The instruction for medical use
of Skinoren® medicine
the Trade name
the International unlicensed name
the Dosage form
Cream of 20%
of 1 g of cream contains
active agent – the azelaic acid micronized 0, 2 g,
excipients: benzoic acid, arlaton 983 S, cutin of CBS, propylene glycol, glycerin of 85%, water purified tsetirit oktanoat.
White opaque cream.
Drugs for treatment of acne rash. Other drugs for topical treatment of acne rash.
The code of automatic telephone exchange D10AX03
Pharmacokinetics Later properties of local putting cream azelaic acid gets into all layers of skin. Penetration happens quicker in the injured skin, than in healthy. After single topical administration of 1 g of azelaic acid (1 g of cream) about 3.6% of the put dose are soaked up. A part of the soaked-up acid is removed by kidneys in not changed look. The rest in the form of the dicarboxylic acids from the chain (C7, C5) shortened by length which are formed as a result of beta oxidation is removed also by kidneys.
Is considered that the therapeutic effectiveness of Skinoren cream at treatment of an acne is caused by its antimicrobic action and direct influence on a follicular hyperkeratosis. Considerable decrease in density of colonization of Propionibacterium acnes and significant reduction of fraction of free fatty acids in lipids of a surface of skin is clinically observed. In vitro and in Vivo azelaic acid inhibits proliferation of keratinotsit and normalizes disturbance of processes of terminal differentiation of epidermis at formation of an acne. On model of a rabbit ear azelaic acid accelerates komedolizis the induced tetradecanomas of comedones. Experimental results show that azelaic acid has the inhibiting effect depending on a dose and duration of treatment on growth and viability of pathological melanocytes. Molecular mechanisms on which this process happens finally are not found out. On the basis of the available data it is supposed that the main effects of azelaic acid at treatment of a melazma are caused by inhibition of synthesis of DNA and/or inhibition of cellular respiration of pathological melanocytes.
– an acne disease ((acne vulgaris)
– a melazma type hyperpegmentation, for example a hloazma
the Route of administration and doses
Outwardly. Cream is applied on affected areas of skin and slightly rubbed 2 times a day (in the morning and in the evening). About 2.5 cm of cream are enough for all surface of a face. Before drug Skinoren use the skin should be cleaned with water or the soft cleaning cosmetic, then to dry up. It is important that Skinoren cream was used regularly during the entire period of treatment.
Duration of a course of treatment can change depending on an individual picture of a disease and is defined by degree of its weight. At patients with acne rash the notable improvement is observed, as a rule, in 4 weeks. However for achievement of optimum result it is recommended to use the drug Skinoren continuously for several months. In clinical experience duration of use of drug reached 1 years. At a melazma the minimum course of treatment makes about 3 months. Skinoren cream should be applied to achievement of the best results regularly. During treatment of a melazma it is necessary to apply surely sun-protection creams (UV B and UV A) to prevent exacerbation of a disease and/or repeated pigmentation of the clarified sites of skin under the influence of the sun.
In case of excessive irritation of skin it is necessary to reduce either the number of the put Skinoren of cream, 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.
Very often (≥1/10)
– burning, an itching and hyperaemia on the site of application of drug (by results of clinical trials)
– peeling of skin, pain, dryness, coloring change, irritation on the site of application of drug
– seborrhea, an acne, a skin depigmentation
– paresthesias, dermatitis, discomfort also swelled on the site of application of drug
– bubbles, ulcers, eczema, feeling of warmth on the site of application of drug
– reactions of hypersensitivity
– rash (in the course of post-marketing observations)
the Local irritation of skin usually passes in treatment process.
With an unknown frequency:
– cases of deterioration in bronchial asthma at the patients receiving treatment by azelaic acid (in the course of postmarketinovy observations)
– hypersensitivity to drug components
of Clinically significant interactions at Skinoren’s use cream is not revealed.
instructions Drug it is intended only for external use.
Patsiyentov it is necessary to inform that when using Skinoren’s of cream 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 mucous membranes with 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.
The epidermal and mixed epiyedermalno-dermalny types of a melazma well respond to treatment by Skinoren while the thermal melazma, is not treated by Skinoren. Benzoic acid causes moderate irritation of skin, eyes and mucous membranes. Propilnglikol can cause irritation of skin.
Pregnancy and the period of a lactation
Adequate and controlled researches at topical administration of azelaic acid at women during pregnancy were not conducted. Researches on animals did not reveal straight lines and the mediated adverse effects concerning pregnancy, development of an embryo/fruit, childbirth and post-natal development.
It is necessary to be careful at Skinoren’s appointment of cream to pregnant women.
It is unknown whether azelaic acid with breast milk in the researches in Vivo is emitted. Nevertheless, experience with equilibrium dialysis of in vitro showed that penetration of drug into breast milk is possible. However, it is not expected that penetration of azelaic acid promotes a significant change in its basal level in breast milk as azelaic acid does not concentrate in breast milk and less than 4% of the azelaic acid applied outwardly are absorbed systemically, without increasing its endogenous influence above physiological level.
Nevertheless, the feeding women should be careful when prescribing drug.
Use in pediatrics
Drug is appointed to children 12 years are more senior. Dose adjustment of drug is not required from teenagers of 12-18 years. Safety and efficiency of drug at children are younger than 12 years is not established.
Features of influence of medicine on ability to run motor transport and potentially dangerous mechanisms.
Use of drug does not affect ability to run motor transport and potentially dangerous mechanisms.
Results of a research of acute toxicity do not indicate any risk of developing acute intoxication at single overdose of drug (when drawing on the big surface of skin under conditions, favorable for absorption) or at accidental swallowing drug.
A form of release and packing
Cream for external use of 20% on 30 g in the aluminum, laminated by polyethylene tuba, with the screw-on cover. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a cardboard pack.
To Store storage conditions in the place protected from light at a temperature not above 30 °C.
To store in places inaccessible for children!
Not to use a period of storage of 5 years after an expiration date.
the Producer Intendis Manufacturing of SPA, Italy
Intendis Manufacturing SpA,
Italy Via E.Schering, 2120090 Segrate Milano Italy
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of a product (goods):
TOO Bayer KAZ Timiryazev St., 42, business center Expo-City, peahens. 15
050057 Almaty, Republic of Kazakhstan
ph. +7 727 258 80 40, fax: +7 727 258 80 39,
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