Advantan, ointment 0.1% 50 g

The oral GCS is a nonhalogenated synthetic steroid. When used externally, Advantan suppresses inflammatory and allergic skin reactions as well as reactions associated with increased proliferation, which leads to a reduction of objective symptoms (erythema, edema, lichenification) and subjective sensations (itching, irritation, pain).

When methylprednisolone aceponate is used externally, the systemic effect is expressed minimally in both humans and animals. After multiple application of Advantan on large surfaces (40-60% of the skin surface), as well as when used under the occlusive dressing no adrenal disturbances are observed: the level of cortisol in the blood plasma and its circadian rhythm remain within normal limits, there is no reduction of cortisol level in daily urine.

In clinical studies, no skin atrophy, telangiectasia, striae, or acne-like rashes have been observed in adults and children (including infants) up to 12 weeks when Advantan is used in the form of an ointment, cream, fatty ointment, or emulsion.

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

In particular, binding of the steroid-receptor complex to DNA leads to induction of macrocortin synthesis. Macrocortin inhibits the release of arachidonic acid and thus the formation of inflammatory mediators such as prostaglandins and leukotrienes.

The inhibition of vasodilatory prostaglandin synthesis by GCS and potentiation of the vasoconstrictor effect of adrenaline leads to a vasoconstrictor effect.

Indications

Inflammatory skin diseases sensitive to topical GCS therapy:

– atopic dermatitis, neurodermatitis, pediatric eczema;

– true eczema;

– microbial eczema;

– Occupational eczema;

– dyshidrotic eczema;

– simple contact dermatitis;

– allergic (contact) dermatitis.

Active ingredient

Composition

1 g of the ointment contains:

Methylprednisolone aceponate 1 mg.

Auxiliary substances:

soft white paraffin – 350 mg,

liquid paraffin – 239 mg,

beeswax white – 40 mg,

Emulsifier Dehimuls E – 70 mg,

purified water – 300 mg.

How to take, the dosage

The drug is applied once a day in a thin layer on the affected skin areas.

Continuous daily use of Advantan in the form of ointment is not more than 12 weeks for adults, and not more than 4 weeks for children.

The ointment is prescribed for the treatment of skin conditions not accompanied by mottling and in the presence of infiltration, which require a dosage form with a balanced fat to water ratio. Advantan in the form of an ointment makes the skin slightly oily without retaining heat and moisture.

Interaction

Drug interactions of the drug 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

– Tuberculosis of the skin and cutaneous manifestations of syphilis in the area of application;

– Viral skin lesions in the area of application (e.g., chicken pox, shingles);

– Rosacea, perioral dermatitis in the application area;

– skin reactions to the vaccine;

– children under 4 months of age;

– hypersensitivity to the ingredients of the drug.

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 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 when Advantan was used 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 and allergic reactions to one of the ingredients of the drug may occur.

Overdose

In a study of acute toxicity of methylprednisolone aceponate, no risk of acute intoxication was found 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 can develop skin atrophy (skin thinning, telangiectasia, stretch marks).

Treatment: Cancellation of the drug.

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 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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