Description
Release form
Cream for external use
Pharmacological action
Comfoderm ® M2 is a combined preparation whose action is due to its constituent components.
Methylprednisolone aceponate – is a non-halogenated synthetic steroid.
With external use of methylprednisolone, aceponate suppresses inflammatory and allergic skin reactions associated with increased proliferation, which leads to a decrease in objective symptoms of inflammation (erythema, edema, weeping) and subjective sensations (itching, irritation, pain, etc.). When using methylprednisolone aceponate 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 is no adrenal gland dysfunction: the plasma cortisol level and its circadian rhythm remain within normal limits, the decrease in the concentration of cortisol in daily urine does not going on.
Methylprednisolone aceponate (especially its main metabolite, 6β-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to certain sections of the DNA of the cells of the immune response, 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, thus, the formation of inflammatory mediators such as prostaglandins and leukotrienes.
Glucocorticosteroid inhibition of the synthesis of vasodilating prostaglandins and potentiation of the vasoconstrictor action of adrenaline lead to a vasoconstrictor effect.
Urea – has keratolytic and moisturizing effects. Urea promotes water binding and, as a result, softens the stratum corneum. In addition to keratolytic action, urea has proteolytic activity.
Pharmacokinetics
With topical administration of methylprednisolone, aceponate is hydrolyzed in the epidermis and dermis. The main and most active metabolite is 6β-methylprednisolone-17-propionate, which has a significantly higher affinity for skin glucocorticosteroid receptors, which indicates the presence of its bioactivation in the skin.
The degree of percutaneous absorption depends on the condition of the skin and method of application (with or without occlusive dressing).
Percutaneous absorption in patients with atopic dermatitis (neurodermatitis) and psoriasis is not more than 2.5%, which is only slightly higher than that in healthy volunteers (0.5-1.5%).
When 6 -methylprednisolone-17-propionate enters the systemic circulation, it is rapidly conjugated with 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 cumulate in the body.
Due to the low absorption of urea with topical application, the probability of its systemic effects is low.
Indications
Inflammatory skin diseases that are sensitive to therapy with topical glucocorticosteroids and accompanied by impaired keratinization: – atopic dermatitis, neurodermatitis
– true eczema
– microbial eczema
– simple contact dermatitis
– allergic (contact) dermatitis
– dyshidrotic eczema.
Contraindications
Hypersensitivity to the components of the
tuberculosis or syphilitic processes in the area of application of the drug
viral diseases (for example, serous larynx manifestations of the reaction to
vaccination in children under 18 years of age.
Special instructions
In the presence of bacterial complications and / or dermatomycosis in addition to drug therapy Comfoderm M2 requires specific antibacterial and / or antifungal treatment.
The drug is not intended for use in ophthalmology. Avoid contact with eyes and mucous membranes.
As with the use of systemic glucocorticoids, with external use of corticosteroids, glaucoma may develop (for example, after use in high doses, due to very long-term use, use of occlusive dressings or application to the skin around the eyes).
On the skin of the face more often than on other surfaces of the body, after prolonged treatment with corticosteroids for external use, atrophic changes can develop.
Influence on ability to drive vehicles and control mechanisms
Not identified.
Dosage and Administration
Externally.
The drug is applied 1 time / day with a thin layer on the affected skin. As a rule, the duration of continuous daily treatment with
Comfoderm M2 should not exceed 12 weeks. In the treatment of patients with facial skin lesions, the course of treatment should not exceed 5 days.
Side effects
Very rarely (in less than 0.01% of cases) local reactions such as itching, burning, erythema, the formation of a vesicular rash.
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: atrophy of the skin, telangiectasia, striae, acneform changes in the skin, systemic effects due to absorption of the corticosteroid.
In rare cases (0.01% -0.1%), folliculitis, hypertrichosis, perioral dermatitis, skin depigmentation, allergic reactions to one of the components of the drug can be observed.
Drug interaction
No drug interaction with other drugs has been identified, however, it should be borne in mind that the simultaneous use of the drug
Comfoderm M2 with other ointments or creams can lead to increased resorption of their constituent drugs.
Overdose of
Symptoms: with excessively long and / or intensive local use of corticosteroids, skin atrophy may develop (thinning of the skin, telangiectasia, striae).
Treatment: if signs of skin atrophy appear, the drug must be discontinued.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C.
Expiration
2 years.
Pharmacy
over-the-counter
Form of Treatment
cream
