Schinoren, 15% gel 50 g

Pharmaceutical group:

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

Pharmic action:

Skinoren is an acne treatment.
Azelaic acid normalizes the disturbed keratinization processes in the follicles of the sebaceous glands, reduces the content of free fatty acids in the skin lipids and reduces the oiliness of the skin.

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

Pharmacokinetics:

Intake
Azelaic acid is virtually not absorbed into the systemic bloodstream after application to the skin (no more than 3.6% in a single application of 5 g of gel or cream).

Elimination
Part of the absorbed azelaic acid is excreted unchanged by the kidneys, and part of it as dicarboxylic acid (C7, C5) formed from azelaic acid by beta-oxidation.

Indications

— acne (acne vulgaris);
– rosacea.

Pharmacological effect

Pharmgroup:

A drug with antiproliferative and antibacterial effects for the treatment of acne, hyperpigmentation and rosacea.

Pharmaceutical action:

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

Shows 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 species. 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).

Removal
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.

Special instructions

The drug is intended for external use only.

It is necessary to avoid getting the drug into the eyes, as well as onto wound surfaces.

In case of accidental contact with eyes or wound surfaces, rinse thoroughly with warm water.

Epidermal and mixed epidermal-dermal types of melasma respond well to treatment with Skinoren.

Dermal melasma – on the contrary, Skinoren cannot be treated. For differential diagnosis, it is recommended to use a Wood’s lamp.

Active ingredient

Azelaic acid

Composition

1 g of gel for external use contains:

active ingredient:

azelaic acid (micronized) – 0.15 g.

excipients:

propylene glycol,

polysorbate 80,

lecithin,

polyacrylic acid,

triglycerides,

sodium hydroxide,

disodium edetate,

benzoic acid,

purified water.

Pregnancy

The use of the drug during pregnancy and breastfeeding is possible after consultation with the doctor, but it is necessary to avoid applying it to the mammary glands before feeding.

Contraindications

Hypersensitivity to the components of the drug Skinoren.

Side Effects

At the beginning of treatment, local irritation, hyperemia and peeling of the skin, burning, erythema, and itching are rarely possible.

In most cases, side effects are mild, disappear during treatment and do not require discontinuation of the drug.

In very rare cases, allergic skin reactions (such as rash) may occur.

In case of skin irritation, reduce the single application of the drug or reduce the frequency of use to 1 time per day.

If necessary, it is possible to temporarily interrupt treatment for several days.

Interaction

Skinoren can be used in combination with other acne treatment methods.

In this case, it is possible to adjust the dosage regimen of simultaneously used drugs.

Overdose

Animal studies have shown that there is no risk of acute intoxication with a single overdose for cutaneous application and oral administration.

Storage conditions

At a temperature not higher than 25°C.

Shelf life

3 years.

Manufacturer

LEO Pharma Manufacturing Italy S.r.l., Italy