Komfoderm to cream naruzhn.prim-I 0.1% 15g tube

Description

Composition
Active substance:
100 g of cream contains: methylprednisolone aceponate in terms of 100% substance – 0.10g ;.
Excipients:
Ceramides – 0.50 g, preservative Euxyl PE 9010 (fenorksietanol – 90%, etilgeksilglitserol 10%) based on phenoxyethanol – 0.90 g, isopropyl myristate – 7.00 g, octyldodecanol – 7.00 g, geksildetsilstearat – 7.00 g dimethicone 100 cst – 1,00 g, propylene glycol – 7.00 g, macrogol 40 stearate – 1.50 g glyceryl monostearate – 8.50 g cetostearyl alcohol (60% cetyl alcohol, stearyl alcohol 40%) – 2 0 g disodium edetate – 0.10 g, potassium dihydrogen phosphate – 0.49g, sodium hydrogen phosphate dodecahydrate – 0.01 g purified water – 100 g
Description:
Cream white or off-white color with a weak specific smell.
Product form:
Cream for external use of 0.1%.
15 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, herpes zoster) in the coating formulation; rosacea, perioral dermatitis in applying the product; areas of skin manifestations response to vaccination; Children up to age 4 months.
Dosage
0.1%
Indications
Inflammatory skin diseases which are sensitive to therapy with topical corticosteroids: atopic dermatitis, atopic dermatitis, infantile eczema; true eczema; microbial eczema; simple contact dermatitis; allergic (contact) dermatitis; disgidroticheskaya eczema.
Interaction with other drugs
It has not been studied.
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 external application of glucocorticosteroids may develop skin atrophy (thinning of the skin, telangiectasia, striae). If signs of skin atrophy drug should be abolished.
pharmachologic effect
Pharmacological group:
Glucocorticosteroids for local use.
Pharmacodynamics:
The active drug component Komfoderm® K – methylprednisolone aceponate – represents a non-halogenated synthetic steroid.
When applied topically Komfoderm® K 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 externally at the recommended dose, systemic exposure 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 level in daily urine not It is happening.
Methylprednisolone aceponate (particularly its major metabolite – 6alfa-methylprednisolone – 17- propionate) binds to the intracellular glucocorticoid receptor. The steroid-receptor complex binds to certain regions of the DNA of cells of the immune response, thus causing 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 lead to vasoconstrictor effect.
Pharmacokinetics:
When applied topically methylprednisolone aceponate hydrolyzed in the epidermis and dermis.
The main and most active metabolite is 6-alpha-methylprednisolone-17-propionate, having a much higher affinity to glucocorticoid receptors in the skin,
indicating the presence of his “bioactivation” in the skin.
Degree of percutaneous absorption is dependent on the skin and application of the process (with or without okkyuzionnoy bandages). Percutaneous absorption in children and adults with atopic dermatitis (neurodermatitis), psoriasis and not more than 2.5%, only slightly higher than in healthy volunteers (0.5 – 1.5%).
After entering the systemic circulation of 6-alpha-methylprednisolone-17-propionate is rapidly conjugated with glucuronic acid and thus in the form of 6-alpha-methylprednisolone-17-propionate glucuronide 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.
Pregnancy and breast-feeding
If necessary, use Komfoderm® K 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
The frequency of adverse events classified in accordance with the recommendations of the World Health Organization (WHO): very often (> 10%), frequent (> 1%, 0.1%, 0.01%,
Disorders of the skin and subcutaneous tissue disorders: rarely – perioral dermatitis, skin depigmentation, allergic reactions to components of the drug; frequency is unknown – skin atrophy, telangiectasia, striae, aknepodobnye skin changes (when using the drug for more than 4 weeks and / or the area of ​​10% or more of the body surface).
General disorders and administration site in seldom – folliculitis, hypertrichosis; very rarely – itching, burning, erythema, vesicular rash; frequency is unknown – systemic effects due to absorption. If any of these instructions side effects are compounded, or observed any other side effects not mentioned in the instructions, you should immediately inform your doctor.
special instructions
In the presence of bacterial dermatoses and / or dermatomycosis in addition to drug therapy
Komfoderm® to the need to carry out a specific antibacterial 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., at high doses, due to very long application or occlusive dressings applied to the skin around the eyes).
Effect on vehicle management capability mechanisms
Not found.
Storage conditions
Store at a temperature not higher than 25 ° C. Keep out of the reach of children.
Dosing and Administration
Outwardly. Adults and children from 4 months of age.
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® K should not exceed 12 weeks for adults and 4 weeks for children. By Komfoderm® drug for the treatment of subacute and acute inflammatory processes without the express soak, in the localization process as smooth skin and scalp, including the skin, prone to fat.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist