Betasalin

General characteristics. Structure:

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

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 – 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:

Betasalin is appointed for external use at treatment of the inflammatory conditions of skin first of all having the allergic nature which react to corticosteroids, with symptoms of a severe itch or the hyperkeratosis which do not have a complication in the form of consecutive bacterial infections.

Medicine is appointed at:
- seborrheal dermatitis of a pilar part of the head;
- psoriasis of a pilar part of the head;
- psoriasis defeats of other localization;
- a dermatosis at which corticosteroid therapy is shown.

Route of administration and doses:

Outside (topical administration). The doctor has to appoint the frequency and a route of administration.

To adults and children is more senior than 2 years to apply several drops of solution on affected areas, quiet movements to rub in skin or a pilar part of the head. Usually put two times a day – in the morning and in the evening. At some patients of satisfactory effect it is possible to reach at less frequent use of medicine.

It is not necessary to continue use of medicine more than 2 weeks. On face skin it is longer impossible to apply medicine than 1 week. In a week it is impossible to use more than 20 ml of medicine.

At children do not accept this medicine aged up to 2 years. For children medicine is more senior than 2 years take with caution, only once a day on small sites of skin – 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, according to salicylic acid, and, therefore, and manifestation of system toxicity. Do not apply on face skin at children. Use under the diapers which are (especially plasticized) strengthens absorption since diapers work as an occlusive bandage.

Features of use:

If against the background of Betasalin's use the irritation of skin or hypersensitivity to drug appeared, treatment should be stopped. In case of accession of an infection it is necessary to appoint the corresponding therapy.

System absorption of GKS and salicylic acid at their topical administration by that will be higher, than the big body surface is exposed to treatment. It is necessary to take the appropriate measures of precaution if long use of drug, especially at children is supposed.

Putting salicylic acid on an open wound or the injured skin is not allowed.

At Betasalin's use it is impossible to use the closing bandages.

At emergence of dryness or irritation of skin, treatment by drug should be stopped.

At prolonged treatment by drug its cancellation is recommended to be carried out gradually.

Betasalin, solution is not intended for use in ophthalmology. It is necessary to avoid hit in eyes and on mucous membranes.

Prolonged use on face skin is not recommended.

It is necessary to avoid use in anogenitalny area.

Use in pediatrics. Children are more subject to risk of oppression of function гипоталамо - pituitary and adrenal system owing to use of local GKS, than adults, because of a bigger ratio of body surface area at them both weight and, respectively, the increased drug absorption.

Function suppression гипоталамо - pituitary and adrenal system at children is defined by the low level of cortisol in plasma and lack of the response to stimulation of adrenocorticotropic hormone. Increase in intracranial pressure is shown by protrusion of a fontanel, headaches, a bilateral papilledema.

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:

During treatment it is contraindicated to carry out by medicine vaccination and immunization in connection with immunodepressive effect of medicine. It is not necessary to appoint in a combination with other medicines for external use.

At system absorption of GKS medicine reduces effect of insulin, peroral hypoglycemic means, hypotensive medicines, anticoagulants, reduces concentration of a prazikvantel in blood serum.

Increases risk of development of side effects of a combination of a betasalin with the following medicines: androgens, are oestrogenic, oral contraceptives, anabolic steroids (a hirsutism, acne rash), antipsychotic means, букарбан, Azathioprinum (cataract), holinoblokator, antihistaminic drugs, tricyclic antidepressants, nitrates (glaucoma), diuretics (hypopotassemia), cardiac glycosides (digitalis intoxication).

Contraindications:

- hypersensitivity to any of medicine components;
- children's age up to 2 years;
- pregnancy;
- lactation period;
- pink eels;
- perioral dermatitis;
- bacterial, viral or fungal infection of skin (pyoderma, syphilis, tuberculosis cutis, Negres of simplex, chicken pox, Herpes zoster, actinomycosis, zymonematosis, sporotrichosis);
- trophic ulcers against the background of chronic venous insufficiency;
- skin tumors (carcinoma cutaneum, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma);
- postvaccinal skin reactions;
- diaper dermatitis;
- an itch in a vulva;
- on extensive sites of skin, especially with damage of integuments, for example at burns.

With care: children's age up to 12 years; liver failure; long therapy.

Use during pregnancy and during breastfeeding. Safety of use of local GKS for pregnant women is not established. As so far it is not found out whether local GKS get into mother's milk, it is necessary to resolve an issue of the termination of breastfeeding or use of drug.

Overdose:

Symptoms: when putting 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:

In the place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

On 25 ml and 30 ml in the bottles placed together with a leaf insert in a pack from a cardboard.