Advantan, cream 0.1% 15 g

Advantan – glucocorticoid, anti-allergic, anti-inflammatory.

Pharmacodynamics

The active ingredient of Advantan® – methylprednisolone aceponate – is a nonhalogenated steroid. When applied externally, Advantan® suppresses inflammatory and allergic skin reactions as well as reactions associated with increased proliferation, resulting in reduction of objective symptoms of inflammation (including erythema, edema, mottling) and subjective sensations (including itching, irritation, pain).

When methylprednisolone aceponate is applied topically at the recommended dose, systemic effects are minimal in both humans and animals. After multiple application of Advantan® on large surfaces (40-60% of the skin surface), as well as application under the occlusive dressing no adrenal dysfunction is noted: plasma cortisol levels and its circadian rhythm remain within normal limits, there is no reduction of cortisol levels in daily urine.

In clinical studies, use of Advantan® for up to 12 weeks in adults and up to 4 weeks in children (including infants) showed no evidence of skin atrophy, telangiectasia, stricture, or acne-like rashes.

Methylprednisolone aceponate (especially its main metabolite, 6α-methylprednisolone-17-propionate) binds to intracellular GCS receptors. The steroidreceptor complex interacts with certain DNA sites of the immune response cells, thus causing a series of biological effects. In particular, binding of the steroidreceptor complex to the DNA of the immune response cells leads to induction of macrocortin synthesis. Macrocortin inhibits the release of arachidonic acid and thus the formation of inflammatory mediators like PG and LT.

The inhibition of GCS synthesis of vasodilatory PGs and potentiation of the vasoconstrictor effect of adrenaline, lead to a 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 significantly higher affinity for skin GCS receptors, indicating the presence of its bioactivation in the skin.

The intensity of percutaneous absorption for ointment and cream depends on the skin condition, dosage form and method of application (on the exposed skin or under the occlusive dressing). Percutaneous absorption in children and adults with atopic dermatitis (neurodermatitis) and psoriasis was not more than 2.5%, which was only slightly higher than in healthy volunteers (0.5-1.5%).

After entering the systemic bloodstream, 6α-methylprednisolone-17-propionate rapidly conjugates with glucuronic acid and is thus inactivated as 6α-methylprednisolone-17-propionate-21-glucuronide. Metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys with a T1/2 of about 16 hours. Methylprednisolone aceponate and its metabolites do not cumulate in the body.

Indications

Skin diseases (including chronic course) amenable to therapy with GCS for external use, in adults and children aged 4 months and older:

Active ingredient

Composition

Active ingredient:

methylprednisolone aceponate 1 mg;

Supplements:

decyloate – 100 mg,

glyceryl monostearate 40-55% – 85 mg,

cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) – 25 mg,

solid fat – 25 mg,

softisan 378 – 75 mg,

macrogoal stearate – 30 mg,

glycerol 85% – 50 mg,

dinatrium edetate – 1 mg,

/p>

benzyl alcohol – 10 mg,

butylhydroxytoluene – 60 µg,

purified water – 597.94 mg.

How to take, the dosage

Oternally.

Adults and children from 4 months of age apply the drug once a day in a thin layer on the affected skin.

Continuous daily use of Advantan in cream form is no more than 12 weeks for adults and no more than 4 weeks for children.

The Advantan cream is a low-fat, high-water formulation, so it is recommended for treating acute inflammation and the wet stage of eczema when the skin is very oily and when the process is localized to both the smooth skin and the scalp.

If the skin becomes excessively dry with prolonged use of the cream, it is necessary to switch to the drug form of Advantan.

Interaction

Drug interactions of Advantan have not been described.

Special Instructions

In the presence of bacterial dermatoses and/or dermatomycoses, specific antibacterial or antifungal treatment should be given in addition to therapy with Advantan.

Contact with the drug in the eyes should be avoided.

As with systemic corticosteroids, glaucoma may occur with external use of GCS (e.g., after high doses or very prolonged use, use of occlusive dressings, or application to the skin around the eyes).

It does not affect the ability to drive or operate machinery.

Contraindications

Side effects

The drug is usually well tolerated.

Very rare (less than 0.01% of cases) local reactions such as itching, burning, erythema, formation of vesicular rash may be observed. If the drug is used for more than 4 weeks and/or over 10% or more of the body surface area, the following reactions may occur: skin atrophy, telangiectasia, stretch marks, acneiform skin changes, and systemic effects caused by absorption of the corticosteroid.

In clinical studies, none of the above side effects were noted with 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, skin depigmentation, and allergic reactions to one of the components of the drug may occur.

Overdose

In studies of acute toxicity of methylprednisolone aceponate, no risk of acute intoxication has been identified with excessive single external administration (application of the drug to a large area under conditions favorable for absorption) or unintentional oral administration.

Symptoms: excessive long-term and/or intensive topical use of GCS may result in skin atrophy (skin thinning, telangiectasia, stretch marks).

Treatment: drug withdrawal.

Pregnancy use

If it is necessary to use Advantan during pregnancy and lactation, the expected benefit to the mother and the potential risk to the fetus or the infant should be carefully weighed.

In this category of patients, long-term use on large areas of skin is not recommended.

Lactating mothers should not apply the drug to the mammary glands.

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