Comfoderm M2 cream, 30 g

Inflammatory skin diseases sensitive to therapy with typical glucocorticosteroids and accompanied by impaired keratinization:

• atopic dermatitis, neurodermatitis;

• true eczema;

• microbial eczema;

• simple contact dermatitis;

• allergic (contact) dermatitis;

• dyshidrotic eczema.

Outwardly. The drug is applied once a day with a thin layer on the affected skin. As a rule, the duration of continuous daily treatment with ComfodermЃ M2 should not exceed 12 weeks. When treating patients with facial skin lesions, the course of treatment should not exceed 5 days

100 g of cream contain:
Active substance: methylprednisolone aceponate in terms of 100% substance - 0.1 g, urea in terms of 100% substance - 2 g;
Excipients: liquid paraffin (liquid paraffin) - 15 g, propylene glycol - 5 g, polysorbate-80 - 1 g, carbomer interpolymer (type A) - g, trometamol - 0.4 g, methyl parahydroxybenzoate - 0.1 g, purified water - up to 100 g.

• hypersensitivity to the components of the drug;

• 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;

• areas of the skin with manifestations of a reaction to vaccination;

• children under 18 years of age.

Trade name of the drug:

ComfodermЃ M2

International non-proprietary or group name:

methylprednisolone aceponate + urea

Dosage form:

cream for external use

Composition:

100 g of cream contain:
Active substance: methylprednisolone aceponate in terms of 100% substance - 0.1 g, urea in terms of 100% substance - 2 g;
Excipients: liquid paraffin (liquid paraffin) - 15 g, propylene glycol - 5 g, polysorbate-80 - 1 g, carbomer interpolymer (type A) - g, trometamol - 0.4 g, methyl parahydroxybenzoate - 0.1 g, purified water - up to 100 g.

Description:

Cream is white or off-white. The presence of a weak specific odor is allowed.

Pharmacotherapeutic group:

topical glucocorticosteroid + keratolytic agent

ATX code:

D07XC

pharmachologic effect

Pharmacodynamics
ComfodermЃ M2 is a combined drug, the effect of which is due to its constituent components.
Methylprednisolone aceponate is a non-halogenated synthetic steroid.
When used externally, methylprednisolone aceponate suppresses inflammatory and allergic skin reactions associated with increased proliferation, which leads to a decrease in the objective symptoms of inflammation (erythema, edema, oozing) and subjective sensations (itching, irritation, pain, etc.). When methylprednisolone aceponate is used externally at the recommended dose, the systemic effect is minimal in both humans and animals. After repeated application of methylprednisolone aceponate to large surfaces (40-60% of the skin surface), as well as when applied under an occlusive dressing, there are no adrenal dysfunctions: the level of cortisol in plasma and its circadian rhythm remain within normal limits, the concentration of cortisol in daily urine does not decrease. happens.
Methylprednisolone aceponate (especially its main metabolite - 6? -Methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to specific regions of the immune response cells' DNA, thus causing a series of biological effects.
In particular, the binding of the steroid-receptor complex to DNA cells of the immune response 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 of the synthesis of vasodilating prostaglandins by glucocorticosteroids and the potentiation of the vasoconstrictor action of adrenaline lead to a vasoconstrictor effect.
Urea- has keratolytic and moisturizing effects. Urea helps to bind water and thereby soften the stratum corneum. In addition to keratolytic action, urea has proteolytic activity.

Pharmacokinetics
When methylprednisolone is applied topically, 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 glucocorticosteroid receptors in the skin, which indicates the presence of its УbioactivationФ in the skin.
The degree of percutaneous absorption depends on the condition of the skin and the method of application (with or without an occlusive dressing).
Percutaneous absorption in patients with atopic dermatitis (neurodermatitis) and psoriasis is no more than 2.5%, which is only slightly higher than that in healthy volunteers (0.5-1.5%).
After entering the systemic circulation, 6?-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid and, thus, is inactivated.
Metabolites of methylprednisonolone aceponate are eliminated mainly by the kidneys with a half-life of about 16 hours. Methylprednisolone aceponate and its metabolites do not accumulate in the body.
Due to the low absorption of urea when applied topically, the likelihood of its systemic effects is low.

Indications for use

Inflammatory skin diseases sensitive to therapy with typical glucocorticosteroids and accompanied by impaired keratinization:

• atopic dermatitis, neurodermatitis;

• true eczema;

• microbial eczema;

• simple contact dermatitis;

• allergic (contact) dermatitis;

• dyshidrotic eczema.

Contraindications

• hypersensitivity to the components of the drug;

• 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;

• areas of the skin with manifestations of a reaction to vaccination;

• children under 18 years of age.

Application during pregnancy and during breastfeeding

If you need to use the drug ComfodermЃ M2 during pregnancy and lactation, you should carefully weigh the potential risk to the fetus and the expected benefits of treatment for the mother. During these periods, long-term use of the drug on extensive skin surfaces is not recommended. Breastfeeding mothers should not apply the drug to their breasts.

Method of administration and dosage

Outwardly. The drug is applied once a day with a thin layer on the affected skin. As a rule, the duration of continuous daily treatment with ComfodermЃ M2 should not exceed 12 weeks. When treating patients with facial skin lesions, the course of treatment should not exceed 5 days

Side effects

Very rarely (less than 0.01% of cases), local reactions can occur, such as itching, burning, erythema, and the formation of a vesicular 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, acneform skin changes, systemic effects due to corticosteroid absorption.
In rare cases (0.01% -0.1%), folliculitis, hypertrichosis, perioral dermatitis, skin depigmentation, allergic reactions to one of the components of the drug can be observed.

Overdose

When studying the acute toxicity of metelprednisolone 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 with unintentional ingestion.
With excessively long and / or intensive local use of glucocorticosteroids, skin atrophy (thinning of the skin, telangiectasia, striae) may develop.
If signs of skin atrophy appear, the drug must be canceled.
With topical application of urea, an overdose is unlikely.

Interaction with other medicinal products

Interaction of the drug with other drugs has not been identified, however, it should be borne in mind that the simultaneous use of the drug ComfodermЃ M2 with other ointments or creams can lead to an increase in the resorption of their constituent drugs

special instructions

In the presence of bacterial complications and / or dermatomycosis, in addition to therapy with ComfodermЃ M2, it is necessary to carry out specific antibacterial and / or antimycotic treatment.
The drug is not intended for use in ophthalmology. Avoid contact with eyes and mucous membranes.
As with the use of systemic glucocorticosteroids, after external use of glucocorticosteroids, glaucoma may develop (for example, after using high doses, due to very long use of occlusive dressings or after application to the skin around the eyes).
On the skin of the face more often than on other surfaces of the body, after long-term treatment with topical glucocorticosteroids, atrophic changes may appear.

Influence on the ability to drive vehicles, mechanisms

Not found.

Release form

Cream for external use 0.1% + 2%. 30 g in an aluminum tube. Each tube, together with instructions for use, is placed in a cardboard box.

Storage conditions

List B
In a dry, dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life

3 years. Do not use after the expiration date printed on the package.

Conditions of dispensing from pharmacies

On prescription.