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medicalmeds.eu Medicines Remedy for acne rash. Skinonorm

Skinonorm

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Producer: LLC Pharmtekhnologiya Republic of Belarus

Code of automatic telephone exchange: D10AX03

Release form: Soft dosage forms. Gel for external use.

Indications to use: Pink eels (rozatsea). Acne. Post-acne.


General characteristics. Structure:

Active ingredient: 150 mg of the azelaic acid in 1 g of gel.

Excipients: propylene glycol, polysorbate 80, sorbitan stearate, carbomer, the castor oil which is not refined sodium hydroxide, dinatrium эдетат, the benzoic acid, water purified.




Pharmacological properties:

Pharmacodynamics. Acne disease. It is considered that the therapeutic effectiveness of the azelaic acid at treatment of an acne is caused by its antimicrobic action and direct influence on a follicular hyperkeratosis.

In vitro and in vivo azelaic acid inhibits proliferation of keratinotsit and normalizes the broken processes of terminal differentiation of epidermis at formation of an acne.

Considerable decrease in density of colonization of Propionibacterium acnes and reduction of fraction of free fatty acids in skin lipids is clinically observed.

Rozatsea. The mechanism of influence of the azelaic acid on pathogenetic links of development of a rozatse is finally not found out. Several researches in vitro and in vivo indicate that the azelaic acid has antiinflammatory effect, reducing education of pro-inflammatory free radicals.

Pharmacokinetics. After external use of gel the azelaic acid gets into all layers of skin. Penetration happens with greater speed through the affected skin, than through unimpaired. After single drawing on the surface of skin of 1 g of the azelaic acid 3,6% of the put dose get to a system blood stream.

Part of the azelaic acid absorbed through skin is removed by kidneys in not changed look. The rest is exposed to β-oxidation, turning into dicarboxylic acids with less short chain (C7, C5) which are also removed by kidneys.

Extent of absorption through skin when putting the azelaic acid 2 times a day does not influence system loading of the azelaic acid received from endogenous sources and as a result of meal.


Indications to use:

Acne disease (easy and average degree papulo-pustular face skin blackheads), papulo-pustular rozatsea.


Route of administration and doses:

Outwardly. Before Skinonorm's use skin should be cleared water or the soft clearing cosmetic, then to dry up. Gel is applied on affected areas of skin and slightly rubbed 2 times a day (in the morning and in the evening).

It is important that during the entire period of treatment gel Skinonorm was used regularly. Duration of a course of treatment can change depending on an individual picture of a disease and is defined by degree of its weight.

In case of irritation of skin it is necessary to reduce either amount of the applied gel, or frequency of use of drug to 1 time a day before disappearance of irritation. If necessary it is possible to interrupt temporarily treatment for several days.

During treatment by gel Skinonorm it is not necessary to use occlusive coverings of affected areas of skin.

Acne disease: At patients with an acne noticeable improvement is noted, as a rule, in 4 weeks, however gel Skinonorm should be applied to achievement of the best results continuously for several months. In the absence of improvement after 1 month of treatment of an acne disease or in case of an exacerbation of a disease it is necessary to stop use of gel and to consider other options of treatment.

Rozatsea: Noticeable improvement is noted, as a rule, in 4 weeks of treatment. If after 2 months of treatment of a rozatse improvement or in case of an exacerbation of a disease is not observed, it is necessary to stop use of gel and to consider other options of treatment.


Features of use:

Drug is intended only for external use. Gel Skinonorm contains the benzoic acid which causes moderate irritation of skin, eyes and mucous membranes, and propylene glycol which can cause irritation of skin.

It is necessary to avoid hit of drug in eyes, in a mouth and on mucous membranes. At accidental hit it is necessary to wash out carefully eyes, a mouth and/or mucous membranes a large amount of water. If the irritation of eyes remains, it is necessary to consult with the doctor. Hands should be washed after each putting drug.

Skinonorm for treatment papulo-pustular a rozatsea is recommended not to use the alcohol-containing clearing means, infusions and the peeling means at gel use.

Pregnancy and feeding by a breast. Appropriate and well controlled researches of drugs of the azelaic acid for external use with the assistance of pregnant women were not conducted.

It is necessary to be careful at purpose of gel Skinonorm to pregnant women. It is unknown whether the azelaic acid with in vivo breast milk is emitted, but the experiment of in vitro shows that penetration of drug into breast milk is possible. The amount of the azelaic acid which can potentially get to the child's organism with breast milk is minimum, nevertheless, to women who nurse, it is necessary to apply with care gel Skinonorm. The child should not adjoin to the skin and a breast processed by drug.

Use for children. Safety and efficiency of use of gel Skinonorm for treatment of an acne disease at children are younger than 12 years is not established. Dose adjustment of drug is not required from teenagers of 12-18 years.

Safety and efficiency of use of gel Skinonorm for treatment of a rozatse at children are younger than 18 years is not established.

Influence on ability of control of vehicles and other difficult mechanisms. Skinonorm does not exert impact on speed of response at control of vehicles or work with other mechanisms.


Side effects:

At use of the drugs for external use containing the azelaic acid side reactions from skin are described. In most cases symptoms have gentle or moderate disposition, the irritation of skin gradually decreases in the course of treatment.

Very frequent side reactions (≥1/10): Complications of the general character and reaction in an injection site: burning, itch and pain on site putting drug;

Frequent side reactions (≥1/100, <1/10): Complications of the general character and reaction in an injection site: dryness, rash and paresthesias on site of putting drug (at treatment of an acne disease), dryness, rash, paresthesias also swelled on site putting drug (at treatment of a rozatse);

Infrequent side reactions (> 1/1000, <1/100): Disturbances from skin and hypodermic fabrics: contact dermatitis (at treatment of an acne disease), contact dermatitis, an acne (at treatment of a rozatse);
Complications of the general character and reaction in an injection site: an erythema, a skin peeling, feeling of warmth and change of coloring of skin on site putting drug (at treatment of an acne disease), an erythema, discomfort, a small tortoiseshell on site putting drug (at treatment of a rozatse);

Rare side reactions (> 1/10000, <1/1000): Disturbances from immune system: hypersensitivity reactions, cases of deterioration in bronchial asthma.


Interaction with other medicines:

Interaction cases with other drugs are not described.


Contraindications:

Hypersensitivity to active ingredient or to any component of drug.


Overdose:

Considering very low local and system toxicity of the azelaic acid, intoxication at one-time overdose (putting cream on the big surface of skin under favorable conditions for adsorption) or at unintentional oral administration is improbable.


Storage conditions:

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


Issue conditions:

Without recipe


Packaging:

On 30,0 g or 50,0 g in the tuba from polymeric materials placed together with a leaf insert in a pack from a cardboard.



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