Investigation on Labeling and Drug Strategy on Dermatologic Drugs for Pregnant Women
DU Bo-ran1, FENG Xin1*, YIN Cheng-hong1*, SHI Xiang-jun2
1. Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China; 2. School of Pharmaceutical Science, Tsinghua University, Beijing 100084, China
Abstract��OBJECTIVE The aim of this study is to investigate labelings on dermatologic drugs for pregnant women and provide qualitative and quantitative pharmaceutical support for clinical use. METHODS Labelings and formularies on pregnancy of topical drugs were analyzed and sorted according to classification on pregnancy use. Transdermal abilities of the drugs not forbidden nor avoided were evaluated through ACD/LAB 6.0 software and Potts-Guy formulation. Through TOXNET database and dose conversion equation, toxicities on animals were collected and human doses for pregnant women were calculated. RESULTS In dermatologic drugs, there are 16 drugs forbidden, 8 not recommended/avoided/should not be used, 14 used with caution/weighed pros and cons, 7 used under instruction, 16 unclear or with no statement. In topical drugs not forbidden nor avoided, there are 9 drugs�� logKp above-5, butenafine and sertaconazole with strongest transdermal abilities, 7 drugs�� logKp influenced under pH5.5 or pH7.0, with a decline in logK��p compared with logKp, still 15 drugs not influenced by pH, 7 drugs�� toxicities on animals unknown, 14 drugs�� pregnancy human doses under 10 mgkg-1. CONCLUSION Currently,only a few topical drugs�� instructions on pregnancy are clear. With properties and animal experiments, better pharmaceutical support can be provided for clinical use on qualitative or quantitative reference.
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DU Bo-ran, FENG Xin, YIN Cheng-hong, SHI Xiang-jun. Investigation on Labeling and Drug Strategy on Dermatologic Drugs for Pregnant Women. Chinese Pharmaceutical Journal, 2018, 53(10): 826-831.
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