FLUOROURACIL INJECTION USP SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

FLUOROURACIL

Commercializzato da:

PFIZER CANADA ULC

Codice ATC:

L01BC02

INN (Nome Internazionale):

FLUOROURACIL

Dosaggio:

50MG

Forma farmaceutica:

SOLUTION

Composizione:

FLUOROURACIL 50MG

Via di somministrazione:

INTRAVENOUS

Confezione:

100ML

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0107505001; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2020-11-27

Scheda tecnica

PRODUCT MONOGRAPH
PR
FLUOROURACIL INJECTION USP
50 MG/ML
(5 g/100 mL)
Antineoplastic Agent
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Control #227813
Date of Revision:
August 7, 2019
_Product Monograph - _
_Pr_
_Fluorouracil Injection USP _
_Page 2 of 21_
PRODUCT MONOGRAPH
PR
FLUOROURACIL INJECTION USP
50 MG/ML
(5 g/100 mL)
Antineoplastic agent
CAUTION
FLUOROURACIL IS A POTENT DRUG AND SHOULD BE ADMINISTERED BY, OR
UNDER SUPERVISION OF A PHYSICIAN, WHO IS EXPERIENCED IN CANCER
CHEMOTHERAPY.
ACTIONS AND CLINICAL PHARMACOLOGY
There appears to be two mechanisms of action of fluorouracil which
result in cytotoxic effects.
One
is
the
competitive
inhibition
of
thymidylate
synthetase,
the
enzyme
catalyzing
the
methylation of deoxyuridylic acid to thymidylic acid. The consequent
thymidine deficiency
results in inhibition of deoxyribonucleic acid (DNA) synthesis, thus
inducing cell death. A
second mechanism of action is evidenced by the moderate inhibition of
ribonucleic acid (RNA)
and incorporation of fluorouracil into RNA. The predominant mechanism
of antitumour action
appears to be dependent, at least in part, on individual tumour
intracellular metabolism.
The effects of DNA and RNA deprivation are most significant on those
cells which are most
rapidly proliferating.
Following intravenous injection, fluorouracil is cleared rapidly from
the plasma (half-life about
10 to 20 minutes), and distributed throughout body tissues including
the cerebrospinal fluid and
malignant effusions, exhibiting a volume of distribution equivalent to
the total body water.
Plasma concentrations fall below measurable levels within 3 hours.
Oral administration of
fluorouracil has shown marked variability in its bioavailability, from
28% to 100%. Constant
intravenous infusion for 96 hours showed constant plasma drug levels
and significantly less drug
(50- to 1000-fold) in the bone marrow.
Fluorouracil is converted to active nucleotide metabolites,
5-fluorouridine monophosphate and
5-fluorodeoxyuridylate within the tar