Advantan cream 0.1%, 15g

Skin diseases, incl. chronic course, in which the local use of glucocorticosteroids is effective, including:

• atopic dermatitis,

• neurodermatitis;

• true eczema;

• contact dermatitis;

• allergic dermatitis;

• dyshidrotic eczema;

• microbial eczema;

• dermatoses in children from 4 months of age, incl. atopic dermatitis, neurodermatitis, eczema, contact dermatitis, etc.

The drug is applied once a day with a thin layer on the lesions.
As a rule, the duration of continuous daily treatment with Advantan should not exceed 12 weeks for adults and 4 weeks for children.

Since AdvantanЃ cream is a low fat, high water dosage form, it is suitable for the treatment of acute inflammation and weeping eczema in very oily skin, as well as for localization of the process both on smooth skin and on the scalp.

1 g of cream contains : The
active ingredient is methylprednisolone aceponate 1 mg.
Excipients:
decyl oleate, glycerol monostearate, cetylsteryl alcohol, solid fat, softizan 378, polyoxyl-40-stearate, glycerin 85%, disodium edetate, benzyl alcohol, butylhydroxytoluene, purified water.

• Tuberculous or syphilitic processes in the area of ??application of the drug;

• viral diseases (for example, chickenpox, shingles),

• rosacea,

• perioral dermatitis in the area of ??application of the drug;

• should not be applied to areas of the skin with manifestations of a reaction to vaccination.

• Hypersensitivity to the constituent components of the drug

Trade name
AdvantanЃ

Dosage form
Cream, ointment, fatty ointment.

The composition of
1 g of cream contains : The
active ingredient is methylprednisolone aceponate 1 mg.
Excipients:
decyl oleate, glycerol monostearate, cetylsteryl alcohol, solid fat, softizan 378, polyoxyl-40-stearate, glycerin 85%, disodium edetate, benzyl alcohol, butylhydroxytoluene, purified water.
1 g of ointment contains : The
active ingredient is methylprednisolone aceponate 1 mg.
Excipients: white wax, liquid paraffin, emulsifier E, white petrolatum, purified water.
1 g of fatty ointment contains : The
active ingredient is methylprednisolone aceponate 1 mg.
Excipients: white soft paraffin, liquid paraffin, microcrystalline wax, hydrogenated castor oil.

Description
Cream: a white or almost white opaque cream.
Ointment: white to yellowish opaque homogeneous ointment.
Greasy ointment: white to yellowish, translucent greasy ointment.

Pharmacotherapeutic group
Topical glucocorticosteroid

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

Pharmacodynamics
When applied externally, AdvantanЃ 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 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.
In the course of clinical studies with the use of Advantan 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, 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, which indicates the presence of its 'bioactivation' in the skin.
The intensity of percutaneous absorption depends on the condition of the skin, the dosage form and the route of administration (on an open skin area or under an occlusive dressing). Percutaneous absorption in adolescents and adults with neurodermatitis and psoriasis was less than 2.5%, which only slightly differed from absorption through intact skin in healthy adult volunteers (0.5-1.5%).
After entering the systemic circulation, 6?-methylprednisolone-17-propionate is rapidly conjugated with glucoronic acid and, thus, is 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
Skin diseases, incl. chronic course, in which the local use of glucocorticosteroids is effective, including: 'atopic dermatitis, neurodermatitis; true eczema; 'contact dermatitis; '' allergic dermatitis; 'dyshidrotic eczema; 'microbial eczema; '' dermatoses in children from 4 months of age, incl. atopic dermatitis, neurodermatitis, eczema, contact dermatitis, etc.

Contraindications:

'' tuberculous or syphilitic processes in the area of ??application of the drug; 'viral diseases (for example, chickenpox, shingles), rosacea, perioral dermatitis in the area of ??application of the drug; '' should not be applied to areas of skin with manifestations of a reaction to vaccination. '' Hypersensitivity to the components of the drug

Method of administration and doses
The drug is applied once a day with a thin layer on the lesions.
As a rule, the duration of continuous daily treatment with Advantan should not exceed 12 weeks for adults and 4 weeks for children.

Cream
Since AdvantanЃ cream is a low fat and high water dosage form, it is suitable for the treatment of acute inflammatory processes and the weeping stage of eczema in very oily skin, as well as for localization of the process both on smooth skin and on the scalp ...

Ointment
For the treatment of skin diseases that are not accompanied by oozing, and in the presence of infiltration, a dosage form with a balanced ratio of fat and water is required. AdvantanЃ ointment makes the skin slightly oily without retention of heat and moisture. Of the three dosage forms, Advantan ointment has the widest field of application.

Fatty ointment
For the treatment of processes with very dry skin and chronic stages of skin diseases, an anhydrous dosage form is required. The occlusive effect of the oily ointment provides a pronounced therapeutic effect.

Drug Interactions
Drug interactions have not been described.

Side effects The
drug is usually well tolerated.
In rare cases, local reactions can be observed, such as itching, burning, erythema, and blistering.
As with the external use of other glucocorticosteroids, in rare cases, folliculitis, hypertrichosis, perioral dermatitis, allergic reactions to one of the components of the drug can be observed.

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.
With excessively long and / or intensive local use of glucocorticosteroids, skin atrophy (thinning of the skin, telangiectasia, striae) may develop.
If skin atrophy occurs as a result of such an 'overdose', the drug must be canceled.

Precautions and warnings
In the presence of bacterial dermatoses and / or dermatomycosis, in addition to Advantan therapy, specific antibacterial or antimycotic treatment should be carried out.
If the skin dries excessively with prolonged use of AdvantanЃ cream, it is necessary to switch to a dosage form with a higher fat content (AdvantanЃ ointment or AdvantanЃ fatty ointment).
Avoid getting the drug in the eyes. 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).

Pregnancy and lactation
If it is necessary to use AdvantanЃ ointment during pregnancy and lactation, the potential risk and the expected benefit of treatment should be carefully weighed. During these periods, prolonged use of the drug on extensive skin surfaces is not recommended.
Breastfeeding mothers should not apply the drug to their breasts.

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

Release form
Cream: 15 g each in aluminum tubes sealed with screw-on plastic caps; the tube together with the instructions for use is placed in a cardboard box ..

Ointment: 15 g each in aluminum tubes, sealed with screw-on plastic caps; the tube together with the instructions for use is placed in a cardboard box ..

Greasy ointment: 15 g each in aluminum tubes sealed with screw-on plastic caps; the tube together with the instructions for use is placed in a cardboard box.

Storage conditions
Ointment, cream: store at a temperature not exceeding 25C.
Greasy ointment: store at a temperature not exceeding 30C.
Keep out of the reach of children!

Shelf life
Ointment, cream - 3 years.
Greasy ointment - 5 years.
Do not use the drug after the expiration date indicated on the package!

Terms of dispensing from pharmacies
Without prescription.