Skinlight^® (Cream) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

ATC Code

D07XC03 (Mometasone in combination with other drugs)

Active Substances

Heparin sodium (Rec.INN registered by WHO)

Mometasone (Rec.INN registered by WHO)

Dosage Form

Skinlight®

Cream for external use 100 mcg+60 IU/1 g: tube 15 g

Dosage Form, Packaging, and Composition

Cream for external use white or white with a yellowish tint, odorless.

* with heparin sodium activity of 120 IU/mg.

Excipients: liquid paraffin, petrolatum, propylene glycol, stearic acid 50, distilled monoglycerides, glycerol, macrogol cetostearyl ether, poloxamer (emulsol 268), cetostearyl alcohol [cetyl alcohol not more than 60%, stearyl alcohol not more than 40%], imidurea, butylated hydroxytoluene, purified water.

15 g – tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with anti-inflammatory and antithrombotic action for external use

Pharmacotherapeutic Group

Combined topical glucocorticosteroid

Pharmacological Action

Mometasone furoate is a glucocorticoid for topical use. It has anti-inflammatory, anti-allergic, antipruritic, and anti-exudative effects. It inhibits the release of inflammatory mediators. It increases the production of lipocortin, which is an inhibitor of phospholipase A2, which leads to inhibition of arachidonic acid release. It prevents the marginal accumulation of neutrophils, which reduces inflammatory exudate and cytokine production, inhibits macrophage migration, and leads to a reduction in infiltration and granulation processes.

It reduces inflammation by decreasing the formation of chemotaxis substance (effect on “late” allergic reactions), inhibits the development of an “immediate” allergic reaction (due to inhibition of arachidonic acid metabolite production and reduced release of inflammatory mediators from mast cells).

Heparin is a direct-acting anticoagulant with anti-inflammatory, antiproliferative, anti-edema, and analgesic effects. It reduces platelet aggregation, binds to antithrombin III, preventing the conversion of prothrombin to thrombin. It inhibits thrombin activity. It reduces hyaluronidase activity and increases the fibrinolytic properties of blood. Heparin improves microcirculation and activates tissue metabolism, thereby accelerating the resorption of hematomas and blood clots, ultimately restoring venous patency, which is clinically accompanied by a pronounced analgesic and anti-inflammatory effect.

Pharmacokinetics

Absorption of the cream is insignificant. After 8 hours of application to intact skin (without an occlusive dressing), 0.4% of mometasone is detected in the systemic circulation.

A small amount of heparin is absorbed from the skin surface into the systemic circulation. The C_max of heparin in the blood is observed 8 hours after application. Heparin elimination occurs mainly through the kidneys, with a T_1/2 of 12 hours.

Indications

Skin diseases (including those of a chronic nature) amenable to therapy with topical glucocorticosteroids

• Psoriasis;
• Atopic dermatitis;
• Simple chronic lichen (circumscribed neurodermatitis);
• Eczema;
• Pruritic dermatoses;
• Insect bites;
• First-degree burns;
• Sunburns;
• Lichen planus;
• Discoid lupus erythematosus.

ICD codes

Dosage Regimen

Apply externally only.

Apply a thin layer to the affected skin areas once daily.

Rub in gently and completely.

The standard treatment duration is 7 to 28 days, depending on the disease severity and therapeutic response.

For limited plaque psoriasis, the treatment course is 21 days.

Do not use on large body surface areas, under occlusive dressings, or for prolonged periods without medical supervision.

Avoid application on the face, intertriginous areas, and areas with atrophic skin.

Discontinue treatment gradually after a long course to prevent rebound dermatitis.

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

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

Prevent contact with eyes and mucous membranes.

Adverse Reactions

Local reactions burning, itching, paresthesia, folliculitis, acne, skin atrophy, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, striae, miliaria.

When using topical glucocorticosteroid forms for a long time and/or for treating large areas of skin (total application area larger than the patient’s palm), or with the use of occlusive dressings, side effects characteristic of systemic glucocorticosteroids may occur, including adrenal insufficiency and Cushing’s syndrome.

Contraindications

• Hypersensitivity to the components of the drug or glucocorticosteroids;
• Rosacea, perioral dermatitis;
• Bacterial, viral (Herpes simplex, Herpes zoster, chickenpox), fungal skin infection;
• Tuberculosis, syphilis;
• Post-vaccination reactions;
• Pregnancy (treatment of extensive skin areas, long-term treatment);
• Breastfeeding period;
• Children under 18 years of age.

With caution: application to facial skin and intertriginous skin surfaces, use of occlusive dressings, use on large skin areas and/or for a long time. Long-term therapy with systemic glucocorticosteroids.

Use in Pregnancy and Lactation

The safety of using Skinlight^® cream for external use during pregnancy and lactation has not been studied. Glucocorticosteroids cross the placental barrier. Prescribe during pregnancy only in cases where the expected benefit to the mother outweighs the potential risk to the fetus; in this case, use small doses and apply for a short time.

Glucocorticosteroids are excreted in breast milk. If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

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

During treatment, it is recommended to regularly monitor adrenal function. If side effects occur, treatment should be discontinued and symptomatic therapy prescribed. If a secondary infection occurs, antimicrobial therapy should be initiated.

Avoid getting the drug into the eyes.

Propylene glycol, which is part of the drug, may cause irritation at the application site. In such cases, the use of the drug should be discontinued and appropriate treatment prescribed.

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

During long-term glucocorticosteroid therapy, sudden discontinuation of therapy may lead to the development of a rebound syndrome, manifested as 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 completely stopping it.

Effect on the ability to drive vehicles and operate machinery

Does not affect the ability to drive a car and operate other machinery.

Overdose

Symptoms suppression of hypothalamic-pituitary-adrenal system function, including secondary adrenal insufficiency.

Treatment symptomatic, if necessary – correction of electrolyte imbalance, drug withdrawal (with long-term therapy – gradual withdrawal).

Drug Interactions

Data on the interaction of the drug with other medicinal products are not available.

Storage Conditions

Store the drug out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use the drug after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.