EFUDEX

This brand name is authorized in United States. It is also authorized in Canada.

Active ingredients

The drug EFUDEX contains one active pharmaceutical ingredient (API):

1
UNII U3P01618RT - FLUOROURACIL
 

Fluorouracil is an antineoplastic anti-metabolite. Anti-metabolites masquerade as purine or pyrimidine – which become the building blocks of DNA. They prevent these substances from becoming incorporated into DNA during the “S” phase (of the cell cycle), stopping normal development and division. Fluorouracil blocks an enzyme which converts the cytosine nucleotide into the deoxy derivative. In addition, DNA synthesis is further inhibited because Fluorouracil blocks the incorporation of the thymidine nucleotide into the DNA strand. Fluorouracil is used 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. Fluorouracil injection is indicated in the palliative management of some types of cancer, including colon, esophageal, gastric, rectum, breast, biliary tract, stomach, head and neck, cervical, pancreas, renal cell, and carcinoid.

 
Read more about Fluorouracil

Medication package inserts

Below package inserts are available for further reading:

Document Type Information Source  
 EFUDEX Topical solution / Cream MPI, US: SPL/Old FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group Classification
L01BC02 Fluorouracil L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01B Antimetabolites → L01BC Pyrimidine analogues
Discover more medicines within L01BC02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
CA Health Products and Food Branch 00330582
US FDA, National Drug Code 0187-3204

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