Description
Pharmacological action
The active ingredient of Comfoderm ® – methylprednisolone aceponate – is a non-halogenated steroid.
With the external use of methylprednisolone, aceponate suppresses inflammatory and allergic skin reactions, as well as reactions associated with increased proliferation, which leads to a decrease in objective symptoms of inflammation (erythema, edema, weeping, etc.) and subjective sensations (itching, irritation, pain, etc.). When applying methylprednisolone aceponate externally at the recommended dose, the systemic effect is minimal in both humans and animals. After repeated application of the drug to large surfaces (40-60% of the skin surface), as well as application under an occlusive dressing, adrenal gland dysfunctions are not observed: the plasma cortisol level and its circadian rhythm remain within normal limits, and there is no decrease in the level of cortisol in daily urine. Methylprednisolone aceponate (especially its main metabolite, 6 -methylprednisolone-17-propionate) binds to intracellular glucocorticosteroid receptors. The steroid receptor complex binds to certain regions of the DNA of the immune response cells, 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 thereby the formation of inflammatory mediators such as prostaglandins and leukotrienes. Inhibiting glucocorticosteroid synthesis of vasodilating prostaglanditis and potentiating the vasoconstrictor action of adrenaline leads to a vasoconstrictor effect
Indications
Inflammatory skin diseases that are sensitive to topical glucocorticosteroid therapy:
– atopic dermatitis, atopic dermatitis, childhood eczema
– true eczema
– microbial eczema
– occupational eczema
– simple contact dermatitis
– allergic (contact) dermatitis
– dyshidrotic eczema.
Contraindications
– tuberculosis or syphilitic processes in the field of application of the drug
– viral diseases (e.g. chicken pox, shingles), in the area of application of the
preparation – rosacea, perioral dermatitis in the area of application of the
preparation – children under 4 months of age
– skin areas with manifestations of the reaction to vaccination
– hypersensitivity to the components of the drug
Composition of
100 g of ointment contains:
Active ingredient: methylprednisolone aceponate in terms of 100% substance – 0.1 g
Excipients: petrolatum – 44.7 g liquid paraffin – 34.1 g castor oil seed oil – 3, 2 g beeswax white – 17.9 g.
Dosage and Administration
Externally. Adults and children from 4 months of age. The drug is applied 1 time per day with a thin layer on affected skin areas. As a rule, the duration of continuous daily treatment with Comfoderm ® should not exceed 12 weeks for adults and 4 weeks for children. For the treatment of prolonged chronic inflammatory skin processes with very dry skin, an anhydrous dosage form is necessary. The occlusal effect of Comfoderm ® provides a pronounced therapeutic effect even with significant lichenification and infiltration.
Side effects
The incidence of side effects is classified according to the recommendations of the World Health Organization (WHO): very often ( 10%), often ( 1%, <10%), infrequently ( 0.1%, <1 %), rarely ( 0.01%, <0.1%), very rarely (<0.01%), the frequency is unknown (it is not possible to estimate the frequency of occurrence). Disorders of the skin and subcutaneous tissues: rarely – perioral dermatitis, skin depigmentation, allergic reactions to the drug components, frequency is unknown – atrophy of the skin, telangiectasia, striae, acne-like skin changes (when using the drug for more than 4 weeks and / or on an area of ² ¹ ² ¹10 % or more of the surface of the body). General disorders and disorders at the injection site: rarely – folliculitis, hypertrichosis very rarely – itching, burning, erythema, formation of a vesicular rash, frequency is unknown – systemic effects due to absorption of glucocorticosteroid (when using the drug for more than 4 weeks and / or on an area of ² ¹ ² ¹10 % or more of the body surface). If any of the side effects indicated in the instructions are aggravated, or any other side effects not listed in the instructions are noted, you should immediately inform your doctor. Overdose of When studying the acute toxicity of methylprednisolone aceponate, there was no risk of acute intoxication with excessive single skin use (applying the drug over a large area under conditions favorable for absorption) or unintentional ingestion. Excessively long and / or intensive use of glucocorticosteroids for external use can lead to skin atrophy (thinning of the skin, telangiectasia, striae). If atrophy occurs, the drug must be discontinued. Storage conditions At a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 2 years lekarstvennaja form ointment
