SKINOREN

Active material: Azelaic acid
When ATH: D10AX03
CCF: Drug for the treatment of acne and rosacea
ICD-10 codes (testimony): L70, L71.9, L81
When CSF: 29.12.01
Manufacturer: INTENDIS GmbH (Germany)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

◊ Cream 20% white, opaque, mat.

Excipients: benzoic acid, arlaton 983 S, quince, cetiriloktanoat, propylene glycol, glycerol 85%, Purified water.

30 g – aluminum tuba (1) – packs cardboard.

◊ Gel for external use 15% white to yellowish-white, opaque.

Excipients: lecithin, trigliceridy, polysorbate 80, propylene glycol, polyacrylic acid, Sodium hydroxide, disodium эdetat, benzoic acid, Purified water.

5 g – aluminum tuba (1) – packs cardboard.
30 g – aluminum tuba (1) – packs cardboard.
50 g – aluminum tuba (1) – packs cardboard.

Pharmacological action

The drug for the treatment of acne vulgaris, or common, and hyperpigmentation. Normalizes the process of keratinization in the wall of the follicles of the sebaceous glands, reducing the content of free fatty acids in the lipids of the skin. Exhibit antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. Azelaic acid dose-dependently inhibited the growth and vitality of abnormal melanocytes.

Pharmacokinetics

Absorption

After application to the skin cream Skinoren azelaic acid is practically not absorbed into the systemic circulation (about 3.6% when applied 5 g of gel or cream).

Deduction

Some suck azelaic acid excreted by the kidneys in unchanged form, and a part of the dicarboxylic acid (C5, C7), formed of azelaic acid by beta-oxidation.

Testimony

- Acne (acne vulgaris);

- Giperpigmentatsiya, incl. melasma, chloasma (Cream);

- Rosacea (Gel).

Dosage regimen

The dosage regimen and duration of therapy is determined individually. The drug is used without age restrictions.

Before using the product the skin should be cleaned with water or a mild detergent cosmetic product, then dry.

Cream or gel is applied to the affected skin evenly with a thin layer 2 times / day (in the morning and in the evening) and lightly rubbed. The drug should be used in sufficient quantities, but not excessively (about 2.5 enough to see the entire surface of the face). The drug should be used regularly throughout the course of treatment, the duration of which depends on the clinical disease and the severity of the symptoms). At acne (acne vulgaris) improvement usually occurs within 4 of the week. For best results, use of the drug should continue for several months.

At Melasma the drug is used in the form of a cream. The minimum duration of therapy is 3 Months, For best results, you should regularly use the cream Skinoren. During the entire period of treatment of melasma, be sure to apply in parallel with skinorenom wide range of sunscreens (UVB and UVA), to prevent exposure to the sun caused by the aggravation of the disease and / or re-pigmentation of the bleached areas.

Side effect

Local reactions: rarely (preferably at the beginning of therapy) – local irritating effect, hyperemia, peeling, эritema, burning sensation, itch, that, usually, not pronounced and are alone in the further course of treatment.

In very rare cases, allergic skin reactions (rash); the application of gel – contact dermatitis, folliculitis.

Contraindications

- Hypersensitivity to the drug.

Pregnancy and lactation

Given the low systemic bioavailability and low toxicity of azelaic acid can be applied during lactation (breast-feeding), tk. the amount of azelaic acid, which can get the baby with breast milk, insignificant and does not involve any danger.

IN experimental studies in laboratory animals have not revealed the possible risk of the drug during pregnancy.

Cautions

Avoid contact with the eyes, and the mucous membranes of the nose, lips and mouth; Accidental contact – Immediately rinse with water.

In case of severe skin irritation expressed in the first weeks of treatment may be used Skinoren 1 time / day; if necessary, can be short-term removal of the drug (for a few days). After the disappearance of the symptoms of skin irritation should resume regular use of the drug at the recommended dose.

Epidermal and dermal-epidermal mixed types of melasma respond well to therapy cream Skinoren. When dermal melasma cream Skinoren is not effective. For the differential diagnosis is recommended to use the lamp Wood.

Overdose

Animal studies showed no risk of acute intoxication in single overdose (when applied topically) or accidental ingestion.

Drug Interactions

Skinoren drug interactions with other drugs has not yet been identified.

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

Conditions and terms

The drug in the form of a cream should be stored at a temperature no higher than 30 ° C. Shelf life – 5 years.

The drug is in the form of gel should be stored at a temperature no higher than 25 ° C. Shelf life – 3 year.