Comfoderm, ointment 0.1% 30 g

The active ingredient in Comfoderm®, methylprednisolone aceponate, is a nonhalogenated steroid.

When applied topically, methylprednisolone aceponate suppresses inflammatory and allergic skin reactions as well as those associated with increased proliferation, resulting in reduction of objective symptoms of inflammation (erythema, edema, mucous, etc.) and subjective sensations (itching, irritation, pain, etc.).

When methylprednisolone aceponate is applied topically at the recommended dose, systemic effects are minimal in both humans and animals. After repeated application of the drug to large surfaces (40-60% of the skin surface), as well as after application under the occlusive dressing no disorders of adrenal functions are observed: the level of cortisol in plasma and its circadian rhythm remain within normal limits, there is no reduction of cortisol level in daily urine.

Methylprednisolone aceponate (especially its main metabolite, 6α-methylprednisolone-17-propionate) binds to intracellular glucocorticosteroid receptors. The steroid-receptor complex binds to specific DNA sites of the 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 the synthesis of vasodilatory prostaglandites and potentiation of the vasoconstrictor effect of adrenaline, result in a vasoconstrictor effect.

Indications

Active ingredient

Composition

100 g of the ointment contains:

The active substance:

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

Auxiliary substances:

Vaseline – 44.7 g;

liquid paraffin – 34.1 g;

Oil of castor oil – 3,2 g;

White beeswax – 17,9 g.

How to take, the dosage

Apply externally 1 time/day in a thin layer on the affected area, rubbing gently.

Possible to use with an occlusive dressing.

The course of treatment is usually no more than 12 weeks for adults and no more than 4 weeks for children. Several courses of therapy are possible over the course of a year.

Special Instructions

Contraindications

Tuberculosis or syphilitic process in the area of application;

Viral diseases (e.g., chicken pox, shingles), in the area of application;

Rosacea, perioral dermatitis in the area of application;

children under 4 months of age;

areas of skin showing signs of reaction to the vaccine;

hypersensitivity to the components of the drug.

Side effects

Overdose

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

In excessive long-term and/or intensive use of glucocorticosteroids for paracute use, skin atrophy (thinning of the skin, telangiectasia, stretch marks) may develop.

Pregnancy use

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