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Psoriatec (Anthralin) - Warnings and Precautions

 
 



WARNINGS

For external use only. Avoid contact with the eyes or mucous membranes. Exercise care when applying Psoriatec cream to the face or intertriginous skin areas. Discontinue use if a sensitivity reaction occurs or if excessive irritation develops. Keep out of the reach of children.

PRECAUTIONS

General:    To prevent the possibility of staining clothing or bed linen, it may be advisable to use protective dressings. To prevent discoloration of tub/shower, always rinse the tub/shower with cool to lukewarm water immediately after washing/showering and then use a suitable cleanser to remove any deposit on the surface of the tub or shower. Contact with fabrics, plastics and other materials may cause staining and should be avoided. Always wash hands thoroughly after use.

Carcinogenesis, Mutagenesis, Impairment of Fertility: 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.

Pregnancy:    Pregnancy Category C. Animal reproduction studies have not been conducted with Psoriatec cream. It is also not known whether Psoriatec cream can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Psoriatec cream should be given to a pregnant woman only if clearly needed.

Nursing Mothers:    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.

Pediatric Use:    Safety and effectiveness in children have not been established.

Page last updated: 2006-09-05

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