Betasalin

General characteristics. Structure:

Active ingredient: 0,5 mg of betamethasone (in the form of Dipropionas betamethasone) and 20 mg of salicylic acid in 1 ml of solution.

Excipients: isopropyl alcohol, dinatrium эдетат, a gipromelloza, sodium hydroxide, the water purified.

The combined medicine with antiinflammatory and keratolytic action for external use.

Pharmacological properties:

Pharmacodynamics. Betamethasone – the synthetic fluorinated glucocorticoid (GKS) – renders the expressed antiinflammatory, immunodepressive and anti-proliferative effect at insignificant mineralokortikoidny effect. Reduces education, release and activity of mediators of an inflammation (kinin, a histamine, prostaglandins, etc.), inhibits migration of leukocytes and macrophages to the place of defeat, reduces a vazodilatation and a hyperpermeability of blood vessels of this area. 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 development of an allergic vasculitis. Inhibits also effect of lymphokines and macrophages who cause development of reactions as allergic contact dermatitis. Besides, prevents access of sensibilized T lymphocytes and macrophages to cells - "targets".
Salicylic acid has keratolytic effect, facilitates penetration of betamethasone into skin, renders also skvamolitichesky, antimicrobic and antifungal action, and also recovers normal value рН skin.

Pharmacokinetics. Betamethasone. Absorption and distribution. When drawing on the healthy, unimpaired skin betamethasone is soaked up in insignificant degree. Injuries of skin, existence of inflammatory process and use with an occlusive bandage can increase absorption. System absorption after external use makes 12-14%. Linkng with proteins of plasma makes about 64%. Vd – 84 l.

Metabolism and removal. Betamethasone biotransformirutsya in a liver. Metabolites are brought out of an organism preferential with urine and in insignificant quantity – with bile.

Salicylic acid. Absorption. At external use with an occlusive bandage of Cmax of salicylic acid in plasma it is reached approximately in 5 h.

Metabolism and removal. The most part of salicylic acid is removed with urine in the form of metabolites: salitsilmochevy acid (52%) and salicylate glucuronides (42%), in not changed look – about 6%.

Indications to use:

The subacute and chronic giperkeratichesky dermatosis reacting to treatment by corticosteroids:
- psoriasis;
- acute and chronic eczema;
- neurodermatitis;
- flat deprive;
- dyshydrosis;
- seborrheal dermatitis;
- monetopodobny eczematic dermatitis;
- ichthyosis.

Route of administration and doses:

Medicine is sprayed on affected areas, pressing a nozzle sprayer, in the quantity sufficient for their careful moistening, 1-2 times a day. In certain cases it is enough to apply medicine of 1 times a day.

Duration of treatment has to make no more than 3 weeks. In need of longer therapy it is possible to use less often (every other day).

For prevention of a recurrence at treatment of chronic diseases it is necessary to continue medicine use still some time after disappearance of all symptoms.

To children medicine is appointed carefully, to less long term because at the bigger area of integuments in relation to body weight in comparison with adults and insufficiently developed epidermis at children perhaps absorption is proportional bigger amount of betamethasone, and, respectively, salicylic acid and consequently, and manifestations of system toxicity. Use under the diapers which are (especially plasticized) strengthens absorption since diapers work as an occlusive bandage.

If time of use of medicine is passed, it should be applied as soon as possible. If time of use of the following dose comes, the passed dose should not be applied, at the following use there is no need to increase amount of medicine.

Features of use:

In cases if at the first use of medicine hypersensitivity reactions develop (an itch, burning and reddening), use of spray should be stopped.

It is not necessary to apply medicine on skin a century and periorbital area and to allow its hits in eyes.

Prolonged use on face skin because of possible development of a rozatse, perioral dermatitis, an acne and an atrophy of face skin is not recommended.

It is necessary to avoid use of medicine in anogenitalny area.
At use of medicine for patients with an abnormal liver function and at long therapy, especially with use of occlusive bandages, it is necessary to consider possible strengthening of absorption of active agents and manifestation of system effects of betamethasone and salicylic acid.

Side effects:

Local reactions: burning, itch, folliculitis, acne, hypopigmentation, atrophy and thinning of skin, striya and hypertrichosis.

The system reactions caused by effect of betamethasone: a growth inhibition, reversible suppression гипоталамо - pituitary and adrenal system, Cushing's syndrome, increase in intracranial pressure, a hyperglycemia and a glycosuria.

The system reactions caused by effect of salicylic acid: pallor of integuments, increased fatigue, drowsiness, hyperventilation, nausea, vomiting, hearing disorder, confusion of consciousness.

System side reactions can arise at prolonged use, at use on big surfaces of integuments or when using occlusive bandages.

Interaction with other medicines:

Use at the same time with spray of cosmetic or dermatological medicines for therapy of an acne, etanolsoderzhashchy medicines for external use, medical soap with the expressed drying action can cause irritation of skin.

Contraindications:

- tuberculosis cutis;

- viral infections of skin; skin reactions after vaccination;

- perioral dermatitis;

- rozatsea;

- hypersensitivity to medicine components.

Use of medicine is contraindicated during pregnancy and a lactation.

Overdose:

Symptoms: when spraying medicine on big sites of the affected skin during the long period (more than 3 weeks), especially when using occlusive bandages, or at prolonged use at children, strengthening of absorption of active ingredients in a system blood stream and strengthening of the system by-effects connected with effect of betamethasone and salicylic acid is possible.

Treatment: medicine cancellation. If necessary carry out symptomatic therapy. At sharp phase-out of medicine and emergence of symptoms of cancellation of GKS (fever, a mialgiya, an arthralgia, weakness) it is necessary to conduct a course of replacement therapy of GKS for system use.

Storage conditions:

List B. To store in the place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children. The term of a hnaneniye is 2 years.

Issue conditions:

According to the recipe

Packaging:

On 10 ml and 25 ml in the bottles corked by the nozzle spraying, placed together with a leaf insert for the consumer in packs from a cardboard.