Beloderm Express, external spray 0.05% 50ml

Composition

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of 1 g of the solution contains:

Active ingredient:

betamethasone dipropionate – 0.640 mg (0.064%), which corresponds to 0.500 mg of betamethasone;

excipients:

isopropanol – 400.0 mg,

carbomer 934 P-2.50 mg,

water-596.86 mg,

sodium hydroxide-q. s.

Pharmacological action

Pharmacodynamics

Betamethasone dipropionate is a synthetic glucocorticosteroid (corticosteroid) that has anti-inflammatory, anti-allergic, anti-exudative, antipruritic and vasoconstrictor effects.

When applied to the skin surface, it narrows blood vessels, relieves itching, reduces the release of inflammatory mediators (from eosinophils and mast cells), interleukins 1 and 2, gamma interferon (from lymphocytes and macrophages), inhibits the activity and lowers the permeability of the vascular wall.

It interacts with specific receptors in the cell cytoplasm, stimulates the synthesis of matrix ribonucleic acid, which induces the formation of proteins, including lipocortin, that mediate cellular effects.

Lipocortin inhibits phospholipase_A2, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, prostaglandins, and leukotrienes (which contribute to the development of inflammation, allergies, and other pathological processes).

Pharmacokinetics

When the drug Beloderm Express is applied externally in therapeutic doses, the transdermal absorption of the Active ingredient into the blood is very insignificant.

The use of occlusive dressings, inflammation and skin diseases increase the transdermal absorption of betamethasone, which may lead to an increased risk of systemic side effects.

It is mainly metabolized in the liver. It is excreted by the kidneys and bile.

Indications

Skin diseases amenable to glucocorticosteroid therapy:

• eczema (various forms)
• atopic dermatitis / neurodermatitis
• erythroderma
• psoriasis
• bullous dermatoses
• exudative erythema multiforme
• photodermatoses (including sunburn)
• allergic contact dermatitis
• contact dermatitis (including occupational)
• non-allergic dermatitis (including sun, radiation)
• reactions to insect bites
• pruritus of various etiologies
• discoid lupus erythematosus
• lichen planus

Use during pregnancy and lactation

The use of the drug Beloderm express, spray for external use in pregnant women is allowed in cases where the intended benefit to the mother exceeds the risk to the fetus.

In such cases, the use of the drug should be carried out under the supervision of a doctor, should be short-lived and, if possible, limited to small areas of the skin.

If it is necessary to use the drug during lactation, stop breastfeeding.

Contraindications

• Hypersensitivity to betamethasone or any of the auxiliary components of the drug;
• bacterial (tuberculosis, skin, cutaneous manifestations of syphilis),
• fungal, viral (varicella, herpes simplex) skin diseases,
• post-vaccination skin reactions,
• open wounds,
• trophic ulcers,
• rosacea,
• acne vulgaris,
• skin cancer,
• nevus,
• sebaceous cyst,
• melanoma,
• hemangioma,
• a xanthoma,
• sarcoma,
• lactation,
• children’s age up to 2 years.

Side effects

When used in therapeutic doses, the drug is usually well tolerated, side effects are absent or poorly expressed.

As with other corticosteroids, hypersensitivity reactions may develop (itching, burning, redness, dry skin, acne-like changes (“steroid” acne, perioral dermatitis, allergic contact dermatitis, hypopigmentation)).

With prolonged use, as well as when using occlusive dressings – maceration of the skin, secondary infections, skin atrophy, hirsutism, hypertrichosis, telangiectasia, folliculitis, sweating, purpura.

When applied to large areas of the body, systemic side effects of glucocorticosteroids may occur (hyperglycemia, glucosuria, reversible suppression of the adrenal cortex, manifestation of Itsenko-Cushing syndrome).

If a hypersensitivity reaction or side effects occur, therapy should be discontinued and a doctor should be consulted.

How to take, course of use and dosage

For external use only.

Beloderm express, a spray for external use, is sprayed on the affected area of the skin in the amount necessary to cover the affected surface,2 times a day.

The duration of treatment depends on the effectiveness and tolerability of the therapy and usually does not exceed 4 weeks. Within a year, it is possible to repeat therapy. In children and patients with facial skin lesions, the course of treatment should not exceed 5 days. If clinical improvement does not occur, the diagnosis should be clarified.

To evenly cover the skin area of 100 cm2, apply 2 ml of the spray, which corresponds to 1 mg of betamethasone (that is,13 smooth and complete taps on the dispenser; the dose of the drug with one tap on the dispenser is 0.15 ml and contains 0.075 mg of betamethasone).

Overdose

Acute overdose is unlikely, however, with excessive or prolonged use of the drug, especially in children, on large skin surfaces, applied to skin with impaired integrity, or when used under an occlusive dressing, chronic overdose is possible, accompanied by signs of hypercorticism (hyperglycemia, glucosuria, reversible suppression of the adrenal cortex, manifestation of Itsenko-Cushing syndrome).

Treatment: Gradual discontinuation of the drug and symptomatic treatment is recommended.

Special instructions

Beloderm express in the form of a spray is preferred for use in the acute form of dermatosis, including those accompanied by exudation (formation of wet surfaces).

Long-term external use of Beloderm express on the skin of the face is not recommended, as rosacea, perioral dermatitis and acne may develop. The course of treatment should not exceed 5 days.

Beloderm express should not be used in the eye area due to the likelihood of getting the drug on the mucous membrane, which can contribute to the development of cataracts, glaucoma, fungal infections of the eyes and exacerbation of herpes infection.

Some areas of the body, such as the armpits, inguinal folds, where there is a kind of natural occlusion, are more susceptible to the risk of striae, so the continuous use of the drug on these skin areas should be short (no more than 4 weeks).

If a fungal or bacterial infection develops on the skin, additional use of an antibacterial or antifungal agent is necessary.

For children, the drug is prescribed only for strict indications and under medical supervision, as it is possible to develop systemic side effects associated with betamethasone.

When using the drug in children, it is necessary to limit the total duration of treatment and exclude measures leading to increased resorption and absorption (warming, fixing and occlusive dressings, diapers).

When using the drug on large surfaces and/or under an occlusive dressing, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system and develop symptoms of hypercorticism, there may be a decrease in the excretion of growth hormone, an increase in intracranial pressure.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and mechanisms.

Form of production

Spray for external use

Storage conditions

At a temperature not exceeding 25 °C.

Shelf

life is 2 years.

Active ingredient

Betamethasone

Dosage form

spray for external use

Description

For adults, Pregnant women as prescribed by a doctor, Children as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Children over 6 months of age

Indications

Dermatosis, Eczema, Dermatitis, Psoriasis, Insect Bites, Allergies, Neurodermatitis