Advantan cream 0.1%, 15g

Composition

Active ingredient:  

methylprednisolone aceponate 1 mg;

Auxiliary substances:  

deterreat 100 mg,

glyceryl monostearate 40-55% – 85 mg,

cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) – 25 mg,

fat hard – 25 mg,

softisan 378 – 75 mg,

macrogol stearate 30 mg

glycerol 85% – 50 mg,

edetate disodium 1 mg,

benzyl alcohol 10 mg,

the butylhydroxytoluene – 60 mcg,

purified water – 597.94 mg.

Pharmacological action

Advantan – glucocorticoid, anti-allergic, anti-inflammatory.

Pharmacodynamics

The active component of Advantan® – methylprednisolone aceponate-is a non-halogenated steroid. When applied externally, Advantan® suppresses inflammatory and allergic skin reactions, as well as reactions associated with increased proliferation, which leads to a decrease 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 Advantan® on large surfaces (40-60% of the skin surface), as well as when applied under an occlusal dressing, there are no violations of adrenal functions: the level of cortisol in plasma and its circadian rhythm remain within normal limits, a decrease in the level of cortisol in the daily urine does not occur.

No skin atrophy, telangiectasias, striae, or acne-like rashes were detected in clinical trials using Advantan® for up to 12 weeks in adults and up to 4 weeks in children (including young children).

Methylprednisolone aceponate (especially its main metabolite,6α — methylprednisolone-17-propionate) binds to intracellular GCS receptors. The steroidoreceptor complex interacts with specific regions of the DNA of immune response cells, thus causing a series of biological effects. In particular, binding of the steroidreceptor complex to the DNA 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 PG and LT.

Inhibition of the synthesis of vasodilating PG by corticosteroids and potentiation of the vasoconstrictor effect of epinephrine 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 corticosteroid receptors in the skin, which indicates the presence of its bioactivation in the skin.

The intensity of percutaneous absorption for the ointment and cream depends on the skin condition, dosage form and method of application (on an open area of the skin or under an occlusive dressing). Percutaneous absorption in children and adults with atopic dermatitis (neurodermatitis) and psoriasis was not more than 2.5%, which is only slightly higher than in healthy volunteers (0.5-1.5%).

After entering the systemic circulation,6α-methylprednisolone-17-propionate is rapidly conjugated to glucuronic acid and thus inactivated in the form of 6α-methylprednisolone-17-propionate-21-glucuronide. Metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys with a T1 / 2 of about 16 h. Methylprednisolone aceponate and its metabolites do not accumulate in the body.

Indications

Skin diseases (including chronic course) that can be treated with corticosteroids for external use, in adults and children aged 4 months and older:

– Atopic dermatitis, neurodermatitis. – True eczema. – Contact dermatitis. – Allergic dermatitis. – Dyshidrotic eczema. – Microbial eczema. – Degenerative eczema.

Use during pregnancy and lactation

If it is necessary to use Advantan during pregnancy and lactation, the expected benefit of therapy for the mother and the potential risk to the fetus or children should be carefully weighed.

In this category of patients, it is not recommended to use the drug for a long time on extensive skin surfaces.

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

Contraindications

-hypersensitivity to the components of the drug;- tuberculosis or syphilitic processes in the area of application of the drug; – viral diseases (for example, chickenpox, shingles) in the area of application of the drug;- rosacea, perioral dermatitis in the area of application of the drug;- skin reactions to vaccination in the area of application of the drug; – children’s age (up to 4 months).

Side effects

The drug is usually well tolerated.

Very rarely (less than 0.01% of cases), local reactions may occur, such as itching, burning, erythema, and vesicular rash formation. 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 clinical studies, none of the above side effects were observed when Advantan was used for up to 12 weeks in adults and up to 4 weeks in children.

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

Interaction

Drug interaction of Advantan is not described.

How to take, course of use and dosage

Externally.

Adults and children from 4 months of age apply the drug 1 time / day in a thin layer on the affected areas of the skin.

Continuous daily use of Advantan in the form of cream is for adults no more than 12 weeks, for children-no more than 4 weeks.

Advantan cream is a dosage form with a low fat content and a high water content, so it is recommended for the treatment of acute inflammatory processes and the wet stage of eczema in very oily skin, as well as when the process is localized both on smooth skin and on the scalp.

If the skin dries excessively with prolonged use of the cream, it is necessary to switch to the dosage form of Advantan.

Overdose

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

Symptoms: excessive and / or intensive topical application of corticosteroids may cause skin atrophy (thinning of the skin, telangiectasia, striae).

Treatment: discontinuation of the drug.

Special instructions

In the presence of bacterial dermatoses and / or dermatomycosis, specific antibacterial or antifungal treatment should be performed in addition to Advantan therapy.

Avoid contact with the eyes.

As with the use of systemic corticosteroids, glaucoma may develop when corticosteroids are applied externally (for example, after high doses or very prolonged use, the use of occlusive dressings or application to the skin around the eyes).

It does not affect the ability to drive vehicles and work with mechanisms.

Form of production

Cream 0.1%.

Storage conditions

At a temperature not exceeding 25 °C.

Shelf

life is 3 years.

Active ingredient

Methylprednisolone aceponate

Dosage form

cream

Description

Children older than 4 months, Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, Adults

Indications

Neurodermatitis, Dermatitis, Diathesis, Eczema