Betliben

General characteristics. Structure:

Active ingredient: 0,0643 g of betamethasone of Dipropionas (in terms of betamethasone - 0,05 g).

Excipients: paraffin white soft,  liquid paraffin, A25 cremophore (macrogoal ether cetostearyl A25), A6 cremophore (macrogoal ether cetostearyl A6), cetostearyl alcohol [cetyl alcohol of 60%, stearyl alcohol of 40%], propylene glycol, methylparahydroxybenzoate, пропилпарагидроксибензоат, dinatrium эдетат, a dihydrate of dihydrosodium phosphate, hydrophosphate sodium a dihydrate, the water purified.

It is used for effective elimination of symptoms of allergic diseases of skin, including contact dermatitis, atopic dermatitis, solar dermatitis, eczema, neurodermatitis; not allergic dermatitis and psoriasis. Renders antiinflammatory, antiallergic, anti-exudative and antipruritic action. The form of cream is more often used for therapy of a dermatosis in an acute and subacute stage, in the presence of exudate.

Pharmacological properties:

Pharmacodynamics. The betamethasone glucocorticosteroid Dipropionas renders antiinflammatory, antiallergic, anti-exudative, antiedematous and antipruritic action.

Slows down accumulation of leukocytes, release of lizosomalny enzymes and antiinflammatory mediators in the inflammation center, phagocytosis oppresses, reduces vascular and fabric permeability, interferes with formation of inflammatory hypostasis.

Pharmacokinetics. Betamethasone is absorbed from the surface of skin depending on amount (dose) of the applied drug and existence of damage of a corneous layer of skin. It is supposed that no more than 5% of the caused amount (dose) of drug are absorbed. The absorbed betamethasone is metabolized in a liver by hydrolysis and oxidation and removed through kidneys.

Penetration and absorption of drug are higher in case of the injured, covered skin slime (at inflammatory and/or other diseases of skin). Drug contacts proteins of plasma in number of about 64%. The elimination half-life makes 6,5 hours. Less than 5% of concentration of betamethasone in serum are removed with urine in not changed look. Considerably the most part of drug is soaked up in case of use of an occlusive bandage that is caused by local temperature increase and humidity.

Indications to use:

Allergic diseases of skin (including acute, subacute and chronic contact dermatitis, professional dermatitis, seborrheal dermatitis, atopic dermatitis, solar dermatitis, neurodermatitis, skin itch, disgidrotichesky dermatitis, eczema), acute and chronic forms of not allergic dermatitis, psoriasis.

Route of administration and doses:

Drug is intended only for external use. External use cream is applied on an affected area of skin with a thin layer by 1 or 2 times a day, slightly rubbing. On sites with more dense skin (for example, elbows, palms and feet), and also drug it is possible to put places from which drug is easily erased to a thicket. Duration of continuous treatment usually makes no more than 4 weeks.

At children and at patients with damage of face skin the course of treatment should not exceed 5 days. For prevention of a recurrence at treatment of chronic diseases, therapy it is necessary to continue still some time after disappearance of all symptoms. Within a year carrying out repeated courses of therapy is possible. External use cream is applied to therapy of the acute, including becoming wet damages of skin.

Features of use:

If the signs of hypersensitivity or irritation of skin connected using drug are noted it is necessary to stop treatment.

At long treatment, when putting drug on the extensive surfaces of skin, when using occlusive bandages, and also at children system absorption of glucocorticosteroids is possible.

To children since 1 drug is appointed only according to strict indications and under medical control as development of the system side effects connected with betamethasone is possible. At use of drug on extensive surfaces and/or under an occlusive bandage increase in absorption of betamethasone and manifestation of the system side effects connected with function suppression гипоталамо - pituitary and adrenal system and development of symptoms of a hypercorticoidism is possible.

When using drug on face skin the course of treatment should not exceed 5 days as at prolonged use of glucocorticosteroids of local action the probability of development of atrophic changes of skin increases.

Drug is not intended for use in ophthalmology. To avoid hit of cream in eyes.

At long use of drug its cancellation should be carried out gradually.

Use at pregnancy and in the period of a lactation. At pregnant women Betliben in a large number, on extensive body parts or for an appreciable length of time is not recommended to apply. Betliben's use during pregnancy has to be carried out only when the potential advantage exceeds potential risk for a fruit.

Lactation. At use in large amounts of cream Betliben, feeding by a breast is not recommended.

Influence on ability to driving of the car or to control of difficult mechanisms. Drug does not influence ability to driving of the car or to control of difficult mechanisms.

Side effects:

At topical administration of glucocorticosteroids can be observed: burning, irritation, xeroderma, folliculitis, hypertrichosis, aknepodobny rashes, skin itch, striya, heat rash, hypopigmentation, perioral dermatitis.

At prolonged use, and also use of occlusive bandages – maceration of skin, consecutive infection, a skin atrophy, a heat rash, a purpura, a local hirsutism, a teleangiectasia.

When drawing on extensive body surfaces, especially at children emergence of system side effects of glucocorticosteroids (gastritis, an ulceration of a mucous membrane of digestive tract, a hyperglycemia, a glucosuria, reversible oppression of function of bark of adrenal glands, manifestation of an Icenco-Cushing syndrome) is possible.

At manifestation of the side reactions which are not described in the instruction it is necessary to see a doctor.

Interaction with other medicines:

Cream interaction Betliben with other medicines is unknown.

Contraindications:

— tuberculosis cutis;

— skin displays of syphilis;

— chicken pox;

— viral, bacterial and fungal infections of skin;

— skin postvaccinal reactions;

— open wounds;

— trophic ulcers;

— rozatsea;

— vulgar eels;

— tumors of skin and hypodermic structures;

— children's age till 1 year;

— hypersensitivity to betamethasone or to any of auxiliary components of drug.

With care. This drug should be used with care at pregnancy. At prolonged use or drawing on big surfaces it is necessary to be careful at the following diseases - a cataract, a diabetes mellitus, glaucoma, tuberculosis.

Overdose:

At long continuous use of drug, especially at children, on the extensive surfaces of skin, when drawing on skin with the broken integrity or when using under an occlusive bandage, development of the side effects connected with suppression and insufficiency of function of bark of adrenal glands is possible.

Treatment: it is recommended to cancel drug and if necessary to appoint symptomatic therapy.

Storage conditions:

At a temperature not above 25 °C, in the place, unavailable to children. Period of validity 2 years. Not to use after the period of validity specified on packaging.

Issue conditions:

Without recipe

Packaging:

Cream for external use of 0,05%. On 25 g of drug in the aluminum tuba covered with twice protective varnish with the soldered opening, a protective membrane and the plastic cap supplied with the cone-shaped device for a puncture of a protective membrane. The tuba together with the application instruction is placed in a cardboard pack.