Methylprednisolone aceponate (Komfoderm K) cream 0.1% – [15 g tube]

Description

Komfoderm K Pharmacodynamics
The active ingredient of Komfoderm® K, methylprednisolone aceponate, is a nonhalogenated synthetic steroid.
When applied topically Komfoderm® K suppresses inflammatory and allergic skin reactions, as well as reactions related to increased proliferation, which leads to a 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: the plasma level of cortisol and its circadian rhythm remain within normal limits, there is no reduction of cortisol levels in daily urine.
Methylprednisolone aceponate (especially its main metabolite, 6α-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 glucocorticoids of the synthesis of vasodilatory prostaglandins and potentiation of the vasoconstrictor effect of adrenaline result in a vasoconstrictor effect.

Indications
Inflammatory skin diseases sensitive to therapy with topical glucocorticosteroids:
– Atopic dermatitis, neurodermatitis, pediatric eczema;
– 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 where the drug is applied;
– Viral diseases (e.g. chicken pox, shingles) in the application area;
– Rosacea, perioral dermatitis in the area of application;
– Areas of skin with signs of a reaction to the vaccine;
– Children under four months of age.
Use during pregnancy and lactation:
If it is necessary to use Comfoderm® K during pregnancy and during breastfeeding, the potential risk to the fetus and the expected benefit of the treatment to the mother should be carefully weighed. During these periods, prolonged use of the drug on large areas of skin is not recommended.
Nursing mothers should not apply the drug to the mammary glands.

Directions for use and dosages

• Outwardly.
• Adults and children from 4 months of age. The drug is applied once a day with a thin layer on the affected skin areas.
• As a rule, the duration of continuous daily treatment with Comfoderm® K must not exceed 12 weeks for adults and 4 weeks for children.
• Komfoderm® K is suitable for the treatment of subacute and acute inflammatory processes without marked mucous membrane, when localized on both smooth skin and the scalp, including skin with a tendency to grease.