Advantan: instructions for using the medicine, structure, Contraindications

Active material: methylprednisolone aceponate
When ATH: D07AC14
CCF: SCS for external use
ICD-10 codes (testimony): L20.8, L21, L23, L24, L28.0, L30.0, L30.3, L55, L56.2
Manufacturer: INTENDIS GmbH (Germany)

Advantan: dosage form, composition and packaging

◊ Cream for external application 0.1% white or nearly white, opaque.

Excipients: decyl, glycerol monostearate, tsetosterilovy alcohol, tallow, softizan 378, polyoxyl-40-stearate, glycerol 85%, disodium эdetat, benzyl alcohol, butylhydroksytoluol, Purified water.

15 g – aluminum tuba (1) – packs cardboard.

◊ Ointment for external application 0.1% white to yellowish, opaque, Homogeneous.

Excipients: white wax, Liquid paraffin, emulsifier E, white petrolatum, Purified water.

15 g – aluminum tuba (1) – packs cardboard.
50 g – aluminum tuba (1) – packs cardboard.

◊ Ointment for external use fat 0.1% white to yellowish, translucent.

Excipients: white soft paraffin, Liquid paraffin, microcrystalline wax, Hydrogenated castor oil.

15 g – aluminum tuba (1) – packs cardboard.

◊ Emulsion for topical use 0.1% white, opaque.

Excipients: medium-chain triglycerides of magnitude, softizan 378, polyoxyethylene-2-stearyl alcohol, polyoxyethylene-21-stearyl alcohol, glycerol 85%, benzyl alcohol, sodium edetate, Purified water.

20 g – aluminum tuba (1) – packs cardboard.

Advantan: pharmachologic effect

SCS for external use, It is a non-halogenated synthetic steroid. For external use Advantan suppresses inflammatory and allergic skin reactions, as well as the reaction, associated with increased proliferation, which reduces the objective symptoms (эritema, edema, lihenifikatsiya) and subjective sensations (itch, irritation, pain).

When applied topically methylprednisolone atseponat systemic effect is expressed as the minimum a person, and animal. After repeated application Advantan vast surface (40-60% skin), as well as in the application under occlusive dressing is not marked disorders of the adrenal glands or the children, audio in adults: Cortisol levels in the plasma and its circadian rhythm remain within the normal range, Reduction in the daily urine cortisol occurs.

In clinical trials when used as an ointment Advantan, fatty cream or ointment to 12 weeks to adults and 4 weeks in children (incl. early age) there was no evidence of skin atrophy, teleangiэktaziy, stretch marks and acne-like rash.

Methylprednisolone aceponate (especially its major metabolite - 6α-methylprednisolone-17-propionate) It binds to the intracellular glucocorticoid receptors. The steroid-receptor complex binds to specific DNA regions, thus, causing a series of biological effects.

In particular, binding steroid receptor complex leads to the induction of DNA synthesis makrokortina. Makrokortin inhibits the release of arachidonic acid and, thereby, Education mediator of inflammation such as prostaglandins and leukotrienes.

Inhibition of GCS synthesis of vasodilating prostaglandins and potentiating the vasoconstrictor action of adrenaline leads to a vasoconstrictor effect.

Advantan: pharmacokinetics

Absorption

The intensity of absorption through the skin depends on the skin condition, formulation and method of application (the open area of ​​the skin or under occlusive dressing). When applying the ointment, fatty cream or ointment percutaneous absorption in adolescents and adults, suffering from neurodermatitis and psoriasis, was less than 2.5%, that is only slightly different from the absorption through intact skin in adults healthy volunteers (0.5-1.5%).

In applying the drug in the form of an emulsion absorption through the skin with artificial inflammation was very low (0.27%) and slightly higher than absorption through the skin healthy (0.17%). Absorption through the skin with the stratum corneum removed was significantly higher (15% dose).

In the case of treating the whole body (eg, sunburn) systemic dose is approximately 4 ug / kg of body weight per day (which excludes systemic effects).

Metabolism and excretion

Methylprednisolone atseponat hydrolyzed in the epidermis and dermis. The main and most active metabolite is a 6α-methylprednisolone-17-propionate, has a much higher affinity corticoid receptor skin, which indicates its presence in the skin bioactivation.

After entering the systemic circulation 6α-methylprednisolone-17-propionate rapidly conjugated with glucuronic acid and, thus, inactivated.

Metabolitы methylprednisolone aceponata (chief among which is 6α-methylprednisolone-17-propionate-21-glucuronide) derived mainly kidneys, half-life of approximately 16 no.

Methylprednisolone atseponat and its metabolites do not cumulate in the body.

Advantan: testimony

Ointment, cream, fatty cream

Skin diseases (incl. chronic course), amenable to SCS therapy for external use, in adults and children 4 months and older:

• atopic dermatitis, neurodermatitis;
• true eczema;
• contact dermatitis;
• atopic dermatitis;
• dyshidrotic eczema;
• Microbial eczema;
• degenerative eczema.

Emulsion for topical use

Acute inflammatory diseases of the skin in adults and children 4 months and older:

• atopic dermatitis, neurodermatitis;
• contact dermatitis;
• true eczema;
• seborrheic dermatitis;
• Microbial eczema;
• dyshidrotic eczema;
• degenerative eczema;
• solar dermatitis (expressed sunburn).

Advantan: dosing regimen

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

Continuous daily use in the form of a cream Advantan, ointment or fatty ointment is for Adult no more 12 weeks, to children - No more 4 weeks. The treatment Advantanom in emulsion form is not more 2 weeks.

Cream Advantan dosage form is a low fat, high water content, so it is recommended to acute inflammation and weeping stages of eczema with very oily skin, as well as the localization process as smooth skin, and on the scalp.

Ointment to appoint dermatological, not accompanied by weeping and with the infiltration, where necessary dosage form with a balanced ratio of fat and water. In the form of ointments Advantan makes the skin lightly without delay fatty heat and moisture.

Oily ointment indicated for treatment processes at very dry skin and chronic skin diseases in steps, when required anhydrous dosage form of the drug. Occlusive effect of fatty ointment provides a pronounced therapeutic effect.

The emulsion applied to the skin, gently rubbing. When the sun burns the emulsion can be used a maximum of 2 times / day.

If the skin excessively dry when applying emulsion or long-term use of cream, must go to a dosage form Advantan higher fat (ointment or fatty ointment).

Advantan: side effects

In rare cases,: itching, burning, эritema, bubble formation at the site of drug.

Rarely: As with other glucocorticosteroids – folliculitis, gipetrihoz, perioral dermatitis, allergic reactions.

Advantan: Contraindications

• skin tuberculosis and skin manifestations of syphilis in the area of ​​application of the drug;
• viral skin lesions in the area of ​​application of the drug (eg, varicella, shingles);
• Rosacea, perioral dermatitis in the field of application of the drug;
• skin manifestations of reaction to vaccination;
• hypersensitivity to the drug.

Advantan: Pregnancy and lactation

If necessary, use Advantan during pregnancy and lactation should carefully weigh the potential benefits of therapy to the mother and the potential risk to the fetus or infant. This category of patients is not recommended to use the drug for a long time over a large surface of the skin.

Nursing mothers should not apply the preparation on the mammary glands.

Advantan: Special instructions

In the presence of bacterial dermatitis and / or tinea, in addition to therapy Advantanom necessary to carry out a specific antibacterial or antifungal treatment.

The emulsion should not be used under occlusive dressing. It must be borne in mind, diapers that (diapers) can create the effect of occlusal.

Avoid contact with the eyes.

As in the case of systemic corticosteroids, with topical corticosteroids may develop glaucoma (eg, After very high doses or prolonged use, the use of occlusive dressings or applied to the skin around the eyes).

Effects on ability to drive vehicles and management mechanisms

It does not affect the ability to drive vehicles and operate machinery.

Advantan: overdose

The study of acute toxicity was methylprednisolone atseponat not reveal any risk of acute toxicity at a single excessive external application (applying the product to a larger area under the conditions, favorable absorption) Accidental ingestion or.

Symptoms: if too long and / or intensive use of local corticosteroids may develop skin atrophy (thinning of the skin, teleangiэktazii, striae).

Treatment: removal of the drug.

Advantan: drug interaction

Drug Interactions drug Advantan not described.

Advantan: terms of dispensing from pharmacies

The drug is resolved to application as an agent Valium holidays.

Advantan: terms and conditions of storage

Ointment, cream and emulsion should be stored at a temperature no higher than 25 ° C. Shelf life - 3 year.

Fatty Ointment should be stored at a temperature no higher than 30 ° C. Shelf life - 5 years.

The drug should be stored out of reach of children.