Comfoderm K cream 0.1%, 30 g

Inflammatory skin diseases sensitive to topical GCS therapy:

• atopic dermatitis, neurodermatitis, childhood eczema;

• true eczema;

• microbial eczema;

• simple contact dermatitis;

• allergic (contact) dermatitis;

• dyshidrotic eczema.

The drug is used externally.

For adults and children from 4 months of age, 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 ComfodermЃ K should not exceed 12 weeks for adults and 4 weeks for children.

ComfodermЃ K is suitable for the treatment of subacute and acute inflammatory processes without pronounced wetness , with the localization of the process both on smooth skin and on the scalp, incl. on oily skin.

Active ingredient: methylprednisolone aceponate - 0.1 g

Excipients: ceramides - 0.5 g, preservative Euxyl PE 9010 (phenoxyethanol 90%, ethylhexylglycerol 10%) in terms of phenoxyethanol - 0.9 mg, isopropyl myristate - 7 g, octyldodecanol - 7 g, hexyldecyl stearate - 7 g, dimethicone 100 cst - , 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 hydrophosphate dodecahydrate - 0.01 g, purified water - up to 100 g.

• tuberculous or syphilitic processes in the area of ??application of the drug;

• viral diseases (for example, chickenpox, shingles) in the area of ??application of the drug;

• rosacea, perioral dermatitis in the area of ??application of the drug;

• areas of the skin with manifestations of a reaction to vaccination;

• children's age up to 4 months;

• hypersensitivity to the components of the drug.

Description:

Cream for external use, white or almost white, with a weak specific odor.

Composition:

Active ingredient: methylprednisolone aceponate - 0.1 g

Excipients: ceramides - 0.5 g, preservative Euxyl PE 9010 (phenoxyethanol 90%, ethylhexylglycerol 10%) in terms of phenoxyethanol - 0.9 mg, isopropyl myristate - 7 g, octyldodecanol - 7 g, hexyldecyl stearate - 7 g, dimethicone 100 cst - , 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 hydrophosphate dodecahydrate - 0.01 g, purified water - up to 100 g.

Clinical and pharmacological group: Drug with anti-inflammatory action for external use

Pharmaco-therapeutic group: Topical glucocorticosteroid

pharmachologic effect

The active component of ComfodermЃ K - methylprednisolone aceponate - is a non-halogenated synthetic steroid.

When applied externally, ComfodermЃ K suppresses inflammatory and allergic skin reactions, as well as reactions associated with increased proliferation, which leads to a decrease in the objective symptoms of inflammation (erythema, edema, weeping) 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 aceponate to large surfaces (40-60% of the skin surface), as well as when applied under an occlusive dressing, there are no adrenal dysfunctions: the concentration of cortisol in the plasma and its circadian rhythm remain within normal limits, there is no decrease in the content of cortisol in daily urine. happens.

Methylprednisolone aceponate (especially its main metabolite - 6? -Methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to specific regions of the immune response cells' DNA, 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.

Inhibition of the synthesis of vasodilating prostaglandins by glucocorticoids and the potentiation of the vasoconstrictor action of adrenaline lead to a vasoconstrictor effect.

Pharmacokinetics

Absorption and distribution

The degree 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 than in healthy volunteers (0.5-1.5%). After entering the systemic circulation, 6?-methylprednisolone-17-propionate rapidly conjugates with glucuronic acid and, thus, in the form of 6?-methylprednisolone-17-propionate glucuronide is inactivated.

Methylprednisolone aceponate and its metabolites do not accumulate in the body.

Metabolism and excretion

When used externally, methylprednisolone aceponate is hydrolyzed in the epidermis and dermis. The main and most active metabolite is 6?-methylprednisolone-17-propionate, which has a significantly higher affinity for glucocorticoid receptors in the skin, which indicates the presence of its 'bioactivation' in the skin.

Metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys with a T1 / 2 of about 16 hours.

Indications

Inflammatory skin diseases sensitive to topical GCS therapy:

• atopic dermatitis, neurodermatitis, childhood eczema;

• true eczema;

• microbial eczema;

• simple contact dermatitis;

• allergic (contact) dermatitis;

• dyshidrotic eczema.

Dosage regimen

The drug is used externally.

For adults and children from 4 months of age, 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 ComfodermЃ K should not exceed 12 weeks for adults and 4 weeks for children.

ComfodermЃ K is suitable for the treatment of subacute and acute inflammatory processes without pronounced wetness , with the localization of the process both on smooth skin and on the scalp, incl. on oily skin.

Side effect

The incidence of side effects is classified according to the WHO recommendations: 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).

On the part of the skin and subcutaneous tissues: rarely - perioral dermatitis, skin depigmentation, allergic reactions to the components of the drug; the 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, the formation of a vesicular rash; frequency is unknown - systemic effects due to absorption of GCS (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 not indicated in the instructions are noted, the patient should immediately inform the doctor about it.

Contraindications for use

• tuberculous or syphilitic processes in the area of ??application of the drug;

• viral diseases (for example, chickenpox, shingles) in the area of ??application of the drug;

• rosacea, perioral dermatitis in the area of ??application of the drug;

• areas of the skin with manifestations of a reaction to vaccination;

• children's age up to 4 months;

• hypersensitivity to the components of the drug.

Application during pregnancy and lactation

If it is necessary to use the drug ComfodermЃ K during pregnancy and during breastfeeding, the potential risk to the fetus / child and the expected benefits of treatment for the mother should be carefully weighed. During these periods, long-term use of the drug on extensive skin surfaces is not recommended. Breastfeeding mothers should not apply the drug to their breasts.

Application in children

The use of the drug is contraindicated in children under 4 months of age.

special instructions

In the presence of bacterial dermatoses and / or dermatomycosis, in addition to therapy with ComfodermЃ K, it is necessary to carry out specific antibacterial or antimycotic treatment.

The drug is not intended for use in ophthalmology. Avoid contact with eyes and mucous membranes.

As with the use of systemic corticosteroids, after external use of glucocorticoids, glaucoma may develop (for example, when using the drug in high doses, due to the very long use of occlusive dressings or application to the skin around the eyes).

Influence on the ability to drive vehicles and mechanisms

Not found.

Overdose

When studying the acute toxicity of methylprednisolone aceponate, there was no risk of acute intoxication with excessive single skin use (application of the drug over a large area under conditions favorable for absorption) or with unintentional ingestion.

Symptoms: with excessively long and / or intense external use of GCS, skin atrophy (thinning of the skin, telangiectasia, striae) may develop.

Treatment: if signs of skin atrophy appear, the drug must be canceled.

Drug interactions

Has not been studied.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25 ? C.

Shelf life

Shelf life is 2 years. Do not use after the expiration date.

Terms of sale

The drug is dispensed without a prescription.