Universal reference book for medicines
Product name: ADVANTAN ® (ADVANTAN)

Active substance: methylprednisolone aceponate

Type: GCS for external use

Manufacturer: BAYER (Russia) manufactured by BAYER HealthCare Manufacturing (Italy)
Composition, form of production and packaging

?
Cream for external use of white or yellowish color, opaque.
1 g

methylprednisolone aceponate 1 mg

Auxiliary substances: decyloleate - 100 mg, glyceryl monostearate 40-55% - 85 mg, cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) - 25 mg, solid fat - 25 mg, softin 378 - 75 mg, macrogol stearate - 30 mg, glycerol 85% - 50 mg, disodium edetate - 1 mg, benzyl alcohol - 10 mg, butylhydroxytoluene - 60 μg, purified water - 597.94 mg.

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

10 g - aluminum tubes (1) - packs of cardboard.

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

20 g - aluminum tubes (1) - packs of cardboard.

25 grams - tubes of aluminum (1) - packs of cardboard.

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

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

?
Ointment for external application of white or slightly yellowish color, homogeneous, opaque.
1 g

methylprednisolone aceponate 1 mg

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

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

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

20 g - aluminum tubes (1) - packs of cardboard.

25 grams - tubes of aluminum (1) - packs of cardboard.

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

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

?
Ointment for external use (oily) white or slightly yellowish, translucent.
1 g

methylprednisolone aceponate 1 mg

Excipients: paraffin white soft - 425 mg, paraffin liquid - 394 mg, wax microcrystalline - 150 mg, castor oil hydrogenated - 30 mg.

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

10 g - aluminum tubes (1) - packs of cardboard.

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

20 g - aluminum tubes (1) - packs of cardboard.

25 grams - tubes of aluminum (1) - packs of cardboard.

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

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

?
Emulsion for external use in white, opaque.
1 g

methylprednisolone aceponate 1 mg

Auxiliary substances: medium chain triglycerides 150 mg, softitans 378-50 mg, polyoxyethylene-2-sterol alcohol 40 mg, polyoxyethylene-21-sterol alcohol 40 mg, glycerol 85% 30 mg, disodium edetate 10 mg, benzyl alcohol - 12.5 mg, purified water - 675.5 mg.

20 g - aluminum tubes (1) - packs of cardboard.

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

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

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

When applying methylprednisolone aceponate topically at the recommended dose, the systemic effect is expressed minimally in both humans and animals.
After repeated application of Advantan on large surfaces (40-60% of the skin surface), as well as with application to the occlusal bandage, there are no abnormalities of the adrenal glands: the level of cortisol in the blood plasma and its circadian rhythm remain within normal limits, the level of cortisol in daily urine occurs.
In clinical trials with the use of Advantan up to 12 weeks in adults and up to 4 weeks in children (including the early age), there was no development of skin atrophy, telangiectasia, striae and acne-like eruptions.

Methylprednisolone aceponate (especially its main metabolite - 6? -methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors.
The steroid-receptor complex binds to certain parts of the DNA of the cells of the immune response, thus causing a series of biological effects.
In particular, binding of the steroid-receptor complex to the DNA of the immune response cells results in the induction of macrocortin synthesis.
Macrocortin inhibits the release of arachidonic acid and, thereby, the formation of inflammatory mediators such as prostaglandins and leukotrienes.
Inhibition of GCS synthesis of vasodilating prostaglandins and potentiation of vasoconstrictive action of epinephrine results in a vasoconstrictor effect.

PHARMACOKINETICS

Suction

The degree of percutaneous absorption depends on the condition of the skin, the dosage form and the method of administration (with or without occlusive dressing).When applying ointment, cream or oily ointment, 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%).

When using the preparation 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 case of treatment of the whole body (for example, with sunburn), the systemic dose is about 4 μg / kg of body weight / day, which excludes systemic effects.
Metabolism and excretion

Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis.
The main and most active metabolite is 6? -methylprednisolone-17-propionate, which has a much higher affinity for glucocorticoid skin receptors, which indicates the presence of its bioactivation in the skin.
After entering the systemic bloodstream, 6? -methylprednisolone-17-propionate is rapidly conjugated to glucuronic acid and, thus, in the form of 6? -methylprednisolone-17-propionate, glucuronide is inactivated.

Metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys, T 1/2 - about 16 hours.

Methylprednisolone aceponate and its metabolites are not cumulative in the body.

INDICATIONS

Ointment, cream, oily ointment

Inflammatory skin diseases, sensitive to therapy with topical SCS:

- Atopic dermatitis, neurodermatitis, childhood eczema;

- true eczema;

- microbial eczema;

- Occupational eczema;

- Dyshidrotic eczema;

- simple contact dermatitis;

allergic (contact) dermatitis.

Emulsion

Inflammatory skin diseases, sensitive to therapy with topical SCS:

- Atopic dermatitis, neurodermatitis, childhood eczema;

- simple contact dermatitis;

- allergic (contact) dermatitis;

- true eczema;

- seborrheic dermatitis / eczema;

- microbial eczema;

- photodermatitis, sunburn.

DOSING MODE

Outwardly.

For adults and children from 4 months, the drug is applied 1 time / day in a thin layer on the affected skin.

Continuous daily application of Advantan in the form of a cream, ointment or oily ointment should not exceed for adults 12 weeks, for children - 4 weeks.
The course of treatment with Advantan in the form of an emulsion usually should not exceed 2 weeks.
The cream is a dosage form with a low fat content and a high water content, so it is recommended for subacute and acute inflammation without pronounced wetting.Cream
provides elimination of the inflammatory process both on smooth skin and on the scalp, incl. on the skin, prone to fat.
Ointment is a dosage form with a balanced ratio of fat and water, so it is recommended for subacute or chronic inflammatory skin diseases that are not accompanied by wetting.
Ointment has a therapeutic effect, also helping to eliminate dry skin and restore its normal fat content.
Oily ointment is an anhydrous dosage form, therefore it is recommended for the treatment of prolonged chronic inflammatory skin processes with very dry skin .
The occlusive effect of oily ointment provides a pronounced therapeutic effect even with significant lichenification and infiltration.
Emulsion applied a thin layer on the affected areas of the skin, slightly rubbing.
With sunburn, the emulsion is applied 1-2 times / day. If the skin is excessively dry when using the emulsion, it is necessary to switch to the drug form of the drug Advantan ® with a higher fat content (ointment or oily ointment).
SIDE EFFECT

Usually the drug is well tolerated.

Very rarely (less than 0.01% of cases) local reactions can occur, such as itching, burning, erythema, the formation of vesicle 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, acneiform skin changes, systemic effects due to absorption of the corticosteroid. In clinical trials, none of the above side effects were noted with the use of the drug Advantan ® up to 12 weeks in adults and up to 4 weeks in children.
In rare cases (0.01-0.1%), folliculitis, hypertrichosis, perioral dermatitis, depigmentation of the skin, allergic reactions to one of the components of the drug can be observed.

CONTRAINDICATIONS

- tuberculosis or syphilitic processes in the application area;

- viral diseases in the area of ​​drug application (for example, with chicken pox, shingles);

- rosacea, perioral dermatitis in the application area;

- areas of the skin with a spin response to vaccination;

- Children's age up to 4 months;

hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

If you need to use the drug Advantan ® during pregnancy and lactation, you should carefully weigh the potential risk to the fetus and the expected benefit of therapy for the mother.
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.

APPLICATION FOR CHILDREN

Continuous daily application of Advantan in the form of a cream, ointment or oily ointment is for adults not more than 12 weeks, for children - no more than 4 weeks.

Contraindicated in children under 4 months.

SPECIAL INSTRUCTIONS

In the presence of bacterial complications and / or dermatomycosis in addition to therapy with the drug Advantan ®, it is necessary to carry out specific antibacterial or antifungal treatment.

Avoid contact with the eyes.

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

Impact on the ability to drive vehicles and manage mechanisms

Not found.

OVERDOSE

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

Symptoms: with excessively long and / or intense topical application of SCS, skin atrophy can develop (thinning of the skin, telangiectasia, striae).

When the manifestation of atrophy, the drug must be canceled.

DRUG INTERACTION

Medicinal interaction of the drug Advantan ® was not revealed.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

Ointment, cream and emulsion should be stored at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
Oily fat should be stored at a temperature of no higher than 30 ° C.
Shelf life - 5 years.
The drug should be stored out of the reach of children.


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