Pharmaceutical packages and methods for enhancing the safety of imiquimod
when used to treat children affected by skin disorders are disclosed.
More particularly, the safety profile of imiquimod use is enhanced by
providing information to the children, guardians of the children,
including parents and health care professionals, that systemic absorption
of imiquimod and other effects may be observed when imiquimod therapy is
used to treat children of between about 2 and about 12 years of age.
Examples of systemic absorption include a serum imiquimod concentrations
of less than about 2 ng/mL, a decrease in median white blood cell count
by about 1.4*10.sup.9/L or a decrease in median absolute neutrophil count
by about 1.42*10.sup.9/L. Topical and/or transdermal delivery of
imiquimod, including creams, ointments, gels, lotions, salves and
pressure-sensitive adhesive compositions to treat dermatological
disorders in children, namely, molluscum contagiosum, viral infections,
such as Type I or Type II Herpes simplex infections and condyloma
acuminata, genital warts and perianal warts, actinic keratosis and
superficial basal cell carcinoma, and to induce interferon biosynthesis,
are disclosed.