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Comfoderm ointment 30g
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Active ingredients: Methylprednisolone aceponate.
Dosage form.
Ointment for external use 0.1% from white or to white with a grayish or yellowish tint, a characteristic odor is allowed.
Composition.
100 g of methylprednisolone aceponate (in terms of 100% substance) \ 0009100 mg
Auxiliary substances: petrolatum - 44.7 g, liquid paraffin - 34.1 g, castor oil seed oil - 3.2 g, white beeswax - 17.9 g.
pharmachologic effect
GKS for external use. Suppresses the function of leukocytes and tissue macrophages. Limits the migration of leukocytes to the area of inflammation. Violates the ability of macrophages to phagocytosis, as well as the formation of interleukin-1. It contributes to the stabilization of lysosomal membranes, thereby reducing the concentration of proteolytic enzymes in the area of inflammation. Reduces capillary permeability due to histamine release. Suppresses the activity of fibroblasts and the formation of collagen.
Inhibits the activity of phospholipase A2, which leads to the suppression of the synthesis of prostaglandins and leukotrienes. Suppresses the release of COX (mainly COX-2), which also helps to reduce the production of prostaglandins.
Reduces the number of circulating lymphocytes (T-and B-cells), monocytes, eosinophils and basophils due to their movement from the vascular bed to the lymphoid tissue;inhibits the formation of antibodies
With direct application to the vessels causes vasoconstrictor effect.
With external and local useThe therapeutic activity of methylprednisolone is due to the anti-inflammatory, anti-allergic and anti-exudative (due to the vasoconstrictor effect) action.
Pharmacokinetics
Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis. The main and most active metabolite is 6 alpha-methyl predisolone-17-propionate, which has a significantly higher affinity for the glucocorticosteroid receptors of the skin, which indicates the presence of its “bioactivation” in the skin.
The degree of percutaneous absorption depends on the condition of the skin, the dosage form and the method of application (with or without an occlusive dressing).
After entering the systemic bloodstream 6, alpha-methylprednisolone-17-propionate quickly contacts with glucuronic acid and, thus, in the form of 6 alpha-methylprednisolone-17-propionate, glucuronide is inactivated.
Metabolites of methylprednisolone aceponate are eliminated mainly by the kidneys with a half-life of about 16 hours. Methylprednisolone aceponon and its metabolites do not accumulate in the body.
Side effects.
Violations of the skin and subcutaneous tissues: rarely - perioral dermatitis, skin depigmentation, allergic reactions to the components of the drug; frequency is unknown - skin atrofofia, 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; it is rarely - itching, burning, erythema, the formation of vesicular rash; the frequency of the unknown systemic effects1> 1, due to the absorption of a glucocorticosteroid (when using the npei arata 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 that are not indicated in the instructions are noted, you should immediately inform your doctor.
Features of sale.
Over-the-counter
Special conditions.
In the presence of bacterial complications and / or dermatomycosis, in addition to therapy with Komfodermk, specific antibacterial and / or mycotic treatment is necessary.
Avoid contact with eyes.
As with the use of systemic glucocorticosteroids, glaucoma may develop after external use of glucocorticosteroids (for example, when using large doses or very long use of occlusive dressings or on the skin around the eyes)
Impact but the ability to drive vehicles, mechanisms
Not found.
Indications.
Inflammatory skin diseases sensitive to therapy with topical glucocorticosteroids:
atopic dermatitis, neurodermatitis, children eczema;
true eczema;
microbial eczema
professional eczema;
simple contact dermatitis;
allergic (contact) dermatitis;
dyshidrotic eczema.
Contraindications:
tuberculous or syphilitic processes in the field of drug application; viral diseases (for example, chicken pox, shingles) in the area of application of the drug;
rosacea, perioral dermatitis in the area of application of the drug; children's age up to 4 months;
skin areas with reactions to vaccination; hypersensitivity to the drug.
Use during pregnancy and during breastfeeding.
If necessary, the use of the drug Komfoderm® during pregnancy and during breastfeeding should carefully weigh the potential risk to the fetus and the expected benefit of treatment for the mother. During these periods, prolonged use of the drug on the extensive surfaces of the skin is not recommended; nursing mothers should not apply the drug to the mammary glands.
Drug interaction
Not studied.
Keep at room temperature 15-25 ° C.
Keep out of the reach of children!
Store in a dark place.
Shelf life- 2 years.