FLUOROURACIL cream

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Spear Dermatology Products

INN (Algemene Internationale Benaming):

FLUOROURACIL

Samenstelling:

FLUOROURACIL 5 mg in 1 g

Prescription-type:

PRESCRIPTION DRUG

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FLUOROURACIL- FLUOROURACIL CREAM
SPEAR DERMATOLOGY PRODUCTS
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FLUOROURACIL CREAM USP, 0.5% (MICROSPHERE*)
FOR TOPICAL DERMATOLOGICAL USE ONLY
(NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE)
DESCRIPTION
Fluorouracil Cream USP, 0.5% (Microsphere), contains fluorouracil for
topical dermatologic use.
Chemically, fluorouracil is 5-fluoro-2,4(1H, 3H)-pyrimidinedione. The
molecular formula is
C H FN O . Fluorouracil has a molecular weight of 130.08.
*Fluorouracil Cream USP, 0.5% (Microsphere) contains 0.5%
fluorouracil, with 0.425% being
incorporated into a porous microsphere composed of methyl
methacrylate/glycol dimethacrylate
crosspolymer and dimethicone. The cream formulation contains the
following other inactive
ingredients: carbomer 980, dimethicone, glycerin, methyl gluceth-20,
methyl methacrylate/glycol
dimethacrylate crosspolymer, methylparaben, octyl hydroxy stearate,
polyethylene glycol 400,
polysorbate 80, propylene glycol, propylparaben, purified water,
sorbitan monooleate, stearic acid, and
trolamine.
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 for cell division and
growth, the effect of fluorouracil
may be to create a thymine deficiency that provokes unbalanced growth
and death of the cell. The
effects of DNA and RNA deprivation are most marked on those cells that
grow more rapidly and take up
fluorouracil at a more rapid rate. The contribution to efficacy or
safety of individual components of the
vehicle has not been established.
PHARMACOKINETICS :
A multiple-dose, randomized, open-label, parallel study was performed
in 21 patients with actinic
keratoses. Twenty patients had pharmacokinetic samples collected: 10
patients treated with Fluorouracil
Cream USP, 0.5% (Microsphere)