Fluorouracil

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.

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.

Systemic exposure to Fluorouracil reflects Complete (~100%) parenteral systemic delivery for Fluorouracil (50 mg/mL Injection, Solution) absorption kinetics and mixed metabolic conjugation and unchanged urinary excretion across fluorouracil regimens, sustaining receptor engagement across a Terminal t½ estimated at 10–16 hrs depending on renal/hepatic reserve (Fluorouracil) half-life window (rapid intravascular/parenteral onset within 15–45 minutes after fluorouracil administration response profile).

Dosing protocols (50 mg/mL Injection, Solution or 50 mg/g Cream or 2 g/40g Cream or 50 mg/mL Solution or 20 mg/mL Solution) balance efficacy (90.00% patient satisfaction across 8 logs) against nausea (9.3% of reports), headache (7.5% of reports), dizziness (5.3% of reports), with strict avoidance in contraindications 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..