Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Takeda UK Limited, 1 Kingdom Street, London, W2 6BD, United Kingdom
Podophyllotoxin is an anti-mitotic agent, with a topical action against warts. It is applied locally to the lesion (e.g. wart) and causes destruction of the tissues locally. Podophyllotoxin and its derivatives have a special affinity for the microtubule protein of the mitotic spindle and thus arrest mitosis in metaphase leading to epithelial cell death. It is also caustic to normal skin if applied to it and can be absorbed into the systemic circulation with resultant toxic effects, in particular nausea, vomiting and thrombocytopenia.
After topical application, podophyllotoxin is absorbed through the skin or mucous membranes. The extent of absorption depends on the concentration used.
Topical application of 0.1 ml of 5 mg/ml podophyllotoxin on an area of 4 cm² resulted in maximum plasma concentrations of 5 ng/ml after 1-2 hours. After topical application of 0.1-0.15 ml on extreme large lesions the maximum plasma concentrations was 1-17 ng/ml.
Owing to its high lipid solubility, it is distributed through the body including the CNS.
No data are available on the metabolism of podophyllotoxin.
The serum half-life varies between 1 to 4.5 hours.
Podophyllotoxin toxicity in animals is related to its cytotoxic activity. As a cytotoxic agent it has teratogenic potential and in reproductive toxicity studies has been associated with intrauterine deaths in mice and rats. Results from genotoxicity studies suggest podophyllotoxin has aneugenic activity consistent with its pharmacological action. No carcinogenic effects were reported in long term studies in rodents dosed via dietary administration up to 0.3 mg/kg/day.
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