Instruction for use: Silkaren

Active substance Mometasone

ATX Code D07AC13 Mometasone

Pharmacological group

Glucocorticosteroid for topical use [Glucocorticosteroids]

Nosological classification (ICD-10)

L20 Atopic dermatitis

Itchy atopic eczema, Common neurodermatitis, Allergic skin diseases, Allergic skin diseases of non-infectious etiology, Allergic skin diseases of non-microbial etiology, Allergic skin diseases, Allergic skin lesions, Allergic manifestations on the skin, Allergic dermatitis, Allergic diathesis, Allergic itching dermatosis, Allergic Skin Disease, Allergic skin irritation, Dermatitis allergic, Atopic dermatitis, Dermatosis allergic, Diathesis exudative, Skin Allergic Disease, Skin allergic reaction to medicinal and chemical preparations, Skin reaction to medication, Skin and allergic disease, Acute eczema, Chronic atopic dermatitis, Exudative diathesis, Itching allergic dermatosis

L21 Seborrheic dermatitis

Dermatitis seborrheic, Increased sebum separation, Seborrheic Eczema, Seborrheic dermatitis of the scalp, Seborrheic pyodermatitis, Seborrhea, Eczema seborrheic

L29 Itching

Itching with partial obstruction of the biliary tract, Dermatitis itchy, Dermatosis with persistent itching, Other itching dermatoses, Itching dermatoses, Itching allergic dermatosis, Itching dermatitis, Itching itch, Excruciating itching, Severe itching, Endogenous itching, Skin itching with dermatosis, Limited itching dermatitis, Itching of the skin, Itchy scalp, Itching eczema

L30.9 Dermatitis, unspecified

Allergic dermatoses complicated by a secondary bacterial infection, Anal eczema, Bacterial maturation, Varicose Eczema, Venous dermatitis, Inflammation of the skin, Inflammation of the skin upon contact with plants, Inflammatory Skin Diseases, Inflammatory skin reactions, Inflammatory processes of the skin, Hypostatic dermatitis, Fungal Eczema, Fungal dermatosis, Dermatitis, Dermatitis is stagnant, Dermatitis and eczema in the anal area, Dermatitis acute contact, Perianal dermatitis, Dermatosis, Dermatosis of the scalp, Dermatosis of psoriasis, Dermatosis with persistent itching, Dermatoses, Dermatoses itchy, Other itching dermatoses, Significant eczematous manifestations, Itching with, dermatoses, Itching eczema, True eczema, Skin reaction to insect bites,Skin itching with dermatosis, Constitutional eczema, Weeping eczema, Drowsing inflammatory skin disease, Dying Infectious-Inflammatory Skin Disease, Non-allergic dermatitis, Nummular eczema, Acute contact eczema, Acute inflammatory skin disease, Acute dermatosis, Acute severe dermatosis, Perianal dermatitis, Superficial dermatosis, Subacute Contact Eczema, Simple dermatitis, Occupational dermatitis, Psychogenic dermatosis, Bubble dermatitis of newborns, Pustular eruptions, Irritation and redness of the skin, Low-flammable eczema, Dry atrophic eczema, Dry eczema, Toxic dermatitis, Ear eczema like dermatitis, Chronic eczema, Chronic dermatosis, Chronic common dermatosis, Scaly papular dermatosis, Eczema, Eczema anal region, Eczema of the hands, Eczema Contact, Eczema lichenized, Eczema Nummular, Eczema acute, Eczema acute contact, Eczema subacute, Eczematous dermatitis, Eczema-like rashes, Ecome exogenous, Endogenous eczema, Gluteal dermatitis, Restricted itchy dermatitis

L40 Psoriasis

Chronic psoriasis with diffuse plaques, Generalized psoriasis, Psoriasis of the scalp, Psoriasis of the scalp, Generalized form of psoriasis, Psoriasis dermatitis, Psoriasis complicated by erythroderma, Invalidative psoriasis, Isolated psoriatic plaque, Exfoliative psoriasis, Psoriatic Erythroderma, Psoriasis with eczematosis, Hyperkeratosis in psoriasis,Inverse psoriasis,Psoriasis eczematous, Dermatosis of psoriasis, Psoriasis of the genitals, Psoriasis with lesions of hairy areas of skin, Erythrodermal psoriasis, Chronic psoriasis of the scalp, Chronic psoriasis, Ordinary psoriasis, Refractory psoriasis, Kebner phenomenon, Scaly lichen

Composition

Cream for external use 100 g

active substance:

Mometasone furoate 0.1 g

Auxiliary substances: propylene glycol - 12 g; Propylene glycol monostearate (propylene glycol monopalmitostearate) 8 g; Purified water - 3 g; Macrogol cetostearate (macrogol 20 cetostearyl ether) - 4 g; Stearyl alcohol - 3 g; Wax bee white (white wax) - 5 g; Titanium dioxide - 1 g; Methyl parahydroxybenzoate (methylparaben) - 0.02 g; Propyl parahydroxybenzoate (propylparaben) 0.18 g; Talc - 10 g; Phosphoric acid - up to pH 4; Vaseline (soft paraffin, petrolatum) - up to 100 g

Description of dosage form

Cream: homogeneous, white or almost white.

pharmachologic effect

Pharmacological action - antipruritic, antiexudative, anti-inflammatory local.

Pharmacodynamics

Mometasone - a synthetic SCS (glucocorticosteroids). Has anti-inflammatory, antipruritic and antiexudative action.

SCS induces the release of proteins that inhibit phospholipase A2 and are known collectively as lipocortins that control the biosynthesis of inflammatory mediators such as PG and LT (leukotrienes) by inhibiting the release of their common precursor, arachidonic acid.

Pharmacokinetics

Absorption of mometasone is low. 8 hours after application to the intact skin (without occlusive dressing), about 0.4% of the dose is found in the systemic blood stream. With inflammation and damage to the skin, absorption increases.

indications

Inflammation and itching of the skin with dermatoses (including psoriasis, atopic dermatitis, seborrheic dermatitis), in which therapy is shown.

Contraindications

Hypersensitivity to any component of the drug or other SCS;

Rosacea;

Perioral dermatitis;

Bacterial, viral (Herpes simplex, chicken pox, Herpes zoster) or fungal skin infection;

Tuberculosis, syphilis;

Postvaccinal reactions;

Pregnancy (treatment of extensive skin areas, long-term treatment);

Lactation period (use in large doses and / or for a long time);

Children under 2 years.

With caution: apply on the face and intertriginous skin surface; Application of occlusive dressings, as well as treatment of lesions of large areas of the skin and / or long-term treatment (especially in children).

Application in pregnancy and lactation

The safety of mometasone during pregnancy and lactation has not been studied.

GCS penetrate the placental barrier. Avoid prolonged treatment and use of large doses during pregnancy due to the threat of adverse effects on fetal development.

GCS is excreted in breast milk. In the event that the use of GCS is expected in large doses and / or for a long time, breastfeeding should be discontinued.

Side effects

Local reactions: burning, itching, paresthesia, folliculitis, acne, skin atrophy, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, attachment of secondary infection, striae, sweating. The probability of occurrence of the listed undesirable phenomena increases at application of occlusive dressings.

Systemic action: when applying external forms of SCS for a long time and / or for treating large areas of the skin (the total area of application is larger than the palm of the patient), or with the use of occlusive dressings, especially in children and adolescents, Systemic action, including adrenal insufficiency and the Itenko-Cushing syndrome.

Interaction

Not found.

Dosing and Administration

External

A thin layer of Silkaren® cream is applied to the affected areas of the skin 1 time per day. Duration of treatment: 7-28 days, determined by the effectiveness of therapy, as well as patient tolerability, the presence and severity of side effects.

Special patient groups

Children. Due to the fact that the ratio of surface area and body weight is greater in children than in adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal system and the development of the Itenko-Cushing syndrome with any local GCS. Long-term treatment of children with SCS can lead to disruption of their growth and development. The use of the drug in children for more than 3 weeks has not been studied. Children should receive a minimum dose of the drug sufficient to achieve the effect.

Overdose

Symptoms: oppression of the hypothalamic-pituitary-adrenal system (including secondary adrenal insufficiency).

Treatment: symptomatic. If necessary - correction of electrolyte imbalance, drug withdrawal (with prolonged therapy - gradual cancellation).

special instructions

If there is no effect for 2 weeks, the diagnosis should be clarified.

When applied to large areas of the skin for a long time, especially when using occlusive dressings, it is possible to develop a systemic action of GCS. Given this, it is necessary to monitor the function of the hypothalamic-pituitary-adrenal system.

Avoid contact with the eyes.

Propylene glycol, which is part of Silkaren®, may cause irritation at the site of application, in such cases, discontinue use of the drug and prescribe appropriate treatment.

It should be borne in mind that the GCS can change the manifestations of certain skin diseases, which can make it difficult to diagnose. In addition, the use of GCS may be a cause of delayed wound healing.

With prolonged therapy with SCS, sudden discontinuation of therapy can lead to the development of a rebound syndrome, manifested in the form of dermatitis with intense reddening of the skin and a burning sensation. Therefore, after a long course of treatment, the drug should be discontinued gradually, for example by switching to an intermittent treatment regimen before it is completely discontinued.

Influence on the ability to drive vehicles and work with machinery. There is no data on the effect of Silkaren® cream on the ability to drive vehicles and mechanisms.

Form of issue

Cream for external use, 0,1%. In tubes of aluminum, 5, 15 or 30 g. Each tube in a pack of cardboard.

Terms of leave from pharmacies

On prescription.

storage Conditions

At a temperature not exceeding 25 ° C. Do not freeze.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.