Skinoren^® (Cream, Gel) Instructions for Use

ATC Code

D10AX03 (Azelaic acid)

Active Substance

Azelaic acid (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug with antiproliferative and antibacterial action for the treatment of acne, hyperpigmentation, and rosacea

Pharmacotherapeutic Group

Acne treatment agent

Pharmacological Action

Azelaic acid normalizes the disturbed processes of keratinization in the sebaceous gland follicles, reduces the content of free fatty acids in skin lipids and reduces its oiliness. It exhibits antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. The anti-inflammatory effect is also due to a reduction in neutrophil metabolism and a decrease in the production of free radical forms of oxygen. Azelaic acid exerts a dose- and time-dependent inhibitory effect on the growth and viability of abnormal melanocytes.

Pharmacokinetics

Absorption

After application to the skin, Azelaic acid is practically not absorbed into the systemic circulation (no more than 3.6% with a single application of 5 g of gel or cream).

Elimination

Part of the absorbed azelaic acid is excreted by the kidneys unchanged, and part in the form of dicarboxylic acids (C7, C5), formed from azelaic acid as a result of beta-oxidation.

Indications

• Acne (acne vulgaris);
• Hyperpigmentation, including melasma, chloasma (for cream);
• Rosacea (for gel).

ICD codes

Dosage Regimen

Cream, Gel

The dosage regimen and duration of therapy are set individually. Used in adults and children over 12 years.

Before using this product, the skin should be cleansed with water or a mild cleansing cosmetic, then dried.

Apply to the affected areas of the skin in a uniform thin layer 2 times/day (morning and evening) and rub in lightly.

This product should be used in sufficient quantity, but not excessively (approximately 2.5 cm is enough for the entire surface of the face). It should be used regularly throughout the entire course of treatment, the duration of which depends on the clinical picture of the disease and the severity of symptoms. In acne (acne vulgaris) improvement is usually observed after 4 weeks. To achieve the best results, use should be continued for several months. Additional skin protection from UV radiation during the treatment of acne is not required.

For melasma the drug is used in the form of a cream. The minimum duration of therapy is 3 months; for better results, the product should be used regularly. Throughout the entire period of melasma therapy, it is mandatory to use sunscreens (UVB and UVA) to prevent sun-induced exacerbation of the disease and/or repigmentation of lightened areas.

Adverse Reactions

At the beginning of treatment, a small number of patients may experience local irritation, manifested as hyperemia, peeling, erythema, burning, itching. In most cases, these symptoms are not severe and resolve on their own within a few days during treatment.

In very rare cases, skin allergic reactions (rash) are possible.

Contraindications

• Hypersensitivity to the components of the drug used.

Use in Pregnancy and Lactation

Use during pregnancy and lactation is possible after consulting a doctor, however, application of this product to the breast area before feeding should be avoided.

Pediatric Use

Used in children over 12 years of age.

Special Precautions

In cases of skin irritation, the amount of this product per application should be reduced or the frequency of application should be reduced to 1 time/day; if necessary, temporary discontinuation of therapy (for several days) is possible.

Avoid getting this product into the eyes and on wound surfaces; in case of accidental contact, rinse immediately with water.

Additional skin protection from UV radiation during treatment with this product is not required.

Epidermal and mixed epidermal-dermal types of melasma respond well to therapy with this product in the form of a cream. For dermal melasma, the cream is not effective. A Wood’s lamp is recommended for differential diagnosis.

Drug Interactions

Interaction of this product with other drugs has not been identified to date.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.