Komfoderm m2 cream 30g

Description

Composition
Active substance:
100 g of cream methylprednisolone aceponate in terms of 100% substance – 0.1 g of urea in terms of 100% substance – 2 g ;.
Excipients:
Liquid paraffin (paraffin oil) – 15 g propylene glycol – 5 g Polysorbate 80 – 1 g, carbomer interpolymer (type A) – 1 g, Trometamol – 0.4 g methyl parahydroxybenzoate – 0.1 g Purified water – up 100 g
Description:
Cream, white or nearly white. Presence of weak specific smell.
Product form:
Cream for external use 0.1% + 2%.
10 or 30 g of aluminum into a tube.
Each tube together with instructions for use placed in a pile of cardboard.
Contraindications
Hypersensitivity to the drug; tuberculous or syphilitic processes in applying the product; viral diseases (e.g., chicken pox, shingles); rosacea, perioral dermatitis in applying the product; areas of skin manifestations response to vaccination; Children up to age 18 years.
Indications
Inflammatory skin diseases which are sensitive to treatment with topical gluco-corticosteroids, and accompanied by a keratinization disorder: atopic dermatitis, neurodermatitis; true eczema; microbial eczema; simple contact dermatitis; allergic (contact) dermatitis; disgidroticheskaya eczema.
Interaction with other drugs
Drug interactions with other drugs is not revealed, but it should be borne in mind that the simultaneous use of the drug with other Komfoderm® M2 ointments or creams can lead to increased resorption of their constituent drugs.
Overdose
The study of acute toxicity methylprednisolone aceponate not revealed any risk of acute toxicity at a single cutaneous excessive use (applying the preparation on a large area under conditions favorable for absorption) or Accidental ingestion.
When excessively long and / or intense local application of glucocorticosteroids may develop skin atrophy (thinning of the skin, telangiectasia, striae).
If signs of skin atrophy drug should be abolished.
When applied topically, urea overdose unlikely.
pharmachologic effect
Pharmacological group:
Glucocorticosteroid + topical keratolytic agent.
Pharmacodynamics:
Komfoderm® M 2 – Combined drug action is due to its constituent components.
Methylprednisolone aceponate – represents a non-halogenated synthetic steroid. When applied topically methylprednisolone aceponate suppresses inflammatory and allergic skin reactions as well as reactions associated with enhanced proliferation, leading to reduced inflammation objective symptoms (erythema, edema, oozing) and subjective sensations (itching, irritation, pain, etc. ).
In the application of methylprednisolone aceponate in topically recommended dose systemic effect is minimal in both humans and animals. After repeated application of methylprednisolone aceponate large surfaces (40-60% of the skin surface), as well as in the application under an occlusive dressing is not marked disorders of adrenal function: cortisol plasma level and its circadian rhythm remain within the normal range, reducing cortisol concentration in urine is not a daily It is happening.
Methylprednisolone aceponate (particularly its major metabolite – 6a-methylprednisolone-17-propionate) binds to the intracellular glucocorticoid receptor.
The steroid-receptor complex binds to certain regions of the DNA of the immune response, causing the cells, so a series of biological effects.
In particular, binding of the steroid-receptor complex to DNA by cells of the immune response leads to the induction of synthesis macrocortin.
Macrocortin inhibits the release of arachidonic acid and, thus, the formation of inflammatory mediators type prostaglandins and leukotrienes.
Inhibition of glucocorticoid synthesis of prostaglandins vasodilating and vasoconstrictive effect of epinephrine potentiation result vasoconstrictor effect.
Urea has a keratolytic and moisturizing effects. Urea promotes the binding water and thereby softening the stratum corneum.
In addition to a keratolytic action, urea possesses proteolytic activity.
Pharmacokinetics:
When applied topically, methylprednisolone aceponate hydrolyzed in the epidermis and dermis. The main and most active metabolite is metilprednizo- 6a-Lon-17-propionate, having a much higher affinity for the skin glyukokortiko- steroid receptors, indicating that its presence “bioactivation” of the skin.
Degree of percutaneous absorption is dependent on the skin and application of the process (with or without occlusive dressing).
Percutaneous absorption in patients with atopic dermatitis (neurodermatitis), psoriasis and not more than 2.5%, only slightly higher than that in healthy volunteers (0.5-1.5%). After entering the systemic circulation 6a-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid and thus inactivated. Metabolites methylprednisolone aceponate eliminated primarily by the kidneys with a half-life of about 16 hours.
Methylprednisolone aceponate and its metabolites do not cumulate in the organism.
Due to the low absorbability of urea in topical application probability of systemic effects is small.
Pregnancy and breast-feeding
If necessary, use Komfoderm® M2 of the drug during pregnancy and lactation should carefully weigh the potential risk to the fetus and the expected treatment benefit to the mother. These periods are not recommended for prolonged use of the drug on extensive skin surfaces. Nursing mothers should not be applied in the preparation of the mammary glands.
Conditions of supply of pharmacies
Without recipe.
side effects
Very rare (less than 0.01% of cases), local reactions can occur, such as itching, burning, erythema, vesicular rash. If the drug is used for more than 4 weeks and / or the area of ​​10% or more of the body surface, the following reaction may occur: skin atrophy, telangiectasia, striae, akneformnye skin lesions, systemic effects due to absorption of the corticosteroid.
In rare cases (0.01% – 0.1%) could be observed folliculitis, hypertrichosis, perioral dermatitis, skin depigmentation, allergic reactions to a component of the drug.
special instructions
In the presence of bacterial complications, and / or tinea in addition to drug therapy M2 Komfoderm® necessary to carry out a specific antibacterial and / or antimycotic treatment. The drug is not intended for use in ophthalmology. Avoid contact with the eyes and mucous membranes. As with the use of systemic corticosteroids after topical use of corticosteroids may develop glaucoma (e.g., after use of high doses, due to very long application of occlusive dressings, or after application to the skin around the eyes). On the face more often than on other surfaces of the body, after long-term treatment of topical corticosteroids may appear atrophic changes.
The effect on the ability to operate vehicles, machinery
Not found.
Storage conditions
At temperatures above 25 ° C.
Keep out of the reach of children.
Dosing and Administration
Outwardly. The drug is applied 1 time a day a thin layer to the affected skin.
As a rule, the duration of continuous daily treatment with
Komfoderm® M 2 should not exceed 12 weeks.
In the treatment of patients with lesions of the skin treatment should not exceed 5 days.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist