Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom
Pharmacotherapeutic group: Anti-acne
ATC code: D10AF52
Erythromycin is known to be efficacious, at 4%, in the topical treatment of acne vulgaris. Zinc, topically, is established as an aid to wound healing. The zinc acetate is solubilised by complexing with the erythromycin, and delivery of the complex is enhanced by the chosen vehicle.
The complex does not survive in the skin, and erythromycin and zinc penetrate independently. The erythromycin penetrates, and is partially systemically absorbed (0-10% in vitro, 40-50% in animal studies); that portion absorbed is excreted in 24-72 hours. The zinc is not absorbed systemically.
Non-clinical data from repeated dose toxicity and reproduction and developmental toxicity studies reveal no additional hazard other than those described elsewhere in the SPC.
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