Compound
Solution for external use | 1 g |
active substances: | |
betamethasone dipropionate | 0.64 mg (0.064%) |
(corresponds to 0.5 mg betamethasone) | |
salicylic acid | 20 mg (2%) |
excipients: disodium edetate - 0.3 mg; hypromellose 4000 cP - 5 mg; sodium hydroxide - 5 mg; isopropanol - 392 mg; water - 577.06 mg |
Solution for external use in a bottle with a spray nozzle (spray) | 1 g |
active substances: | |
betamethasone dipropionate | 0.64 mg |
(corresponds to 0.5 mg betamethasone) | |
salicylic acid | 20 mg |
excipients: disodium edetate - 0.3 mg; hypromellose 4000 cP - 5 mg; sodium hydroxide - 5 mg; isopropanol - 392 mg; water - 577.06 mg |
Pharmacodynamics
Belosalik®lotion has anti-inflammatory, antipruritic, anti-edematous, antiallergic, antiproliferative, immunosuppressive, keratolytic, antimicrobial and antifungal effects.
Betamethasone dipropionate is a synthetic corticosteroid that has anti-inflammatory, antiallergic, antipruritic and vasoconstrictor effects. When applied to the surface of the skin, it constricts blood vessels, relieves itching, reduces the release of inflammatory mediators (from eosinophils and mast cells), IL-1 and -2, interferon gamma (from lymphocytes and macrophages), inhibits the activity of hyaluronidase and reduces the permeability of the vascular wall. Interacts with specific receptors in the cytoplasm of the cell, stimulates the synthesis of mRNA, inducing the formation of proteins, incl. lipocortin, mediating cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, PGs, and leukotrienes (which contribute to the development of inflammation, allergies and other pathological processes).
Salicylic acid, due to its keratolytic action, cleanses affected areas of scales, promotes the penetration of betamethasone into the skin, maintains the acidic environment of the skin, preventing the development of bacterial and fungal infections.
Side effects
Side effects are usually reversible and mild in nature.
From the skin: hypersensitivity reaction (itching, burning or redness), acne-like changes, hypopigmentation, stretch marks, skin atrophy, hypertrichosis, secondary skin infections.
With long-term continuous uncontrolled use and application to large areas of skin: telangiectasia, systemic manifestations of side effects of corticosteroids or salicylates.
If a hypersensitivity reaction or side effects occur, therapy should be discontinued and consult a doctor.
Indications for use
Belosalik lotion is used for the following diseases and conditions:
- dermatoses , subacute and chronic, in which desquamation and hyperkeratosis , and which demonstrate high sensitivity to treatment with corticosteroids ;
- seborrheic dermatitis
- neurodermatitis;
- psoriasis;
- seborrhea;
- lichen asbestos;
- ichthyosis;
- lichen planus , which is localized on the scalp;
- eczema;
- dyshidrosis of the skin.
Indications for use of the ointment are determined as follows:
- dermatoses , subacute and chronic, in which desquamation and hyperkeratosis , and which demonstrate high sensitivity to treatment with corticosteroids ;
- psoriasis;
- seborrheic, tylotic, dyshidrotic eczema ;
- lichen planus red;
- neurodermatitis;
- lichen asbestos;
- ichthyosis , as well as ichthyotic lesions of the skin;
- seborrhea;
- seborrheic dermatitis;
- chronic discoid lupus erythematosus .
Directions for use and doses
Externally.
Bottle with spray nozzle
Belosalik® lotion is sprayed 2 times a day onto the affected areas of the scalp with hair, using a convenient elongated spray nozzle. In some cases, once a day is sufficient.
Before spraying, shake the bottle, place it in a vertical position, then bring the nozzle of the nozzle to the affected area of skin with hair and press the sprayer all the way with your index finger. Apply the required number of sprays to the affected areas of the scalp.
The duration of the course of treatment is individual, as a rule, until the main symptoms of the disease disappear, but is usually limited to 3–4 weeks. If a longer course of therapy is necessary, it is recommended to use the drug less frequently, for example every other day, and consult a specialist.
Dropper bottle
Belosalik® lotion is used 2 times a day. A few drops of lotion are evenly distributed with a cotton swab or fingers over the surface of the skin, lightly rubbing. In some cases, once a day is sufficient. The duration of treatment is usually limited to 3–4 weeks. If a longer course of therapy is necessary, it is recommended to use the drug less frequently, for example every other day, or consult a specialist. Belosalik® lotion can be prescribed to children from 6 months of age with caution and for the shortest possible time.
Overdose
If the combination of betamethasone and salicylic acid is used for a long time on large areas of the skin, the drug is used under an occlusive dressing, or the product is applied to a surface with compromised integrity, absorption of the active components may occur and, as a result, their systemic effect will appear. This is especially likely in childhood patients.
hypercortisolism , secondary adrenal insufficiency, and Itsenko-Cushing syndrome may develop . In this case, the medicine is discontinued and symptomatic treatment is practiced.
special instructions
Belosalik® lotion is intended for external use only.
Avoid contact with eyes and mucous membranes, as well as use of the drug in the anogenital area.
It is not recommended to use the drug under occlusive dressings, except when necessary. If fungal or bacterial microflora develops on the skin, additional use of an antibacterial or antifungal agent is necessary.
The drug Belosalik® lotion in the form of a solution for external use is especially convenient for use on the scalp. The solution is easily distributed over the surface of the skin, does not stick or dry out hair, does not leave visible marks, and has a cooling effect on the skin.
Impact on the ability to drive vehicles and machinery. There are no data on the adverse effects of Belosalik® lotion on the ability to drive vehicles and operate machinery.
Belosalik ointment for external use 15g
Compound
Active substance: betamethasone dipropionate 640 mcg, which corresponds to the content of betamethasone 500 mcg, salicylic acid 30 mg.
Excipients: liquid paraffin - 100 mg, soft white paraffin - 869.36 mg.
Indications for use
Reduction of inflammatory manifestations of dry and hyperkeratic dermatoses, sensitive to GCS therapy, including psoriasis, chronic atopic dermatitis, neurodermatitis, lichen planus, eczema (including coin-shaped eczema, eczema of the hands, eczematous dermatitis), dyshidrosis, seborrheic dermatitis of the scalp head, ichthyosis and other ichthyosis-like conditions.
Contraindications
- Hypersensitivity to betamethasone, salicylic acid, and other components of the drug;
- rosacea, acne, perioral dermatitis;
- bacterial, viral or fungal skin infections;
- trophic ulcers against the background of chronic venous insufficiency, wounds;
- skin tumors;
- post-vaccination skin reactions;
- perianal and genital itching;
- children under 2 years of age;
- pregnancy (long-term treatment in large doses);
- breastfeeding period.
With caution:
Children under 12 years of age, liver failure, long-term treatment, use on large areas of skin, use of occlusive dressings.
Directions for use and doses
Externally.
The drug is applied in a thin layer to the affected areas of the skin 2 times a day (morning and night). In some patients, a maintenance effect can be achieved with less frequent applications.
Children aged 2 to 12 years - apply a thin layer 1 or 2 times a day for no more than 5 days. The course of treatment should not exceed 3 weeks. The duration of treatment, features of the treatment regimen, and repeated courses of treatment must be agreed with the doctor.
Use the drug only according to the method of use and in the doses indicated in the instructions for use. If necessary, please consult your doctor before using the medicine.
Storage conditions
At a temperature not higher than 25°C. Keep out of the reach of children.
Best before date
4 years. Do not use after the expiration date.
special instructions
If signs of allergic reactions or local irritation appear when using the drug, treatment should be discontinued.
In case of a fungal or bacterial infection on the skin, additional use of an antibacterial and antifungal agent is necessary. Care must be taken to prevent contact with the eyes as cataracts and glaucoma may develop from repeated exposure. If the patient experiences symptoms such as blurred vision or other visual disturbances, it is necessary to consult an ophthalmologist. If the drug accidentally gets into your eyes, rinse them thoroughly with water.
You should avoid getting the drug on the mucous membranes, as well as using the drug in the anogenital area, in areas of extensive skin damage, especially with a violation of the integrity of the skin.
When GCS is used externally, visual impairment is observed, in which case you should consult an ophthalmologist.
Use in children under 12 years of age is possible only under medical supervision.
Children, more than adults, are at risk of suppressing the function of the hypothalamic-pituitary-adrenal system when using local corticosteroids due to the larger ratio of body surface area to body weight and, as a result, increased absorption of the drug. There have been reports of decreased function of the hypothalamic-pituitary-adrenal axis, Itsenko-Cushing syndrome, growth retardation, insufficient body weight gain and increased intracranial pressure in children receiving topical corticosteroids. Inhibition of the function of the hypothalamic-pituitary-adrenal system in children is determined by low plasma cortisol levels and lack of response to stimulation of adrenocorticotropic hormone. Increased intracranial pressure is manifested by protrusion of the fontanelle, headaches, and bilateral papilledema.
When using the drug in children or for the treatment of lesions on the skin of the face, the duration of treatment should not exceed 5 days. The use of the drug under occlusive dressings is not recommended.
With prolonged treatment, when applied to large areas of the skin or when using occlusive dressings, systemic absorption of glucocorticosteroids and salicylic acid is possible.
During long-term treatment with the drug, it is recommended to discontinue it gradually.
Description
Glucocorticosteroid for local use + keratolytic agent.
Action
Belosalik® is a combination drug containing the active ingredients betamethasone dipropionate and salicylic acid.
Betamethasone dipropionate, a synthetic fluorinated glucocorticosteroid (GCS), has anti-inflammatory, antipruritic and vasoconstrictor effects.
Salicylic acid, having a keratolytic effect, promotes the penetration of betamethasone into the skin. It has a bacteriostatic and some fungicidal effect. The combined action of the active components leads to a rapid reduction in the severity of symptoms such as itching, irritation, erythema and pain.
Side effects
When used externally, adverse reactions are usually reversible and mild in nature.
Classification of the frequency of adverse reactions: very often (≥ 10%), often (≥ 1% and < 10%), uncommon (≥0.1% and < 1%), rarely (≥0.01% and < 0.1% ), very rare (<0.01%), frequency unknown - it is not possible to determine the frequency of occurrence based on available data.
Disorders of the skin and subcutaneous tissues: often - burning, itching, irritation, dry skin, folliculitis, hypertrichosis, acne-like rashes, acne, hypopigmentation, telangiectasia, perioral dermatitis, allergic contact dermatitis, skin maceration, skin atrophy, miliaria, secondary infections .
Endocrine system disorders: with long-term use and application to large areas of skin, mainly in children, systemic side effects of glucocorticosteroids may occur - hypoglycemia, glucosuria, reversible inhibition of adrenal cortex function, manifestation of Itsenko-Cushing syndrome.
Systemic adverse reactions, such as blurred vision, have been reported with the use of topical glucocorticosteroids.
If you experience side effects listed in the instructions or they get worse, or you notice other side effects not listed in the instructions, you should tell your doctor.
Use during pregnancy and breastfeeding
Pregnancy
The safety of glucocorticosteroids when applied to the skin has not been established. During pregnancy, the use of the drug is possible if the potential benefit to the mother outweighs the possible risk to the fetus or child. Glucocorticosteroids for external use should not be used during pregnancy in large doses or for a long time.
Before using Belosalik®, if you are pregnant, or think you might be pregnant, or are planning a pregnancy, you should consult your doctor.
Breastfeeding period
Since it has not yet been determined whether the level of systemic absorption of local glucocorticosteroids is sufficient for their detectable concentrations to appear in mother's milk, either breastfeeding or the use of the drug should be discontinued, taking into account how necessary its use is for the mother. Before using Belosalik®, you should consult your doctor.
Interaction
Interaction with other drugs has not been studied.
Overdose
Symptoms
Long-term use of local corticosteroids in large doses can cause inhibition of the function of the pituitary-adrenal system, which can cause the development of secondary adrenal insufficiency and the appearance of symptoms of hypercortisolism, including Itsenko-Cushing syndrome.
Long-term use of drugs containing salicylic acid in large doses can lead to salicylic acid poisoning.
Treatment
Symptomatic. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte balance is recommended. In case of chronic toxicity, gradual withdrawal of glucocorticosteroids is recommended. In case of poisoning with salicylic acid, measures should be taken to quickly remove salicylic acid from the body, for example, ingesting sodium bicarbonate to alkalinize urine and force diuresis.
Impact on the ability to drive vehicles and operate machinery
The drug does not affect the ability to drive or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.