Advantan ointment fat 0.1% 15g
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Description
White or slightly yellowish translucent fatty ointment.
Active ingredients
Methylprednisolone aceponate
Release form
Ointment
Composition
1 g ointment (fatty) contains the Active ingredient: methylprednisolone aceponate 0.001 g. Excipients: white soft paraffin - 0.425 g, liquid paraffin - 0.394 g, microcrystalline wax - 0.150 g, castor oil, hydrogenated - 0.030 g.
Pharmacological effect
When applied externally, Advantan suppresses inflammatory and allergic skin reactions, as well as those associated with enhanced proliferation, which leads to a decrease in the objective symptoms of inflammation (erythema, edema, oozing, etc.) and subjective sensations (itching, irritation, pain and etc.). When using methylprednisolone aceponate externally in the recommended dose, the systemic effect is minimal in both humans and animals. After repeated application of Advantan on large surfaces (40-60% of the skin surface), as well as application under the occlusive dressing, there are no violations of the adrenal functions: plasma cortisol level and its circadian rhythm remain within the normal range, and there is no decrease in cortisol level in daily urine. In clinical studies with Advantan up to 12 weeks in adults and up to 4 weeks in children (including young children), there was no development of skin atrophy, telangiectasias, striae and acne-like rashes. Methylpredni aceponate Olona (particularly, its major metabolite - 6a metilprednizolon--17-propionate) binds to intracellular receptors glucocorticosteroid. The steroid-receptor complex binds to certain parts of the DNA of the cells of the immune response, thus causing a series of biological effects. In particular, the binding of the steroid-receptor complex to the DNA of the cells of the immune response leads to the induction of macrocortin synthesis. Macrocortin inhibits the release of arachidonic acid and, thereby, the formation of inflammatory mediators such as prostaglandins and leukotrienoids.
Pharmacokinetics
Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis.The main and most active metabolite is 6a-methylprednisolone-17-propionate, which has a significantly higher affinity for the glucocorticosteroid receptors of the skin, which indicates the presence of its "bioactivation" in the skin. Percutaneous absorption depends on the skin condition, dosage form and method of application ( with or without an occlusive dressing). Percutaneous absorption in children and adults with atopic dermatitis (neurodermatitis) and psoriasis was no more than 2.5%, which is only slightly higher compared with healthy volunteers. with limbs (0.5-1.5%). After entering the systemic circulation, 6a-methylprednisolone-17-propionate is quickly conjugated with glucuronic acid and, thus, in the form of 6-methylprednisolone-17-propionate, glucuronide is inactivated. mainly by the kidneys with a half-life of about 16 hours. Methylprednisolone aceponate and its metabolites do not accumulate in the body.
Indications
Inflammatory skin diseases sensitive to treatment with topical glucocorticosteroids: • atopic dermatitis, neurodermatitis, children's eczema, • true eczema, • microbial eczema, • professional eczema, • simple contact dermatitis, • allergic (contact) dermatitis, • dishydrotic eczema.
Contraindications
• tuberculosis or syphilitic processes in the area of drug application, • viral diseases (eg, chicken pox, shingles), in the area of drug application, • rosacea, perioral dermatitis in the area of drug application, • children up to 4 months, • skin areas with manifestations of the reaction to vaccination, • hypersensitivity to the components of the drug.
Use during pregnancy and lactation
If necessary, the use of ointment (oily) Advantan during pregnancy and lactation should carefully weigh the potential risk to the fetus and the expected benefit of treatment for the mother. During these periods, prolonged use of the drug on the extensive surfaces of the skin is not recommended. Nursing mothers should not put the drug on the mammary glands.
Dosage and administration
Outwardly. Adults and children from 4 months of age. The drug is applied 1 time per day with a thin layer on the affected skin. As a rule, the duration of continuous daily treatment with Advantan should not exceed 12 weeks for adults and 4 weeks for children. For the treatment of long-term chronic inflammatory skin processes with very dry skin, an anhydrous dosage form is necessary.The occlusal effect of oily ointment Advantan provides a pronounced therapeutic effect even with significant lichenification and infiltration.
Side effects
Usually, the drug is well tolerated. Very rarely (less than in 0.01% of cases) local reactions can occur, such as itching, burning, erythema, and vesicular rash. If the drug is used for more than 4 weeks and / or over an area of 10% or more of the body surface, the following reactions may occur: skin atrophy, telangiectasia, stretch marks, acneform skin changes, systemic effects due to absorption of a corticosteroid. In clinical studies, none of the above side effects were noted when using Advantan ointment for up to 12 weeks in adults and up to 4 weeks in children. In rare cases (0.01% - 0.1%) folliculitis may be observed. hypertrichosis, perioral dermatitis, skin depigmentation, allergic reactions to one of the components of the drug.
Overdose
When studying the acute toxicity of methylprednisolone aceponate, there was no risk of acute intoxication in case of excessive single skin application (application of the drug over a large area under conditions favorable for absorption) or unintentional ingestion. With excessively long and / or intensive use of glucocorticosteroids, skin atrophy may develop (thinning of the skin, telangiectasia, striae). With the appearance of atrophy, the drug must be canceled.
Interaction with other drugs
Not found.
special instructions
In the presence of bacterial complications and / or dermatomycosis, in addition to treatment with Advantan, specific antibacterial and / or antimycotic treatment is necessary. Contact with the drug should be avoided. As with systemic corticosteroids, glaucoma may develop after external use of glucocorticosteroids (for example, when using large doses or very long-term use of occlusive dressings or on the skin around the eyes).
Storage conditions
Store at a temperature not higher than 25 ° С. Keep out of the reach of children.