Comfoderm M2 cream, 10g

Composition

>of 100 g of cream contains: Active ingredients:  methylprednisolone aceponate 100 mg; urea 2 g; Excipients:  liquid paraffin (petroleum jelly oil) – 15 g, propylene glycol-5 g, polysorbate 80-1 g, carbomer interpolymer (type A) – 1 g, trometamol-400 mg, methyl parahydroxybenzoate-100 mg, purified water – up to 100 g.

Pharmacological action

Comfoderm ® M2 is a combined drug, the action of which is due to the components included in its composition. Methylprednisolone aceponate is a non-halogenated synthetic steroid. When applied externally, methylprednisolone aceponate suppresses inflammatory and allergic skin reactions associated with increased proliferation, which leads to a decrease in objective symptoms of inflammation (erythema, edema, wetness) and subjective sensations (itching, irritation, pain, etc. ). When used externally at the recommended dose, the systemic effect is minimal in both humans and animals. After repeated application of methylprednisolone aceponate on large surfaces (40-60% of the skin surface), as well as when applied under an occlusive dressing, there are no violations of adrenal functions: the level of cortisol in plasma and its circadian rhythm remain within normal limits, and there is no decrease in the concentration of cortisol in the daily urine. Methylprednisolone aceponate (especially its main metabolite,6α – methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to specific regions of the DNA of immune response cells, thus causing a series of biological effects. In particular, binding of the steroid-receptor complex to the DNA of immune response cells 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 potentiation of the vasoconstrictor effect of epinephrine lead to a vasoconstrictor effect. Urea-has keratolytic and moisturizing effects. Urea helps to bind water and, as a result, soften the stratum corneum of the skin. In addition to keratolytic action, urea has proteolytic activity.

Pharmacokinetics: When applied topically, 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 glucocorticoid receptors in the skin, which indicates the presence of its” bioactivation ” 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,6α-methylprednisolone-17-propionate is rapidly conjugated to glucuronic acid and thus 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

Inflammatory skin diseases that are sensitive to topical corticosteroid therapy and are accompanied by a violation of keratinization: — atopic dermatitis, neurodermatitis— – true eczema;- microbial eczema;- simple contact dermatitis;- allergic (contact) dermatitis;- dyshidrotic eczema.

Contraindications

• Hypersensitivity to the components of the drug;
• tuberculosis 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;
• skin areas with manifestations of a reaction to vaccination;
• children under 18 years of age.

Side effects

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

Interaction

Interaction of the drug with other medicinal products has not been revealed, however, it should be borne in mind that the simultaneous use of Drugacomfoderm M2 with other ointments or creams may lead to increased resorption of their constituent medicinal substances.

How to take, course of use and dosage

Externally. The drug is applied 1 time / day in a thin layer on the affected skin areas. As a rule, the duration of continuous daily treatment with Comfoderm M2 should not exceed 12 weeks. When treating patients with facial skin lesions, the course of treatment should not exceed 5 days.

Overdose

Symptoms:  skin atrophy (thinning of the skin, telangiectasia, striae) may develop with excessively long and/or intensive topical application of corticosteroids. Treatment: if signs of skin atrophy appear, the drug should be discontinued.

Special instructions

In the presence of bacterial complications and/or dermatomycosis, specific antibacterial and / or antifungal treatment should be performed in addition to therapy with Comfoderm M2. The drug is not intended for use in ophthalmology. Avoid contact with the eyes and mucous membranes. As with the use of systemic glucocorticoids, external use of corticosteroids can lead to glaucoma (for example, after applying high doses, due to very long-term use, the use of occlusive dressings or application to the skin around the eyes). On the skin of the face, more often than on other body surfaces, after long-term treatment with corticosteroids for external use, atrophic changes may develop. The effect on the ability to drive motor vehicles and manage mechanisms was not revealed.

Form of production

Cream for external use

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf

life is 2 years.

Active ingredient

Methylprednisolone aceponate, Urea

Dosage form

cream