FLUOROURACIL cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

fluorouracil (UNII: U3P01618RT) (fluorouracil - UNII:U3P01618RT)

Tilgjengelig fra:

Spear Dermatology Products Inc

INN (International Name):

fluorouracil

Sammensetning:

fluorouracil 5 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Fluououracil cream 0.5% is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp. Fluorouracil may cause fetal harm when administered to a pregnant woman. Fluorouracil is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. No adequate and well-controlled studies have been conducted in pregnant women with either topical or parenteral forms of fluorouracil. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when fluorouracil was applied to mucous membrane areas. Multiple birth defects have been reported in the fetus of a patient treated with intravenous fluorouracil. Animal reproduction studies have not been conducted with fluorouracil cream 0.5%. Fluorouracil, the active ingredient, has been shown to be teratogenic in mice, rats, and hamsters when adm

Produkt oppsummering:

Cream - 30 gram tube NDC 66530-258-30 Store at Controlled Room Temperature 20 to 25° C (68 to 77° F) [see USP]. Keep out of the reach of children.

Autorisasjon status:

New Drug Application Authorized Generic

Preparatomtale

FLUOROURACIL- FLUOROURACIL CREAM
SPEAR DERMATOLOGY PRODUCTS INC
----------
FLUOROURACIL CREAM, 0.5%
FOR TOPICAL DERMATOLOGICAL USE ONLY (NOT FOR OPHTHALMIC, ORAL, OR
INTRAVAGINAL USE)
DESCRIPTION
Fluorouracil cream 0.5%, 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 contains 0.5% fluorouracil, with 0.35% being
incorporated into a patented porous
microsphere (Microsponge
) composed of methyl methacrylate/glycol dimethacrylate crosspolymer
and dimethicone. The cream formulation contains the following other
inactive ingredients: Carbomer
Homopolymer Type C, 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 0.5% and 10 treated with Efudex
5% Cream. Patie