Skinoren gel 15% 15g

Trade name

Skinoren

International non-proprietary name

Azelaic acid.

Dosage Form

Gel for external use.

Composition

1 g of gel contains

Active ingredient: azelaic acid micronized 0.15 g

Excipients: propylene glycol 0.12 g, polysorbate 80 0.015 g, lecithin 0.01 g, polyacrylic acid 0.01 g, triglycerides 0.01 g, sodium hydroxide 0.002 g, disodium edetate 0.001 g, benzoic acid 0.001 g, purified water 0.681

Description

Opaque gel from white to white with a yellowish sheen color.

Pharmacotherapeutic group

Acne treatment rash.

Pharmacological properties

Pharmacodynamics

Azelaic acid in the treatment of acne normalizes impaired keratinization processes in the follicles of the sebaceous glands, and also reduces the content of free fatty acids in the skin lipids. Shows antimicrobial activity against Propionbacterium acnes and Staphyloccocus epidermidis. The mechanism of action of azelaic acid in rosacea is unknown. It can be assumed that the anti-inflammatory effect is due to a decrease in the metabolism of neutrophils and a decrease in the production of free-radical forms of oxygen by them. Azelaic acid has a dose-and time-dependent suppressive effect on the growth and viability of abnormal melanocytes.

Pharmacokinetics

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

Indications for use

Acne rash of mild and moderate severity, including the presence of papules and pustules; Rosacea, including the presence of papules and pustules.

Contraindications

Hypersensitivity to azelaic acid and other components of the drug; children's age up to 12 years (acne), up to 18 years (rosacea).

Carefully

Bronchial asthma.

Use during pregnancy and during breastfeeding

The use of the drug during pregnancy and lactation is possible after consultation with the doctor.

Adequate and strictly controlled studies in the external use of azelaic acid in pregnant women have not been conducted. An animal study revealed no adverse effect of azelaic acid on pregnancy, fetal development, childbirth, or postnatal development. The potential risk to humans is unknown. During pregnancy, Skinoren® is used only if the intended benefit to the mother outweighs the potential risk to the fetus.

It is not known whether azelaic acid is absorbed into breast milk. Considering the low systemic acid absorption when applied externally, during breastfeeding, Skinoren® is used only if the intended benefit to the mother outweighs the potential risk to the baby. When breastfeeding it is necessary to avoid applying the drug to the area of ​​the mammary glands before feeding; children should not be allowed to contact skin, including breast skin, after applying Skinoren®.

Dosage and administration

Outwardly. Before applying the gel, wash the skin thoroughly with water or a mild cleansing cosmetic, then dry, or use a mild cleansing cosmetic. Do not use occlusal dressings. Hands should be washed after each application of the gel to the skin. The gel is applied with a thin layer to the affected skin 2 times a day (morning and evening), gently rubbing into the skin (2.5 cm of gel is enough for the entire surface of the face). In children from 12 to 18 years, the drug Skinoren® is used in the treatment of acne, dose adjustment is not required. The efficacy and safety of the drug in children younger than 12 years in the treatment of acne has not been established. The efficacy and safety of the drug in children younger than 18 years in the treatment of rosacea has not been established. It is important that Skinoren® is used regularly throughout the treatment period. The duration of treatment is individual and depends on the severity of the disease. Improvement occurs, as a rule, after 4 weeks of treatment, if necessary, use of the drug Skinoren® for several months is possible.If within 1 month in the treatment of acne and 2 months in the treatment of rosacea, there was no improvement or an exacerbation of the disease, then you should stop using Skinoren® and consult a doctor. In case of irritation on the skin, reduce the amount of gel with each application or reduce the frequency of application of the gel to 1 time per day. Possible short-term withdrawal of the drug with subsequent resumption after the disappearance of symptoms of irritation in the recommended dose. Use the drug only according to the method of use and in those doses that are indicated in the instructions. If necessary, please consult a physician before using the drug.

Side effect

Observed in clinical studies and during post-registration observation the most frequent side effects were: itching, burning and pain at the site of application.

frequency is unknown - hypersensitivity reactions (including angioedema, swelling of the eyes, swelling of the face, shortness of breath), exacerbation of bronchial asthma.

Violation of the skin and subcutaneous tissues:

infrequently - contact dermatitis, acne (acne).

General disorders and disorders at the place of use:

very often - at the site of application: itching, burning, pain;

often - at the site of application: dryness, rash, paresthesia, edema **;

rarely - at the site of application: erythema (redness), desquamation * (epidermis detachment), sensation of heat, depigmentation (discoloration) of the skin, discomfort **, urticaria *; frequency is unknown: irritation on the skin, urticaria.

If any of the side effects indicated in the instruction are aggravated, or you have noticed any other side effects not indicated in the instruction, inform your doctor.

Footnotes: * - for acne, ** - for rosacea.

Overdose

Phenomena of overdose with external use is not installed.

Interaction with other drugs

Clinically significant interactions at use of the drug Skinoren® are not revealed.

special instructions

For external use only. Avoid getting the gel in the eyes, mouth and other mucous membranes. In case of accidental ingestion of the drug on the mucous membranes, including the eyes, mouth, it is necessary to wash them with plenty of water.If eye irritation persists, consult a doctor. After each use of Skinoren®, hands should be washed. During treatment with Skinoren® rosacea, it is recommended not to use cosmetics with an alcohol content, alcohol solutions and astringents, abrasives or exfoliating agents (for peeling). Skinoren® contains benzoic acid, which can cause irritation to the skin, irritation of the eyes and mucous membranes, and propylene glycol, which can cause irritation to the skin. During post-registration follow-up, rarely an exacerbation was reported in asthma patients with topical azelaic acid. Read the instructions carefully before you start using the drug. Save the instructions, it may be necessary again. If you have any questions consult your doctor.

The drug that you are treating is intended for you personally and should not be passed on to other persons, because it can harm them even if you have the same symptoms as you.

Influence on ability to steer vehicles, mechanisms

Skinoren® does not affect the ability to drive and work with mechanisms.

Release form:

Gel for external use of 15% on 5 g, 30 g or 50 g in the aluminum, laminated by polyethylene tube with the screw-on cover. The tube with the instruction for application is placed in a cardboard pack.

Shelf life

3 years.

Do not use after expiration date.

Storage conditions

At a temperature not higher than 30 ° C.

Keep out of the reach of children.

Vacation conditions

Let go without a prescription.