Advantan cream 0.1% 15g

Tradename:

Advantan

International non-proprietary name or grouping name

Methylprednisolone aceponate.

Dosage Form

Cream for external use.

Composition

1 g of cream contains:

Active ingredient: methylprednisolone aceponate 0.001 g.

Auxiliary substances: decyloleate - 0.100 g, glyceryl monostearate 40-55% - 0.085 g,

cetyl steryl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) - 0, 025 g, fat

solid - 0.025 g, softizan-378 - 0.075 g, macrogol stearate - 0.030 g, glycerol 85% -

0.050 g, disodium edetate - 0.001 g, benzyl alcohol - 0.010 g, butylhydroxytoluene -

0.00006 g, purified water - 0.59794 g.

Description

White or yellowish opaque cream.

Pharmacotherapeutic group

Glucocorticosteroid for topical use.

Pharmacological properties

The active ingredient of Advantan, methylprednisolone aceponate, is a non-halogenated steroid.

Pharmacodynamics

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 methylprednisolone aceponate is used externally at 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), no development of skin atrophy, telangiectasia, striae and acne-like rashes were detected.

Methyl prednisolone aceponate (especially its main metabolite, 6α-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to specific parts of the DNA of the cells of the immune response, thus causing a series of biological effects.

In particular, the binding of a steroid-receptor complex to the DNA of 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 leukotrienes.

Inhibition of the synthesis of vasodilating prostaglandins by glucocorticoids and the potentiation of the vasoconstrictive action of adrenaline lead to a vasoconstrictor effect.

Pharmacokinetics

Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis. The main and most active metabolite is 6α-methylprednisolone-17-propionate, which has a significantly higher affinity for glucocorticoid receptors of the skin, which indicates the presence of its "bioactivation" in the skin.

The degree of percutaneous absorption depends on the condition of the skin, the dosage form and the 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 (0.5-1.5%).

After entering the systemic circulation, 6α-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid and thus inactivated.

Metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys with a half-life of about 16 hours. Methylprednisolone aceponate and its metabolites do not accumulate in the body.

Indications for use

Inflammatory diseases of the skin that are sensitive to glucocorticosteroid therapy:

• atopic dermatitis, neurodermatitis, children eczema;
• true eczema;
• microbial eczema;
• professional eczema;
• simple contact dermatitis;
• allergic (contact) dermatitis;
• dyshidrotic eczema.

Contraindications

• tuberculous or syphilitic processes in the field of drug application;
• viral diseases (for example, chicken pox, shingles) in the area of ​​application of the drug;
• rosacea, perioral dermatitis in the area of ​​application of the drug;
• children's age up to 4 months;
• skin areas with manifestations of reaction to vaccination.
• hypersensitivity to the drug.

Pregnancy and lactation

If necessary, use of Advantan cream 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 large skin surfaces 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.

In subacute and acute inflammation without pronounced soak, a dosage form with a low fat content and high water content is required. Advantan cream provides the elimination of the inflammatory process on smooth skin and scalp, including on skin prone to gironsty.

Side effect

Usually the drug is well tolerated.

Very rarely (less than in 0.01% of cases) local reactions can be observed, such as itching, burning, erythema, and the formation of 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 corticosteroid absorption. In clinical studies, none of the above side effects were noted with Advantan used for up to 12 weeks in adults and up to 4 weeks in children.

In rare cases (0.01% - 0.1%), folliculitis, hypertrichosis, perioral dermatitis, depigmentation of the skin, allergic reactions to one of the components of the drug can be observed.

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 ringworms, in addition to treatment with Advantan, specific antibacterial or antimycotic treatment is necessary.

Avoid contact with eyes.

As with the use of systemic glucocorticosteroids, glaucoma may develop after external use of glucocorticosteroids (for example, when using large doses or very long use of occlusive dressings or on the skin around the eyes).

Influence on ability to steer vehicles, mechanisms

Not found.

Release form

Cream for external use of 0.1% in 5, 10, 15, 20, 25, 30 and 50 g in an aluminum, laminated with polyethylene tube, sealed with a membrane, with a screw-on plastic cap. The tube together with the instructions for use is placed in a cardboard box.

Storage conditions

Store at a temperature not higher than 25 ºС. Keep out of the reach of children.

Shelf life

3 years.

Do not use after expiration date.

Pharmacy sales terms

Without a prescription.