Methylprednisolone aceponate (Komfoderm M2) cream 0.1% + 2% – [30 g tube]

Description

Comfoderm M2 Pharmacodynamics
Comfoderm® M2 is a combination drug, the effect of which is due to its constituent components.
Methylprednisolone aceponate is a nonhalogenated synthetic steroid. When applied topically, methylprednisolone aceponate suppresses inflammatory and allergic skin reactions, as well as reactions associated with increased proliferation, which leads to reduction of objective symptoms of inflammation (erythema, edema, mucous) and subjective sensations (itching, irritation, pain, etc.).
When methylprednisolone aceponate is applied topically at the recommended dose, systemic effects are 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 used under the occlusive dressing, no adrenal dysfunction is observed: plasma cortisol level and its circadian rhythm remain within normal limits, there is no reduction of cortisol concentration in daily urine.
Methylprednisolone aceponate (especially its main metabolite, 6 alpha-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors.
The steroid-receptor complex binds to specific DNA sites of immune response cells, thus causing a series of biological effects.
In particular, binding of the steroid-receptor 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 prostaglandins and leukotrienes.
Inhibition by glucocorticosteroids of the synthesis of vasodilatory prostaglandins and potentiation of the vasoconstrictor effect of adrenaline lead to a vasoconstrictor effect.
Urea has keratolytic and moisturizing effects. Urea promotes water binding and consequently softening of the stratum corneum of the skin. In addition to its keratolytic effect, urea has proteolytic activity.

Indications
Inflammatory skin diseases susceptible to therapy with topical gluco-
corticosteroids and accompanied by impaired keratinization:
● atopic dermatitis, neurodermatitis;
● true eczema;
● microbial eczema;
● simple contact dermatitis;
● allergic (contact) dermatitis;
Dyshidrotic eczema

Contraindications
Hypersensitivity to the ingredients of the medicine;
Tuberculosis or syphilitic process in the application area;
Viral diseases (e.g., chicken pox, shingles);
Rosacea, perioral dermatitis in the application area;
● areas of the skin with signs of a reaction to vaccination;
Children under 18 years of age.
Use during pregnancy and lactation
If it is necessary to apply Komfoderm® M2 during pregnancy and
If it is necessary to apply Komfoderm® M2 during pregnancy and lactation, the potential risk to a fetus and expected benefits of treatment to a mother should be carefully weighed. During these periods, prolonged use of
of the drug on extensive skin surfaces is not recommended during these periods. Nursing mothers should not apply
the drug on the mammary glands

Directions for use and dosages

• Outwardly. The drug is applied once a day with a thin layer on the affected skin areas.
• Generally the duration of continuous daily treatment with Comfoderm® M 2 must not exceed 12 weeks.
• When treating patients with facial skin lesions the treatment course should not exceed 5 days.