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Pharmacological properties

the drug is a combination of corticosteroids betamethasone and salicylic acid.

Betamethasone is a synthetic fluorinated adrenocorticosteroid for topical use in dermatology, which has a strong anti-inflammatory, immunosuppressive and antiproliferative effect. This is a synthetic analogue of prednisolone, shows a high degree of corticosteroids activity with a slight mineralocorticoid effect.

Corticosteroids reduce the formation, release, and activity of chemical inflammatory mediators (kinins, histamine, lysosomal enzymes, prostaglandin). Since the presence of leukocytes and macrophages is necessary for the onset of the inflammatory process caused by the aforementioned mediators, corticosteroids inhibit cell migration to the damaged area and reduce vasodilation and increased permeability of blood vessels in a certain place. This vasoconstrictor effect reduces extravasation and the occurrence of edema.

Corticosteroids exhibit an immunosuppressive effect on hypersensitivity reactions of the 3rd and 4th types, inhibiting the toxic effect of the antigen-antibody complex, which settles on the walls of blood vessels and causes skin allergic vasculitis, and also inhibits the action of lymphokines, target cells and macrophages, leading to reactions in the form of allergic contact dermatitis. Corticosteroids also impede the access of sensitized T-lymphocytes and macrophages to target cells.

Salicylic acid with its keratolytic effect facilitates the penetration of corticosteroids into the skin.

Pharmacokinetics The absorption of betamethasone is influenced by many factors, including the presence of inflammation and the state of the epidermis. When applied topically, corticosteroids can be absorbed to a lesser extent by normal intact skin, and the presence of inflammatory processes in the skin can enhance absorption. Systemic absorption after topical application is 12-14%. The volume of distribution is 1.4 l / kg. About 64% of betamethasone reversibly binds to plasma proteins. Betamethasone is metabolized in the liver, metabolites are excreted primarily with bile, some with urine (only about 5%).

When applied to the skin under an occlusive dressing, salicylic acid reaches its highest concentration in plasma after 5 hours. About 6% of the total absorbed amount of salicylic acid is excreted unchanged in urine, while most of it is excreted as a metabolite.

Indications

To reduce the severity of inflammatory manifestations of psoriasis, seborrheic dermatitis of the scalp, psoriatic lesions of a different location, as well as other dermatoses that are sensitive to corticosteroid therapy.

Application

Belosalic lotion is used only externally.

A few drops are applied to the affected areas, rubbed into the skin or scalp with gentle movements. Usually applied 2 times a day - in the morning and in the evening. In some patients, a satisfactory effect may be achieved even with less frequent use of the drug.

The duration of treatment is usually limited to 3 weeks. The frequency and duration of use, other than recommended, can be determined by the doctor, taking into account the severity of the disease.

The drug can not be used on the face and near the eyes.

Contraindications

Hypersensitivity to betamethasone, salicylic acid or any excipient of the drug; lupus; skin reactions after vaccination; perioral dermatitis; rosacea; children under 2 years old.

Side effects

Topical application of betamethasone can lead to a decrease in the collagen content in the subcutaneous tissue and, as a result, cause atrophic changes in the skin, irreversible stretch marks, ecchymosis, telangiectasia, folliculitis, hypertrichosis and allergic contact dermatitis.

Very long-term therapy can lead to rash, itching, local hyperpigmentation, as well as depigmentation of the skin, depigmentation of hair and inhibition of sweat gland function.

Secondary skin infections can occur as a result of a depressed immune system.

Topical use of salicylic acid can cause dermatitis.

Systemic side effects of the use of betamethasone, which is a consequence of absorption into the bloodstream, occur quite rarely, mainly with an overdose, usually disappear immediately after treatment is stopped.

special instructions

If, during the first use of the drug, a reaction of increased sensitivity of the skin occurs (itching, redness), the use of the drug should be stopped immediately.

The use of the drug Belosalic Lotion under occlusive dressings is not recommended, except when necessary. The use of diapers (especially plasticized ones) in children enhances absorption, as diapers act as occlusive dressings.

Long-term topical use of the drug on the face is not recommended due to the possible appearance of dermatitis, such as rosacea, perioral dermatitis and acne.

Belosalic lotion can not be used to treat eyes and skin around the eyes due to the possibility of cataracts, glaucoma, fungal diseases of the eyes, as well as exacerbation of herpes.

Belosalic Lotion is not used to treat varicose veins.

For patients with liver failure, as well as patients who require long-term local therapy with Belosalic Lotion, especially if occlusive dressings are necessary, careful monitoring is necessary due to the possible manifestation of increased absorption of betamethasone, as well as systemic manifestations (see OVERDOSAGE). Periodic monitoring of the function of the hypothalamus-pituitary-adrenal gland system should be carried out (test of free cortisol in urine and blood plasma, ACTH stimulation test). If inhibition is established, it is necessary to stop the use of the drug, reduce the frequency of use or replace it with a less powerful corticosteroid.

Some places on the body where there is some kind of natural occlusion (groin, armpits, perianal area) are more likely to have stretch marks with local treatment with Belosalic Lotion, so its use in these areas should be as limited as possible.

In cases of fungal or bacterial infection of the skin, additional topical use of antibiotics or antifungal agents is also necessary.

Use during pregnancy and lactation

Period of pregnancy. Corresponding well-controlled studies on the teratogenic effect of topically applied corticosteroids in pregnant women have not been carried out. Therefore, the local use of the drug in pregnant women is allowed only in cases where, according to the doctor, the expected benefit to the mother outweighs the possible risk to the fetus. In such cases, the application should be short-term and limited to a small surface of the body.

The period of breastfeeding. It is not known whether topically applied corticosteroids, including betamethasone, can be absorbed sufficiently to affect the appearance of a sufficient amount of this drug in human milk. There is evidence that systemically used corticosteroids are excreted in breast milk in an amount that does not have a harmful effect on the baby. Salicylic acid may be systemically absorbed, but no evidence of adverse effects in infants has been obtained.

By decision of the doctor, Belosalic Lotion can be used by mothers who are breastfeeding, but the drug can not be applied to the area of ​​the mammary glands.

Children. Use in children over the age of 2 years is possible only after consultation with a doctor and under his supervision. It should be taken into account the large absorption of the drug in children due to the greater value of the ratio of the surface area of ​​the skin to the body weight of the child, which can be manifested by an increase in systemic toxicity and inhibition of the hypothalamic-pituitary-adrenal system.

The duration of treatment in children should be reduced to the minimum possible time.Do not use under diapers.

The ability to influence the reaction rate when driving a vehicle or working with machinery. Does not affect.

Interactions

There are no clinically significant interactions with other drugs.

The simultaneous use of cosmetic or dermatological agents for the treatment of acne, as well as those containing ethanol, medical soaps with a strong drying effect and others, may in some cases additionally irritate the skin.

Overdose

In the case of applying betamethasone to large damaged areas of the skin for a long time (more than 3 weeks) and with the use of an occlusive dressing, as well as with prolonged use in children or patients with renal failure, increased absorption and the manifestation of a systemic effect are possible. symptoms: suppression of the function of the hypothalamic-pituitary-adrenal system with growth retardation, intracranial hypertension (occurring only in children), hyperglycemia, glucosuria and cushing syndrome.

Suppression of the function of the hypothalamic-pituitary-adrenal system in children includes growth retardation, weight gain, decreased cortisol in blood plasma and urine, as well as a lack of response to ACTH stimulation. Intracranial hypertension manifests itself in a protrusion of the fontanel and headache.

Symptoms of an overdose of salicylates: pallor, fatigue, drowsiness, nausea, vomiting, hearing impairment.

Treatment: appropriate symptomatic treatment. The acute symptoms of hypercorticism are usually reversible. If necessary, correction of electrolyte imbalance is indicated. In the case of chronic toxic effects, gradual withdrawal of corticosteroids is recommended.

The treatment of salicylism is symptomatic. Take measures to more quickly remove salicylates from the body. Sodium bicarbonate is orally used to alkalize urine and enhance urine output.

Storage conditions

At a temperature not exceeding 25 ° C.

Tags: Betamethasone, Salicylic Acid