Komfoderm^® M2 (Cream) Instructions for Use

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Contact Information

Akrikhin AO (Russia)

ATC Code

D07XC (Corticosteroids with high activity in combination with other drugs)

Active Substances

Methylprednisolone aceponate (Rec.INN registered by WHO)

Urea (Ph.Eur. European Pharmacopoeia)

Dosage Form

Komfoderm M2

Cream for external use 100 mg+2 g/100 g: tubes 10 g or 30 g

Dosage Form, Packaging, and Composition

Cream for external use white or almost white in color, a slight specific odor is allowed.

Excipients: liquid paraffin (vaseline oil), propylene glycol, polysorbate 80, carbomer interpolymer (type A), trometamol, methylparahydroxybenzoate, purified water.

10 g – aluminum tubes (1) with caps – cardboard packs.
30 g – aluminum tubes (1) with caps – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory and moisturizing action for external use

Pharmacotherapeutic Group

Corticosteroids used in dermatology; corticosteroids in combination with other agents; high-potency corticosteroids in combination with other agents

Pharmacological Action

Komfoderm M₂ is a combined drug, the action of which is determined by its constituent components.

Methylprednisolone aceponate is a non-halogenated synthetic steroid. When applied externally, Methylprednisolone aceponate suppresses inflammatory and allergic skin reactions, as well as reactions associated with enhanced proliferation, which leads to a reduction in objective symptoms of inflammation (erythema, edema, oozing) and subjective sensations (itching, irritation, pain, etc.).

When Methylprednisolone aceponate is applied externally at the recommended dose, the systemic effect is minimal in both humans and animals. After multiple applications of Methylprednisolone aceponate to extensive surfaces (40-60% of the skin surface), as well as when used under an occlusive dressing, no impairment of adrenal function was noted: plasma cortisol levels and its circadian rhythm remain within the normal range, and no decrease in cortisol concentration in daily urine occurs.

Methylprednisolone aceponate (especially its main metabolite, 6α-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to specific DNA regions of immune system cells, thereby causing a series of biological effects. In particular, the binding of the steroid-receptor complex to DNA by immune system cells 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 vasodilatory prostaglandin synthesis by glucocorticoids and potentiation of the vasoconstrictive action of adrenaline lead to a vasoconstrictor effect.

Urea has keratolytic and moisturizing effects, promotes water binding and, as a result, softens the stratum corneum of the skin. In addition to its keratolytic action, Urea has proteolytic activity.

Pharmacokinetics

Methylprednisolone aceponate

Absorption and Distribution

When applied topically, Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis. 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 patients 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%).

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

Metabolism and Excretion

The main and most active metabolite is 6α-methylprednisolone-17-propionate, which has a significantly higher affinity for glucocorticoid receptors in the skin, indicating its “bioactivation” in the skin. After entering the systemic circulation, 6α-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid and thus inactivated.

Metabolites of Methylprednisolone aceponate are eliminated mainly by the kidneys. T_1/2 is about 16 hours.

Urea

Due to the low absorption of urea when applied topically, the likelihood of its systemic effects is low.

Indications

Inflammatory skin diseases sensitive to therapy with topical corticosteroids and accompanied by impaired keratinization

• Atopic dermatitis, neurodermatitis;
• True eczema;
• Microbial eczema;
• Simple contact dermatitis;
• Allergic (contact) dermatitis;
• Dyshidrotic eczema.

ICD codes

Dosage Regimen

Apply the drug once daily in a thin layer to the affected skin areas.

Use the cream for the shortest duration necessary to achieve therapeutic control.

Do not exceed a continuous treatment period of 12 weeks for body lesions.

Limit treatment of facial skin to a maximum of 5 days.

Avoid application to large body surface areas, under occlusive dressings, or on broken skin to minimize systemic absorption.

Discontinue use and consult a physician if no improvement is observed within one week.

Wash hands after application unless the hands are the treatment area.

Do not use in children and adolescents under 18 years of age.

Adverse Reactions

Very rarely (less than 0.01% of cases) local reactions such as itching, burning, erythema, and vesicular rash formation may be observed.

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, telangiectasias, striae, acneiform skin changes, systemic effects due to absorption of the glucocorticoid.

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

Contraindications

• Hypersensitivity to the components of the drug;
• Tuberculous or syphilitic processes in the area of application of the drug;
• Viral diseases (e.g., chickenpox, herpes zoster);
• Rosacea, perioral dermatitis in the area of application of the drug;
• Areas of the skin with manifestations of a reaction to vaccination;
• Age under 18 years.

Use in Pregnancy and Lactation

If it is necessary to use Komfoderm M₂ during pregnancy and lactation, the potential risk to the fetus and the expected benefit of treatment for the mother should be carefully weighed. During these periods, long-term use of the drug on large skin areas is not recommended.

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

Pediatric Use

The use of the drug is contraindicated in children and adolescents under 18 years of age.

Special Precautions

In the presence of bacterial complications and/or dermatomycoses, specific antibacterial and/or antifungal treatment should be carried out in addition to therapy with Komfoderm M₂.

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

As with the use of systemic glucocorticoids, the topical application of corticosteroids may lead to the development of glaucoma (e.g., after use in large doses, due to very long-term use, occlusive dressings, or application to the skin around the eyes).

Atrophic changes may develop on the facial skin more often than on other body surfaces after long-term treatment with topical corticosteroids.

Effect on the ability to drive vehicles and operate machinery

No effect has been identified.

Overdose

Methylprednisolone aceponate

In studies of the acute toxicity of Methylprednisolone aceponate, no risk of acute intoxication was identified with excessive single cutaneous application (application of the drug to a large area under conditions favorable for absorption) or with unintentional oral ingestion.

Symptoms with excessively prolonged and/or intensive topical application of corticosteroids, skin atrophy (thinning of the skin, telangiectasias, striae) may develop.

Treatment if signs of skin atrophy appear, the drug should be discontinued.

Urea

Overdose is unlikely with the topical use of urea.

Drug Interactions

No interaction of the drug with other medicinal products has been identified, however, it should be taken into account that the simultaneous use of Komfoderm M₂ with other ointments or creams may lead to increased absorption of the medicinal substances contained in them.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

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

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.