Beloderm Express, spray 0.05% 20 ml

Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS) with anti-inflammatory, anti-allergic, anti-exudative, antipruritic and vasoconstrictive effects. Applied on the skin surface it narrows vessels, relieves itching, reduces release of inflammatory mediators (from eosinophils and mast cells), interleukins 1 and 2, gamma interferon (from lymphocytes and macrophages), inhibits activity and reduces vascular wall permeability.

It interacts with specific receptors in the cell cytoplasm, stimulating the synthesis of matrix ribonucleic acid, inducing the formation of proteins, including lipocortin, mediating cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and biosynthesis of endoperoxides, prostaglandins, leukotrienes (contributing to inflammation, allergy and other pathological processes).

Pharmacokinetics

In external application of the drug in therapeutic doses, transdermal absorption of the active substance into the blood is very low. Use of occlusive dressings, inflammation and skin conditions increase transdermal absorption of betamethasone, which may increase the risk of systemic side effects.

Indications

– Glucocorticosteroid-relieved skin diseases:

– eczema (various forms)

– atopic dermatitis/neurodermatitis

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– erythroderma

– psoriasis

– bullous dermatoses

– exudative erythema multiforme

– photodermatosis (including sunburn)

– allergic contact dermatitis

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– contact dermatitis (including occupational)

– non-allergic dermatitis (including sunburn, radiation dermatitis)

– reactions to insect bites

– skin itching of various etiologies

– discoid lupus

– lichen planus

Active ingredient

Composition

1 g of the solution contains:

active ingredient:

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

excipients:

isopropanol – 400.0 mg,

carbomer 934P – 2.50 mg,

water – 596.86 mg,

sodium hydroxide – q.s.

How to take, the dosage

For external use only.

Beloderm® Express External Spray is sprayed on the affected skin area in the amount needed to cover the affected surface twice a day.

The duration of treatment depends on the effectiveness and tolerability of the therapy and is usually no more than 4 weeks.

Within a year it is possible to repeat the 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 needs to be clarified.

Special Instructions

Beloderm® Express in spray form is preferred for use in acute dermatoses, including those with exudation (formation of mucous membranes).

The long-term use of Beloderm® Express on the face is not recommended because it can cause rosacea, perioral dermatitis and acne. The course of treatment should not exceed 5 days.

Beloderm® Express should not be used on the eye area because of possible contact of the drug with the mucosa that may lead to cataracts, glaucoma, fungal eye infections and exacerbation of herpes infections.

Some areas of the body, such as the armpits and groin folds, where there is a kind of natural occlusion, are more at risk for stretch marks, so continuous use in these areas of skin should be short-lasting (max. 4 weeks).

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

In children the drug is prescribed only with strict indications or under medical supervision, since there may be systemic side effects associated with betamethasone.

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

When the drug is used on large surfaces and/or under the occlusive dressing, suppression of hypothalamic-pituitary-adrenal system function and development of hypercorticism symptoms may occur, decreased excretion of growth hormone, increased intracranial pressure may be observed.

Impact on ability to drive vehicles and mechanisms

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

Contraindications

Hypersensitivity to betamethasone or any of the excipients of the drug; Bacterial (skin tuberculosis, cutaneous manifestations of syphilis), fungal, viral (varicella, herpes simplex) skin diseases, skin postvaccination reactions, open wounds, trophic ulcers of the shin, rosacea, vulgar acne, skin cancer, nevi, atheroma, melanoma, hemangioma, xanthoma, sarcoma, lactation period, children under 2 years old.

Side effects

When used in therapeutic doses, the drug is generally well tolerated, with no or mild side effects.

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

In case of hypersensitivity reactions or side effects the therapy should be stopped and a physician should be consulted.

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