Целестодерм®-В

General characteristics. Structure:

Active ingredient: 1,22 mg of betamethasone of valerate (that ekvivaletno 1 mg of betamethasone).

Excipients: paraffin white soft, cetostearyl alcohol, liquid paraffin, a macrogoal cetostearyl ether, phosphoric acid and sodium hydroxide - q.s. (in the form of 5% of solutions in the quantity necessary for establishment of pH), dihydrophosphate sodium a dihydrate (corresponds to sodium to monohydrate dihydrophosphate), chlorocresol, the water purified.

Pharmacological properties:

Pharmacodynamics. Betamethasone has antiinflammatory and antiallergic effect by means of braking of release of cytokines and mediators of an inflammation, reduction of metabolism of arachidonic acid, induction of formation of the lipokortin having antiedematous activity, decrease in permeability of vessels.

Microdispersion of this glucocorticosteroid (GKS) in the low-fat, not having a smell, not leaving marks on clothes, easily washing away ointment or cream basis provides effective penetration into skin and quick start of action.

Indications to use:

The inflammatory diseases of skin which are giving in to glucocorticosteroid (GKS) therapy:

— eczema (atonic, children's, monetovidny);

— contact dermatitis;

— seborrheal dermatitis;

— neurodermatitis;

— solar dermatitis;

— exfoliative dermatitis;

— beam dermatitis;

— intertriginozny dermatitis;

— psoriasis;

— anogenitalny and senile itch.

Route of administration and doses:

Outwardly. Tselestoderm-V it is necessary to apply with a thin layer on affected areas of 1-3 times/days, depending on weight of a state. In most cases for achievement of effect there is sufficient a drawing 1-2 times/days.

Features of use:

Use at pregnancy and feeding by a breast. Because safety of use of local GKS for pregnant women is not established, purpose of drugs of this class during pregnancy is justified only if the advantage for mother obviously exceeds possible harm for a fruit. Drugs of this group should not be used at pregnant women in high doses or for a long time.

As so far it is not established whether GKS at topical administration and system absorption can get into breast milk, it is necessary to stop breastfeeding or use of drug, considering as far as its use is necessary for mother.

Use for children. Tselestoderm-V it can be used for treatment of children aged from 6 months. Children can be more susceptible to use of the local GKS causing oppression гипоталамо - pituitary and adrenal system (GGN), than patients of advanced age, in connection with the increased absorption of drug connected with the bigger size of a ratio at them of surface area and body weight.

Special instructions. In the absence of effect of treatment within 2 weeks it is recommended to see the attending physician for the purpose of possible specification of the diagnosis. If at use of drug the irritation or hypersensitivity reaction is noted, treatment the patient should stop and pick up adequate therapy. At a consecutive fungal or bacterial infection it is necessary to appoint the corresponding medicines. In case of lack at the same time of bystry positive effect, use of GKS has to be stopped until all symptoms of an infection are liquidated.

Any side effects of system GKS, including oppression of function of bark of adrenal glands, can be noted also when using local GKS, especially at children.

System absorption of local GKS is increased at their prolonged use, at treatment of extensive body surfaces or when using of the closing bandages, and also at children.

Tselestoderm-V it is shown only for external use and not intended for use in ophthalmology.

Use in pediatric practice. Tselestoderm-V it can be used for treatment of children aged from 6 months.

Children can be more susceptible to use of the local GKS causing oppression гипоталамо - pituitary and adrenal system (GGN), than patients of advanced age, in connection with the increased absorption of drug connected with the bigger size of a ratio at them of surface area and body weight.

At the children receiving local GKS the following side effects were noted: suppression of the GGN function of system, Cushing's syndrome, a linear growth inhibition, lag in a weight increase, increase in intracranial pressure. Symptoms of oppression of function of bark of adrenal glands at children include decrease in level of cortisol in plasma and lack of the response to stimulation of AKTG. Increase in intracranial pressure is shown by protrusion of a fontanel, a headache, a bilateral papilledema.

Side effects:

At use of GKS of local action the following undesirable phenomena were observed: burning, irritation and xeroderma, folliculitis, hypertrichosis, acneform rashes, hypopigmentation, neutral dermatitis, allergic contact dermatitis, maceration of skin, consecutive infection, atrophy of skin, striya and heat rash.

Contraindications:

— hypersensitivity to any of drug components;

— pregnancy (use of high doses, prolonged treatment);

— lactation period;

— children's age up to 6 months.

Overdose:

Symptoms. Excessive or prolonged use of local GKS can cause oppression of function of pituitary and adrenal system that there can be the reason of development of secondary insufficiency of bark of adrenal glands and emergence of symptoms of a hypercorticoidism, including Cushing's syndrome.

Treatment. The corresponding symptomatic treatment is shown. Acute symptoms of a hypercorticoidism are usually reversible. If necessary correction of an electrolytic imbalance is shown. In case of chronic toxic action gradual cancellation of GKS is recommended.

Storage conditions:

To store in the place, unavailable to children, at a temperature not above 25 °C. Period of validity of 5 years. Not to use after a period of validity.

Issue conditions:

Without recipe

Packaging:

15 g - tubas aluminum (1) - packs cardboard.
30 g - tubas aluminum (1) - packs cardboard.