March 28, 2017
Recommended Topic Related To:

Efudex

"The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. 

Psoriasis is a skin condition that causes patches of skin redness and flaking. Psoriasis is an autoimm"...

A A A

Efudex




Indications
Dosage
How Supplied

INDICATIONS

Efudex 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 Efudex Cream and Solution is approximately 93%, based on 113 lesions in 54 patients. Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.

DOSAGE AND ADMINISTRATION

When Efudex is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion and reepithelialization.

Efudex should be applied preferably with a nonmetal applicator or suitable glove. If Efudex is applied with the fingers, the hands should be washed immediately afterward.

Actinic Or Solar Keratosis

Apply cream or solution twice daily in an amount sufficient to cover the lesions. Medication should be continued until the inflammatory response reaches the erosion stage, at which time use of the drug should be terminated. The usual duration of therapy is from 2 to 4 weeks. Complete healing of the lesions may not be evident for 1 to 2 months following cessation of Efudex therapy.

Superficial Basal Cell Carcinomas

Only the 5% strength is recommended. Apply cream or solution twice daily in an amount sufficient to cover the lesions. Treatment should be continued for at least 3 to 6 weeks. Therapy may be required for as long as 10 to 12 weeks before the lesions are obliterated. As in any neoplastic condition, the patient should be followed for a reasonable period of time to determine if a cure has been obtained.

HOW SUPPLIED

Efudex Solution is available in 10-mL drop dispensers containing either 2% (NDC 0187-3202-10) or 5% (NDC 0187-3203-10) fluorouracil and 25-mL drop dispensers containing either 2% (NDC 0187- 3202-02) or 5% (NDC 0187-3203-02) fluorouracil on a weight/weight basis compounded with propylene glycol, tris (hydroxymethyl) aminomethane, hydroxypropyl cellulose, parabens (methyl and propyl) and disodium edetate.

Efudex Cream is available in 40 g tubes containing 5% fluorouracil (NDC 0187-3204-47) in a vanishing cream base consisting of white petrolatum, stearyl alcohol, propylene glycol, polysorbate 60, parabens (methyl and propyl), and purified water.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA. by: Valeant Pharmaceuticals International Inc., Laval, QC H7L 4A8, Canada. Revised: 2016

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/9/2017

Indications
Dosage
How Supplied

Efudex - User Reviews

Efudex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Efudex sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.