FLUOROURACIL injection solution

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Pfizer Laboratories Div Pfizer Inc.

INN (Medzinárodný Name):

FLUOROURACIL

Zloženie:

FLUOROURACIL 50 mg in 1 mL

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

FLUOROURACIL- FLUOROURACIL INJECTION, SOLUTION
PFIZER LABORATORIES DIV PFIZER INC.
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FLUOROURACIL INJECTION, USP
Rx Only
BOXED WARNING
It is recommended that Fluorouracil Injection be given only by or
under the supervision of a
qualified physician who is experienced in cancer chemotherapy and who
is well versed in the use
of potent anti-metabolites. Because of the possibility of severe toxic
reactions, it is recommended
that patients be hospitalized at least during the initial course of
therapy. These instructions should
be thoroughly reviewed before administration of Fluorouracil
Injection, USP
DESCRIPTION
Fluorouracil Injection, USP, an antineoplastic anti-metabolite, is a
colorless to yellow aqueous sterile,
nonpyrogenic injectable solution for intravenous administration. Each
mL contains: 50 mg fluorouracil;
pH is adjusted to 8.6 to 9.4 with sodium hydroxide.
Chemically, fluorouracil, a fluorinated pyrimidine, is 5-fluoro-2, 4
(1_H_, 3_H_)-pyrimidinedione. It is a
white to practically white crystalline powder which is sparingly
soluble in water. The molecular
weight of fluorouracil is 130.08 and the structural formula is:
C H FN O
CLINICAL PHARMACOLOGY
There is evidence that the metabolism of fluorouracil in the anabolic
pathway blocks the methylation
reaction of deoxyuridylic acid to thymidylic acid. In this manner,
fluorouracil interferes with the
synthesis of deoxyribonucleic acid (DNA) and to a lesser extent
inhibits the formation of ribonucleic
acid (RNA). Since DNA and RNA are essential to cell division and
growth, the effect of fluorouracil
may be to create a thymine deficiency which provokes unbalanced growth
and death of the cell. The
effects of DNA and RNA deprivation are most marked on those cells
which grow more rapidly and
which take up fluorouracil at a more rapid rate.
Following intravenous injection, fluorouracil distributes into tumors,
intestinal mucosa, bone marrow,
liver and other tissues throughout the body. In spite of its limited
lipid solubility, fluorouracil diffuses
readily