FLUOROURACIL cream

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

NuCare Pharmaceuticals,Inc.

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Fluorouracil Cream USP is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil Cream USP is approximately 93%, based on 113 lesions in 54 patients. Eighty-eight lesions treated with the cream produced 7 failures. Fluorouracil cream may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. One bi

Resumen del producto:

Fluorouracil Cream USP is available in 40 g tubes containing 5% fluorouracil (NDC 68071-2961-4) . Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Preserve in tight containers.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

FLUOROURACIL- FLUOROURACIL CREAM
NUCARE PHARMACEUTICALS,INC.
----------
FLUOROURACIL CREAM USP 5%
TOPICAL CREAM
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC, ORAL,
OR INTRAVAGINAL USE
DESCRIPTION:
Fluorouracil Cream USP is topical preparations containing the
fluorinated pyrimidine 5-
fluorouracil, an antineoplastic antimetabolite.
Fluorouracil Cream USP contains 5% fluorouracil in a vanishing cream
base consisting of
methylparaben, polysorbate 60, propylene glycol, propylparaben,
purified water, stearyl
alcohol, and white petrolatum.
Chemically, fluorouracil is a 5-fluoro-2,4(1 _H_,3
_H_)-pyrimidinedione. It is a white to
practically white crystalline powder which is sparingly soluble in
water and slightly soluble
in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene
glycol. The
molecular weight of 5-fluorouracil is 130.08 and the structural
formula is:
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
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
take up
fluorouracil at a more rapid rate. The catabolic metabolism of
fluorouracil results in
degradation products (e.g., CO
, urea, α-fluoro-β-alanine) which are inactive.
Systemic absorption studies of topically applied fluorouracil have
been performed on
2
14
patients with actinic keratoses using tracer amounts of
C-labeled fluorouracil added to
a 5% preparation. All patients had been receiving nonlabeled
fluorouracil until the peak of
the inflammatory reaction occurred (2 to 3 weeks), ensuring that the
time of maximum
absorption was used