Kleore (Cream) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Betamethasone (Rec.INN)

Urea (Ph.Eur.)

Dosage Form

Kleore

Cream for external use 20 mg+1 mg/1 g: tube 15 g

Dosage Form, Packaging, and Composition

10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with anti-inflammatory and keratolytic action for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid + keratolytic agent

Pharmacological Action

A combined drug, the action of which is due to the components that make up its composition.

Betamethasone is a glucocorticosteroid for external use; it has local anti-inflammatory, anti-allergic, anti-edematous, and anti-proliferative effects. When acting on the skin, it prevents the marginal accumulation of neutrophils, which leads to a reduction in exudation, cytokine production, and inhibition of macrophage migration, ultimately resulting in a reduction in infiltration and granulation processes.

Urea has keratolytic (softening and causing rejection of the stratum corneum of the epidermis) and moisturizing effects. Urea promotes water binding and softening of the skin’s stratum corneum. In addition to its keratolytic action, Urea has proteolytic activity.

Kleore cream has anti-inflammatory, anti-allergic, anti-exudative, keratolytic, and antipruritic effects.

Indications

Kleore cream is used to reduce inflammatory manifestations of dry and hyperkeratotic dermatoses sensitive to external glucocorticosteroid therapy, such as

• Psoriasis;
• Atopic dermatitis;
• Eczema (atopic, infantile, nummular, pruriginous, tylotic, dyshidrotic);
• Lichen planus;
• Discoid lupus erythematosus;
• Dermatitis of various etiologies (including contact dermatitis);
• Lichen simplex chronicus (circumscribed neurodermatitis);
• Seborrheic dermatitis;
• Diffuse neurodermatitis;
• Skin itching;
• Prurigo.

ICD codes

Dosage Regimen

Externally. Apply a thin layer 2 times a day – in the morning and in the evening – to the affected areas of the skin.

Use in children under 12 years of age is possible only under medical supervision. For children aged 2 to 12 years – apply a thin layer to a small area of skin 1 or 2 times a day.

The duration of treatment and the amount of the drug applied depends on the type and severity of the disease and is determined by the doctor.

When treating children, as well as patients with skin lesions on the face, the course of treatment should not exceed 5 days.

Adverse Reactions

Adverse events that are possible when using topical glucocorticosteroids: burning, itching, skin irritation, dry skin, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation.

With prolonged use and when using occlusive dressings, the following are possible: skin maceration, secondary infection, skin atrophy, striae, and miliaria.

If adverse reactions not described in this instruction occur, you should consult a doctor.

Contraindications

• Children under 2 years of age;
• Acne vulgaris;
• Dermatitis (perioral, toxic-allergic, dermatitis herpetiformis);
• Bacterial, viral, or fungal skin lesions (pyoderma, Herpes simplex, chickenpox, Herpes zoster, actinomycosis, blastomycosis, sporotrichosis);
• Syphilis;
• Skin tuberculosis;
• Trophic ulcers (including those due to chronic venous and arterial insufficiency);
• Nevus;
• Atheroma;
• Hemangioma;
• Angiokeratoma;
• Skin tumors (skin cancer, epithelioma, melanoma, xanthoma, basal cell carcinoma, sarcomas, Kaposi’s sarcoma);
• Gottron’s carcinoid papillomatosis of the skin;
• Erythema multiforme exudativum;
• Pemphigus;
• Benign pemphigus;
• Eosinophilic granuloma;
• Photodermatitis;
• Neurofibromatosis;
• Skin injuries;
• Post-vaccination skin reactions;
• Lactation period;
• Hypersensitivity to any of the components of the drug.

With caution: long-term treatment, application to large areas of the skin, use of occlusive dressings, pregnancy.

Use in Pregnancy and Lactation

Since the safety of using topical glucocorticosteroids in pregnant women has not been established, the prescription of this group of drugs during pregnancy is justified only if the potential benefit to the mother outweighs the potential risk to the fetus.

Drugs of this class should not be used during pregnancy in large doses or for a long time.

Pediatric Use

Contraindicated in children under 2 years of age.

Use in children under 12 years of age is possible only under medical supervision. For children aged 2 to 12 years – apply a thin layer to a small area of skin 1 or 2 times a day.

When treating children, the course of treatment should not exceed 5 days.

Special Precautions

If skin irritation or increased sensitivity to the drug appears during the use of the drug, treatment should be discontinued. If an infection occurs, appropriate therapy should be prescribed.

Systemic absorption of glucocorticosteroids and urea during their topical application will be higher when using occlusive dressings and when applied to large areas of the body.

Children are more susceptible than adults to the risk of suppression of the hypothalamic-pituitary-adrenal system function due to the use of topical glucocorticosteroids, due to the larger ratio of body surface area to its mass and, consequently, increased absorption of the drug.

The drug is not intended for use in ophthalmology. Avoid contact with eyes and mucous membranes.

Atrophic changes may appear on the facial skin more often than on other body surfaces after long-term treatment with topical glucocorticosteroids. When discontinuing the drug after long-term treatment, it is recommended to do so gradually.

Overdose

Symptoms long-term use of topical glucocorticosteroids in large doses can cause suppression of the pituitary-adrenal system function, leading to secondary adrenal insufficiency and manifestations of hypercortisolism, including Cushing’s syndrome.

Treatment appropriate symptomatic treatment is indicated. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte imbalance. In case of chronic toxicity, gradual withdrawal of glucocorticosteroids is recommended.

Storage Conditions

Store at a temperature not exceeding 15°C (59°F). Keep out of the reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

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.