Ts-dermas And

General characteristics. Structure:

Active ingredient: 0,5 mg of betamethasone (in the form of Dipropionas betamethasone), 1050 ME gentamycin (in a look Gentamycini sulfas).

Excipients: paraffin liquid, lanolin alcohol, cetostearyl alcohol, paraffin soft, white.

The combined medicine for external use rendering antiinflammatory, antipruritic, antiallergic and antimicrobic action.

Pharmacological properties:

The combined medicine for external use, the betamethasone and an antibiotic of a broad spectrum of activity containing a glucocorticosteroid from group of aminoglycosides – gentamycin. Renders antiinflammatory, antipruritic, antiallergic and antimicrobic action.

Betamethasone Dipropionas is the synthetic fluorinated glucocorticoid, renders the expressed antiinflammatory, antipruritic, antiallergic and anti-proliferative action at insignificant mineralokortikoidny effect. Reduces education, release and activity of chemical mediators of an inflammation (a kinin, a histamine, liposomal enzymes, prostaglandins), inhibits migration of macrophages and leukocytes to the place of defeat, reduces a vazodilatation and a hyperpermeability of blood vessels that reduces an ekstravazation of blood serum and formation of hypostases. Inhibits III and the IV type of reactions of hypersensitivity, blocking at the same time toxic effect of the antigen antibody complexes which concentrate at walls of blood vessels, causing an allergic vasculitis. Inhibits effect of lymphokines, target cells and macrophages. Prevents access of sensibilized T lymphocytes and macrophages to cells - "targets".

Gentamycini sulfas – an antibiotic from group of aminoglycosides with the expressed bactericidal action. It is active concerning gram-negative microorganisms: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumoniae; gram-positive microorganisms: Streptococcus spp. (sensitive strains of an alpha and beta and hemolitic streptococcus of group A), Staphylococcus aureus (a coagualase - positive, a coagualase - the negative and some strains producing a penicillinase).

Pharmacokinetics. Betamethasone Dipropionas easily gets into skin through a corneous layer. Is not exposed to biotransformation in skin and gets through it into an organism. It Biotransformirutsya mainly in a liver. In the form of connections with glucuronic acid and in a small amount in an invariable look, mainly, it is removed with urine and in smaller quantity – with bile. Dipropionas betamethasone absorption through skin increases at use on gentle skin in the field of folds, at use on skin with the injured epidermis or the skin injured by inflammatory process. Besides, absorption increases at frequent use of medicine or after use on the considerable surface of skin. Dipropionas betamethasone absorption through skin at persons of younger age is expressed stronger, than at adults.

Gentamycini sulfas after topical administration on the unimpaired skin is not absorbed, and after use on the skin injured by pathological process can be soaked up in a blood channel. Gentamycini sulfas does not biotransformirutsya in an organism and is removed with urine in an invariable look.

Indications to use:

The inflammatory and allergic dermatosis complicated by secondary infection or at suspicion on secondary infection: psoriasis, contact dermatitis, atopic dermatitis, allergic contact dermatitis, eczemas, neurodermatitis, intertriginozny dermatitis, seborrheal dermatitis, solar dermatitis, erythrosis, radiation dermatitis, simple chronic herpes, skin form of a lupus erythematosus, polymorphic erythema.

Considering existence in its structure of a strong glucocorticosteroid, ointment needs to be applied in an initiation of treatment, within a short period of time, on the insignificant surface of skin.

Route of administration and doses:

Locally apply a small amount of ointment of Ts-dermas And on the struck surface of skin, 1-2 times a day. It is not necessary to apply ointment under an occlusive bandage.

If use of a bandage is extremely necessary, it is necessary to apply a bandage which passes air and not to use the squeezing, oil-cloth bandage. It is not necessary to spend treatment more than 2 weeks, without interruption. Not to apply more than 45 g of ointment within one week.

Not to apply at children 12 years are younger.

Features of use:

It is necessary to avoid hit of medicine in eyes.

Use of medicine under occlusive bandages is not recommended.

If at the first use of drug skin reactions of hypersensitivity (an itch, burning and reddening) develop, drug needs to be cancelled immediately.

Patients with abnormal liver functions and patients who need prolonged treatment need careful medical observation as at them perhaps strengthened absorption of betamethasone and development of system side reactions.

Some body parts, such as inguinal area, axillary hollows, and perianal area where there is a peculiar natural occlusion, are more subject to emergence of striya at external use of cream therefore use of medicine on these sites of integuments it has to be most limited.

It is necessary to avoid prolonged use as at the same time the frequency of emergence of side effects increases and resistance of bacteria to Gentamycini sulfas can develop. In case of activation of an infection on site of ointment use, it is necessary to apply additional antimicrobic or antifungal treatment.

If symptoms of an infection do not pass, it is necessary to stop use of ointment for full treatment of an infection.

It is not necessary to apply medicine on face skin in connection with a possibility of emergence of teleangiectasias, dermatitis perioralis even after short use. On skin in axillary and inguinal area to apply ointment only in emergency cases, considering the increased absorption.

It is not necessary to apply ointment under an occlusive bandage as it can lead to an epidermis atrophy, emergence of striya, development of superinfection.
With care to apply at already existing atrophy of hypodermic cellulose, especially at elderly people.

It is necessary to avoid contact of medicine with a mucous membrane of eyes and skin a century because of risk of development of glaucoma and a cataract.

Considering that corticosteroids and gentamycin are soaked up through skin, during use of Ts-dermas And, ointment exists risk of emergence of system side effects of corticosteroids (suppression of function of adrenal glands) and gentamycin (from - and nephrotoxicity, especially at people with a renal failure). Therefore it is necessary to avoid use of drug in high doses, on big sites of skin, on the injured skin at patients with an abnormal liver function, kidneys and at children. It is necessary to apply with extra care at patients with psoriasis as local drawing glucocorticosteroids at psoriasis can be dangerous, owing to a palindromia at the development of tolerance, risk of generalization of pustular psoriasis and the systemic toxic effect connected with disturbance of integrity of integuments.

Any side effects of system glucocorticosteroids, including oppression of function of bark of adrenal glands, can be noted also when using local glucocorticosteroids, especially at children. System absorption of local glucocorticosteroids can increase at prolonged use, treatment of extensive body surfaces and use of occlusive bandages. In such cases, especially at children, it is necessary to observe the appropriate measures of precaution including the possibility of drug withdrawal determined by the doctor depending on disease severity. System absorption of gentamycin at topical administration can increase in case of drawing on extensive sites of skin, especially at prolonged treatment or in the presence of skin cracks. In such cases development of the undesirable phenomena characteristic of gentamycin at its system use (see the section "Side effect") is possible therefore careful use, especially at children, the providing determination of the frequency of use by the doctor and durations of therapy is recommended. Cross allergic reactions to antibiotics from group of aminoglycosides were observed.

At prolonged topical administration of gentamycin growth of insensitive microflora, including fungal can be observed occasionally. In this case, as well as at development of irritation of hypersensitivity reaction and superinfection, treatment it is necessary to stop and appoint the corresponding therapy.

Ointment is shown only for external use and not intended for use in ophthalmology.

Use at pregnancy and a lactation. Safety of use at pregnancy: category C. In the researches conducted on animals it is established that glucocorticosteroids show teratogenic action even at use of small doses inside. Teratogenic action is also confirmed at animals after use on skin of strong glucocorticosteroids. Controlled researches regarding possible teratogenic effect of betamethasone of Dipropionas at pregnant women after topical administration on skin are not conducted. Betamethasone Dipropionas is a strong glucocorticosteroid, and it is not recommended to apply ointment of Ts-dermas And at pregnant women.

It is unknown in what degree of betamethasone Dipropionas is allocated with breast milk after topical administration. Betamethasone Dipropionas is a strong glucocorticosteroid, and it is not recommended to apply ointment of Ts-dermas at women during feeding by a breast.

Influence on ability to control of vehicles and to service of moving mechanisms. Medicine does not limit psychophysical activity, ability to control of vehicles and service of moving mechanisms.

Side effects:

Diseases of skin and hypodermic fabric. Acne rash, purpura steroid, oppression of growth of epidermis, atrophy of hypodermic fabric, xeroderma, depigmentation or hyperpegmentation of skin, atrophy and extension of skin, inflammation of hair bulbs, overgrowth of hair on skin, allergic contact inflammation of skin. There can sometimes be urticaria or rash. After use on face skin can cause an inflammation around lips.

Endocrine frustration. At prolonged use of drug (more than 2 weeks), when drawing on big sites of skin or on the injured skin, in case of use of the closed compresses, and also in case of use for children, as a result of the strengthened absorption by circulatory system of betamethasone of Dipropionas there can be general undesirable symptoms caused by action of corticosteroids. To the general undesirable symptoms characteristic of corticosteroids, belongs, including work braking гипоталамо - pituitary and adrenal system, Cushing's syndrome, growth inhibition of development in children, a hyperglycemia, sugar in urine, hypostases, a hypertension, decrease in immunity.

Disorders of immunity. There can be hypersensitivity signs. At emergence of symptoms of hypersensitivity it is necessary to stop treatment immediately.

Diseases of eyes. After topical administration on skin the century can sometimes come strengthening of symptoms of glaucoma or acceleration of development of a cataract.

Diseases of vessels. There can occur expansion of superficial blood vessels.

Ear diseases. Because drug contains gentamycin, ototoxicity symptoms, especially can be observed if drug is applied on the big site of skin or on the injured skin.

Diseases of kidneys and uric ways. Because drug contains gentamycin, there is a risk of damage of kidneys, especially in case of a concomitant use of nefrotoksichny drugs, and also at a disease of kidneys.

Drug contains cetostearyl alcohol which can cause local skin reaction (for example, contact dermatitis).

At children, besides, the following side effects caused by betamethasone use can be noted: function suppression гипоталамо – gipofizarno - adrenal system, an Icenco-Cushing syndrome, a growth inhibition, lag in a body weight increase, increase in intracranial pressure. Symptoms of oppression of function of bark of adrenal glands at children include decrease in concentration of cortisol in plasma and lack of the response to stimulation of adrenocorticotropic hormone (AKTG). Increase in intracranial pressure is shown by protrusion of a fontanel, a headache, a bilateral papilledema.

Interaction with other medicines:

During treatment by glucocorticosteroids it is not necessary to do smallpox inoculations. It is not necessary to carry out also other types of immunization, especially at long use on considerable sites of skin, in connection with danger of emergence of immunological deficit in the form of detection of antibodies. Medicine can strengthen effect of immunosuppressive drugs and weaken effect of the immunostimulating drugs.

Contraindications:

Hypersensitivity to corticosteroids, gentamycin or making ointment bases. Viral, fungus or tubercular diseases of skin, skin new growth, pink and youthful eels, chicken pox, phlebitis and trophic ulcers. Not to apply on the sites of extensive damage of skin which are especially proceeding with disturbance of integrity of skin, for example, at burns. Not to apply long time in connection with the developing resistance of bacteria. Not to apply on face skin. Not to apply at children up to 12 years. Not to apply medicine in proctal and genital areas, and at a skin inflammation around a mouth.

Overdose:

At single use of 7 g of ointment there can come reversible allocation by a hypophysis of adrenocorticotropic hormone (AKTG) as a result of oppression of nadpochechnikovogipofizarny system.

In case of long or inadequate use, symptoms of a disease of Cushing can appear. In that case it is necessary to cancel use of Ts-dermas And ointments. From - for risk of acute adrenal insufficiency it is necessary to carry out it under observation of the doctor.

There is a possibility of system side effects of gentamycin, such as hearing loss and risk of damage of kidneys too.

Storage conditions:

At a temperature not above 25 °C. To store in the place, unavailable to children. Period of storage 2 years.

Issue conditions:

According to the recipe

Packaging:

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