Ts-dermas

General characteristics. Structure:

Active ingredient: 1 mg of betamethasone of valerate in terms of betamethasone in 1 g of ointment.

Excipients: liquid paraffin and paraffin soft, white.

The ointment applied in dermatology and rendering local antiinflammatory, antiallergic and antipruritic action.

Pharmacological properties:

Pharmacodynamics. At topical administration drug 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 lowers permeability of a vascular wall. Interacts with specific receptors in cell cytoplasm, stimulates synthesis of MRNK inducing formation of proteins including a lipokortina, the processes of an inflammation, an allergy mediating cellular effects, etc.

Pharmacokinetics. Researches of pharmacokinetics of medicine of "Ts-dermas" ointment were not conducted. Topical corticosteroids can be absorbed when drawing on skin. A determinal factor of size of possible penetration of betamethasone into a system blood stream is the condition of an epidermal barrier, ability to which diffusion in the conditions of inflammatory process against the background of skin diseases can increase, especially at excessive and/or prolonged use of this medicine and especially at children, and also when using of the closing bandages.

Absorption of betamethasone through a skin surface can also increase at application of drug by a subject intertrigo of sites of skin (axillary hollows, smelled) and face skin, and also in the presence of skin erosion. Possible effects of such phenomenon are described in the sections "Overdose" and "Features of Use".

Indications to use:

Medicine of "Ts-dermas" ointment is shown for reduction of inflammatory manifestations of a dermatosis sensitive to glucocorticosteroid therapy, such as:

- dermatitis (contact, exfoliative, seborrheal, solar, radiation, intertriginozny);
- neurodermatitis;
- eczema (atopic, monetoobrazny);
- psoriasis (except for widespread psoriasis);
- diskoidny lupus erythematosus;
- a generalized erythrosis (as a part of complex therapy).

Route of administration and doses:

Medicine of "Ts-dermas" ointment is applied a thin layer on affected areas of skin by 1-3 times a day, depending on weight of a state. In most cases for achievement of effect it is enough to put 1-2 times a day. Frequency of putting medicine is determined according to severity of a disease. At easy severity of a disease medicine can be applied once a day. In case of more severe defeats the frequency of drawing needs to be increased. Valerate betamethasone drug use in this dosage form (ointment) in the presence at patients of dry lishayny or scaly damages of skin is the most reasonable.

Not to apply under occlusive bandages as side effect of medicine can amplify.

After achievement of therapeutic effect it is necessary to reduce the frequency of use of medicine of "Ts-dermas" ointment or to pass to less active corticosteroid for topical administration and to continue a maintenance therapy with gradual drug withdrawal. If the state does not improve or worsens within 2-4 weeks of therapy, it is necessary to conduct repeated examination and to reconsider treatment. Continuous use of medicine should not exceed 4 weeks.

At children and at patients with damage of face skin the course of treatment should not exceed 5 days. Use of the closing bandages is not recommended.

Features of use:

Cautions. 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 drug has to be stopped until all signs of infectious process are liquidated.

At prolonged use of drug, especially at treatment of extensive body surfaces and when using of the closing bandages, at application on sites of skin with an intertrigo, erosion and on face skin the risk of emergence of side reactions of system character increases.

Medicine of "Ts-dermas" ointment is shown to use only in dermatological practice and not intended for use in ophthalmology.
Medicine of "Ts-dermas" ointment should not be applied on eyelids in connection with risk of development of glaucoma or subkapsulyarny cataract.

Medicine of "Ts-dermas" ointment should be applied with extra care at patients with psoriasis owing to probability of a palindromia, development of tolerance, risk of generalization of pustular psoriasis and development of local or system toxicity owing to disturbance of barrier function of skin. It is necessary to watch attentively the patient with psoriasis in case of use of topical corticosteroids.

Prolonged use of strong corticosteroids can lead to development of atrophic changes, especially on face skin and other sensitive sites of skin. This circumstance should be considered at treatment of such diseases as psoriasis, a system lupus erythematosus and heavy eczema.

As well as in a case with all strong drugs on the basis of glucocorticoids, it is necessary to avoid use of medicine of "Ts-dermas" ointment for a long time, on big sites of skin, and also on the person and skin folds. It is necessary to avoid hit of drug on wounds and mucous membranes.

Glucocorticoids can change outward of some skin defeats that complicates diagnosis.

Any by-effects which meet at system use of glucocorticoids including suppression of bark of adrenal glands, can arise also at their topical administration.

Use in pediatric practice. Clinical data on use of medicine for children are not enough. Use of medicine for children till 1 year is contraindicated. At children 1 years are more senior duration of use of medicine should not exceed 5 days, occlusive bandages should not be used.

Children can be more susceptible to local glucocorticosteroids, than adult patients, from the point of view of a possibility of oppression гипоталамо - pituitary and adrenal system. It can be caused by the increased valerate betamethasone absorption from the place of application at the expense of the bigger size of a ratio at children of surface area to body weight. At the same time at children Cushing's syndrome, a linear growth inhibition, lag in an increase of weight and/or increase in intracranial pressure can be noted.

Use during pregnancy and a lactation. Because safety of use of local glucocorticosteroids for pregnant women is still thoroughly not studied, purpose of drugs of this class during pregnancy can be justified only if the advantage for mother obviously exceeds possible harm for a fruit. Considering it, medicine of "Ts-dermas" ointment should not be applied at pregnant women in high doses and is long.

So far there are also no data and on a possibility of penetration of glucocorticosteroids after their topical administration in breast milk that gives the grounds to make the decision or on the termination of chest feeding or on drug withdrawal depending on degree of need for performing local hormonal therapy of the nursing mother.

Influence on ability of control of motor transport or work with moving mechanisms. Researches on impact assessment of use of medicine on ability to drive the car or to work with the equipment, it is not conducted. Taking into account a profile of side reactions of influence on speed of reaction at control of motor transport or work with other mechanisms it is not expected.

Side effects:

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

Face skin, the surface of skin with indumentum and skin of generative organs are especially sensitive to development of local side reactions.

After prolonged use for treatment of a dermatosis cancellation of strong topical corticosteroids to which medicine of "Ts-dermas" ointment belongs can aggravate signs and symptoms of a disease and to result in dependence on topical corticosteroids.

All undesirable phenomena which were registered at purpose of glucocorticoids of systemic action including oppression of function of gipotalamogipofizarny system, can develop at purpose of strong glucocorticoids for topical administration.

Interaction with other medicines:

Information on possible interactions is absent.

Contraindications:

Medicine of "Ts-dermas" ointment, as well as others betamethasone - the containing drugs intended for topical administration (ointments, creams, lotions) is contraindicated to patients with hypersensitivity to any of components of a dosage form. Besides, it is not recommended to appoint drugs of this kind at: skin displays of syphilis and tuberculosis; bacterial, viral and fungus diseases of skin (a pyoderma, the herpes simplex surrounding herpes, chicken pox, vulgar warts (condylomas), a contagious mollusk, parasitic infections (for example, a mange); skin cankers, skin wounds; skin tumors (carcinoma cutaneum, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma); existence of acne rash (pink, ordinary), postvaccinal skin reactions; ichthyosis, bottom dermatosis of minors; anogenitalny itch; a hyperpermeability of walls of skin blood vessels, a skin atrophy, existence of side reactions after use of corticosteroids.

Overdose:

Excessive or prolonged use of local glucocorticosteroids can cause function oppression гипоталамо - 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 (emergence of hypostases, puffiness of the person, increase in arterial pressure).

At emergence of such phenomena the symptomatic treatment is shown. Acute symptoms of a hypercorticoidism are usually reversible. If necessary correction of electrolytic balance is carried out. In case of chronic toxic action gradual cancellation of glucocorticosteroid drug is recommended.

Storage conditions:

To store at a temperature not over 25 ºС. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

On 30,0 g and 50,0 g in the tubas placed together with a leaf insert for the consumer in packs from a cardboard.