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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.

Belosalic®

If signs of allergic reactions or local irritation appear when using the drug, treatment should be discontinued.

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.

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.