Fluorac Cream

Generic name: fluorouracil and diclofenac sodium
Dosage form: cream
Drug class:Topical antineoplastics

Medically reviewed by Drugs.com. Last updated on Dec 22, 2021.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Fluorac Cream Description

Fluorac Cream is topical preparation containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite and diclofenac sodium, a nonsteroidal anti-inflammatory.

Fluorac Cream contains 5% fluorouracil and 1% diclofenac sodium on a weight/weight basis.

Chemically, fluorouracil is 5-fluoro-2,4(1H,3H)-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:

Diclofenac sodium is a white to slightly yellow crystalline powder. Diclofenac sodium is a benzene–acetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C 14H 10Cl 2NNaO 2. It has the following structural formula:

INACTIVE INGREDIENTS

Inactive ingredients include: aloe barbadensis leaf juice, cyclopentasiloxane, disodium EDTA, emulsifying wax NF, ethylhexyl stearate, methylchloroisothiazolone, methylisothiazolone, sorbitol, tocopheryl acetate, and water.

Fluorac Cream - Clinical Pharmacology

Fluorouracil

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. The effects of DNA and RNA deprivation are most marked on those cells which grow more rapidly and take up fluo...