Komfoderm M2 - instructions for use, dose, side effects, contraindications

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Dosage form: & nbspcream for external use

Composition:

100 g of cream contain:

active substances: methylprednisolone aceponate in terms of 100% substance - 0.1 g of urea in terms of 100% substance - 2 g;

Excipients: liquid paraffin (vaseline oil) - 15 g propylene glycol - 5 g Polysorbate 80 - 1 g, carbomer interpolymer (type A) - 1 g, Trometamol - 0.4 g, 0.1 g-metiliaragidroksibenzoat, purified water - up to 100 g .

Description:The cream is white or almost white. A weak specific odor is allowed.

Pharmacotherapeutic group:Glucocorticosteroid for topical use + keratolytic agent

Pharmacodynamics:

Komfoderm® M2 is a combined preparation, the effect of which is due to its constituent components.

Methylprednisolone aceponate - is a non-halogenated synthetic steroid. With external application methylprednisolone aceponate inhibits inflammatory and allergic skin reactions as well as reactions associated with enhanced proliferation, leading to reduced inflammation objective symptoms (erythema, edema, oozing) and subjective sensations (itching, irritation, pain, etc.).

When applying methylprednisolone aceponate externally at the recommended dose, the systemic effect is minimal both in humans and in animals.After repeated application of methylprednisolone aceponate on large surfaces (40-60% of the skin surface), and also when applied under the occlusive dressing, there are no abnormalities of the adrenal glands: the level of cortisol in the plasma and its circadian rhythm remain within normal limits, the decrease in the concentration of cortisol in the daily urine is not occurs. Methylprednisolone aceponate (especially its main metabolite - 6α-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, binding of the steroid-receptor complex to the DNA 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.

Inhibition of glucocorticosteroid synthesis of vasodilating prostaglandins and potentiation of vasoconstrictive action of epinephrine lead to a vasoconstrictor effect.

Urea - possesses keratolytic and moisturizing effects. Urea promotes the binding of water and, as a result, softening of the stratum corneum. In addition to keratolytic action, urea has proteolytic activity.

Pharmacokinetics:

With topical application methylprednisolone aceponate hydrolyzed in the epidermis and dermis. The main and most active metabolite is 6α-methylprednisolone-17-propionate, which has a much higher affinity for glucocorticosteroid skin receptors, indicating its "bioactivation" in the skin.

The degree of percutaneous absorption depends on the condition of the skin and the way it is used (with or without occlusive dressing).

Percutaneous absorption in patients with atopic dermatitis (neurodermatitis) and psoriasis is no more than 2.5%, which is only slightly higher than that of healthy volunteers (0.5-1.5%).

After entering the systemic bloodstream, 6α-methylprednisolone-17-propionate is rapidly conjugated to glucuronic acid and thus inactivated.

Metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys with a half-life of about 16 hours. Methylprednisolone aceponate and its metabolites are not cumulative 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, sensitive to therapy with topical glucocorticosteroids and accompanied by a violation of keratinization:

- Atopic dermatitis, neurodermatitis;

- true eczema;

- microbial eczema;

- simple contact dermatitis;

- allergic (contact) dermatitis;

- Dyshidrotic eczema.

Contraindications:

- Hypersensitivity to the components of the drug;

- tuberculosis or syphilitic processes in the application area;

- viral diseases (for example, chicken pox, shingles);

- rosacea, perioral dermatitis in the application area;

- skin areas with manifestations of response to vaccination;

- Children under 18 years.

Pregnancy and lactation:

If you need to use Comfoderm® M2 during pregnancy and lactation, you should carefully weigh the potential risk to the fetus and the expected benefit of treatment for the mother. During these periods, prolonged use of the drug on extensivesurfaces of the skin.

Nursing mothers should not apply the drug to the mammary glands.

Dosing and Administration:

Outwardly.

The drug is applied once a day with a thin layer on the affected areas of the skin.

As a rule, the duration of continuous daily treatment with Comfoderm® M2 should not exceed 12 weeks.

In the treatment of patients with skin lesions, treatment should not exceed 5 days.

Side effects:

Very rarely (less than 0.01% of cases) local reactions can occur, such as itching, burning, erythema, the formation of a vesicle 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: skin atrophy, telangiectasia, striae, acneiform skin changes, systemic effects due to absorption of corticosteroids.

In rare cases (0.01% - 0.1%) folliculitis, hypertrichosis, perioral dermatitis, depigmentation of the skin, allergic reactions to one of the drug components can be observed.

Overdose:

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

If the glucocorticosteroids are excessively long and / or intensely topical, skin atrophy may develop (thinning of the skin, telangiectasia, striae).

When there are signs of skin atrophy, the drug should be discarded.

With topical application of urea, an overdose is unlikely.

Interaction:Interactions of the drug with other drugs have not been identified, but it should be noted that the simultaneous use of KomFoderm® M2 with other ointments or creams may lead to increased resorption of the medicinal substances entering into their composition.

Special instructions:

In the presence of bacterial complications and / or dermatomycosis, in addition to therapy with Comfoderm® M2, specific antibacterial and / or antimycotic treatment should be performed.

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

As with systemic glucocorticosteroids, after external application of glucocorticosteroids, glaucoma may develop (for example, after using large doses,due to very long application of occlusive dressings or after 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 topical glucocorticosteroids, atrophic changes may appear.

Effect on the ability to drive transp. cf. and fur:Not found.

Form release / dosage:Cream for external use 0,1% + 2%.

Packaging:10 or 30 grams in an aluminum tube. Each tube together with the instruction for use is placed in a pack of cardboard.

Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002911

Date of registration:13.03.2015 / 31.05.2017

Expiration Date:13.03.2020

The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia

Manufacturer: & nbsp

AKRIKHIN HFK, JSC Russia

Information update date: & nbsp02.02.2018

Illustrated instructions

Instructions

Comfoderm® M2 (Komfoderm-m2)