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Description
White opaque smooth cream.
Active ingredients
Azelaic acid
Release form
Cream
Composition
1 g of cream contains the Active ingredient: azelaic acid 0.2 g. Excipients: benzoic acid 0.002 g, macrogol glyceryl stearate 0.05 g, mixture of glyceryl stearate, cetostearyl alcohol, cetyl palmitate and glyceride fatty acids of coconut oil 0.07 g, cetostearyl ethyl caproate , 03 g, propylene glycol 0.125 g, glycerol 85% 0.015 g, purified water 0.508 g.
Pharmacological effect
Azelaic acid in the treatment of acne normalizes impaired keratinization processes in the follicles of the sebaceous glands, reduces the content of free fatty acids in the skin lipids. Shows antimicrobial activity against Propionobacterium acnes and Staphylococcus epidermidis. The anti-inflammatory effect is also 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. The molecular mechanisms of this effect are not fully established. Available data suggest that the main effect of azelaic acid in the treatment of melasma is associated with inhibition of DNA synthesis and / or cell respiration in abnormal melanocytes.
Pharmacokinetics
After application to the skin, azelaic acid penetrates into the epidermis and dermis, penetration into damaged skin occurs faster than into intact skin. After a single external application of 5 g of cream, 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
Acne rash of mild and moderate severity, including the presence of papules and pustules. Hyperpigmentation type melasma, for example chloasma.
Contraindications
Hypersensitivity to azelaic acid and other components of the drug; children's age up to 12 years (acne), up to 18 years (melasma-type hyperpigmentation).
Precautionary measures
In case of bronchial asthma.
Use during pregnancy and lactation
The use of the drug during pregnancy and lactation is possible only 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 precisely known whether azelaic acid enters breast milk. Given the low systemic absorption of azelaic acid when applied externally, during breastfeeding, Skinoren® is used only if the intended benefit to the mother outweighs the potential risk to the baby. During breastfeeding, it is necessary to avoid applying the drug to the area of the mammary glands before feeding; avoid contact of children with skin, including skin of the mammary glands, after applying Skinoren®.
Dosage and administration
Outwardly. Before applying the cream, rinse the skin thoroughly with clean water and then dry it, or use a mild cleansing cosmetic. Do not use occlusive dressings. Hands should be washed after each application to the skin. The cream is applied with a thin layer on the affected skin 2 times a day (morning and evening), gently rubbing into the skin (2.5 cm of cream 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 melasma has not been established. It is important that Skinoren® is used regularly throughout the entire 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, the treatment of acne may use Skinoren® for several months. At treatment of a melasma the minimum period of use of the drug Skinoren® - 3 months. During the treatment of melasma, sunscreens with a wide range of UV protection (UVA and UVB) (UVA and UVB) should be used to prevent exacerbation of the disease and / or re-pigmentation of the clarified skin when exposed to the sun.If within 1 month in the treatment of acne and 3 months in the treatment of melasma there was no improvement or an exacerbation of the disease occurred, then you should stop using Skinoren® and consult a doctor. In case of irritation on the skin, reduce the amount of cream with each application or reduce the frequency of application of the cream 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 effects
Observed in clinical studies and during post-registration observation, the most frequent side effects were: burning, itching, and erythema at the site of application. Immune system disorders: frequency is unknown - hypersensitivity reaction (including angioedema, contact dermatitis, eye edema, swelling of the face), exacerbation of bronchial asthma. 4 Violations of the skin and subcutaneous tissues: rarely - seborrhea, acne (acne), depigmentation (discoloration) of the skin; rarely cheilitis. Common disorders and disorders at the site of application: very often - at the site of application: burning, itching, erythema (redness); often - at the site of application: desquamation (epidermis detachment), pain, dryness, discoloration of the skin, irritation of the skin; infrequently - paresthesia, dermatitis, discomfort, edema; rarely - at the site of application: rash, eczema, sensation of heat, ulcers; frequency is unknown - rash, 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.
Overdose
To date, information about overdose is not available.
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 cream in the eyes, mouth and other mucous membranes. In case of accidental contact of the cream with mucous membranes, including eyes, mouth, it is necessary to wash them with plenty of water.If eye irritation persists, then you should consult a doctor. Hands should be washed after each use of Skinoren® cream. Melasma, located in the epidermis or simultaneously in the epidermis and dermis, responds well to treatment with Skinoren®. Melasma, located only in the dermis, is insensitive to treatment. For carrying out differential diagnostics use Wood's lamp. 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 patients with bronchial asthma after topical application of azelaic acid. Read the instructions carefully before you start using the drug. Save the instructions, you may need them again. If you have any questions, consult your doctor. The medication with which you are being treated is intended for you personally, and should not be passed on to others, since it can harm them even if you have the same symptoms as you. Influence on the ability to drive vehicles, machinery: Skinoren® preparation does not affect the ability to drive and work with machinery.
Storage conditions
To store the opened aluminum tuba within 6 months. At a temperature not higher than 30 ° C. Keep out of the reach of children.