Drug Catalog - Product Detail
FLUOROURACIL CREAM 5% 40GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 51862-0362-40 | MAYNE PHARMA | 40 | 5% | CREAM |
PACKAGE FILES
Generic Name
FLUOROURACIL
Substance Name
FLUOROURACIL
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA077524
Description
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 white petrolatum, cetyl alcohol, stearyl alcohol, propylene glycol, polysorbate 60, parabens (methyl and propyl), and purified water. 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: Chemical Structure
How Supplied
HOW SUPPLIED Fluorouracil Cream, USP 5% is available in 40 g tubes containing 5% fluorouracil (NDC 51862-362-40) in a vanishing cream base consisting of white petrolatum, cetyl alcohol, stearyl alcohol, propylene glycol, polysorbate 60, parabens (methyl and propyl), and purified water. Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature].
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION When Fluorouracil Cream is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion, and re-epithelialization. Fluorouracil Cream should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil Cream is applied with the fingers, the hands should be washed immediately afterward. Actinic or Solar Keratosis Apply cream twice daily in an amount sufficient to cover the lesions. Medication should be continued until the inflammatory response reaches the erosion stage, at which time use of the drug should be terminated. The usual duration of therapy is from 2 to 4 weeks. Complete healing of the lesions may not be evident for 1 to 2 months following cessation of Fluorouracil Cream therapy. Superficial Basal Cell Carcinomas Only the 5% strength is recommended. Apply cream twice daily in an amount sufficient to cover the lesions. Treatment should be continued for at least 3 to 6 weeks. Therapy may be required for as long as 10 to 12 weeks before the lesions are obliterated. As in any neoplastic condition, the patient should be followed for a reasonable period of time to determine if a cure has been obtained.