"The US Food and Drug Administration (FDA) has approved a foam containing calcipotriene and betamethasone dipropionate (Enstilar, Leo Pharma Inc) for topical treatment of plaque psoriasis in adults 18 years of age and older, according to a "...
Avoid contact with the eyes or mucous membranes. Dritho-Scalp should not normally be applied to intertriginous skin areas and high strengths should not be used on these sights. Remove any unintended residue which may be deposited behind the ears. Avoid applying to the folds and creases of the skin. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops on uninvolved skin areas. Keep out of the reach of children.
For external use only. Dritho-Scalp may stain the hair and should be applied sparingly and carefully to psoriatic lesions only. Contact with fabrics, plastics and other materials may cause staining and should be avoided. To prevent the possibility of discoloration, always rinse the bath/shower with hot water immediately after washing/showering and then use a suitable cleanser to remove any deposit on the surface of the bath or shower. Always wash hands thoroughly after use, 15-30° C (59-86° F). Long-term studies in animals have not been performed to evaluate the carcinogenic potential of the drug. Although anthralin has been found to have tumor-promoting properties on mouse skin, there have been no reports to suggest carcinogenic effects in humans after many years of clinical use. As long-term use of topical corticosteroids may destabilize psoriasis, and withdrawal may also give rise to a 'rebound' phenomenon, an interval of at least one week should be allowed between the discontinuance of such steroids and the commencement of Dritho-Scalp therapy. Petrolatum or a suitably bland emollient may usefully be applied during the intervening period.
Pregnancy Category C. Animal reproduction studies have not been conducted with Dritho-Scalp. It is also not known whether Dritho-Scalp can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dritho-Scalp should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in milk and because of the potential for tumorigenicity shown for anthralin in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/26/2011
Additional Dritho-Scalp Information
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.
Find out what women really need.