Instructions for Komfoderm K (Methylprednisolone aceponate) cream
Komfoderm K (Methylprednisolone aceponate) cream suppresses inflammatory and allergic skin reactions, anti-inflammatory and anti-allergic agent
Release form Komfoderm:
Outdoor cream
description:
Cream for external use of white or almost white color, with a weak specific smell.
100g
methylprednisolone aceptonate 0.1 g
Auxiliary substances: ceramides - 0.5 g, preservative Euxyl PE 9010 (phenoxietanol 90%, ethylhexylglycerol 10%) phenoxyethanol - 0.9 mg, isopropylmiristat - 7 g, octyldodecanol - 7 g, hexyldecilstearatate - 7 g, dimethon 100 cst - 1 g, propylene glycol - 7 g, macrogola 40 stearat - 1.5 g, glyceril monostearat - 8.5 g, cetostearalyl alcohol (60%, stearil alcohol 40%) - 2 g, edetate dynatri - 0.1 g, potassium dihydrophosphate - 0.49 g, sodium hydrophosphate dodegahydrate - 0.01 g, purified water - up to 100 g.
15 g - aluminium tubes (1) - packets of cardboard.
30 g - aluminum tubes (1) - packets of cardboard.
ATH codes
D07AC14 Methylprednisolone aceponate
Clinical-pharmacological groups / Group affiliation Komfoderm K:
Drug Komfoderm K with anti-inflammatory effect for external use
Active substance Komfoderm K:
methylprednisolone aceponate
Pharmaco Therapeutic Group:
Glucocorticosteroid for local useKomfoderm K
storage conditions
The drug should be stored out of the reach of children at a temperature not higher than 25 degrees Celsius.
The expiration date is 2 years.
Drugs
The active component of the drug Komfoderm K - methylprednisolone aceptonate - is a non-halogenized synthetic steroid.
In the external application of Komfoderm® K suppresses inflammatory and allergic skin reactions, as well as reactions associated with increased proliferation, which leads to a reduction of objective symptoms of inflammation (erythema, swelling, wetness) and subjective sensations (itching, irritation, pain, etc.).
When methylprednisolone is used externally in the recommended dose, systemic action 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 used under the occlusive bandage, there are no violations of the functions of the adrenal glands: the concentration of cortisol in plasma and its circadian rhythm remain within the norm, there is no decrease in cortisol in daily urine.
Methylprednisolone aceponate (especially its main metabolite - 6α-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid receptor complex binds to certain DNA sites of immune response cells, thus causing a series of biological effects. In particular, binding of the steroid receptor complex to DNA cells of the immune response leads to induction of the synthesis of macrocortin. Macrocortin inhibits the release of arachidonic acid and thereby the formation of inflammatory mediators such as prostaglandins and leukotrienes.
Inhibition by glucocorticoids of the synthesis of vasodilating prostaglandins and potentiation of the vasoconstrictive effect of adrenaline lead to vasoconstrictor effect.
Indications Komfoderm K:
- Inflammatory skin diseases sensitive to topical GCS therapy:
- atopic dermatitis, neurodermitis, pediatric eczema;
- true eczema;
- microbial eczema;
- simple contact dermatitis;
- allergic (contact) dermatitis;
- dishydrotic eczema.
Method of use, course and dosage Komfoderm K:
The preparation is applied externally.
Adults and children from 4 months of age, the drug is applied 1 time/day in a thin layer on the affected areas of the skin.
As a rule, the duration of continuous daily treatment with Comfort ® K should not exceed 12 weeks for adults and 4 weeks for children.
The preparation Comfort K is suitable for the treatment of subacute and acute inflammatory processes without pronounced moisture, when localizing the process both on smooth skin and on the scalp, including on skin prone to fat.
Overdose:
When studying the acute toxicity of methylprednisolone aceponate, there was no risk of acute intoxication with excessive single skin use (application of 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 GCS, skin atrophy (thinning of the skin, telangiectasia, striia) can develop.
Treatment: if signs of skin atrophy appear, the drug Komfoderm must be canceled.
Drug interaction:
Not studied.
Use in pregnancy and breast-feeding
If necessary, the drug Komfoderm K during pregnancy and during breastfeeding should carefully weigh the potential risk to the fetus/baby and the expected benefits of treatment for the mother.
Side effect:
The incidence of side effects is classified in accordance with WHO recommendations: very often (≥10%), often (≥1%, <10%), infrequently (≥0.1%, <1%), rarely (≥0.01%, <0.1%), very rarely (<0.01%), frequency is unknown (estimate of the frequency is not possible).
From the skin and subcutaneous tissues: rarely - perioral dermatitis, skin depigmentation, allergic reactions to the components of the drug Komfoderm K ; frequency is unknown - skin atrophy, teleangiotasia, stria, acne-like skin changes (when used for more than 4 weeks and/or on the area of 10% or more of the body surface).
Common disorders and disorders at the place of administration: rarely - folliculitis, hypertrichosis; very rarely - itching, burning, erythema, the formation of a vesiculosis rash; frequency is unknown - systemic effects caused by absorption of GKS (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 mentioned in the instructions are exacerbated or any other side effects are noted that are not specified in the instructions, the patient should immediately notify the doctor.
Contraindications to use Komfoderm K:
tuberculosis or syphilitic processes in the field of drug application;
viral diseases (for example, varicella, shingles) in the area of application of the drug Komfoderm ;
rosacea, perioral dermatitis in the application area;
skin areas with manifestations of response to vaccination;
children under 4 months of age;
increased sensitivity to drug components.
Special instructions
In the presence of bacterial dermatoses and/or dermatomycoses, specific antibacterial or antimicotic treatment is required in addition to therapy with the preparation Komfoderm K.
The drug is not intended for use in ophthalmology. Eye and mucous membranes should be avoided.
As with the use of systemic GCS, glaucoma can develop after external use of glucocorticoids (for example, when using the drug in high doses, due to the very long use of occlusive bandages or application to the skin around the eyes).
Impact on the ability to drive vehicles and machinery
Not detected.
Conditions of implementation
The drug is dispensed without a prescription.
Use in children
The use of the drug Komfoderm K in childhood up to 4 months is contraindicated.
Other atopic dermatitis (neurodermitis, eczema)
Allergic contact dermatitis
Simple irritant contact dermatitis
Simple chronic lichen (limited neurodermitis)
Coin-like eczema
Dishydrosis [pomfolix]
Infectious dermatitis (infectious eczema)
