Comfoderm cream 15g

Composition

Active substance: methylprednisolone aceponate (in terms of 100% substance) 0.1 g
Excipients: ceramides - 0.5 g, Euxyl PE 9010 preservative (phenoxyethanol - 90%, ethylhexylglycerol - 10%) in terms of phenoxyethanol - 0.9 mg, isopropyl myristate - 7 g, octyldodecanol - 7 g, 7 g of hexyl decyl stearate - 7 g, dimeth, 3 g, and dimethyl docecanol - 7 g; 1 g, propylene glycol - 7 g, macrogol 40 stearate - 1.5 g, glyceryl monostearate - 8.5 g, cetostearyl alcohol (cetyl alcohol - 60%, stearyl alcohol - 40%) - 2 g, disodium edetate - 0.1 g, potassium dihydrogen phosphate - 0.49 g, sodium hydrogen phosphate dodecahydrate - 0.01 g, purified water - up to 100 g

Indications and usage

Inflammatory skin diseases sensitive to therapy with topical glucocorticosteroids:
atopic dermatitis, neurodermatitis, children eczema; true eczema; microbial eczema; simple contact dermatitis; allergic (contact) dermatitis; dyshidrotic eczema.

Contraindications

Hypersensitivity to the drug;
tuberculous or syphilitic processes in the field of drug application; viral diseases (for example, chicken pox, shingles) in the area of ​​application of the drug;
rosacea, perioral dermatitis in the area of ​​application of the drug; skin areas with reactions to vaccination; children's age up to 4 months.

The active component of the drug Komfodsrm10 K - methylprednisolone aceponate - is a non-halogenated synthetic steroid.
When applied externally, Komfodsrm® K suppresses inflammatory and allergic skin reactions, as well as reactions associated with enhanced proliferation, which leads to a decrease in objective symptoms of inflammation (erythema, edema, oozing) and subjective sensations (itching, irritation, pain, etc..).
When methylprednisolone aceponate is used externally at the recommended dose, the systemic effect is minimal in both humans and animals. After repeated application of methylprednisolone aceponon on large surfaces (40-60% of the skin surface), as well as when applied under the occlusive dressing, there are no violations of the adrenal glands: plasma corgizol level and its circadian rhythm remain within the normal range, cortisol does not decrease in daily urine going on. Methyl prednisolone aceponate (especially its main metabolite, 6a-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to certain parts 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 with DNA cells of the immune response leads to the induction of macrocortin synthesis. Macrocortin inhibits the release of arachidopic acid and, thereby, the formation of inflammatory mediators such as prostaglandins and leukotrienes.
Inhibition of the synthesis of vasodilating prostaglandins by glucocorticoids and the potentiation of the vasoconstrictive action of adrenaline lead to a vasoconstrictor effect.

When externally used, methylprednisolone is hydrolyzed in the epidermis and dermis. The main and most active metabolite is 6a-methylprednisolone-17-propionate, which has a significantly higher affinity for the glucocorticosteroid receptors of the skin, which indicates the presence of its "bioactivation" in the skin.
The extent of percutaneous absorption depends on the condition of the skin and the method of application (with or without an occlusive dressing).
Percutaneous absorption in children and adults with atopic dermatitis (neurodermatitis) and psoriasis is no more than 2.5%, which is only slightly higher compared with healthy volunteers (0.5-1.5%).
After entering the systemic circulation, 6a-methylprednisolone-17-propionate quickly conjugates with glucuronic acid and, thus, in the form of ba-methylprednisolone-17-propionate, glucuridide is inactivated.
Metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys with a half-life of about 16 hours. Methylprednisolone aceponate and its metabolites accumulate in the body.
not

Adverse reactions

Violations of the skin and subcutaneous tissues: rarely - perioral dermatitis, skin depigmentation, allergic reactions to the components of the drug; frequency is unknown - skin atrophy, telangiectasia, striae, acne-like skin changes (when using the drug for more than 4 weeks and / or on an area of ​​10% or more of the body surface).
General disorders and disorders at the injection site: rarely - folliculitis, hypertrichosis; very rarely - itching, burning, erythema, formation of vesicular rash; frequency unknown - systemic effects due to absorption of a glucocorticosteroid (when using the drug for more than 4 weeks and / or on an area of ​​10% or more of the body surface). If any of the side effects indicated in the instructions are aggravated, or any other side effects that are not indicated in the instructions are noted, you should immediately inform your doctor.

Outwardly. Adults and children from 4 months of age. The drug is applied 1 time per day with a thin layer on the affected skin.
As a rule, the duration of continuous daily treatment with Komfoderm® K should not exceed 12 weeks for adults and 4 weeks for children. Comfoderm® K is suitable for the treatment of sub-acute and acute inflammatory processes without pronounced soak, with the process localized on both smooth skin and scalp, including skin prone to fat.

With no restrictions

Storage conditions

Store at a temperature not exceeding 25 ° C.