Mesoderms
Producer: HFZ CJSC NPTs Borshchagovsky Ukraina
Code of automatic telephone exchange: D07A C01
Release form: Soft dosage forms. Cream.
General characteristics. Structure:
International and chemical names: betamethasone;
9-фтор-11,21-дигидрокси-16-метил-3,20-диоксопрегна-1,4-диен-17-ил пентаноат; main physical and chemical properties: cream of white color of a homogeneous consistence, inodorous; Structure: 1 g of cream contains valerate betamethasone in terms of betamethasone and 100% dry matter - 1 mg; excipients: methylparahydroxybenzoate, vaseline, a liquid paraffin, cetostearyl alcohol, a macrogoal cetostearyl ether, propylene glycol, dinatrium эдетат (Trilonum of B), dinatrium phosphate dodecahydrate, potassium dihydrophosphate, the water purified.
Pharmacological properties:
Pharmacodynamics. Betamethasone – the synthetic glucocorticosteroid having antiinflammatory, antiallergic and antipruritic effect. At topical administration narrows vessels, removes an itch, reduces allocation of mediators of an inflammation (from eosinophils and mast cells), interleykin 1 and 2, gamma interferon (from lymphocytes and macrophages), brakes activity of hyaluronidase and reduces permeability of vascular walls. Interacts with specific receptors in cytoplasm of cells, stimulates synthesis of MRNK inducing formation of proteins including a lipokortin. Lipokortin oppresses A2 phospholipase, blocks release of arachidonic acid and biosynthesis of the endoperoxides, prostaglandins, leukotrienes (promoting development of an inflammation, an allergy and other pathological processes).
The cream basis provides the softening and moistening action.
Pharmacokinetics. Betamethasone as the fluorinated corticosteroid, very restrictedly is soaked up in a system blood stream through skin. At local application intensity of absorption depends on a condition of an epidermal barrier (the inflammation and skin diseases increase absorption). When putting cream on big sites of skin, and also at use of occlusive bandages increase in system absorption of a glucocorticosteroid is possible. In plasma contacts proteins. Easily gets through gistogematichesky barriers, including placental. It Biotransformirutsya preferential in a liver, the formed metabolites are inactive. It is excreted by kidneys; it is partially allocated with breast milk.
Indications to use:
Drug is used for treatment:
• eczemas of various forms and localization;
• psoriasis;
• neurodermatitises;
• dermatitis (contact, seborrheal, solar, exfoliative, radiation, intertriginozny);
• anogenitalny itch;
• senile itch.
Apply also as addition to system glucocorticoid therapy at a generalized erythrosis.
Route of administration and doses:
Cream is applied locally. The dose of drug is established individually as it depends on the area of an affected area. Cream needs to be applied on an affected area with a thin layer 2 times a day, carefully rubbing in skin. After achievement of clinical improvement the frequency of use of drug can be reduced to 1 time a day. Duration of treatment is defined by elimination of inflammatory process, the termination of an itch, clarification of skin; duration of a course of treatment depends on a look and weight of a course of a disease, is defined by the doctor and usually makes 1-2 weeks, but no more than 3 weeks; between repeated courses the break is necessary not less than 20 days. The course of treatment at children and patients with damage of a face has to make no more than 5 days.
At children it is necessary to apply with care, use of drug on big body parts, and also use of occlusive bandages is not recommended.
Features of use:
It is impossible to allow hits of drug in eyes. It is not necessary to apply cream on skin around eyes. For the purpose of increase in efficiency of therapy use of occlusive bandages is possible, however at the same time it must be kept in mind a possibility of development of systemic action of a glucocorticosteroid. System absorption of betamethasone increases at cream use for a long time, on a big body surface, and also at treatment of children.
Because safety of use of local glucocorticosteroids for pregnant women was not established, prescription of medicines of this group during pregnancy is justified only in that case when the potential advantage for mother surpasses potential risk for a fruit.
During pregnancy drugs of this group should not be used in high doses or long time.
As it is not found out whether system absorption at topical administration of glucocorticosteroids can cause emergence of their defined concentration in mother's milk, it is necessary to make the decision or on the feeding termination by a breast, or on drug phase-out, considering need its use for mother.
Side effects:
Drug is usually well transferred; at the correct use side effects arise seldom, however burning, an itch, irritation, a folliculitis, a hypertrichosis, acneform rashes, hypopigmentation, perioral dermatitis are possible.
At use of occlusive bandages emergence of maceration of skin, striya and a heat rash is possible.
Interaction with other medicines:
At topical administration of drug it is not established its interactions with other medicines.
Contraindications:
Drug should not be used at:
- primary viral, fungal and bacterial damages of skin;
- tuberculosis cutis;
- skin displays of syphilis;
- skin reactions after vaccination;
- acne rash;
- individual hypersensitivity to drug components.
Overdose:
Excessive and prolonged use of drug on the big surface of skin can lead to manifestation of the system effects inherent to glucocorticosteroids, in particular, to oppression гипоталамо - pituitary and adrenal system with development of secondary insufficiency of adrenal glands and to emergence of symptoms of a hypercorticoidism, including Itsenko's syndrome of Cushing (especially at children). Symptomatic treatment.
Storage conditions:
To store in dry, protected from light, the place, unavailable to children, at a temperature from 15 °C to 25 °C.
Period of validity – 2 years.
Issue conditions:
According to the recipe
Packaging:
On 15 g or 30 g in a tuba and a pack.