Belosalik lotion skin solution 50ml (Salicylic acid) — Made in Croatia — Free Delivery

Pharmacological properties

Pharmacodynamics. The preparation is a combination of corticosteroids of 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, exhibits 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 leukocytes and macrophages are necessary for the onset of the inflammatory process caused by the aforementioned mediators, corticosteroids inhibit the migration of cells to the damaged site and reduce vasodilation and increased permeability of blood vessels in a particular site. This vasoconstrictor effect reduces extravasation and 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 deposits 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 prevent sensitized T-lymphocytes and macrophages from reaching target cells.

Salicylic acid, with its keratolytic action, facilitates the penetration of GCS into the skin.

Pharmacokinetics. The absorption of betamethasone is influenced by many factors, including the presence of inflammation and the condition of the epidermis. When applied topically, GCS can be absorbed to a lesser extent by normal intact skin, and the presence of inflammatory skin processes 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 blood plasma proteins. Betamethasone is metabolized in the liver, metabolites are excreted primarily in the bile, some part in the urine (only about 5%).

Salicylic acid, when applied to the skin under an occlusive dressing, reaches its highest concentration in the blood plasma after 5 hours. About 6% of the total absorbed amount of salicylic acid is excreted in the urine unchanged, 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 other localization, as well as other dermatoses sensitive to corticosteroid therapy.

Application

Belosalik lotion is used only externally.

A few drops are applied to the affected areas, rubbed into the skin or scalp with gentle movements. Usually it is applied 2 times a day - in the morning and in the evening. In some patients, it is possible to achieve a satisfactory effect even with a more rare use of the preparation.

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

The preparation should not be used on the face or near the eyes.

Contraindications

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

Side effects

Topical application of betamethasone can lead to a reduction in the collagen content in the subcutaneous tissue and, as a result, cause atrophic skin changes, 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 suppression of the function of the sweat glands.

Secondary skin infections can occur as a consequence of a depression of the immune system.

Topical application of salicylic acid can cause dermatitis.

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

Special instructions

If at the first use of the preparation  there is a reaction of hypersensitivity of the skin (itching, redness), the use of the preparation should be stopped immediately.

It is not recommended to use the preparation Belosalik Lotion under occlusive dressings, except when necessary. Application under diapers (especially plasticized ones) in children enhances absorption, as diapers act as occlusive dressings.

Long-term topical application of the preparation on the face is not recommended due to the possible appearance of dermatitis like rosacea, perioral dermatitis and acne.

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

Belosalik Lotion is not used to treat varicose veins.

For patients with hepatic insufficiency, as well as patients who require long-term local therapy with Belosalik Lotion, especially if it is necessary to use occlusive dressings, careful observation is necessary due to the possible manifestation of increased absorption of betamethasone in them, as well as systemic manifestations (see OVERDOSE). Periodic monitoring of the function of the hypothalamus-pituitary-adrenal system should be carried out (test of free cortisol in urine and blood plasma, ACTH stimulation test). If depression is found, it is necessary to stop using the preparation, reduce the frequency of use, or replace it with a less potent corticosteroid.

Some places on the body, where there is a certain type of natural occlusion (groin, armpits, perianal area), are subject to greater occurrence of stretch marks during local treatment with Belosalik 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 application of antibiotics or antifungal agents is also necessary.

Use during pregnancy and lactation

Pregnancy period. Appropriate well-controlled studies on the teratogenic effect of topically applied corticosteroids in pregnant women have not been performed. Therefore, local use of the preparation in pregnant women is allowed only in cases where, in the opinion of 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.

Breastfeeding period. It is not known whether topically used corticosteroids, including betamethasone, can be absorbed sufficiently to cause sufficient amounts of this preparation to appear 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 can be systemically absorbed, but there is no evidence of adverse effects in infants.

By the decision of the doctor, Belosalik Lotion can be used by mothers who are breastfeeding, but the preparation cannot be applied to the area of ​​the mammary glands.

Children. Application in children over the age of 2 years is possible only after consultation with a doctor and under his supervision. Consideration should be given to the greater absorption of the preparation in children due to the greater value of the ratio of the skin surface area to the child's body weight, which may manifest itself as increased systemic toxicity and inhibition of the hypothalamic-pituitary-adrenal system.

The duration of treatment in children should be kept as short as possible. Do not use under diapers.

The ability to influence the reaction rate when driving or operating machinery. Does not affect.

Interactions

There are no clinically significant interactions with other drugs.

The simultaneous use of cosmetic or dermatological products for the treatment of acne, as well as those containing ethanol, medical soaps with a strong drying effect, and others, may in certain cases further 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 insufficiency, increased absorption and manifestation of systemic action 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's syndrome.

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

Symptoms of a salicylate overdose: pallor, fatigue, drowsiness, nausea, vomiting, hearing impairment.

Treatment: Appropriate symptomatic treatment. Acute symptoms of hypercortisolism are usually reversible. Correction of electrolyte imbalance is indicated if necessary. In the case of chronic toxic effects, a gradual abolition of GCS is recommended.

Treatment of salicylism is symptomatic. Measures are taken to remove salicylates from the body more quickly. Sodium bicarbonate is used orally to alkalize urine and increase urine output.

Storage conditions

At a temperature not higher than 25 ° C.