Acne DERM 20% - Cream (anti-acne, hyperpigmented skin)
Action
As the active substance of the preparation, azelainic acid shows anti-acne action and bleaching the hyperpigmented skin.
Way of anti-acne action is not recognized yet, but probably azelainic acid reveals anti-bacterial activity through restraining the synthesis of cell protein of aerobic and anaerobic bacteria, especially Propionibacterium acnes i Staphylococcus epidermidis. Furthermore, azelainic acid reduces amount of micro-blackheads through normalization of keratin creation and decreasing of thickness of keratose layer, as well as amount and size of keratohyalin pellets.
Bleaching action results from restraining the activity of o-diphenol oxidase and mitochondrial enzymes. Azelainic acid can stop hyperactivity of normal melanocytes. Furthermore, it is able to intercept free radicals, which can cause the hyperactivity of melanocytes.
Indications for use
Indication for use of the cream is acne (Acne vulgaris) and discoloration of the skin (melanoderma).
Contraindications
Hypersensitivity to active substance, i.e. azelainic acid, or auxiliary ingredients constituting the vehicle.
Warnings
Irritation of the skin can result from the first application of the cream. If the irritation remains, apply the preparation once a day until the discomfort disappears. If decreased dose doesn't lead to disappearing of irritation, stop the treatment.
If a dose is omitted, apply the medicine as soon as possible, but do not apply, when a time of next dose is near.
If another preparations are applied to the skin, it is recommended to apply them between consecutive applications of Acne-derm.
Protect your mouth, eyes and mucous membrane from a contact with the medicine. If such a contact ensues, wash affected place using lot of water. If - despite of washing - the irritation remains, ask medical advice.
Because of bleaching properties of the preparation, the skin of dark-complexion patients has to be watched at the spot of application of the medicine, as it can be cleared up.
Application of the medicine in pregnancy and nursing?
The medicine can be applied to the pregnant women solely in such circumstances, when - according to opinion of the physician - advantage for the mother prevails over potential threat to the fetus. Azelainic acid can pass through to mother's milk, so it's not recommended for nursing women.
Influence of the medicine upon ability to drive motor vehicles, to operate machinery and on overall psycho-physical efficiency
No influence of azelainic acid upon ability to drive motor vehicles, to operate machinery and on overall psycho-physical efficiency has been found.
Interaction with other drugs
There are no described cases of interaction of the cream containing azelainic acid with other medicines.
Dosage and directions for use
The cream is applied two times daily (in the morning and in the evening) on washed and thoroughly dried pathologically changed spots on the skin. Gentle rubbing the cream in is recommended. Wash your hands after applying the cream.
Single dose of the cream amounts to 1 g = 4 cm of the cream, equivalent to 0.2 g of active substance.
Daily dose amounts to 2 g = 8 cm of the cream, corresponding to 0.4 g of active substance.
The preparation should be applied for at least 4 weeks. To achieve permanent improvement, the preparation should be applied for few months.
Undesirable action
Rarely observed action:
- White or cleared up spots on the skin after application to the dark-complexion patients.
Actions observed more frequently:
- Peeling and dried-out skin, erythema, mild inflammation of the skin (burns and itching) are observed among 1-5% of patients, which use preparations containing azelainic acid.
These symptoms occur at the beginning of the treatment, particularly if the preparation is applied to inflamed or damaged skin; in most cases they recede after 5 - 20 minutes from application.
Before application of the preparation check expiration date printed on the package; don't use the expired Cream.
Storage
Store the preparation at room temperature, i.e. from 15°C to 25°C, in tightly closed, original package. Do not freeze.
Package
Direct package: aluminum tube containing 20 g of the cream.
External package: carton with a leaflet. |
