Advantan ointment d / nar. approx. 0.1% tube 50g # 1

Release form, composition and packaging

Ointment for external use 0.1% white or slightly yellowish, homogeneous, opaque.

1 g

methylprednisolone aceponate 1 mg

white soft paraffin - 350 mg, liquid paraffin - 239 mg, white beeswax - 40 mg, Dehimuls E emulsifier - 70 mg, purified water - 300 mg.

15 g - aluminum tubes (1) - cardboard packs.

50 g - aluminum tubes (1) - cardboard packs.

pharmachologic effect

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, oozing, etc.) and subjective sensations (including itching, irritation, pain, etc.).

When methylprednisolone aceponate is used externally at the recommended dose, the systemic effect is minimally expressed in both humans and animals.

After repeated application of Advantan to large surfaces (40-60% of the skin surface), as well as when applied under an occlusive dressing, there are no adrenal dysfunctions: the level of cortisol in the blood plasma and its circadian rhythm remain within normal limits, the decrease in the level of cortisol in daily urine is not going on.

In the course of clinical studies with the use of Advantan for up to 12 weeks in adults and up to 4 weeks in children (including young children), the development of skin atrophy, telangiectasias, stretch marks and acne-like rashes was not revealed.

Methylprednisolone aceponate (especially its main metabolite - 6alpha-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors.

The steroid-receptor complex binds to specific regions 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 of cells of the immune response leads to the induction of the synthesis of macrocortin.

Macrocortin inhibits the release of arachidonic acid and thus the formation of inflammatory mediators such as prostaglandins and leukotrienes.

Inhibition of corticosteroids synthesis of vasodilating prostaglandins and potentiation of the vasoconstrictor action of adrenaline leads to a vasoconstrictor effect.

Pharmacokinetics

Suction

The degree of percutaneous absorption depends on the condition of the skin, the dosage form and the route of administration (with or without an occlusive dressing).

When using an ointment, cream or fatty ointment, percutaneous absorption in children and adults with atopic dermatitis (neurodermatitis) and psoriasis was no more than 2.5%, which is only slightly higher than in healthy volunteers (0.5-1.5%).

When using the drug in the form of an emulsion, the intensity of absorption through the skin with artificial inflammation was very low (0.27%), which is only slightly higher than through healthy skin (0.17%).

In the case of whole body treatment (eg, sunburn), the systemic dose is about 4 Ојg / kg bw / day, which excludes systemic effects.

Metabolism and excretion

Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis.

The main and most active metabolite is 6alpha-methylprednisolone-17-propionate, which has a significantly higher affinity for glucocorticoid receptors in the skin, which indicates the presence of its bioactivation in the skin.

After entering the systemic circulation, 6alpha-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid and, thus, in the form of 6alpha-methylprednisolone-17-propionate glucuronide is inactivated.

Metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys, T1 / 2 - about 16 hours.

Methylprednisolone aceponate and its metabolites do not accumulate in the body.

Indications for use

Ointment, cream, oily ointment

Inflammatory skin diseases sensitive to topical GCS therapy:

- atopic dermatitis, neurodermatitis, children's eczema

- true exe

Name ENG

ADVANTAN

Clinical and pharmacological group

GCS for external use

ATX code

Methylprednisolone aceponate

Dosage

0.1% x 50g

Structure

1 g of ointment contains: methylprednisolone aceponate 1 mg.

Excipients: white soft paraffin - 350 mg, liquid paraffin - 239 mg, white beeswax - 40 mg, emulsifier Dehimuls E - 70 mg, purified water - 300 mg.

Indications

Inflammatory skin diseases sensitive to topical GCS therapy:

atopic dermatitis, neurodermatitis, childhood eczema

true eczema

microbial eczema

professional eczema

dyshidrotic eczema

simple contact dermatitis

allergic (contact) dermatitis.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

INN / Active ingredient

methylprednisolone aceponate

Contraindications

tuberculosis of the skin and skin manifestations of syphilis in the area of ��application of the drug

viral skin lesions in the area of ��application of the drug (for example, with chickenpox, shingles)

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

skin manifestations of a reaction to vaccination

children's age up to 4 months

hypersensitivity to drug components.

Specifications

Category

Psoriasis

Scope of the medicinal product

Dermatology

Release form

Ointment

Manufacturer country

Italy

Package quantity, pcs

one

Minimum age from

3 months

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Bayer

The amount of the dosage form in the primary package

50 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Topical glucocorticosteroid

Anatomical and therapeutic characteristics

D07AC14 Methylprednisolone aceponate

Dosage form

Ointment for external use

Dosage (volume) of the substance in the preparation

1 g: methylprednisolone aceponate 1 mg

Expiration date in days

1095

The target audience

Children

Package weight, g

fifty

Mode of application

:

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

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

Information on technical characteristics, delivery set, country of manufacture