Active substanceAzelaic acidAzelaic acid
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  • Dosage form: & nbspcream for external use
    Composition:

    Ingredients per 100 g of cream:

    Active substance: azelaic acid - 20.00 g;

    Excipients: benzoic acid 0.20 g, glyceryl stearate and macrogol-30 stearate 5.00 g, glyceryl stearate and cetostearyl alcohol and cetyl palmitate and coconut oil fatty acid glycerides 7.00 g, cetearyl ethyl hexanoate 3.00 g, propylene glycol 12, 50 g, glycerol (glycerol) - 1.50 g, purified water - up to 100.00 g.

    Description:The cream is white.
    Pharmacotherapeutic group:Acne rash remedy
    ATX: & nbsp

    D.10.A.X.03   Azelanic acid

    Pharmacodynamics:

    Causes a moderate cytotoxic effect (due to inhibition of the synthesis of cellular proteins), manifested in the normalization of keratinization processes in the wall of sebaceous follicles; antimicrobial effect (especially in relation to Propionibacterium acnes and Staphylococcus epidermidis) both on the surface of the skin and in the sebaceous glands, as well as the anti-inflammatory effect (reducing the metabolism of neutrophilic granulocytes and the production of free radical forms of oxygen - important factors in supporting the inflammatoryprocess).

    With prolonged use of the drug, no resistance is formed microorganisms.

    Azelaic acid dose-dependently inhibits the growth and viability of abnormal melanocytes. The therapeutic effect of hyperpigmentation (melasma) is due to inhibition of DNA synthesis and / or suppression of cellular respiration of abnormal melanocytes.

    Pharmacokinetics:

    Suction

    After application on the skin azelaic acid penetrates into the epidermis and dermis. After applying to the skin 1 g of azelaic acid (corresponding to 5 g of cream), about 4% of the dose is absorbed into the systemic bloodstream.

    Excretion

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

    Indications:

    - Acne vulgaris (acne vulgaris);

    - Hyperpigmentation of the melasma type, for example, chloasma.

    Contraindications:

    - Hypersensitivity to azelaic acid and other components of the drug;

    - Children under 12 years.

    Pregnancy and lactation:

    During pregnancy and during breastfeeding, the drug should be used only in the event that,if the intended benefit to the mother exceeds the possible risk to the fetus and the baby. It is necessary to avoid applying cream on the area of ​​the mammary glands before feeding.

    Dosing and Administration:

    Outwardly.

    The maximum duration of therapy depends on the individual pattern of the disease and the severity of the symptoms and is determined by the attending physician.

    Adults and children over 12 years of age are given a uniformly raked layer 2 times / day. (morning and evening) to pre-cleaned (with mild cleansers and water) and dried skin of the face and, if necessary, the neck and upper chest, affected by acne. For the entire surface of the face is about 2.5 cm column of cream. The drug should be used regularly throughout the course of treatment, the duration of which depends on the severity of the disease. The minimum duration of treatment for melasma is 3 months. During the treatment of melasma, sunscreen should be used (UV In and UV A) in order to prevent the exacerbation of the disease and / or re-pigmentation of the skin under the influence of the sun.

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

    Side effects:

    Adverse reactions are presented depending on the frequency of development: very often (> 1/10); often (> 1/100 to <1/10); infrequently (> 1/1000 to <1/100), rarely (> 1/10000 to <1/1000), very rarely (<1/10 000), is unknown (can not be estimated based on available data).

    Disturbances from the skin and subcutaneous fat:

    Infrequently: seborrhea, acne, depigmentation of the skin;

    Rarely: cheilitis;

    General disorders and disorders at the site of administration:

    Often: itching, burning, erythema at the site of application;

    Often: peeling, pain, dryness, discoloration, irritation at the site of application; Infrequently: paresthesia, dermatitis, discomfort, edema at the site of application;

    Rarely: vesicular eruptions, eczema, sensation of heat, rash at the site of application; Immune system disorders:

    Rarely: drug hypersensitivity, worsening of the course of bronchial asthma. As a rule, local skin irritations pass independently during treatment.

    Overdose:

    Currently, cases of an overdose of the cream is not described.

    Interaction:

    The interaction of the drug with other drugs has not been known to date.

    Special instructions:

    The drug is intended for external use only.It should be avoided on the mucous membrane of the eyes, nose, mouth, as it can cause irritation when accidentally ingested in the eyes, they should be washed immediately with running water. In cases of severe skin irritation in the first weeks of treatment, the skin can be applied 1 time / day or reduce the amount of cream applied to the skin; also a short-term cancellation of the drug is possible. After the disappearance of symptoms of skin irritation, you should resume regular use of the drug at the recommended dose.

    Dermal melasma is insensitive to drug treatment. To carry out differential diagnosis, use a Wood lamp.

    The skin can be used in combination with other methods of therapy for acne. It is possible to correct the dosage regimen of concurrently used drugs.

    Effect on the ability to drive transp. cf. and fur:

    The drug does not affect the management of vehicles and employment of other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:Cream for external use 20%.
    Packaging:

    10 or 30 grams of aluminum tubes.

    By 10, 15, 20, 25, 30 or 50 g in cans of dark glass such as BTS made of glass fiber with pull-on lids. The label is self-adhesive on the can.

    Each tube or jar, together with the instruction for use, is placed in a cardboard package (pack) of cardboard for consumer containers.

    It is allowed to bundle 2 or 3 cardboard packages (packs) into a group package (shipping container) from cardboard for consumer packaging.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002786
    Date of registration:24.12.2014
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.12.2014
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