Komfoderm M2, cream 10 g

Comfoderm® M2 is a combination drug with an effect due to its constituents.

Methylprednisolone aceponate is a nonhalogenated synthetic steroid.
When applied externally methylprednisolone aceponate suppresses inflammatory and allergic skin reactions associated with increased proliferation, which leads to reduction of objective symptoms of inflammation (erythema, edema, mucous) and subjective sensations (itching, irritation, pain, etc.). When methylprednisolone aceponate is used topically at the recommended dose, systemic effects are minimal in both humans and animals.

After repeated application of methylprednisolone aceponate on large surfaces (40-60% of the skin surface), as well as when used under the occlusive dressing no adrenal disturbances are noted: plasma cortisol levels and its circadian rhythm remain within normal limits, there is no reduction of cortisol concentration in daily urine.

Methylprednisolone aceponate (especially its main metabolite, 6α-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to specific DNA sites of immune response cells, thus causing a series of biological effects.

In particular, binding of the steroid-receptor complex to the DNA of the immune response cells leads to induction of macrocortin synthesis. Macrocortin inhibits the release of arachidonic acid and thus the formation of inflammatory mediators such as prostaglandins and leukotrienes.

Inhibition by glucocorticosteroids of vasodilatory prostaglandin synthesis and potentiation of vasoconstrictor effect of adrenaline lead to vasoconstrictor effect.

Urea has keratolytic and moisturizing effects. Urea promotes water binding and consequently softens the horny layer of the skin. In addition to its keratolytic effect, urea has proteolytic activity.

Pharmacokinetics

Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis when applied topically. The main and most active metabolite is 6α-methylprednisolone-17-propionate, which has a significantly higher affinity for glucocorticosteroid receptors in the skin, indicating the presence of its “bioactivation” in the skin.

The extent of percutaneous absorption depends on the condition of the skin and the route of application (with or without an occlusive dressing).

The percutaneous absorption in patients with atopic dermatitis (neurodermatitis) and psoriasis is not more than 2.5%, which is only slightly higher than that in healthy volunteers (0.5-1.5%).
After entering the systemic bloodstream 6α-methylprednisolone-17-propionate rapidly conjugates with glucuronic acid and is thus inactivated.

Methylprednisolone aceponate metabolites are eliminated mainly by the kidneys with a half-life of about 16 hours. Methylprednisolone aceponate and its metabolites do not cumulate in the body.
Due to the low absorption capacity of urea when used topically, there is little chance of systemic effects.

Indications

Inflammatory skin diseases susceptible to therapy with topical glucocorticosteroids and accompanied by keratinization disorders:

– atopic dermatitis, neurodermitis;
– true eczema;
– microbial eczema;
– simple contact dermatitis;
– allergic (contact) dermatitis;
– dyshydrotic eczema.

Active ingredient

Methylprednisolone aceponate, Urea

Composition

100 g of cream contains:

Active ingredients:

• methylprednisolone aceponate 100 mg;
• urea 2 g;

Excipients:

• liquid paraffin (vaseline oil) – 15 g,
• propylene glycol – 5 g,
• polysorbate 80 – 1 g,
• carbomer interpolymer (type A) – 1 g,
• trometamol – 400 mg,
• methyl parahydroxybenzoate – 100 mg,
• purified water – up to 100 g.

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How to take, the dosage

Outwardly.

The drug is applied once a day with a thin layer on the affected skin areas. As a rule, the duration of continuous daily treatment with the drug

Komfoderm M2 should not exceed 12 weeks. When treating patients with facial skin lesions the treatment course should not exceed 5 days.

Interaction

Interaction of the drug with other drugs was not detected, but should be aware that the simultaneous use of the drug

Komfoderm M2 with other creams or ointments may increase the resorption of their constituent drugs.

Special Instructions

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

The drug is not intended for use in ophthalmology. Contact of the drug with the eyes and mucous membranes should be avoided.
As with the use of systemic glucocorticoids, glaucoma may develop during external use of GCS (e.g., after high doses, due to very long use, use of occlusive dressings or application to the skin around the eyes).

Atrophic changes may develop on the skin of the face more often than on other body surfaces after long-term treatment with GCS for external use.

Effect on the ability to drive and operate machinery
No effect was found.

Contraindications

• Hypersensitivity to the ingredients of the drug
• Tuberculosis or syphilitic process in the area of application
• viral diseases (e.g., chicken pox, shingles);
• rosacea, perioral dermatitis in the area where the drug is applied;
• sections of the skin with signs of reaction to vaccination;
• children under 18 years of age.

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Side effects

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

If the drug is used for over 4 weeks and/or on 10% or more of the body surface the following reactions may occur: skin atrophy, telangiectasia, stretch marks, acneiform skin changes, systemic effects caused by the absorption of corticosteroid.

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

Overdose

Symptoms: with excessive and/or intensive topical use of GCS skin atrophy may develop (skin thinning, telangiectasia, stretch marks).

Treatment: If there are signs of skin atrophy the drug should be discontinued.

Pregnancy use

If it is necessary to use Komfoderm® M2 during pregnancy and lactation, the potential risk to the fetus should be carefully weighed against the expected benefits to the mother. During these periods, prolonged use of the drug on large areas of skin is not recommended. Nursing mothers should not apply the drug to the mammary glands.

Similarities

Comfoderm , Comfoderm K