Komfoderm ointment appearance. 0.1% 15g tube 1 piece

Description

Composition
Active substance:
100 g of ointment contains: methylprednisolone aceponate in terms of 100% substance – 0.1 g ;.
Excipients:
100 g of ointment contains: Petrolatum – 44.7 g; Liquid paraffin – 34.1 g; castor bean seed oil – 3.2 g; beeswax white – 17.9 g
Description:
Homogeneous translucent ointment from white to white with gray or yellowish tint. Presence of characteristic odor.
Product form:
Ointment for external use 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
– tuberculous or syphilitic processes in applying the product; – viral diseases (e.g., chicken pox, shingles), in applying the product; – rosacea, perioral dermatitis in applying the product; – Children up to age of 4 months; – skin areas with manifestations response to vaccination; – hypersensitivity to the drug.
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; – occupational 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 vigorous application of corticosteroids for topical application may develop skin atrophy (thinning of the skin, telangiectasia, striae).
When the atrophy of the drug should be abolished.
pharmachologic effect
Pharmacological group:
Glucocorticosteroids for local use.
Pharmacological properties:
The active drug component Komfoderm® – methylprednisolone aceponate – represents a non-halogenated steroid.
Pharmacodynamics:
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, etc.) 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 the drug to the large surfaces (40-60% of the surface of the skin), and 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 occurs. Methylprednisolone aceponate (particularly, its major metabolite – 6-alpha- methylprednisolone 17-propionate) binds to intracellular receptors glucocorticosteroid. 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 the synthesis of corticosteroids prostaglanditov vasodilating and vasoconstrictive effect of epinephrine potentiation lead to vasoconstrictor effect.
Pharmacokinetics:
Methylprednisolone aceponate is 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 that indicates the presence of its’ bioaktivizatsii “in the skin.
Degree of percutaneous absorption is dependent on the skin, the formulation and application method (with or without occlusive dressing). After entering the systemic circulation 6alfa-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® 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
On prescription.
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 of glucocorticosteroid (when using the drug for more than 4 weeks and / or the area of ​​10% or more of the body surface). 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 complications, and / or tinea in addition to drug therapy Komfoderm® necessary to carry out a specific antibacterial and / or antimycotic treatment. Avoid getting product in eyes.
As in the case of systemic corticosteroids after topical use of corticosteroids may develop glaucoma (e.g., when using very large doses or prolonged use of occlusive dressings, or application to the skin around the eyes).
Effect on ability to drive and use machines:
Not found.
Storage conditions
At temperatures above 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® should not exceed 12 weeks for adults and 4 weeks for children. For the treatment of long-term chronic inflammatory processes in the skin is very dry skin need anhydrous formulation. Komfoderm® occlusive effect of the drug provides a pronounced therapeutic effect even at a considerable infiltration and lichenification.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist