Advantan 0.1g of 20% emulsion. (External application)

The instruction for medical use of Advantan Torgovoye medicine a name Advantan Mezhdunarodnoye the unlicensed name of Methylprednisolonum atseponat the Dosage form the Emulsion of 0.1% Structure of 1 g of an emulsion contains active agent – Methylprednisolonum atseponat 1.00 mg excipients: triglycerides of an average chain, Softizan 378, polyoxyethylene-2-stearyl alcohol, polyoxyethylene-21-stearyl alcohol, benzyl alcohol, sodium edetat, glycerin of 85%, the water purified. The description the White opaque emulsion Pharmacotherapeutic group Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids active (Group III). Methylprednisolonum atseponat. ATX D07AC14 code the Pharmacological Methylprednisolonum Pharmacokinetics properties atseponat gets into skin from a basis of a dosage form. Its concentration decreases in the direction from a corneal layer to inside layers of skin. Methylprednisolonum atseponat it is hydrolyzed in epidermis and a derma. The main thing and the most active metabolite is 6α-метилпреднизолон-17-пропионат which contacts kortikoidny receptors of skin in comparison with initial drug stronger that indicates existence of its bioactivation in skin. Degree and intensity of transdermal absorption depends on many factors, such as chemical structure of active agent, structure of a basis of a dosage form, concentration of active agent at the heart of a dosage form, conditions when putting drug (the area of drawing, influence duration, on the open site of skin or under an occlusive bandage) and conditions of skin (type and severity of a disease, anatomic localization). For a research of transdermal absorption of Methylprednisolonum of the atseponat from an emulsion basis artificially changed a condition of skin. Healthy skin was compared to skin with artificial inflammation (with an ultra-violet erythema) and skin with artificial damage (with a remote corneal layer). The intensity of absorption through skin with artificial inflammation was very low (0.24% of a dose) and was slightly above, than through healthy skin (0.15% of a dose). Absorption through skin with a remote corneal layer was much higher (15%) than a dose. At the inflamed skin in case of processing of all body Advantan's emulsion on 20 g 2 times a day the system loading makes about 2 mkg of a metiprednizolon of the atseponat for 1 kg of body weight a day. After hit in a system blood stream the product of primary hydrolysis 6α-метилпреднизолон-17-пропионат is quickly conjugated with glucuronic acid, and thus is inactivated. Atseponat Methylprednisolonum metabolites (from which main thing is 6α-метилпреднизолон-17-пропионат-21-глюкуронид) eliminirutsya, mainly, by kidneys with elimination half-life about 16 hours. After intravenous administration the excretion with urine and a stake came to the end within 7 days. Methylprednisolonum atseponat and its metabolites do not kumulirutsya in an organism. The pharmacodynamics the action Mechanism At external use of Advantan an emulsion suppresses inflammatory and allergic skin reactions, also as well as the reactions connected with the strengthened proliferation that leads to reduction of objective symptoms (an erythema, hypostasis, infiltration) and subjective feelings (itching, burning, pain). Pharmakodinamichesky effects of Methylprednisolonum atseponat (especially its main metabolite – 6α-метилпреднизолон-17-пропионат) contacts intracellular glucocorticoid receptors. The steroid-receptor complex contacts certain sites of DNA, thus, causing a series of biological effects. In particular, binding steroid - a receptor complex with DNA leads to macrocortinum synthesis induction. Macrocortinum inhibits release of arachidonic acid and, thereby, formation of mediators of inflammation of type of prostaglandins and leukotrienes. Immunosuppressive action of glucocorticoids can speak inhibition of synthesis of cytokines and antimitotic effect which is still studied insufficiently. The inhibition glucocorticoids of synthesis of vazodilatiruyushchy prostaglandins or potentiation of vasoconstrictive effect of adrenaline finally is resulted in vasopressor effect. Clinical performance and safety of Only 716 patients aged from 4 months up to 95 years underwent treatment Advantan an emulsion in five clinical trials. In clinical trials the reduction of total number of objective symptoms was considered as a key indicator of efficiency: an erythema, hypostasis, a vesicle, a papule, eczema, an itching and moknutiye throughout the entire period of observation. The overall therapeutic effectiveness (full treatment and obvious improvement) in clinical trials using Advantan's emulsion at patients with different types of eczema was once a day from 82.5% to 88.9% (85% on average). Side effects were observed at 5% of patients who received treatment Methylprednisolonum atseponaty once a day. Observed side effects were from easy to moderate degree of manifestation. Patients of children's age Use Advantan of an emulsion was studied within 2 weeks at 73 children aged from 4 months up to 14 years once a day. The cumulative therapeutic effect was 88.9%. Safety of use of drug for children does not differ from that at adults on the nature of side reactions and their frequency, according to the analysis of data at the children making a small part of the studied population of patients. Indications - acute exogenous eczema (allergic contact dermatitis, irritantny contact dermatitis, numulyarny eczema, disgidrotichesky eczema) - atopic dermatitis (neurodermatitis) - seborrheal eczema the Route of administration and doses Advantan use an emulsion for topical administration and apply 1 time a day with a thin layer on affected areas of skin and slightly rub. As a rule, duration of treatment by Advantan at adults should not exceed 2 weeks. At the significant manifestations of seborrheal eczema duration of treatment of affected areas on a face should not exceed one week. If integuments excessively dry when using an emulsion Advantan that depends on specific feature of skin, additional neutral therapy (an oil-water emulsion or ointment fat single-phase) as means for softening of skin is recommended. Patients of children's age children do not need dose adjustment when assigning an emulsion Advantan at the age of 4 months and is more senior and also to teenagers. It is essentially important that children had minimum treatment duration. Safety of use of an emulsion Advantan at babies is younger than 4 months is not established. Data are absent. Side effects according to clinical trials the most frequent by-effect was - burning in the site of application of drug. Frequency of the side effects observed in clinical trials is distributed on classes of a system of bodies according to MedDRA – the Medical dictionary for regulatory activity: Very often (≥1/10), it is frequent (≥1/100 & lt, 1/10), Infrequently (≥1/1000 & lt, 1/100), is rare (≥1/10000 & lt, 1/1000), Is very rare (& lt, 1/10000), with an unknown frequency (it cannot be calculated from the available data). Often (& gt, 1/100, & lt, 1/10) - burning in the site of application of drug Infrequently (& gt, 1/1,000, & lt, 1/100) - pain, vesiculation, an itching, pustules, erosion in the site of application of drug - eczema, peeling and cracks of skin Also as when using other corticosteroids for topical administration, the following local side reactions with an unknown frequency can be noted: - a skin atrophy, dryness, an erythema, striya, a folliculitis on the site of application of drug, a hypertrichosis, telangiectasias, perioral dermatitis, a diskoloration of skin, an acne and/or allergic skin reactions to any of components of a dosage form. System effects of corticosteroids can be observed at their topical administration owing to drug absorption. Contraindications - hypersensitivity to active agent or to any of drug excipients - tubercular or syphilitic processes in the field of putting drug - viral diseases (for example, chicken pox, shingles) in the field of putting drug - a rozatse, perioral dermatitis, ulcers, acne rash, atrophic diseases of skin, vaccine-challenged skin reactions in the field of putting drug - bacterial and mycotic damages of skin Medicinal interactions are not established Special instructions Glucocorticosteroids it is necessary to apply in small quantities as far as it is possible, especially at children, and duration of treatment has to depend on requirement of achievement and maintenance of desirable therapeutic effect. In the presence of a bacterial dermatosis and/or dermatomycoses in addition to therapy by Advantan it is necessary to carry out specific antibacterial or anti-mycotic treatment. External use of glucocorticosteroids can promote local skin infections. Nonprofessional use of any glucocorticosteroids can hide clinical symptomatology. At use of an emulsion Advantan it is necessary to be careful to avoid hit of drug in eyes, deep open wounds and on mucous membranes. The emulsion Advantan should not be applied on big surfaces (more than 40% of a surface of skin) At use Advantan to ointment of 0.1% for 60% of a surface of skin within 22 hours under an occlusive bandage, suppression of level of cortisol in blood plasma and influence on a circadian rhythm at adult healthy volunteers was observed. Extensive putting drug on big sites of skin for a long time, in particular under an occlusive bandage, considerably increases risk of emergence of side effects. It is necessary to apply an emulsion under an occlusive bandage only on doctor's orders. It must be kept in mind that diapers can create occlusal effect. As well as at use of system corticosteroids, glaucoma at use of local corticosteroids can develop (for example, after high doses, or at prolonged use, under an occlusive bandage or putting drug on skin around eyes). When putting drug on the big surfaces of skin duration of treatment has to be as it is possible well as absorption or system effect of drug cannot be completely excluded. Pregnancy and the period of a lactation Pregnancy Adequate data on atseponat Methylprednisolonum use during pregnancy are absent. Studying Methylprednisolonum of the atseponat at animals showed embriotoksichesky and/or teratogenic effect at use of doses above therapeutic. There are epidemiological data indicating perhaps increased risk of development of not fusion of the sky at newborns whose mothers received treatments by glucocorticoids during the first trimester of pregnancy. At the clinical indication for treatment Advantan an emulsion during pregnancy it is necessary to weigh carefully potential risk and the expected advantage of treatment. As a rule, it is necessary to avoid use of the local drugs containing corticosteroids during the first trimester of pregnancy. In particular, during pregnancy it is necessary to avoid putting drug on the big surfaces of skin, prolonged use or drawing under an occlusive bandage. A lactation It is unknown whether it is allocated Methylprednisolonum atseponat with breast milk as system corticosteroids which as it is reported, can cosecrete with breast milk. It is unknown whether Advantan can lead topical administration of an emulsion to the sufficient system absorption of a metiprednizolon of the atseponat sufficient for its identification in breast milk. Therefore, the feeding women should be careful when prescribing drug. At nursing mothers drug cannot be applied on mammary glands. It is necessary to avoid putting drug on the big surfaces of skin, prolonged use or drawing under an occlusive bandage in the period of a lactation. Use in pediatric practice Advantan an emulsion should not be applied under an occlusive bandage. It must be kept in mind that diapers (pampers) can create occlusal effect that is especially important as Advantan is not recommended to apply an emulsion at children 4 months are younger. Assessment advantage/risk when prescribing drug is necessary for children from 4 months to three years. Features of influence of medicine on ability to drive the car or potentially dangerous mechanisms. The Overdose When studying acute toxicity of Methylprednisolonum of the atseponat does not influence any risk of acute intoxication at excessive single skin use was not revealed (putting drug on the big square under the conditions favorable for absorption) or inadvertent intake. A form of release and packing On 20 g of drug in the tubas corked by plastmassovymikryshka. 1 tuba together with the instruction for use in the state Russian languages is put in a cardboard pack. To Store storage conditions at a temperature not above 25 °C. To store out of children's reach! A period of storage 3 years the use Period after the first opening 3 months. Not to apply after an expiration date. Prescription status According to the prescription the Producer/packer Bayer Helsker Manufacturing of Neuter of l., Segreyt, Italy the Owner of the registration certificate of Bayer Pharm AG, Berlin, Germany 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, pavilion 15, office 301 050057 of Almaty, Republic of Kazakhstan, ph. +7 727 258 80 40, fax: +7 727 258 80 39, e-mail: kz.claims@bayer.com the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine. TOO Bayer KAZ Timiryazev St., 42, pavilion 15, office 301 050057 of Almaty, the Republic of Kazakhstan
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