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

Description

Comfoderm Pharmacodynamics
The active ingredient of Komfoderm® – methylprednisolone aceponate – is a nonhalogenated steroid.
Pharmacodynamics
When applied topically methylprednisolone aceponate 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, etc.) 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 the drug on large surfaces (40-60% of the skin surface), as well as after application of the subcutaneous dressing, no adrenal dysfunction is observed: plasma cortisol level and its circadian rhythm remain within normal limits, there is no reduction of cortisol level in daily urine.
Methylprednisolone aceponate (especially its main metabolite, 6α-methylprednisolone-17-propionate) binds to intracellular glucocorticosteroid 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, result in an azoconstrictor effect.

Indications
Inflammatory skin diseases susceptible to therapy with topical glucocorticosteroids:
– Atopic dermatitis, neurodermatitis, pediatric eczema;
– true eczema;
– microbial eczema;
– occupational eczema;
– simple contact dermatitis;
– allergic (contact) dermatitis;
– dyshidrotic eczema.

Contraindications
– Tuberculosis or syphilitic process in the area where the drug is applied;
– Viral diseases (e.g. chicken pox, shingles), in the area of application;
– Rosacea, perioral dermatitis in the application area;
– Children under four months of age; i areas of the skin showing signs of a reaction to the vaccine;
– Hypersensitivity to the drug components.
Use during pregnancy and lactation
If it is necessary to use the drug Komfoderm® during pregnancy and during breast-feeding, it is necessary to carefully weigh the potential risk to the fetus and the expected benefits of the treatment to the mother. 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 daily continuous treatment with Comfoderm® must not exceed 12 weeks for adults and 4 weeks for children.
• For long-lasting chronic inflammatory skin conditions with very dry skin, anhydrous dosage form is required. The occlusive effect of Comfoderm® provides a pronounced therapeutic effect even with significant lichenification and infiltration.