Soderm

General characteristics. Structure:

Active ingredient: 1,22 mg of betamethasone of valerate (in terms of betamethasone of 1,0 mg) in 1 g of solution.

Vvspomogatelny substances: isopropyl alcohol, polysorbate 80, dinatrium эдетат, Acidum hydrochloricum, water очищення.

Pharmacological properties:

Betamethasone, active cleavage product of betamethasone of valerate, represents a synthetic glucocorticoid which efficiency by 30 times exceeds efficiency of cortisol. This substance practically does not possess the action characteristic of mineralokortikoid. From all kortikoid in terms of weight betamethasone shows the highest degree of efficiency.

At the intracellular level betamethasone forms bonds with cytoplasmatic receptor protein. This receptor complex of kortikoid gets into a cell kernel where it purposefully provokes synthesis of MRNK and, thus, indirectly promotes protein synthesis of a certain type (for example, catabolic fermental protein, suppressor protein). Antiinflammatory action which is shown in normalization of a tone of vessels, dissolution of inflammatory infiltrates, splitting of pathological products of accumulation in an organism, and also splitting of autogenic products of metabolism is result of this process. Besides, process of neovascularization and proliferation of cells is at a loss. Also formation of fibroblastomas stops and the acantolysis is slowed down. Along with it stabilization of membranes of lysosomes provides antiinflammatory effect of betamethasone. Thanks to external use of betamethasone such subjective manifestations as an itch and feeling of pain are also suppressed.

Pharmacokinetics. At external use of drug valerate betamethasone absorption is possible, but this process depends more on a condition of skin and a way of imposing of a bandage, than on the applied substance and a medicinal basis. According to the arriving data of clinical trials, it can extend to cases at which usually at the local or limited in time use of medicines for external use there is no absorption systemically of significant amounts of substance.

System time of semi-exchange of plasma makes 5 hours 30 minutes, formation of bonds of proteins of plasma – 64%, and the volume of distribution makes 1,4 l/kg. Betamethasone breaks a blood-brain barrier, gets into plasma and, presumably, into maternal milk. Metabolism of betamethasone happens generally in a liver. At limited in time and topical administration of the drug containing betamethasone there is no absorption systemically of significant amounts of active ingredient.

Indications to use:

Treatment of inflammatory, allergic or pruritic diseases of integuments of the head at which symptomatic use of strong kortikoid is appointed (eczema, psoriasis, dermatitis).

Route of administration and doses:

Soderm it is always necessary to apply strictly as directed the doctor. If there are no other appointments of the doctor, then the usual dose makes: in an initiation of treatment the processed sites moisten with drug in the morning and in the evening.

As soon as action begins to be shown, the number of daily drawings can be reduced to once (in the morning or in the evening), and later – to 3-4 weekly.

Soderm is issued in tanks with a nozzle doser. Thus, on a pilar part of the head solution can be applied through hair directly on the processed sites, without moistening hair completely.

Use duration. The course of treatment is defined by the attending physician. At emergence of feeling of redundancy/insufficiency of effect of drug it is necessary to consult with the doctor. If use Soderm was missed.

If use of drug was missed, then at the following drawing Soderm it is not necessary to double a drug dosage. At drug use interruption. The aggravation of symptoms is possible.

At emergence of further questions concerning use of drug it is necessary to see a doctor.

Features of use:

Use during pregnancy and feeding by a breast. At pregnancy to carry out prolonged topical treatment by drug only according to the recommendation of the doctor. Till today experience of use of glucocorticoids for the person did not reveal suspicion concerning the increased risk of abnormal development.

During pregnancy use of kortikoid of local action on extensive sites or because of possible systemic action of drug since it can lead to disturbances of system of regulation of a hypothalamus, front share of a hypophysis and adrenal glands that can lead to disturbance of development and growth of a fruit essentially is not allowed for a long time. At use of drug at the end of pregnancy at newborns the atrophy of adrenal glands can develop. Betamethasone gets into maternal milk. Still any disturbances at newborns were not revealed. Despite it, indications to use of drug during breastfeeding have to be strictly defined. If owing to a disease use of drug in higher dosage or on extensive sites of skin (more than 20%) is necessary, then breastfeeding should be stopped. During breastfeeding not to apply Soderm on area of a thorax and area of mammary glands.

Ability to influence speed of response at control of motor transport or work with other mechanisms. No effects concerning ability to driving of vehicles or service of cars are expected.

Children. Experience on drug uses by children is limited therefore it is necessary to avoid prolonged use of drug at children since in this case even without air-tight bandages such therapy can lead to the increased assimilation of kortikoid through skin. Not to use drug at children aged till 1 year. Appropriate security measures at use.

Not to apply solution on the erosive, becoming wet sites or on cracks of skin (graze) and an ulceration (gnoynikovy educations).

It is necessary to avoid prolonged use of drug (more than 3-4 weeks), and also high dosages (drawing on extensive sites) and it is necessary to apply the uses of occlusive bandages (shrouding bandages without pressing)!

In such cases it is not possible to exclude penetration of a betametazonvalerat into an organism through skin (a transdermal resorption) and disturbance of hormonal balance.

Soderm it is necessary to apply with care. Face skin in particular is sensitive. Therefore for prevention of development of changes in face skin whenever possible it is necessary to avoid long therapy by drug.

At use of drug in eyes not to allow Soderm's hit on a mucous membrane of eyes. Generally, it is necessary to avoid putting drug on an eyelid since it can cause glaucoma.

Side effects:

As well as all medicines, Soderm can cause side effects, but it is not obligatory at each patient. At manifestation of one of the listed below side effects it is necessary to stop use of drug and to see immediately the attending physician.

Immune system: hypersensitivity reaction. Endocrine system: suppression гипоталамо - pituitary and adrenal system with development of secondary insufficiency of adrenal glands, hypercorticoidism symptomatology, Itsenka-Cushing's syndrome. System of skin and appendages: irritation, burning, свербеж, xeroderma, local atrofichny changes, i.e. thinning of skin, emergence стриив and cracks, folliculitis, hypertrichosis, acne rash, hypopigmentation, perioral dermatitis, allergic contact dermatitis. When using drug for treatment of children, and also at prolonged use on big sites of skin, possible development of the system side reactions characteristic of glucocorticosteroids. Side reactions can be shown more often when using an occlusive bandage.

If any of the listed side effects does considerable harm to your health or if you notice any other side effect which is not mentioned in this instruction, then it is necessary to notify your attending physician on it.

Interaction with other medicines:

It is not revealed.

Contraindications:

Use of drugs – as well as other kortikoid of local action – is contraindicated at:

- specific skin processes (tuberculosis cutis, skin displays of syphilis);
- rozatsea;
- acne rash;
- chicken pox;
- reaction to inoculations;
- Pruritus anogenitalis;
- perioral dermatitis;
- the infectious diseases of skin caused by action of viruses, bacteria or fungi;
- hypersensitivity to betamethasone to valerate or to any of drug components.

Overdose:

Manifestation of acute symptoms of overdose is improbable. At chronic overdose or abuse of drug can be shown a clinical picture of a hypercorticoidism. In this case, treatment by drug should be stopped and, if necessary, to appoint symptomatic therapy.

Storage conditions:

Period of validity 3 years. After opening of a bottle - 3 months. To store drug at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

Bottles on 15 ml, 30 ml, 50 ml and 100 ml.