FLUOROURACIL cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

FLUOROURACIL

Composition:

FLUOROURACIL 50 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluorouracil Cream 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 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 birth defec

Product summary:

Fluorouracil Cream, USP 5% is available in 40-gm tubes (NDC 21695-829-40) containing 5% fluorouracil in a vanishing cream base consisting of purified water, white petrolatum, cetyl alcohol, stearyl alcohol, propylene glycol, polysorbate 60 and parabens (methyl and propyl). Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature]. Manufactured by: CCI Rockledge, FL 32955 Distributed by: Spear Dermatology Products Randolph, NJ 07869 SP15FU4R2 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOROURACIL- FLUOROURACIL CREAM
REBEL DISTRIBUTORS CORP
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FLUOROURACIL
DESCRIPTION
Fluorouracil Cream, USP 5% is a topical preparation containing the
fluorinated pyrimidine 5-
fluorouracil, an antineoplastic antimetabolite.
Fluorouracil Cream contains 5% fluorouracil in a vanishing cream base
consisting of purified water,
white petrolatum, cetyl alcohol, stearyl alcohol, propylene glycol,
polysorbate 60 and parabens (methyl
and propyl).
Chemically, fluorouracil 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 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 (eg, CO , urea, α-fluoro-β-alanine) which are inactive.
Systemic absorption studies of topically applied fluorouracil have
been performed on 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
for measurement. One gram of
labeled preparation was applied to the entire face and neck and lef