Skinoren Gel 15%, 30g

Composition

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of 1 g of gel contains azelaic acid (micronized) – 150 mg;

excipients:

lecithin,

triglycerides,

polysorbate 80,

propylene glycol,

polyacrylic acid,

sodium hydroxide,

disodium edetate,

purified water,

benzoic acid

Pharmacological action

Pharmaceutical group: A drug with antiproliferative and antibacterial action for the treatment of acne, hyperpigmentation and rosacea.

Pharmacology: Skinoren is a drug for the treatment of acne. Azelaic acid normalizes disturbed keratinization processes in the follicles of the sebaceous glands, reduces the content of free fatty acids in skin lipids and reduces its fat content.

It has antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. The anti-inflammatory effect is also due to a decrease in neutrophil metabolism and a decrease in the production of free radical oxygen forms. Azelaic acid has a dose-and time-dependent inhibitory effect on the growth and viability of abnormal melanocytes.

Pharmacokinetics:

 Suction

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).

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

Indications

-acne vulgaris;— rosacea.

Use during pregnancy and lactation

Given the low systemic bioavailability and low toxicity of azelaic acid, it is possible to use the drug during lactation (breastfeeding), since the amount of azelaic acid that can enter the baby with breast milk is insignificant and does not involve any danger.

In experimental studies on laboratory animals, there was no possible risk of using the drug during pregnancy.

Contraindications

Hypersensitivity to the components of the drug.

Side effects

Local reactions:  rarely ( mainly at the beginning of therapy) – skin irritation, erythema, burning sensation, itching, peeling, which pass independently during further treatment.

In very rare cases, when using the gel, allergic skin reactions (rash), contact dermatitis, folliculitis are possible.

How to take, course of use and dosage

The dosage regimen and duration of therapy are set individually. The gel should be applied to pre-thoroughly washed (with water or cleansed with a mild cleansing cosmetic product) and dried skin of the face. The gel is applied in a thin layer to the affected areas of the skin 2 times a day (morning and evening) and lightly rubbed. Approximately 2.5 cm of gel is sufficient for the entire surface of the face.

In patients with acne vulgaris marked improvement is usually observed after 4 weeks. For best results, the drug should be continued for several months.

Special instructions

Avoid getting the drug in the eyes, as well as on the mucous membranes of the nose, lips and mouth.

In cases of severe skin irritation in the first weeks of treatment, Skinoren can be used 1 time / day; short-term withdrawal of the drug is also possible. After the symptoms of skin irritation disappear, regular use of the drug should be resumed at the recommended dose.

Skinoren can be used in combination with other acne treatments. At the same time, it is possible to adjust the dosage regimen of drugs used simultaneously.

Form of production

Gel.

Storage conditions

The drug should be stored at a temperature not exceeding 30°C.

Shelf life

3 years

Active ingredient

Azelaic Acid

Dosage form

gel for external use

Indications

Acne, Rosacea