Silkaren

General characteristics. Structure:

Active ingredient: 0,1 g of a mometazon of furoate.

Excipients: propylene glycol - 12,0 g, propylene glycol monostearate (propylene glycol monopalmito-stearate) - 8,0 g, the water purified - 3,0 g, a macrogoal цетостеарат (Makrogola - the 20th cetostearyl ether) - 4,0 g, stearyl alcohol - 3,0 g, white beeswax (white wax) - 5,0 g, titanium dioxide - 1,0 g, methyl-parahydroxybenzoate (methylparaben) - 0,02 g, пропилпарагидроксибензоат (propylparaben) - 0,18 g, talc - 10,0 g, phosphoric acid - to рН 4,0, vaseline (paraffin soft, petroleum butter) - to 100,0 g.

Synthetic glucocorticosteroid. Has antiinflammatory, antipruritic and anti-exudative effect

Pharmacological properties:

Pharmacodynamics. Mometazon - a synthetic glucocorticosteroid (GKS). Has antiinflammatory, antipruritic and anti-exudative effect. GKS induce release of the proteins inhibiting a phospholipase of A2 and known under the general name of a lipokortina which control biosynthesis of such mediators of an inflammation as prostaglandins and leukotrienes, by braking of release of their common precursor, arachidonic acid.

Pharmacokinetics. Absorption of a mometazon hushing. In 8 h after drawing on the unimpaired skin (without occlusive bandage) in a system blood-groove about 0,4% of a dose are found. At an inflammation and injury of skin absorption increases.

Indications to use:

Psoriasis, atopic dermatitis, simple chronic deprive (limited neurodermatitis), eczema, a pruritic dermatosis, stings of insects, burns of the I degree, sunblisters, red flat deprive, a diskoidny lupus erythematosus.

Route of administration and doses:

Outwardly. A thin film of Silkaren® cream is applied on affected areas of skin once a day. Duration of a course of treatment: 7 - 28 days, are defined by efficiency of therapy, and also portability of drug by the patient, existence and expressiveness of side effects.

Features of use:

At long therapy by glucocorticosteroids the sudden termination of therapy can lead to development of a syndrome of the ricochet which is shown in the form of dermatitis with intensive erubescence and a burning sensation. Therefore after a long course of treatment drug withdrawal should be made gradually, for example, passing to the intermittent scheme of treatment before completely to stop it.

Use at pregnancy and during breastfeeding. Safety of use of Silkaren® cream during pregnancy and in the period of a lactation is not studied. Glucocorticosteroids get through a placental barrier. It is necessary to avoid prolonged treatment and use of high doses during pregnancy in connection with threat of negative action on fetation. To appoint at pregnancy when the estimated advantage for mother exceeds potential risk for a fruit; at the same time to use small doses and to apply short time.

Glucocorticosteroids are allocated with breast milk. In case use of glucocorticosteroids in high doses and/or is supposed for a long time, it is necessary to stop breastfeeding.

Use in pediatrics. Because children have a size of a ratio of surface area and body weight it is more, than at adults, children are subject to bigger risk of suppression of function гипоталамо - pituitary and adrenal system and development of an Icenco-Cushing syndrome at use of any glucocorticosteroids of local action. Prolonged use of glucocorticosteroids of local action at children can lead to disturbance of their growth and development. Use of drug for children within more than 3 weeks was not studied. Children have to receive the minimum dose of Silkarena® sufficient for achievement of effect.

Use at chronic diseases. There are no data on influence of Silkaren® cream on the course of chronic diseases.

Influence on ability of control of vehicles, mechanisms. There are no data on influence of Silkaren® cream on ability to control of vehicles and mechanisms.

Side effects:

Local reactions: burning, itch, paresthesias, folliculitis, acne rash, skin atrophy, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of skin, accession of consecutive infection, striya, heat rash. The probability of emergence of the listed undesirable phenomena increases at use of occlusive bandages.

Systemic action: at use of outside forms of glucocorticosteroids for a long time and/or for treatment of big sites of skin (the total area of drawing is more than the area of the patient's palm), or with use of occlusive bandages, especially children and teenagers, can have side effects characteristic of glucocorticosteroids of systemic action, including adrenal insufficiency and an Icenco-Cushing syndrome.

Interaction with other medicines:

It is not revealed.

Contraindications:

— hypersensitivity to any component of drug or to other GKS;

— pink eels, perioral dermatitis;

— bacterial, virus (Herpes simplex, chicken pox. Herpes zoster) or fungal infection of skin;

— tuberculosis, syphilis;

— postvaccinal reactions;

— pregnancy (treatment of extensive sites of skin, prolonged treatment);

— the lactation period (use in high doses and/or for a long time);

— children's age up to 2 years.

With care. Drawing on face skin and the intertriginozny surface of skin, use of occlusive bandages, and also treatment of big sites of skin and/or prolonged treatment (especially at children).

Overdose:

Symptoms: function oppression гипоталамо - pituitary and adrenal system (including secondary adrenal insufficiency).

Treatment: symptomatic. If necessary - correction of an electrolytic imbalance, drug withdrawal (at long therapy – gradual cancellation).

Storage conditions:

Period of validity 2 years. Not to use after a period of validity. At a temperature not over 25 ºС. To store in the place, unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Cream for topical and external use of 0,1%. On 5 g, 15 g or 30 g in tubas aluminum. Each tuba together with the application instruction in a pack from a cardboard.