Fluorouracil

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%. …

• 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

Safety and effectiveness in children have not been established.

• Patients should be forewarned that the reaction in the treated areas may be unsightly during therapy and, usually, for several weeks following cessation of therapy
• Patients should be instructed to avoid exposure to ultraviolet rays during and immediately following treatment with Fluorouracil Cream because the intensity of the reaction may be increased
• If Fluorouracil Cream is applied with the fingers, the hands should be washed immediately afterward
• Fluorouracil Cream should not be applied on the eyelids or directly into the eyes, nose or mouth because irritation may occur
• Fluorouracil, including Fluorouracil Cream may be fatal if ingested by pets. …

• 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 defect (cleft lip and palate) has been reported in the newborn of a patient using Fluorouracil Cream as recommended
• One birth defect (ventricular septal defect) and cases of miscarriage have been reported when Fluorouracil Cream was applied to mucous membrane areas. …

Application to mucous membranes should be avoided due to the possibility of local inflammation and ulceration. Additionally, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when Fluorouracil Cream was applied to mucous membrane areas during pregnancy. Occlusion of the skin with resultant hydration has been shown to increase percutaneous penetration of several topical preparations. If any occlusive dressing is used in treatment of basal cell carcinoma, there may be an increase in the severity of inflammatory reactions in the adjacent normal skin. A porous gauze dressing may be applied for cosmetic reasons without increase in reaction. …

The most frequent adverse reactions to Fluorouracil Cream occur locally and are often related to an extension of the pharmacological activity of the drug. These include burning, crusting, allergic contact dermatitis, pruritus, scarring, rash, soreness, and ulceration. Ulcerations, other local reactions, cases of miscarriage, and a birth defect (ventricular septal defect) have been reported when Fluorouracil Cream was applied to mucous membrane areas. Leukocytosis is the most frequent hematological side effect. Although a causal relationship is remote, other adverse reactions which have been reported infrequently are: Central Nervous System: Emotional upset, insomnia, irritability. …

Pregnancy See CONTRAINDICATIONS .

There have been no reports of overdosage with Fluorouracil Cream. The oral LD 50 for the 5% topical cream was 234 mg/kg in rats and 39 mg/kg in dogs. These doses represented 11.7 and 1.95 mg/kg of fluorouracil, respectively. The topical application of the 5% cream to rats yielded an LD 50 of greater than 500 mg/kg.

Store at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature].

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.