Advantan ointment 0.1%, 50 g

Composition

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of 1 g of ointment contains:

methylprednisolone aceponate 1 mg.

Auxiliary substances:

soft white paraffin – 350 mg,

liquid paraffin-239 mg,

white beeswax-40 mg,

emulsifier Dehimuls E-70 mg,

purified water-300 mg

. Pharmacological action

Corticosteroids for external use, is a non-halogenated synthetic 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 (erythema, edema, lichenification) and subjective sensations (itching, irritation, pain).

When using methylprednisolone aceponate externally, the systemic effect is expressed minimally in both humans and animals. After repeated application of Advantan on extensive surfaces (40-60% of the skin surface), as well as when applied under an occlusive dressing, there are no violations of adrenal functions: the level of cortisol in blood plasma and its circadian rhythm remain within normal limits, and the level of cortisol in daily urine does not decrease.

No skin atrophy, telangiectasia, striae, or acne-like rashes have been detected in clinical studies using Advantan in the form of an ointment, cream, greasy ointment, or emulsion 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 glucocorticoid receptors. The steroid-receptor complex binds to specific regions of DNA, thus causing a series of biological effects.

In particular, binding of the steroid-receptor complex to DNA leads to the induction of macrocortin synthesis. Macrocortin inhibits the release of arachidonic acid and thus the formation of inflammatory mediators such as prostaglandins and leukotrienes.

Inhibition of the synthesis of vasodilating prostaglandins by corticosteroids and potentiation of the vasoconstrictor effect of epinephrine leads to a vasoconstrictor effect.

Indications

Inflammatory skin diseases sensitive to topical corticosteroid therapy:

— atopic dermatitis, neurodermatitis, children’s eczema;

– true eczema—

– microbial eczema;

– occupational eczema—

– dyshidrotic eczema—

– simple contact dermatitis—

– allergic (contact) dermatitis.

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

— tuberculosis of the skin and cutaneous manifestations of syphilis in the area of application of the drug;

viral skin lesions in the area of application of the drug (e. g., chickenpox, shingles);

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

— cutaneous manifestations of reactions to vaccination;

— children’s age up to 4 months;

— hypersensitivity to the components of the drug.

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 administration and dosage

The drug is applied 1 time / day in a thin layer on the affected skin areas.

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

The ointment is prescribed for the treatment of skin diseases that are not accompanied by wetting and in the presence of infiltration, in which a dosage form with a balanced ratio of fat and water is necessary. Advantan in the form of an ointment makes the skin slightly oily without heat and moisture retention.

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 administration.

Symptoms: skin atrophy (thinning of the skin, telangiectasia, striae) may develop with excessively long and/or intensive topical application of corticosteroids.

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

Ointment 0.1%

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Methylprednisolone aceponate

Dosage form

ointment

Description

Adults, Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, Children over 4 months of age

Indications

Dermatitis, Neurodermatitis, Eczema, Diathesis

Weight

Weight: 70 gr.