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

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 solar, radiation)

• reactions to insect bites

• skin itching of various etiologies

• discoid lupus erythematosus

• lichen planus

Pharmacological effect

Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS) that has anti-inflammatory, antiallergic, antiexudative, 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), interleukins 1 and 2, interferon gamma (from lymphocytes and macrophages), inhibits activity and reduces the permeability of the vascular wall.

Interacts with specific receptors in the cytoplasm of the cell, stimulates 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 the biosynthesis of endoperoxides, prostaglandins, leukotrienes (promoting the development of inflammation, allergies and other pathological processes).

Pharmacokinetics

When the drug is used externally in therapeutic doses, transdermal absorption of the active substance 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.

Special instructions

Beloderm®express in spray form is preferable for use in acute forms of dermatosis, including those accompanied by exudation (formation of weeping surfaces).

Long-term use of the drug Beloderm® Express on the skin of the face is not recommended, as the development of rosacea, perioral dermatitis and acne is possible. The course of treatment should not exceed 5 days.

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

Some areas of the body, such as the armpits, groin folds, where there is a kind of natural occlusion, are more at risk of developing stretch marks, so continuous use of the drug on these areas of the skin should be short-term (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 according to strict indications or under medical supervision, since the development of systemic side effects associated with betamethasone is possible.

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

When using the drug on large surfaces and/or under an occlusive dressing, suppression of the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercortisolism may occur; a decrease in the excretion of growth hormone and an increase in intracranial pressure may be observed.

Impact on the ability to drive vehicles and machinery

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

Active ingredient

Betamethasone

Composition

1 g of solution contains:

active substance:

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

excipients:

isopropanol – 400.0 mg,

carbomer 934P – 2.50 mg,

water – 596.86 mg,

sodium hydroxide – q.s.

Contraindications

Hypersensitivity to betamethasone or to any of the auxiliary components of the drug; bacterial (skin tuberculosis, skin manifestations of syphilis), fungal, viral (varicella, herpes simplex) skin diseases, skin post-vaccination reactions, open wounds, trophic leg ulcers, rosacea, acne vulgaris, skin cancer, nevus, atheroma, melanoma, hemangioma, xanthoma, sarcoma, lactation period, 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 mild.

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

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

Storage conditions

At a temperature not exceeding 25 °C.

Keep out of the reach of children!

Shelf life

2 years.

Do not use after expiration date.

Manufacturer

Belupo, medicines and cosmetics d.d., Croatia