Advantan emulsion for external use 0.1%, 20g

Acute inflammatory skin diseases in adults and children from 4 months of age:

• atopic dermatitis,

• neurodermatitis,

• contact dermatitis,

• true eczema,

• seborrheic eczema

• microbial eczema,

• dyshidrotic eczema,

• degenerative eczema.

• Solar dermatitis (severe sunburn).

The drug is applied once a day (for the treatment of sunburns 1, maximum 2 times a day) with a thin layer on the affected area, rubbing lightly.

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

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

1 g of emulsion contains:
Active ingredient: methylprednisolone aceponate 1 mg.

Excipients:
Medium chain triglycerides, softizan 378, polyoxyethylene-2-steril alcohol, glycerin 85%, benzyl alcohol, disodium edetate, purified water.

• Tuberculous 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.

• Hypersensitivity to drug components

Pregnancy and lactation:

If it is necessary to use Advantan during pregnancy and lactation, the potential risk and the expected benefit of treatment should be carefully weighed. During these periods, long-term use of the drug on extensive skin surfaces is not recommended. In nursing mothers, the drug should not be applied to the mammary glands.

Tradename

Advantan

International non-proprietary name

Methylprednisolone aceponate

Dosage form

Emulsion for external use

Composition: 1 g of emulsion contains:

Active ingredient: methylprednisolone aceponate 1 mg.

Excipients:
Medium chain triglycerides, softizan 378, polyoxyethylene-2-steril alcohol, glycerin 85%, benzyl alcohol, disodium edetate, purified water.

Description
White opaque emulsion.

Pharmacotherapeutic group
Topical glucocorticosteroid

Pharmacological properties The
active component of the drug Advantan - methylprednisolone aceponate - is a non-halogenated synthetic steroid.

Pharmacodynamics
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, oozing) and subjective sensations (itching, irritation, pain).
When methylprednisolone aceponate is used externally in an effective dosage, the systemic effect is minimal in both humans and animals. After repeated application of Advantan to large surfaces (40-60% of the skin surface), as well as application under an occlusive dressing, there are no adrenal dysfunctions: the level of cortisol in the plasma and its circadian rhythm remain within normal limits, and there is no decrease in the level of cortisol in daily urine.
Methylprednisolone aceponate (especially its main metabolite, 6? -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, the 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 by glucocorticoids of the synthesis of vasodilating prostaglandins and potentiation of the vasoconstrictor 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 6-methylprednisolone-17-propionate, which has a significantly higher affinity for corticoid receptors in the skin, indicating that it is 'bioactivated' in the skin. The intensity of absorption through the skin with artificial inflammation was very low (0.27% of the dose) and was slightly higher than through healthy skin (0.17%). Absorption through the skin with the removed stratum corneum was significantly higher (15%) than the dose. In the case of whole body treatment (eg, sunburn), the systemic dose is about 4 mcg per kg of body weight per day, which excludes systemic effects.
After entering the systemic circulation, 6-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid and thus inactivated.
Metabolites of methylprednisolone aceponate (the main of which is 6-methylprednisolone-17-propionate-21-glucuronide) are eliminated mainly by the kidneys with a half-life of about 16 hours. Methylperdnisolone aceponate and its metabolites are not accumulated in the body.

Indications for use:

Acute inflammatory skin diseases in adults and children from 4 months of age:

• atopic dermatitis,

• neurodermatitis,

• contact dermatitis,

• true eczema,

• seborrheic eczema

• microbial eczema,

• dyshidrotic eczema,

• degenerative eczema.

• Solar dermatitis (severe sunburn).

Contraindications:

• Tuberculous 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.

• Hypersensitivity to drug components

Pregnancy and lactation:

If it is necessary to use Advantan during pregnancy and lactation, the potential risk and the expected benefit of treatment should be carefully weighed. During these periods, long-term use of the drug on extensive skin surfaces is not recommended. In nursing mothers, the drug should not be applied to the mammary glands.

Method of administration and dosage:

The drug is applied once a day (for the treatment of sunburns 1, maximum 2 times a day) with a thin layer on the affected area, rubbing lightly.

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

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

Side effect:

The drug is usually well tolerated.
Sometimes, Advantan emulsion can cause local symptoms such as itching, burning, erythema, dry skin, peeling or blistering.
As with the external use of other glucocorticosteroids, in rare cases, folliculitis and allergic reactions may occur.

Drug interactions:

Not described.

Overdose:

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

Special instructions:

In the presence of bacterial dermatoses and / or dermatomycosis, in addition to Advantan therapy, it is necessary to carry out specific antibacterial or antimycotic treatment.

Avoid getting the drug in the eyes.

After repeated application of Advantan on large surfaces (40-60% of the skin surface), as well as application under an occlusive dressing, no adrenal dysfunction is observed in children or adults.

However, Advantan emulsion should not be applied under an occlusive dressing.

It should be borne in mind that diapers (pampers) can create an occlusive effect.

As with systemic corticosteroids, glaucoma may develop after topical corticosteroid use (eg, after high doses, or very long-term use, occlusive dressings, or application to the skin around the eyes).

Effects on ability to drive and use machinery
Does not affect.

Product form
5 g, 20 g and 50 g in laminated aluminum tubes, sealed with screw-on plastic caps. The tube along with the instructions for use is placed in a cardboard box.

Storage conditions
At a temperature not exceeding 25 ? C. Keep out of the reach of children.

Shelf life is
3 years.
Do not use after the expiration date.

Terms of dispensing from pharmacies
Without prescription.