Comfoderm K cream d / nar. approx. 0.1% tube 15g No. 1

Release form, composition and packaging

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

100 g

methylprednisolone aceponate in terms of 100% substance 0.10 g

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 glycol - 1 g, propylene 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 - 0.01 dodecahydrate g, purified water - up to 100 g.

15 g - aluminum tubes (1) - cardboard packs.

30 g - aluminum tubes (1) - cardboard packs.

pharmachologic effect

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

When applied externally, ComfodermK 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, 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 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, the decrease in the content of cortisol in daily urine is not going on.

Methylprednisolone aceponate (especially its main metabolite - 6alpha-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, 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 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, 6alpha-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid and, thus, in the form of 6alpha-methylprednisolone-17-propionate glucuronide is inactivated.

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

Metabolism and excretion

When applied externally, methylprednisolone aceponate is hydrolyzed in the epidermis and dermis.

The main and most active metabolite is 6alpha-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 for use

Inflammatory skin diseases sensitive to topical GCS therapy:

- atopic dermatitis, neurodermatitis, children's eczema

- true eczema

- microbial eczema

- simple contact dermatitis

- allergic (contact

Name ENG

KOMFODERM K

Clinical and pharmacological group

Anti-inflammatory drug for external use

ATX code

Methylprednisolone

Dosage

0.1% x 15g

Structure

methylprednisolone aceponate in terms of 100% substance 0.10 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 - 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 disodium 0.1 g, potassium dihydrogen phosphate - 0.49 g, sodium hydrogen phosphate dodecahydrate - 0.01 g, purified water - up to 100 g.

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.

INN / Active ingredient

methylprednisolone aceponate

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

Contraindications

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 drug components.

Specifications

Category

Antifungal

Scope of the drug

General

Release form

Cream

Manufacturer country

Russia

Package quantity, pcs

one

Scope of application

Allergology

Minimum age from

4 months

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Akrikhin

The amount of the dosage form in the primary package

15 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Topical glucocorticosteroid

Anatomical and therapeutic characteristics

D07AA01 Methylprednisolone

Dosage form

Cream for external use

Item weight, g

15

The target audience

Children

Expiration date in days

730

Package weight, g

twenty

Mode of application

:

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 Comfoderm® K should not exceed 12 weeks for adults and 4 weeks for children.

Comfoderm® 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.

Dosage (volume) of the substance in the preparation

:

In 100 g of methylprednisolone aceponate in terms of 100% substance 0.10 g

Information on technical characteristics, delivery set, country of manufacture "