EFUDIX Cream Ref.[7973] Active ingredients: Fluorouracil

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mylan Products Ltd., Station Close, Potters Bar, Herts, EN6 1TL, United Kingdom

Pharmacodynamic properties

Pharmacotherapeutic group: Pyrimidine analogues
ATC code: L01BC02

Efudix is a topical cytostatic preparation which exerts a beneficial therapeutic effect on neoplastic and pre-neoplastic skin lesions while having less effect on normal cells. The pattern of response follows this sequence: erythema, vesiculation, erosion, ulceration, necrosis and epithelisation.

Pharmacokinetic properties

Fluorouracil is minimally systemically absorbed when applied topically to intact skin. When applied to the skin, the skin’s barrier function is pathologically altered (e.g., as in ulceration), and the absorption rate can increase to 60%. In patients with AK, 2.4-6% of the topical dose was absorbed systemically. Similarly, under occlusion, significantly more fluorouracil is absorbed.

Fluorouracil may be metabolised by catabolic or anabolic routes which are similar to that of endogenous uracil.

Preclinical safety data

There is evidence from animal work that fluorouracil is teratogenic.

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