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

Product name and form

Aknemycin Plus 4.0% w/w and 0.025% w/w cutaneous solution.

Pharmaceutical Form

Cutaneous solution.

Aknemycin Plus is a clear solution for topical administration.

Qualitative and quantitative composition

Each gram of cutaneous solution contains 40 mg of erythromycin and 0.25 mg of tretinoin.

Excipients with known effect:

1 ml of solution contains 752 mg of alcohol (ethanol).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Erythromycin

Erythromycin exerts its antimicrobial action by binding to the 50S ribosomal sub-unit of susceptible microorganisms and suppresses protein synthesis. Erythromycin is bacteriostatic and bactericidal depending on its concentration and the type of organism.

Tretinoin

Tretinoin decreases cohesiveness of follicular epithelial cells resulting in decreased microcomedone formation. Additionally, tretinoin stimulates mitotic activity and increased turnover of follicular epithelial cells, causing extrusion of the comedones.

List of Excipients

Ethanol
Glycerol
Copolyvidone

Pack sizes and marketing

Amber glass bottle, with white screw cap, containing 25ml Aknemycin Plus. The bottle has a polyethylene stopper which holds a foam pad with a nylon gauze covering. Pack sizes 25ml, 50ml (2 × 25ml).

Marketing authorization holder

Almirall Hermal GmbH, Scholtzstrasse 3, D-21465, Reinbek, Germany

Marketing authorization dates and numbers

PL 33016/0007

31 July 1998

Drugs

Drug Countries
AKNEMYCIN PLUS Poland, Singapore, United Kingdom

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