Advantan - instructions for use, dose, side effects, contraindications

Excipients: decyloleate 0.100, glyceryl monostearate 40-55% 0.085 g, cetostearyl alcohol (cetyl alcohol 60%, stearic alcohol 40%) 0.025 g, solid 0.025 g, soft-378-0.075 g, macrogol stearate 0.030 g, glycerol 85% - 0,05Og, disodium edetate - 0,001 g, gasoline alcohol - 0,0 South, butylhydroxytoluene - 0,00006 g, purified water - 0,59794.

Description:

White or yellowish opaque cream.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

D.07.A.A.01 Methylprednisolone

Pharmacodynamics:

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

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

When applying methylprednisolone aceponate topically at the recommended dose, the systemic effect is minimal in both humans and animals. After multiple application of Advantan on large surfaces (40-60% of the skin surface), as well as the use of an occlusive dressing, there are no violations of the adrenal function: the level of cortisol in the plasma and its circadian rhythm remain within normal limits, the level of cortisol in the daily urine does not decrease.

In clinical studies with the use of Advantan up to 12 weeks in adults and up to 4 weeks in children (including, early age), there was no development of skin atrophy, telangiectasias, striae and acne-like rashes.

Methylprednisolone aceponate (especially its main metabolite - 6α-methylprednisolone-17-propionate) binds to intracellular glucocorticosteroid 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 leads to 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 glucocorticosteroids synthesis of vasodilating prostaglandins and potentiation of vasoconstrictive action of epinephrine lead to vasoconstrictor effect.

Pharmacokinetics:

Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis. The main and most active metabolite is 6α-methylprednisolone-17-propionate, which has a much higher affinity for glucocorticosteroid skin receptors, indicating its "bioactivation" in the skin.

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).

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%).

After entering the systemic bloodstream, 6α-methylprednisolone-17-propionate is rapidly conjugated to glucuronic acid and, thus, in the form of 6α-methylprednisolone-17-propionate, glucuronide is inactivated.Metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys with a half-life of about 16 hours.

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

Indications:

Inflammatory skin diseases, sensitive to therapy with topical glucocorticosteroids:

atopic dermatitis, neurodermatitis, childhood eczema;
true eczema;
microbial eczema;
Occupational eczema;
simple contact dermatitis;
allergic (contact) dermatitis;
dyshidrotic eczema.

Contraindications:

tuberculosis or syphilitic processes in the application area;
viral diseases (eg, chicken pox, shingles), in the area of application of the drug;
rosacea, perioral dermatitis in the application area;
children's age up to 4 months;
areas of skin with manifestations of response to vaccination;
hypersensitivity to the components of the drug.

Pregnancy and lactation:

If you need to use ointment (fat) Advantanum during pregnancy and lactation, you should carefully weigh the potential risk to the fetus and the expected benefit of treatment 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.

Dosing and Administration:

Outwardly. Adults and children from 4 months of age. The drug is applied once a day with a thin layer on the affected areas of the skin.

As a rule, the duration of continuous daily treatment by Advantan should not exceed 12 weeks for adults and 4 weeks for children.

In subacute and acute inflammation without pronounced wetting, dosage form with a low fat content and high cwater content. Advantan cream provides elimination of the inflammatory process both on smooth skin and on the scalp, including, on the skin, prone to fat.

Side effects:

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 observed with the use of Advantant oily ointment before 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.

Overdose:

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

With excessively long and / or intensive use of glucocorticosteroids, skin atrophy can develop (thinning of the skin, telangiectasia, striae).

When the appearance of atrophy, the drug should be canceled.

Interaction:Not found.

Special instructions:

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

Avoid contact with the eyes.

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

Effect on the ability to drive transp. cf. and fur:Not found.

Form release / dosage:Cream for external, 0.1% application.

Packaging:By 5, 10, 15, 20, 25, 30 and 50 g in an aluminum, polyethylene-lined tube, sealed with a membrane, with a screw-on plastic cap. The tube together with the instruction for use is placed in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N013563 / 01

Date of registration:07.07.2011/01.06.2016

Expiration Date:Unlimited

The owner of the registration certificate:BAYER, AO BAYER, AO Russia

Manufacturer: & nbsp

BAYER HealthCare, LLC USA

Information update date: & nbsp23.01.2017

Illustrated instructions

Instructions

Advantan® (Advantan®)