Aknestop

General characteristics. Structure:

Active ingredient: 1 g of cream contains the azelaic acid in terms of 100% dry matter of 200 mg;
excipients: the benzoic acid of 2 mg, глицерол monostearate 40-55, a macrogoal the 20th stearate, "CUTINA CBS", octyllauryl alcohol, propylene glycol, glycerin, the water purified.

Pharmacological properties:

It is considered that the therapeutic effectiveness of drug at treatment of an acne is predetermined by its antimicrobic action and direct influence on a follicular hyperkeratosis.
Drug causes considerable decrease in density of colonization of Propionibacterium acnes and considerable reduction of fraction of free fatty acids in lipids of a surface of skin.
In vitro and in vivo azelaic acid inhibits proliferation of keratinotsit, normalizes disturbance of processes of terminal differentiation of epidermis at formation of an acne. The azelaic acid has an inhibiting effect which depends on a dose and duration of treatment, on growth and viability of pathological melanocytes. Molecular mechanisms on which this process proceeds finally are not found out. On the basis of the data which are available currently it is supposed that the main effects of the azelaic acid at treatment of a melazma are caused by inhibition of synthesis of DNA and/or inhibition of breath of cells of patologichny melanocytes. A research of system portability after repeated oral and external use of the azelaic acid did not reveal any signs that even in extreme conditions, for example when drawing on the big square and/or at occlusion it is possible to expect development of side effects. After putting cream the azelaic acid gets into all layers of skin of the person.
Penetration happens with greater speed through the affected skin, than through not affected skin. After one-time drawing on the surface of skin of 1 g of the azelaic acid (5 g of cream) 3,6% of the put dose are subcutaneously adsorbed. A part of the azelaic acid adsorbed through skin is excreted with urine in an invariable look. Other part breaks up by β-oxidation to dicarboxylic acids with shorter length of a chain (C7,C5) which were also found in urine.

Indications to use:

Treatment of an acne (eels ordinary) and melazma.

Route of administration and doses:

To apply cream locally. The mode of dosing and duration of therapy are established by the doctor individually. Before cream use Aknestop skin should be washed out carefully clear water or
the soft cosmetic clearing means. Then skin is completely dried up and cream is applied on dry skin. To apply cream 2 times a day (in the morning and in the evening) on affected areas of skin and to rub softly. About 0,5 g = are enough 2,5 cm of cream for all surface of a face. It is important to provide regular use of cream during all course of treatment. Duration of a course of treatment can change depending on an individual picture of a disease and be defined by degree of its expressiveness. At patients with an acne significant improvement is usually observed, as a rule, approximately in 4 weeks. However for achievement of optimum result it is recommended to use drug continuously in
current of several months (as much as possible up to 6 months). The minimum period of use of drug at treatment of a melazma makes about 3 months. In the course of treatment of a melazma for prevention of the aggravations caused by sunlight and/or a repigmentation of sites of skin which are irradiated with the sun it is necessary to use surely sun-protection drugs with a high factor
protection against all range of sunlight. In case of excessive irritation of skin it is necessary to reduce the frequency of use of cream to 1 time a day, before disappearance of irritation, or to interrupt therapy for several days. After disappearance of symptoms of irritation of skin it is necessary to recover regular use of cream in the recommended dose.

Features of use:

Use during pregnancy or feeding by a breast. Appropriate and well controlled researches of drugs of the azelaic acid for external use with participation of pregnant women were not conducted. Pregnant women should use drug with care. Quantity
the azelaic acid which can potentially get to the child's organism with breast milk in days, extremely low. In pilot studies on animals the negative impact of cream with the azelaic acid on reproductive function was not revealed, and also it is not established embriotoksichny and teratogenic effect of drug. However women during feeding by a breast should use drug with care.
Ability to influence speed of response at control of motor transport or work with other mechanisms.
Does not influence.
Children.
Safety and efficiency of use of drug is not established to children up to 12 years. At cream use Aknestop to children at the age of 12 years is also more senior dose adjustment it is not required.

Side effects:

Frequency of side reactions was defined according to MedDRA: very often (≥1/10); often (from ≥ 1/100 to <1/10); infrequently (from ≥ 1/1000 to <1/100); seldom (from ≥ 1/10000 to <1/1000), it is very rare (<1/10000), frequency is unknown (it cannot be estimated on the basis of the existing data).

Disturbances from skin and hypodermic cellulose: infrequently – seborrhea, an acne, a skin depigmentation; seldom – a cheilitis (an inflammation of lips), rashes.

Local disturbances: very often – burning, an itch and an erythema, is frequent – a peeling, pain, dryness, discoloration of skin and irritation in the place of use; infrequently – paresthesias, dermatitis, discomfort and hypostasis in the place of use; seldom – vesicles, eczema, a caumesthesia and an ulcer in a site of application. Usually local irritations of skin disappear during treatment.
Frustration from immune system: seldom – hypersensitivity. Cases of an aggravation of symptoms of bronchial asthma at patients who applied the azelaic acid are recorded (frequency is unknown).
At emergence of any undesirable effects, including not specified in this instruction it is necessary to tell the doctor.
Local portability of drug at children of 12 years is also more senior is similar to portability at adult patients.

Interaction with other medicines:

Interaction with other medicines is not described so far. The azelaic acid is chemically incompatible with alkalis, strong oxidizers and reducers.

Contraindications:

Hypersensitivity to active ingredient or to any other of drug excipients.
Appropriate security measures at use.
Only for external use. Hit of cream in eyes, an oral cavity or on mucous membranes is not allowed. If drug got into eyes, an oral cavity or on mucous membranes, it is necessary to wash out immediately their large number waters. If the irritation of eyes proceeds, recommended to see a doctor. After each putting cream it is necessary to wash up hands. Melazma located in epidermis or at the same time in epidermis and a derma will well respond to treatment. But if the melazma is located only in a derma, then it is not susceptible to such treatment. For carrying out differential diagnosis like melazma it is recommended to use Wood's lamp. The benzoic acid can causes moderate irritation of skin, eyes and mucous membranes. Propylene glycol can also cause irritation of skin.

Overdose:

It was not recorded cases of acute intoxication at excessive one-time putting drug on the big surface of skin or at unintentional oral administration.

Storage conditions:

Period of validity 2 years. To store in original packaging at a temperature not above 25 °C. Not to freeze.
To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

On 30 g in tubas, 1 tuba in a pack.