Comfoderm K cream d / nar. approx. 0.1% tube 30g No. 1
Category
Regenerating agents
Scope of the drug
Dermatology
Release form
Cream
Manufacturer country
Russia
Package quantity, pcs
one
pharmachologic effect
The active component of Comfoderm K - methylprednisolone aceponate - is a non-halogenated synthetic steroid.
When applied externally, Comfoderm K suppresses inflammatory and allergic skin reactions, as well as reactions associated with increased proliferation, which leads to a decrease in the objective symptoms of inflammation (erythema, edema, oozing) and subjective sensations (itching, irritation, pain, etc.) ).
When methylprednisolone aceponate is used externally at the recommended dose, the systemic effect is minimal in both humans and animals. After repeated application of methylprednisolone aceponate to large surfaces (40-60% of the skin surface), as well as when applied under an occlusive dressing, there are no adrenal dysfunctions: the concentration of cortisol in the plasma and its circadian rhythm remain within normal limits, the decrease in the content of cortisol in daily urine is not going on.
Methylprednisolone aceponate (especially its main metabolite - 6? -Methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors.
The steroid-receptor complex binds to specific regions of the immune response cells' DNA, thus causing a series of biological effects.
In particular, binding of the steroid-receptor complex to DNA cells of the immune response leads to the induction of macrocortin synthesis.
Macrocortin inhibits the release of arachidonic acid and thus the formation of inflammatory mediators such as prostaglandins and leukotrienes.
Inhibition of the 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.
Contraindications
Hypersensitivity to drug components
tuberculous or syphilitic processes in the area of application of the drug viral diseases (for example, chickenpox, shingles) in the area of application of the drug
rosacea, perioral dermatitis in the area of application of the drug
areas of the skin with manifestations of a reaction to vaccination
children's age up to 4 months.
Recommendations for use
Outwardly.
Adults and children from 4 months of age.
The drug is applied once a day with a thin layer on the affected skin.
As a rule, the duration of continuous daily treatment with Comfoderm K should not exceed 12 weeks for adults and 4 weeks for children.
The drug Comfoderm K is suitable for the treatment of subacute and acute inflammatory processes without pronounced weeping, with the localization of the process both on smooth skin and on the scalp, including skin prone to oily.
special instructions
In the presence of bacterial dermatoses and / or dermatomycosis, in addition to therapy with Comfoderm K, specific antibacterial or antimycotic treatment should be carried out.
The drug is not intended for use in ophthalmology.
Avoid contact with eyes and mucous membranes.
As with the use of systemic corticosteroids, after external use of glucocorticoids, glaucoma may develop (for example, when the drug is used in high doses, due to the very long use of occlusive dressings or application to the skin around the eyes).
Influence on the ability to drive vehicles and control mechanisms Not identified.
Structure
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 mg, isopropyl myristate - 7 g, octyldodecanol - 7 g, hexyldecyl stearate - 7 g, dimethicone 100 cst - 1 g , propylene glycol - 7 g, macrogol 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 hydrophosphate dodecahydrate - 0.01 g, purified water - up to 100 g.
Side effects
The incidence of side effects is classified in accordance with 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).
Violations of the skin and subcutaneous tissues: rarely perioral dermatitis, skin depigmentation, allergic reactions to the components of the drug
the frequency is unknown skin atrophy, telangiectasia, striae, acne-like skin changes (when using the drug for more than 4 weeks and / or on an area of 10% or more of the body surface).
General disorders and disorders at the injection site: rarely - folliculitis, hypertrichosis
very rarely - itching, burning, erythema, the formation of a vesicular rash
frequency is unknown - systemic effects due to 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 indicated in the instructions are noted, you should immediately inform your doctor about it.
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, striae) may develop.
Treatment: if signs of skin atrophy appear, the drug must be canceled.
Storage conditions
The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C.
Shelf life
2 years.
Do not use after the expiration date.
Active substance
Methylprednisolone aceponate
Name ENG
KOMFODERM K
Clinical and pharmacological group
Anti-inflammatory drug for external use
ATX code
Methylprednisolone
Dosage
0.1% x 30g
Structure
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 mg, isopropyl myristate - 7 g, octyldodecanol - 7 g, hexyldecyl stearate dimethicone 100 cst - 1 g, propylene glycol - 7 g, macrogol 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 dihydrophosphate - 0.49 g, sodium hydrogen phosphate dodecahydrate - 0.01 g, purified water - up to 100 g.
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.
INN / Active ingredient
Methylprednisolone aceponate, Urea
Contraindications
Hypersensitivity to drug components
tuberculous or syphilitic processes in the area of application of the drug viral diseases (for example, chickenpox, shingles) in the area of application of the drug
rosacea, perioral dermatitis in the area of application of the drug
areas of the skin with manifestations of a reaction to vaccination
children's age up to 4 months.
Storage conditions and periods
At a temperature not higher than 25 degrees.
Expiration date: 2 years
Specifications
Category
Regenerating agents
Scope of the drug
Dermatology
Release form
Cream
Manufacturer country
Russia
Package quantity, pcs
one
Scope of application
Dermatology
Minimum age from
4 months
Way of introduction
Locally
,
Outwardly
Vacation conditions
Without recipe
Brand name
Akrikhin
The amount of the dosage form in the primary package
30 g
Primary packaging type
Tuba
Type of consumer packaging
Pack of cardboard
Pharmaco-therapeutic group
Topical glucocorticosteroid
Anatomical and therapeutic characteristics
D07AA01 Methylprednisolone
Dosage form
Cream for external use
Packaging
Cardboard box
The target audience
Children
Expiration date in days
730
Package weight, g
thirty
Mode of application
:
Outwardly.
< br> Adults and children from 4 months of age.
The drug is applied once a day with a thin layer on the affected skin.
As a rule, the duration of continuous daily treatment with Comfoderm K should not exceed 12 weeks for adults and 4 weeks for children.
The drug Comfoderm K is suitable for the treatment of subacute and acute inflammatory processes without pronounced weeping, with the localization of the process both on smooth skin and on the scalp, including skin prone to oily.
Dosage (volume) of the substance in the preparation
:
methylprednisolone aceponate (in terms of 100% substance) 0.1 g
Information on technical characteristics, delivery set, country of manufacture