Comfoderm K cream d / nar. approx. 0.1% tube 30g No. 1

pharmachologic effect

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

When applied externally, Comfoderm 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, 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 - 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, 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.

Indications

Inflammatory skin diseases sensitive to topical glucocorticosteroid therapy: atopic dermatitis, neurodermatitis, childhood eczema

true eczema

microbial eczema

simple contact dermatitis

allergic (contact) dermatitis

dyshidrotic eczema.

Contraindications

Hypersensitivity to drug components

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.

Recommendations for use

Outwardly.

Adults and children from 4 months of age.

The drug is applied once a 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.

The drug Comfoderm K is suitable for the treatment of subacute and acute inflammatory processes without pronounced weeping, with the localization of the process both on smooth skin and on the scalp, including skin prone to oily.

special instructions

In the presence of bacterial dermatoses and / or dermatomycosis, in addition to therapy with Comfoderm K, specific antibacterial or antimycotic treatment should be carried out.

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 the drug is used 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 control mechanisms Not identified.

Structure

100 g methylprednisolone aceponate 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 edetate - 0.1 g, potassium dihydrogen phosphate - 0.49 g, sodium hydrophosphate dodecahydrate - 0.01 g, purified water - up to 100 g.

Side effects

The incidence of side effects is classified in accordance with the recommendations of the World Health Organization (WHO): 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).

Violations 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 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 not indicated in the instructions are noted, you should immediately inform your doctor about it.

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 intensive 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.

Storage conditions

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

Shelf life

2 years.

Do not use after the expiration date.

Active substance

Methylprednisolone aceponate

Name ENG

KOMFODERM K

Clinical and pharmacological group

Anti-inflammatory drug for external use

ATX code

Methylprednisolone

Dosage

0.1% x 30g

Structure

100 g methylprednisolone aceponate 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 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 edetate - 0.1 g, potassium dihydrophosphate - 0.49 g, sodium hydrogen phosphate dodecahydrate - 0.01 g, purified water - up to 100 g.

Indications

Inflammatory skin diseases sensitive to topical glucocorticosteroid therapy: atopic dermatitis, neurodermatitis, childhood eczema

true eczema

microbial eczema

simple contact dermatitis

allergic (contact) dermatitis

dyshidrotic eczema.

INN / Active ingredient

Methylprednisolone aceponate, Urea

Contraindications

Hypersensitivity to drug components

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.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

Specifications

Category

Regenerating agents

Scope of the drug

Dermatology

Release form

Cream

Manufacturer country

Russia

Package quantity, pcs

one

Scope of application

Dermatology

Minimum age from

4 months

Way of introduction

Locally

,

Outwardly

Vacation conditions

Without recipe

Brand name

Akrikhin

The amount of the dosage form in the primary package

30 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

Packaging

Cardboard box

The target audience

Children

Expiration date in days

730

Package weight, g

thirty

Mode of application

:

Outwardly.

< br> Adults and children from 4 months of age.

The drug is applied once a 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.

The drug Comfoderm K is suitable for the treatment of subacute and acute inflammatory processes without pronounced weeping, with the localization of the process both on smooth skin and on the scalp, including skin prone to oily.

Dosage (volume) of the substance in the preparation

:

methylprednisolone aceponate (in terms of 100% substance) 0.1 g

Information on technical characteristics, delivery set, country of manufacture