Fluorouracil

Tolak is indicated for the topical treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade I and II) of the face, ears, and/or scalp in adults.

EFUDEX is recommended for the topical treatment of premalignant keratoses and superficial basal cell carcinoma. 1 Pediatrics (≥ 18 years of age) Based on the data submitted and reviewed by Health Canada, the safety and efficacy of EFUDEX in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use

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.