Description
Description
Topical cream with a white or almost white color, with a slight specific smell.
Pharmacological action
The active ingredient of the drug Comfoderm ® K – methylprednisolone aceponate – is a non-halogenated synthetic steroid. When applied topically, Komfoderm ® K inhibits inflammatory and allergic skin reactions, as well as reactions associated with increased proliferation, which leads to a decrease in objective symptoms of inflammation (erythema, edema, weeping) and subjective sensations (itching, irritation, pain, etc.).
When using methylprednisolone aceponate externally at the recommended dose, the systemic effect is 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 applied under an occlusive dressing, adrenal gland dysfunctions are not observed: the plasma cortisol concentration and its circadian rhythm remain within the normal range, the cortisol content in the daily urine does not decrease going on.
Methylprednisolone aceponate (especially its main metabolite, 6β-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to certain sections of the DNA of the immune response cells, thus causing a series of biological effects. In particular, the binding of the steroid receptor complex to DNA by the immune response 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 synthesis of vasodilating prostaglandins by glucocorticoids and potentiation of the vasoconstrictor action of adrenaline lead to a vasoconstrictor effect.
Indications
– Inflammatory skin diseases sensitive to topical glucocorticosteroid therapy: atopic dermatitis, neurodermatitis, childhood eczema
– true eczema
– microbial eczema
– simple contact dermatitis
– allergic (contact) dermatitis dyshidrotic eczema.
Recommended Uses for
Externally.
Adults and children from 4 months of age. The drug is applied 1 time per day with a thin layer on the affected areas of the skin. Usually, the duration of continuous daily treatment with Comfoderm ® 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 wetting, with localization of the process both on smooth skin and on the scalp, including on skin prone to oily.
Special instructions
In the presence of bacterial dermatoses and / or dermatomycoses, specific antibacterial or antimycotic treatment is necessary in addition to Comfoderm K therapy.
The drug is not intended for use in ophthalmology. Avoid contact with eyes and mucous membranes. As with systemic corticosteroids, after external use of glucocorticoids, glaucoma can develop (for example, when using the drug in high doses, due to the very long-term use of occlusive dressings or application to the skin around the eyes).
Influence on ability to drive vehicles and control mechanisms
Not identified.
Composition
100 g methylprednisolone aceponate 0.10 g
Excipients: ceramides – 0.5 g, preservative Euxyl PE 9010 (phenoxyethanol 90%, ethylhexylglycerol 10%) in terms of phenoxyethanol – 0.9, ethanol – ethanol – 7 octyldodecanol – 7 g, hexyl decyl stearate – 7 g, dimethicone 100 cst – 1 g, propylene glycol – 7 g, poppy seeds Rogola 40 stearate – 1.5 g, glyceryl monostearate – 8.5 g, cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) – 2 g, disodium edetate – 0.1 g, potassium dihydrogen phosphate – 0.49 g, sodium hydrogen phosphate dodecahydrate – 0. 01 g, purified water – up to 100 g.
Side effects
The incidence of side effects is classified according to the recommendations of the World Health Organization (WHO): very often (? 10%), often (? 1%, <10%), infrequently (? 0.1%, <1 %), rarely (? 0.01%, <0.1%), very rarely (<0.01%), the frequency is unknown (it is not possible to estimate the frequency of occurrence). Disorders from the skin and subcutaneous tissues: rarely perioral dermatitis, skin depigmentation, allergic reactions to the drug components, frequency of atrophy of the skin, telangiectasia, striae, acne-like skin changes (when using the drug for more than 4 weeks and / or on an area of ??10% and over the surface of the body). General disorders and disorders at the injection site: rarely – folliculitis, hypertrichosis very rarely – itching, burning, erythema, the formation of a vesicular rash, the frequency is unknown – systemic effects due to the absorption of a glucocorticosteroid (when using the drug for more than 4 weeks and / or on an area of ??10% or more of the body surface). If any of the side effects indicated in the instructions are aggravated, or any other side effects not listed in the instructions are noted, you should immediately inform your doctor. Overdose When studying the acute toxicity of methylprednisolone aceponate, there was no risk of acute intoxication with excessive single skin use (applying the drug over a large area under conditions favorable for absorption) or with unintentional ingestion. Symptoms: with excessively long and / or intensive external use of corticosteroids, skin atrophy (thinning of the skin, telangiectasia, stria) can develop. Treatment: if signs of skin atrophy appear, the drug must be discontinued. Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C. Expiration 2 years. Do not use after expiration date. dosage form cream
