AKNEMYCIN PLUS Cutaneous solution Ref.[28072] Active ingredients: Erythromycin Tretinoin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Almirall Hermal GmbH, Scholtzstrasse 3, D-21465, Reinbek, Germany

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antiinfectives for treatment of acne, erythromycin in combination with tretinoin
ATC code: D10AF52

Erythromycin is a macrolide antibiotic with bacteriostatic action on all pathogens involved in the development of acne. When applied topically it also effects a reduction in the concentration of skin surface lipids and shows a direct anti-inflammatory effect.

The retinoid tretinoin acts topically as keratolytic agent by markedly increasing cell turnover in the cornified epithelium including the epithelium of the follicular ducts and comedones. In the first instance, skin irritation, erythema and increased vascularization occur followed by thickening and desquamation of the epithelium. The renewal time of the cornified epithelium is therefore shortened.

The alcohol base dissolves sebum.

5.2. Pharmacokinetic properties

Percutaneous absorption or erythromycin is negligible following topical application of Aknemycin Plus solution for several weeks to large areas of skin.

After topical application, up to 6% of the applied dose of tretinoin is recovered in the urine within 50-60 hours, indicating some absorption. The ratio of renal to biliary excretion is approximately 1:3, therefore the maximum likely total absorption is 24%.

5.3. Preclinical safety data

High oral doses of tretinoin are teratogenic in animals and there is evidence of embryotoxicity from studies where tretinoin is applied dermally. Aknemycin Plus should not therefore be used in pregnancy or in women who may become pregnant.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.