Komfoderm^® (Ointment, Cream, Emulsion) Instructions for Use

ATC Code

D07AC14 (Methylprednisolone aceponate)

Active Substance

Methylprednisolone aceponate (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug with anti-inflammatory action for external use

Pharmacotherapeutic Group

Corticosteroids used in dermatology; high-potency corticosteroids (group III)

Pharmacological Action

The active component of the drug Komfoderm^® K – Methylprednisolone aceponate – is a non-halogenated synthetic steroid.

When applied externally, Komfoderm^® K 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 large 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 concentration and its circadian rhythm remain within normal limits, and there is no decrease in cortisol content 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 regions of DNA in immune response cells, thus causing a series of biological effects. In particular, the binding of the steroid-receptor complex to DNA by immune response cells leads to the induction of macrocorin synthesis. Macrocorin 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.

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 compared to healthy volunteers (0.5-1.5%). After entering the systemic bloodstream, 6α-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid and, thus, in the form of 6α-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 6α-methylprednisolone-17-propionate, which has a significantly higher affinity for skin glucocorticoid receptors, indicating its “bioactivation” in the skin.

The metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys with a T_1/2 of about 16 hours.

Indications

Inflammatory skin diseases responsive to therapy with topical corticosteroids

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

ICD codes

Dosage Regimen

Emulsion

For external use. Apply a thin layer to the affected areas of the skin once a day in adults and children aged 4 months and older.

The duration of use in adults should not exceed 6 weeks, in children – 3 weeks.

Ointment

The drug is for external use.

In adults and children from 4 months of age, apply the drug once a day in a thin layer to the affected areas of the skin.

As a rule, the duration of continuous daily treatment with Komfoderm^® 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 necessary.

The occlusive effect of the drug Komfoderm^® provides a pronounced therapeutic effect even with significant lichenification and infiltration.

Cream

The drug is for external use.

In adults and children from 4 months of age, apply the drug once a day in a thin layer to the affected areas of the skin.

As a rule, the duration of continuous daily treatment with Komfoderm^® K should not exceed 12 weeks for adults and 4 weeks for children.

The drug Komfoderm^® K is suitable for the treatment of subacute and acute inflammatory processes without pronounced oozing, with the process localized both on smooth skin and on the scalp, including on skin prone to oiliness.

Adverse Reactions

The frequency of adverse effects is classified according to WHO recommendations: very common (≥10%), common (≥1%, <10%), uncommon (≥0.1%, <1%), rare (≥0.01%, <0.1%), very rare (<0.01%), frequency unknown (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders rare – perioral dermatitis, skin depigmentation, allergic reactions to drug components; frequency unknown – skin atrophy, telangiectasia, striae, acne-like skin changes (when using the drug for more than 4 weeks and/or on 10% or more of the body surface area).

General disorders and administration site conditions rare – folliculitis, hypertrichosis; very rare – itching, burning, erythema, vesicular rash formation; frequency unknown – systemic effects due to corticosteroid absorption (when using the drug for more than 4 weeks and/or on 10% or more of the body surface area).

If any of the side effects mentioned in the instructions worsen, or any other side effects not listed in the instructions are noticed, the patient should immediately inform the doctor.

Contraindications

• Tuberculous or syphilitic processes in the area of drug application;
• Viral diseases (e.g., chickenpox, herpes zoster) in the area of drug application;
• Rosacea, perioral dermatitis in the area of drug application;
• Areas of skin with manifestations of a reaction to vaccination;
• Children under 4 months of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

If it is necessary to use the drug Komfoderm^® K during pregnancy and breastfeeding, the potential risk to the fetus/child 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

Contraindicated in children under 4 months of age.

Special Precautions

In the presence of bacterial dermatoses and/or dermatomycoses, specific antibacterial or antifungal treatment should be carried out in addition to therapy with the drug Komfoderm^® K.

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

As with the use of systemic corticosteroids, glaucoma may develop after external application of glucocorticoids (for example, when using the drug in high doses, due to very long-term use of occlusive dressings or application to the skin around the eyes).

Effect on ability to drive vehicles and operate machinery

Not identified.

Overdose

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 external use of corticosteroids, skin atrophy (thinning of the skin, telangiectasia, striae) may develop.

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

Drug Interactions

Not studied.

Storage Conditions

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

Shelf Life

Shelf life – 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.