Instruction for use: Skinoren
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Active substance Azelaic acid
ATX code D10AX03 Azelaic acid
Pharmacological group
dermotropic means
Nosological classification (ICD-10)
L70 Acne
Acne nodulocystica, Acne, Comedone acne, Acne Treatment, Papulous pustular acne, Papulopustulicular acne, Papulo-pustular acne, Acne, Acne Disease, Acne, Acne vulgaris, Nodular-cystic acne, Nodular-cystic acne
L81.1 Chloasma
Mask of pregnant women (chloasma), Melasma (Chloasma)
L81.8.0 * Hyperpigmentation
Cronkheta-Canada syndrome, Melasma, Pathological hyperpigmentation
Composition
Cream for external use 1 g
active substance:
azelaic acid 0.2 g
auxiliary substances: benzoic acid - 0,002 g; macrogol glycerol stearate - 0.05 g; (glyceryl stearate, cetostearyl alcohol, cetyl palmitate and glycerides of coconut oil fatty acids) - 0.07 g; cetostearyl ethylcaprolate - 0.03 g; propylene glycol 0.125 g; glycerol 85% - 0.015 g; purified water - 0.508 g
Description of dosage form
Cream: white, opaque, matte.
pharmachologic effect
Pharmacological action - anti-inflammatory, antibacterial, keratoregulating.
Pharmacodynamics
Azelaic acid normalizes the disturbed processes of keratinization in the follicles of the sebaceous glands, and also reduces the content of free fatty acids in the lipids of the skin. It shows antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. Azelaic acid has a dose and time-dependent inhibitory effect on the growth and viability of abnormal melanocytes.
Pharmacokinetics
Virtually not absorbed into the systemic circulation (about 3.6% when applying 5 g of cream). Part of the absorbed acid is excreted by the kidneys unchanged, part - in the form of dicarboxylic acids (C7, C5), formed as a result of beta-oxidation.
Indications
acne vulgaris;
hyperpigmentation of the melasma type (eg, chloasma).
Contraindications
Hypersensitivity to the components of the drug.
pregnancy and lactation
The use of the drug during pregnancy and lactation is possible after agreement with the doctor, however, it is necessary to avoid applying it to the area of the mammary glands before feeding.
Side effects
At the beginning of treatment, it is rarely possible for a local irritant effect, flushing and flaky skin, burning, erythema, itching. In most cases, side effects are mild, stop during treatment and do not require drug withdrawal. In very rare cases, allergic skin reactions may occur (for example, rash)
In case of skin irritation, one-time application of the drug should be reduced or the frequency of application reduced to 1 time per day. If necessary, it is possible to interrupt the treatment temporarily for several days.
Interaction
Not found.
Dosing and Administration
Outwardly. Adults and children from 12 years. Before applying Skinoren, the skin should be cleaned with water or a mild cleansing cosmetic, then dried.
Apply to affected areas of the skin and lightly rub twice a day (morning and evening). Approximately 2.5 cm of cream is sufficient for the entire surface of the face. It is important that Skinoren is used regularly throughout the treatment period. The duration of treatment depends on the individual picture of the disease and the severity of the symptoms. With acne, improvement is usually observed after 4 weeks of treatment. However, to achieve better results, it is recommended to continue the use of the drug for several months. Additional protection of the skin from UV radiation during the treatment of acne is not required.
With melasma, the minimum course of treatment is approximately 3 months. For best results, Skinoren should be used regularly. During the treatment of melasma, sunscreens (UV B and UV A) must be used to prevent the exacerbation of the disease and / or the re-pigmentation of the bleached areas of the skin under the influence of the sun.
Overdose
Up to now, there is no information on overdose.
special instructions
The drug is intended for external use only.
It is necessary to avoid getting the drug in the eyes, as well as on the 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 are well suited to treatment with Skinoren. Dermal melasma - on the contrary, Skinoren is not treated. For differential diagnosis, it is recommended to use a Wood lamp.
Form of issue
Cream for external use, 20%. In an aluminum tube sealed with a membrane sealed with a screwed plastic cap, 30 g. Tuba in a cardboard bundle.
Conditions of leave from pharmacies
Without recipe.
Storage conditions
At a temperature not exceeding 30 ° C.
Keep out of the reach of children.
shelf life
3 years.
Do not use after the expiry date printed on the package.