Advantan (Methylprednisolone aceponate)

Inflammatory diseases of the skin, sensitive to treatment with topical corticosteroids:

atopic dermatitis, neurodermatitis, children's eczema,

true eczema,

microbial eczema,

professional eczema (for all forms, except for the emulsion),

simple contact dermatitis,

allergic (contact) dermatitis,

dyshidrotic eczema (for all forms, except for the emulsion).

Optional for the emulsion:

seborrheic dermatitis/eczema,

photodermatitis, a sunburn.

Externally. The drug is applied once a day in a thin layer on the affected areas of the skin for adults and children from 4 months of age.

Cream for external use, ointment for external use, ointment for external use (greasy)

As a rule, the duration of continuous daily treatment with Advantan^® it should not exceed 12 weeks for adults and 4 weeks for children.

Optional for cream for external use

For subacute and acute inflammation without pronounced wetness, a dosage form with a low fat content and a high water content is required. Advantan Cream^® provides the elimination of the inflammatory process both on smooth skin and on the scalp, including on the skin prone to greasiness.

Additionally for ointment for external use

In the case of subacute or chronic inflammatory skin diseases that are not accompanied by wetness, a dosage form with a balanced ratio of fat and water is necessary. Advantan Ointment^® it has a therapeutic effect, also helping to eliminate dry skin and restore its normal fat content.

Additionally for ointment for external use (greasy)

For the treatment of long-term chronic inflammatory skin processes with very dry skin, an anhydrous dosage form is necessary. Occlusive effect of Advantan oil ointment^® provides a pronounced therapeutic effect even with significant lichenification and infiltration.

For emulsion for external use

For the treatment of sunburn, the drug is applied 1-2 times a day, lightly rubbing.

Usually, the course of treatment should not exceed 2 weeks.

If the skin dries excessively when using Advantan emulsion^®, it is necessary to switch to a dosage form with a higher fat content (Advantan ointment^® or fat ointment Advantan^®).

hypersensitivity to the components of the drug,

tuberculosis or syphilitic processes in the area of application of the drug,

viral diseases (including chickenpox, shingles) in the area of application of the drug,

rosacea, perioral dermatitis in the area of application of the drug,

areas of the skin with manifestations of reactions to vaccination,

children under 4 months of age.

Usually the drug is well tolerated.

Very rarely (in less than 0.01% of cases), local reactions may occur, such as itching, burning, erythema, and the formation of a vesicular rash. If the drug is used for more than 4 weeks and/or on an area of 10% or more of the body surface, the following reactions may occur: skin atrophy, telangiectasia, striae, acne-like skin changes, systemic effects due to corticosteroid absorption. In the course of clinical studies, none of the above side effects were observed when using the drug Advantan^® up to 12 weeks in adults and up to 4 weeks in children.

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

When studying the acute toxicity of methylprednisolone aceponate, there was no risk of acute intoxication with excessive single topical application (applying the drug to a large area under conditions favorable for absorption) or unintentional ingestion.

With excessively long and / or intensive topical application of corticosteroids, skin atrophy (thinning of the skin, telangiectasia, striae) may develop. If atrophy occurs, the drug must be discontinued.

The active component of the drug Advantan^® - Methylprednisolone aceponate-is a non-halogenated steroid.

For external use, the drug Advantan^® it suppresses inflammatory and allergic skin reactions, as well as reactions associated with increased proliferation, which leads to a reduction in objective symptoms of inflammation (including erythema, edema, wetness) and subjective sensations (including itching, irritation, pain).

When using methylprednisolone aceponate externally at the recommended dose, the systemic effect is minimal in both humans and animals. After repeated application of the drug Advantan^® on large surfaces (40-60% of the surface of the skin), and when used under occlusive dressing is not marked dysfunction of the adrenal glands: cortisol levels in plasma and its circadian rhythm remains in the normal range, lower cortisol levels in daily urine is not happening.

In the course of clinical studies with the use of the drug Advantan^® up to 12 weeks in adults and up to 4 weeks in children (including young children), the development of skin atrophy, telangiectasia, striae and acne-like rashes was not detected.

Methylprednisolone aceponate (especially its main metabolite, 6α — methylprednisolone-17-propionate) binds to intracellular GCS receptors.

The steroid-receptor complex binds to specific sections of the immune response cells ' DNA, thus causing a series of biological effects. In particular, the binding of the steroid-receptor complex to the DNA cells of the immune response leads to the induction of macrocortin synthesis. Macrocortin inhibits the release of arachidonic acid and thus the formation of inflammatory mediators such as PG and LT.

Inhibition of the GCS synthesis of vasodilating PG and potentiation of the vasoconstrictor effect of epinephrine lead to a vasoconstrictor effect.

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 skin GCS receptors, which indicates the presence of its bioactivation in the skin.

The degree of percutaneous absorption of the ointment and cream depends on the condition of the skin, the dosage form and the method of application (with or without an occlusive dressing).

The intensity of absorption of the emulsion through the skin with artificial inflammation is very low (0.27% of the dose), which is only slightly higher than through healthy skin (0.17%). In the case of whole-body treatment (for example, for sunburn), the systemic dose is about 4 mcg / kg / day, which eliminates systemic effects.

Percutaneous absorption of ointment and cream in children and adults with atopic dermatitis (neurodermatitis) and psoriasis was no more than 2.5%, which is only slightly higher compared to healthy volunteers (0.5–1.5%).

After entering the systemic circulation, 6α-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid and thus inactivated. The metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys with T_1/2 about 16 hours of Methylprednisolone aceponate and its metabolites do not accumulate in the body.

• A glucocorticosteroid for topical application [Glucocorticosteroids]

Not detected.

At a temperature not exceeding 25 °C.

Keep out of reach of children.

cream for external use 0.1% — 3 years.

ointment for external use 0.1% — 3 years.

ointment for external use fat 0.1% — 5 years.

emulsion for external use 0.1% — 3 years. After opening the package — 3 months.

Do not use after the expiration date indicated on the package.

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

Ointment for external application of 0.1%. 5, 15, 20, 25, 30 and 50 g of aluminum, laminated PE tube, sealed with a membrane, with a screw-on plastic cap. The tube is placed in a cardboard box.

Ointment for external use (fat), 0.1%. By 5, 10, 15, 20, 25, 30 and 50 g in an aluminum, laminated PE tube, sealed with a membrane, with a screw-on plastic cap. The tube is placed in a cardboard box.

Emulsion for topical application of 0.1 %. 20 or 50 g each in an aluminum, laminated PE tube, with a screw-on plastic cap. The tube is placed in a cardboard box.

If necessary, the use of the drug Advantan^® During pregnancy and lactation, the potential risk to the fetus and the expected benefit of treatment to the mother should be carefully weighed. During these periods, long-term use of the drug on extensive skin surfaces is not recommended.

Nursing mothers should not apply the drug to the mammary glands.

Without a prescription.

In the presence of bacterial complications and / or dermatomycosis in addition to therapy with Advantan^® specific antibacterial and/or antimycotic treatment should be performed.

Avoid contact with the eyes.

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

Influence on the ability to drive vehicles and work with mechanisms. Not detected.

D07AC14 Methylprednisolone Aceponate

• L20 Atopic dermatitis
• L22 Diaper dermatitis
• L23 Allergic contact dermatitis
• L25 Contact dermatitis, unspecified
• L30. 1 Dyshidrosis [pomfolix]
• L30. 3 Infectious dermatitis
• L30. 9 Unspecified dermatitis
• L71 Rosacea
• L71. 0 Perioral dermatitis
• T88. 1 Other immunization-related complications not elsewhere classified

Cream: white or yellowish opaque.

Ointment: homogeneous white or slightly yellowish opaque.

Greasy ointment: white or slightly yellowish translucent greasy.

Emulsion: white opaque.