Pajjiż: Tajwan
Lingwa: Ċiniż
Sors: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
PODOPHYLLOTOXIN
荷商葛蘭素史克藥廠股份有限公司台灣分公司 台北市中正區忠孝西路一段66號23-24樓 (86927438)
D06BB04
乳膏劑
PODOPHYLLOTOXIN (9200041700) 1.5MG
鋁管裝
製 劑
須由醫師處方使用
STIEFEL LABORATORIES (IRELAND) LTD. FINISKLIN BUSINESS PARK, SLIGO, IRELAND IE
podophyllotoxin
生殖器疣(包括外生殖器及肛門附近的疣)。
註銷日期: 2017/04/10; 註銷理由: 屆期未申請展延; 有效日期: 2016/01/30; 英文品名: WARTEC CREAM 0.15% W/W
已註銷
2001-01-30
[Pharmacodynamics] ATC code PHARMACOTHERAPEUTIC GROUP: ANTIVIRALS - PODOPHYLLOTOXIN ATC CODE: D06BB04 Mechanism of action PODOPHYLLOTOXIN BINDS TO CELLULAR MICROTUBULES AND INHIBITS MITOTIC DIVISION. Pharmacodynamic effects PODOPHYLLOTOXIN INVADES INFECTED CELLS AND INHIBITS GROWTH, THEREBY INDUCING NECROSIS OF THE CELLS AND THUS THE CONDYLOMAS. [Pharmacokinetics] SYSTEMIC ABSORPTION OF PODOPHYLLOTOXIN AFTER TOPICAL APPLICATION OF 100 MG OF 0.3% CREAM OR 100 ΜL OF 0.5% SOLUTION HAS BEEN STUDIED (EXTRAVAGINALLY IN 10 FEMALES, AND WITHIN THE PREPUTIAL CAVITY IN 10 MALES, EACH ON 2 OCCASIONS SEPARATED BY 8 HOURS). C MAX WAS AT OR BELOW 4.7 NG/ML FOLLOWING ALL DOSES AND T MAX RANGED FROM 0.5 TO 36 HRS; IN SOME SUBJECTS CONCENTRATIONS WERE BELOW THE LIMIT OF DETECTION. C MAX AND T MAX WERE COMPARABLE FOR THE 0.3% CREAM AND 0.5% SOLUTION IN BOTH MALES AND FEMALES. IT CAN BE CONCLUDED THAT SYSTEMIC ABSORPTION OF RECOMMENDED DOSES OF PODOPHYLLOTOXIN CREAM OR SOLUTION IS EXPECTED TO BE LOW. Special patient populations •Children SAFETY AND EFFICACY OF TOPICAL PODOPHYLLOTOXIN HAVE NOT BEEN ESTABLISHED IN CHILDREN UNDER THE AGE OF 12. •Elderly NO ADDITIONAL INFORMATION. NON-CLINICAL INFORMATION Carcinogenesis/Mutagenesis PODOPHYLLOTOXIN WAS NOT MUTAGENIC IN AN AMES TEST, USING SALMONELLA TYPHIMURIUM STRAINS TA1535, TA1537, TA98 AND TA100 UP TO 5000 ΜG/PLATE, THE MAXIMUM CONCENTRATION IN ACCORDANCE WITH CURRENT GUIDELINES, AND WAS NEGATIVE IN AN IN VITRO HUMAN CHROMOSOME ABERRATION ASSAY USING HUMAN LYMPHOCYTES AND AN IN VIVO MOUSE MICRONUCLEUS TEST WHEN TESTED UP TO 20 MG/KG. ASSESSMENT OF MUTATIONS AT THE HPRT LOCUS USING CHINESE HAMSTER OVARY (CHO) CELLS IN VITRO SHOWED EVIDENCE OF MUTAGENICITY, BUT THE RESULTS WERE INCONSISTENT WITH REGARD TO THE DOSE RESPONSE OBSERVED ACROSS REPLICATE CULTURES. NO ONCOGENIC EFFECTS WERE OBSERVED WITH PODOPHYLLOTOXIN WHEN ASSESSED IN TWO 80-WEEK MOUSE CARCINOGENICITY STUDIES FOLLOWING DERMAL OR DIETARY ADMINISTRATION, AND IN A 2-YEAR RAT DIETARY CARCINOGENICITY STUDY. ANIMAL STUDIES Aqra d-dokument sħiħ