Comfoderm ointment d / nar. approx. 0.1% tube 15g

Release form, composition and packaging

Ointment for external use from white to white with a grayish or yellowish tint, homogeneous, translucent

the presence of a characteristic odor is allowed.

100 g

methylprednisolone aceponate in terms of 100% substance 0.1 g

petroleum jelly - 44.7 g, liquid paraffin - 34.1 g, castor bean seed oil - 3.2 g, white beeswax - 17.9 g.

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

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

pharmachologic effect

The active component of the drug Comfoderm - methylprednisolone aceponate - is a non-halogenated steroid.

When used externally, methylprednisolone aceponate 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, etc.) 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 the drug to large surfaces (40-60% of the skin surface), as well as application under an occlusive dressing, there are no adrenal dysfunctions: the concentration of cortisol in the plasma and its circadian rhythm remain within normal limits, and there is no decrease in the content of cortisol in daily urine.

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, the dosage form and the route of administration (with or without an occlusive dressing).

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

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

- professional eczema

- simple contact dermatitis

- allergic (contact) dermatitis

- dyshidrotic eczema.

Contraindications for use

- tuberculous or syphilitic processes in the area of ��drug application

- 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

- increased sensitivity to components

Name ENG

KOMFODERM

Clinical and pharmacological group

Anti-inflammatory drug for external use

ATX code

Methylprednisolone aceponate

Dosage

0.1% x 15g

Structure

methylprednisolone aceponate in terms of 100% substance 0.1 g Excipients: petroleum jelly - 44.7 g, liquid paraffin - 34.1 g, castor bean seed oil - 3.2 g, white beeswax - 17.9 g.

Indications

Inflammatory skin diseases sensitive to topical glucocorticosteroid therapy:

atopic dermatitis, neurodermatitis, childhood eczema

true eczema

microbial eczema

professional eczema

simple contact dermatitis

allergic (contact) dermatitis

dyshidrotic eczema.

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

children's age up to 4 months

areas of the skin with manifestations of a reaction to vaccination

hypersensitivity to the components of the drug.

Application during pregnancy and during breastfeeding If it is necessary to use the drug ComfodermВ® during pregnancy and during breastfeeding, the potential risk to the fetus and the expected benefits of treatment for the mother should be carefully weighed.

During these periods, long-term use of the drug on large skin surfaces is not recommended nursing mothers should not apply the drug to the mammary glands.

INN / Active ingredient

methylprednisolone aceponate

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

Specifications

Category

Regenerating agents

Scope of the drug

General

Release form

Ointment

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

D07AC14 Methylprednisolone aceponate

Dosage form

Ointment for external use

Item weight, g

15

Expiration date in days

730

The target audience

Children

Package weight, g

15

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

For the treatment of long-term chronic inflammatory skin processes with very dry skin, an anhydrous dosage form is required.

The occlusive effect of ComfodermВ® provides a pronounced therapeutic effect even with significant lichenification and infiltration.

Dosage (volume) of the substance in the preparation

:

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

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