box with one vial, containing 5 g/100 mL (50 mg/mL) fluorouracil 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)] .  

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

FLUOROURACIL- FLUOROURACIL INJECTION, SOLUTION
ACCORD HEALTHCARE, INC.
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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 ONLY
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
Injection: 500 mg in a 10 mL vial in Single dose vial ( 3)
Injection: 1 g in a 20 mL vial in Single dose 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 dehydroge