Silkaren^® (Cream) Instructions for Use

Marketing Authorization Holder

Vertex, JSC (Russia)

Manufactured By

Vertex, JSC (Russia)

Or

Altayvitamins, JSC (Russia)

ATC Code

D07AC13 (Mometasone)

Active Substance

Mometasone (Rec.INN registered by WHO)

Dosage Form

Silkaren®

Cream for external use 0.1%: tube 15 g

Dosage Form, Packaging, and Composition

Cream for external use 0.1% white or almost white, homogeneous.

Excipients: propylene glycol – 12 g, propylene glycol monostearate (propylene glycol monopalmitostearate) – 8 g, purified water – 3 g, peg cetostearyl ether (macrogol-20 cetostearyl ether) – 4 g, stearyl alcohol – 3 g, white beeswax (white wax) – 5 g, titanium dioxide – 1 g, methylparaben (methylparaben) – 0.02 g, propylparaben (propylparaben) – 0.18 g, talc – 10 g, phosphoric acid – to pH 4, petroleum jelly (soft paraffin, petrolatum) – to 100 g.

15 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

Glucocorticosteroid for external use. It has anti-inflammatory, antipruritic, and anti-exudative effects. Glucocorticosteroids induce the release of proteins that inhibit phospholipase A₂, and known collectively as lipocortins, which control the biosynthesis of inflammatory mediators such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid.

Pharmacokinetics

The absorption of the drug when applied externally is insignificant. After 8 hours of application to intact skin (without an occlusive dressing), 0.7% of mometasone is detected in the systemic circulation.

Indications

Inflammatory reactions and itching in dermatoses amenable to glucocorticosteroid therapy.

ICD codes

Dosage Regimen

Apply a thin layer of Silkaren^® cream to the affected skin areas once daily.

Gently rub the cream into the skin until fully absorbed.

Use the minimum amount necessary to control symptoms.

The duration of treatment is contingent upon the disease and patient response.

For adult patients, treatment duration is typically up to 3 weeks.

For pediatric patients aged 2 years and older, limit treatment to 2 weeks.

Avoid application under occlusive dressings unless directed by a physician.

Do not use on large areas of the body or for prolonged periods, especially in children.

If no clinical improvement is observed within 1-2 weeks, re-evaluate the diagnosis.

For chronic conditions, consider an intermittent dosing regimen for maintenance therapy.

When discontinuing after long-term use, gradually reduce the frequency of application to prevent rebound effects.

Wash hands thoroughly after application, unless the hands are the treatment area.

Avoid contact with eyes, mucous membranes, and broken skin.

Adverse Reactions

Infections and infestations rarely – folliculitis, secondary infection.

Skin and subcutaneous tissue disorders rarely – skin irritation and dryness, burning sensation, itching, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin maceration, signs of skin atrophy, striae, miliaria, formation of papules, pustules.

Nervous system disorders frequency not established – paresthesia.

When using topical glucocorticosteroid forms for a long time and/or for treating large areas of the skin, or when using occlusive dressings, especially in children and adolescents, side effects characteristic of systemic glucocorticosteroids may occur, including adrenal insufficiency and Cushing’s syndrome.

Contraindications

Hypersensitivity to mometasone; rosacea; perioral dermatitis; bacterial, viral (Herpes simplex, Herpes zoster, chickenpox), fungal skin infection; tuberculosis; syphilis; post-vaccination reactions; pregnancy (application to large areas of the skin, long-term treatment); lactation period (use in high doses and/or for a long time); children under 2 years of age.

Use with caution when applying to the skin of the face and intertriginous skin, when using occlusive dressings, and when applying to large areas of the skin and/or for a long time (especially in children).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy on large areas of the skin, for a long time; during breastfeeding.

Pediatric Use

Contraindication: children under 2 years of age.

Special Precautions

When applied to large areas of the skin for a long time, especially when using occlusive dressings, the development of systemic effects of glucocorticosteroids is possible. Given this, patients should be monitored for signs of suppression of the hypothalamic-pituitary-adrenal system function and the development of Cushing’s syndrome.

It should be taken into account that glucocorticosteroids can alter the manifestations of some skin diseases, which may complicate the diagnosis. Furthermore, the use of glucocorticosteroids can cause delayed wound healing.

During long-term glucocorticosteroid therapy, sudden discontinuation of therapy can lead to the development of a rebound syndrome, manifested in the form of dermatitis with intense skin redness 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 stopping it completely.

Any of the side effects described with the systemic use of glucocorticosteroids, including adrenal suppression, can also occur with topical application, especially in children.

Use in pediatrics

Because children have a larger surface area to body weight ratio than adults, they are at greater risk of suppression of the hypothalamic-pituitary-adrenal system function and the development of Cushing’s syndrome when using any topical glucocorticosteroids. Long-term use of glucocorticosteroids in children can lead to disturbances in their growth and development.

In children, it should be used in the minimum effective dose.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.