FLUOROURACIL injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Fluorouracil (UNII: U3P01618RT) (Fluorouracil - UNII:U3P01618RT)

Disponibil de la:

BluePoint Laboratories

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 by intraperitoneal injection

Rezumat produs:

Fluorouracil injection, USP is available in pharmacy bulk vials as follows: PHARMACY BULK PACKAGES 50mL bulk vials are packaged 1 vial per shelf pack with NDC 68001-266-27 Note: Although Fluorouracil solution may discolor slightly during storage, the potency and safety are not adversely affected. Also available as follows: 10ml vials are packaged 10 vials per shelf pack with NDC 68001-266-30 20ml vials are packaged 10 vials per shelf pack with NDC 68001-266-31 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)] . 

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

FLUOROURACIL- FLUOROURACIL INJECTION, SOLUTION
BLUEPOINT LABORATORIES
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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
INJE C TIO N.
FLUOROURACIL INJECTION, FOR INTRAVENOUS USE PHARMACY BULK PACKAGE -
NOT FOR DIRECT INFUSION
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
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DOSAGE FORMS AND STRENGTHS
Injection: 2.5 g in a 50 mL vial in pharmacy bulk package (3)
Injection: 5 g in a 100 mL vial in 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. No fluorouracil dose has been proven safe in patients with
absent DPD activity. (5.1)
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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
appropria