Azelik, gel 15% 5 g

Pharmacological group:

Acne rash treatment
ATX code D10AX03

Pharmacodynamics:

Aselaic acid in the therapy of acne normalizes the disturbed processes of keratinization in the follicles of sebaceous glands, and reduces the content of free fatty acids in the skin lipids. It shows antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. The mechanism of action of azelaic acid in rosacea is unknown.

It may be assumed that the anti-inflammatory effect is caused by a decrease in neutrophil metabolism and the production of free-radical oxygen species. Azelaic acid has a dose-dependent and time-dependent suppressive effect on the growth and activity of abnormal melanocytes.

Pharmacokinetics:

Azelaic acid penetrates into the epidermis and dermis after application to the skin, penetration into damaged skin is faster than in intact skin. After a single external application of 5 g gel, 3.6% of the total dose of azelaic acid enters the systemic bloodstream. Part of the absorbed acid is excreted by the kidneys unchanged, part of it – in the form of dicarboxylic acids (C7, C5), formed as a result of beta-oxidation.

Indications

Acne vulgaris, Rosacea

Acne vulgaris, Rosacea.

Active ingredient

Azelaic acid

Composition

The active ingredient:

100 g of gel contains azelaic acid in terms of 100% substance – 15.00 g.

Auxiliary substances:

Benzoic acid – 0,10 g, methylpyrrolidone – 4,00 g, squalane – 1,00 g, propylene glycol – 8,00 g, dinatrium edetate – 0,10 g, sodium hydroxide – 0,25 g, dimethicone 100 cst – 1,00 g, macrogoal cetoasteryl ether – 1,40 g, carbomer interpolymer (type A) – 1,40 g, purified water – to
100 g.br> 100 g.

How to take, the dosage

Externally. Before applying the gel, rinse the skin thoroughly with clean water and then dry it, or use a mild cleanser. Do not use occlusive dressings. Wash hands after each application of the gel.

The gel is applied by thin layer to the affected skin surface twice a day (morning and evening), lightly rubbing into the skin (2.5 cm of gel is enough for the whole surface of the face). In children 12 to 18 years of age, Azelik® is used for treatment of acne; no dose adjustment is required. Efficacy and safety of using the drug in children younger than 12 years of age in the treatment of acne has not been established. The efficacy and safety of the drug administration in children younger than 18 years old in treatment of rosacea is not established.

It is important that the drug Azelik® is used regularly during the whole period of treatment. The duration of treatment is individual and depends on the severity of the disease. As a rule, improvement occurs after 4 weeks of treatment; if necessary, Azelik® may be used for several months. If within 1 month in acne treatment and 2 months in rosacea treatment there is no improvement or relapse occurs, you should stop using Azelik® and consult a physician.

If there is irritation on the skin, reduce the amount of gel for each application or reduce the frequency of gel application to 1 time per day. It is possible to cancel the drug for a short time and then resume after the disappearance of irritation symptoms in the recommended dose.

Use the drug only according to the method of use and in the doses specified in the instructions. If necessary, please consult your doctor before using the drug.

Special Instructions

For external use only. Avoid contact of the gel with the eyes, mouth and other mucous membranes. In case of accidental contact of the drug with the mucous membranes, including eyes, mouth, you should rinse them with plenty of water. If eye irritation does not go away, you should consult a doctor. Wash hands after each use of the drug.

During the treatment with Azelik® rosacea it is recommended to avoid using cosmetics containing alcohol, alcoholic solutions and astringents, abrasive or exfoliating agents (for peeling).

The drug Azelik® contains benzoic acid, which can irritate the skin, irritate the eyes and mucous membranes, and propylene glycol, which can irritate the skin.

During post-registration monitoring rarely reported exacerbation of bronchial asthma in patients with external use of azelaic acid. containing alcohol, alcoholic solutions and astringents, abrasive or exfoliating agents (for peeling).

Effects on the ability to drive vehicles, machinery The drug does not affect the ability to drive vehicles or engage in other potentially dangerous activities that require increased concentration and rapid psychomotor reactions.

Contraindications

Hypersensitivity to the ingredients of the drug.

Side effects

In the beginning of treatment there may be local irritation, skin hyperemia and peeling, burning, erythema, itching, which usually disappear during treatment. Allergic skin reactions are possible.

Overdose

The phenomena of overdose when used externally have not been established.

Pregnancy use

In pregnancy and during breastfeeding, use only if the estimated benefit to the mother outweighs the risk to the fetus and child.

Similarities

Schinoren, Azix-derm, Schinoclear