Active substanceBetamethasone + UreaBetamethasone + Urea
Dosage form: & nbspcream for external use
Composition:

1 g of cream contains:

active substances: betamethasone valerate 1.22 mg (calculated as betamethasone 1.0 mg), urea 100, 0 mg;

Excipients: imidourea (Germall®) 2.5 mg, paraffin liquid (Vaseline oil medical) 100 mg, stearic acid (stearic acid 50) 25 mg, monoglycerides distilled (Dimodan HP) 30 mg, wax emulsion 15 mg, glycerol (glycerin distilled) 50 mg, sodium hydrophosphate dodecahydrate (sodium phosphate disubstituted 12-water) 0.2 mg, potassium dihydrogen phosphate (potassium phosphate monosubstituted) 7.8 mg, disodium edetate (Trilon B) 2 mg, water up to 1 g.

Description:

The cream is white or almost white.

Pharmacotherapeutic group:Glucocorticosteroid for topical use + keratolytic agent
ATX: & nbsp

D.07.X.C.01   Betamethasone in combination with other drugs

Pharmacodynamics:

Combined drug, the effect of which is due to the components that make up its composition.

Betamethasone - Glucocorticosteroid for external use; has anti-inflammatory local, anti-allergic, anti-edematous and antiproliferative effect.When exposed to the skin, the edge accumulation of neutrophils is prevented, which leads to a decrease in exudation, production of cytokines, inhibition of migration of macrophages, leading ultimately to a decrease in the processes of infiltration and granulation.

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 stratum corneum. In addition to keratolytic action urea has proteolytic activity.

Cleore cream has anti-inflammatory, anti-allergic, anti-exudative, keratolytic and antipruritic effect.

Indications:

Cleore cream is used to reduce the inflammatory manifestations of dry and hyperkeretic dermatoses sensitive to external glucocorticosteroid therapy, such as:

- psoriasis;

- atopic dermatitis;

- eczema (atopic, childish, coin-like, pruriginous, tylotic, dishydrotic);

- red flat lichen;

- discoid lupus erythematosus;

- dermatitis of various etiology (including contact dermatitis);

- simple chronic lichen (limited neurodermatitis);

- seborrheic dermatitis;

- diffuse neurodermatitis;

- itching of the skin;

- prurigo (prurigo).

Contraindications:

Hypersensitivity to any of the components of the drug, infancy (up to 2 years), acne, dermatitis (perioral, toxic and allergic, herpetiformis Duhring), bacterial, viral or fungal skin lesions (pyoderma, Herpes simplex, chickenpox, Herpes zoster, Actinomycosis, blastomycosis, sporotrichosis), syphilis, tuberculosis of the skin, sores (including on the background of chronic venous and arterial insufficiency), nevus, sebaceous cyst, hemangioma, angiokeratoma, skin tumors (skin cancer, epithelioma, melanoma, xanthoma, basal cell carcinoma, sarcomas, Kaposi's sarcoma), carcinoid Gottrona skin papillomatosis, erythema multiforme, pemphigus, benign pemphigus, eosinophilic granuloma, photodermatitis, neurofibromatosis, skin trauma, skin reactions after vaccination, lactation.

Carefully:

Long-term treatment, use in large areas of the skin, the use of occlusive dressings, pregnancy.

Pregnancy and lactation:

Due to the fact that the safety of the use of local glucocorticosteroids in pregnant women is not established,the appointment of this group of medicines during pregnancy is justified only if the potential benefit to the mother exceeds the potential risk to the fetus.

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

Dosing and Administration:

Outwardly. Apply a thin layer 2 times a day - in the morning and evening on the affected skin.

Use in children under 12 years of age is possible only under medical supervision.

Children aged 2 to 12 years - Apply a thin layer on a small area of ​​the skin 1 or 2 times a day.

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

In the treatment of children, as well as patients with facial skin lesions, the course of treatment should not exceed 5 days.

Side effects:

Undesirable effects that are possible with the use of local glucocorticosteroids: burning, itching, skin irritation, dry skin, folliculitis, hypertrichosis, acne, hypopigmentation.

With prolonged use and with the use of occlusive dressings are possible: skin maceration, secondary infection, skin atrophy,stria and sweating.

If there are any side effects not described in this manual, you should consult your doctor.

Overdose:

Symptoms: long-term use of local glucocorticosteroids in large doses can cause oppression of the pituitary-adrenal system, leading to secondary adrenal insufficiency and hypercorticoid phenomena, including Cushing's syndrome.

Treatment: the corresponding symptomatic treatment is indicated. Acute symptoms of hypercorticoidism are usually reversible. If necessary - correction of electrolyte imbalance. In the case of chronic toxicity, gradual elimination of glucocorticosteroids is recommended.

Special instructions:

If there is skin irritation or hypersensitivity to the drug against the background of the drug, treatment should be discontinued. In case of infection, appropriate therapy should be prescribed.

Systemic absorption of glucocorticosteroids and urea with their local application will be higher when using occlusive dressings, when applied to extensive body surfaces.

Children more than adults are at risk of oppression of the hypothalamic-pituitary-adrenal system due tothe use of local glucocorticosteroids, because of the greater the ratio of the surface area of ​​the body to its mass and, as a result, increased absorption of the drug.

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

On the skin of the face more often than on other surfaces of the body, after prolonged treatment with topical glucocorticosteroids, atrophic changes may appear.

With prolonged treatment with the drug, it is recommended to cancel it gradually.

Form release / dosage:

Cream for external use.

Packaging:

By 10, 15, 20, 25, 30, 40, 50 or 100 g in aluminum tubes or in polyethylene laminated tubes.

Each tube together with instructions for medical use of the drug is placed in a pack of cardboard.

Storage conditions:

Store at a temperature not exceeding 15 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription
Registration number:LSR-005291/10
Date of registration:08.06.2010 / 18.05.2012
Expiration Date:Unlimited
The owner of the registration certificate:Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSCNizhny Novgorod Chemical and Pharmaceutical Plant, OJSC
Manufacturer: & nbsp
Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
Information update date: & nbsp25.01.2018
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