METHODS AND PACKAGES TO ENHANCE SAFETY WHEN USING IMIQUIMOD TO TREAT CHILDREN DIAGNOSED WITH SKIN DISORDERS
申请人:Slade Herbert B.
公开号:US20080280943A1
公开(公告)日:2008-11-13
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
9
/L or a decrease in median absolute neutrophil count by about 1.42*10
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.
本发明涉及药物包装和方法,用于增强使用咪喹莫德治疗患有皮肤疾病的儿童的安全性。特别地,通过向儿童、儿童监护人(包括父母和医护人员)提供信息,即在使用咪喹莫德治疗2至12岁儿童时可能观察到咪喹莫德的系统吸收和其他影响,增强了咪喹莫德使用的安全性。系统吸收的示例包括血清咪喹莫德浓度低于约2ng/mL、中位白细胞计数降低约1.4*109/L或中位绝对中性粒细胞计数降低约1.42*109/L。本发明还涉及用于治疗儿童皮肤病的咪喹莫德的局部和/或经皮递送,包括乳膏、软膏、凝胶、洗剂、膏药和压敏粘合剂组合物,用于治疗软疣、病毒感染(如I型或II型单纯疱疹感染和尖锐湿疣)、光化性角化症和浅表性基底细胞癌,并诱导干扰素生物合成。