Prescribing information:

Aknemycin Plus contains erythromycin 4% w/w and tretinoin 0.025% w/w.

Uses:

For the treatment of all forms of acne, both non-inflammatory forms with comedones and inflammatory forms with papules and pustules particularly those associated with a very oily skin.

Dosage and administration:

To be applied to the affected areas once or twice daily. Treatment should continue for 9-12 weeks according to the condition of the skin. A therapeutic improvement may not be observed for several weeks after starting treatment. Excess application should be avoided since it may result in marked erythema, drying and discomfort of the treated areas. The dosage is the same for all ages.

Contra-indications, warnings, etc:

Hypersensitivity to the active ingredients. A family history of cutaneous epithelioma. In acute eczemas, rosacea and acute inflammatory conditions of the skin, especially around the mouth. When underlying sunburn is present. Concomitantly with other skin medications particularly those containing keratolytic agents.

Special warnings and precautions for use:

Exposure to sunlight should be minimised and use of sun lamps avoided during treatment. Patients with sunburn should not use this product until recovered because of the increased susceptibility to sunlight whilst using tretinoin. Wind and rain may be unusually irritating to patients under treatment. Accumulation of the product in skin folds or in the angles of the nose should be avoided. The product should not be allowed to come into contact with the eyes or eyelids - if this occurs, thorough rinsing with water is recommended.

Interactions:

Skin irritation may be enhanced by UV rays, X-rays or by bathing in chlorinated or salt water. Aknemycin Plus should not be used concomitantly with other skin medications, particularly those containing keratolytic agents.

Pregnancy and lactation:

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. It is known that orally administered retinoids and their metabolites are secreted in breast milk. As a precaution therefore, Aknemycin Plus should be avoided in women who are breastfeeding.

Undesirable effects:

Skin irritation in the form of erythema, burning, drying or peeling of the skin may be observed. There may be an apparent deterioration in acne with an increase in inflammatory symptoms at the commencement of treatment; this is usually transitory. If the above occur, treatment should not be interrupted but the frequency of application reduced. A temporary hypopigmentation or hyperpigmentation has been reported in a few individuals treated with tretinoin. Temporary depigmentation in non-caucasians is possible.

Overdose:

Aknemycin Plus is for topical use only. Overdosage will not occur since the amount of erythromycin and tretinoin applied is too small to induce systemic toxicity. If the product is accidentally taken orally, unless the amount is small, gastric lavage should be performed as soon as possible.

Legal category:

POM

Product licence number:

PL 04758/0010

Product licence holder:

Hermal Kurt Herrmann, GmbH & Co OHG, Scholtzstrasse 3, D-21465, Reinbek, Germany.

Date of preparation:

May 2007

Pack sizes & Cost:

25ml applicator bottle, £7.05

* Kreusch J and Bextermoller R Efficacy and tolerability of a topical erythromycin/tretinoin combination preparation in acne treatment: post-marketing surveillance study involving over 6,500 patients. Curr Med Res Opin, 2000; 16 (1): 1-7