Beloderm Express, 0.05% spray 50 ml

Pharmacodynamics

Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS) with anti-inflammatory, anti-allergic, anti-exudative, antipruritic and vasoconstrictor action.

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

Interacts with specific receptors in cell cytoplasm, stimulates synthesis of matrix ribonucleic acid, inducing 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

Transdermal absorption of the active substance into blood is very low when the drug Beloderm Express is applied externally in therapeutic doses.

The use of occlusive dressings, inflammation and skin conditions increase transdermal absorption of betamethasone, which may increase the risk of systemic side effects.

Metabolized mainly in the liver. It is excreted by the kidneys and with the 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 solar, radiation)
reactions to insect bites
skin itching of various etiologies
discoid lupus erythematosus
lichen planus

Pharmacological effect

Pharmacodynamics

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 Beloderm Express is used externally in therapeutic doses, the 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.

Metabolized mainly in the liver. Excreted by the kidneys and bile.

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 external use of Beloderm Express on the facial skin 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).

In cases of fungal or bacterial infection on the skin, additional use of an antibacterial or antifungal agent is necessary.

For children, the drug is prescribed only according to strict indications and 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 ingredient:

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.

Pregnancy

The use of Beloderm Express, spray for external use in pregnant women is permitted in cases where the expected benefit to the mother outweighs the risk to the fetus.

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

If it is necessary to use the drug during lactation, breastfeeding should be stopped.

Contraindications

Hypersensitivity to betamethasone or to any of the auxiliary components of the drug;
bacterial (skin tuberculosis, skin manifestations of syphilis),
fungal, viral (chickenpox, herpes simplex) skin diseases,
skin post-vaccination reactions,
open wounds,
trophic ulcers of the leg,
rosacea,
acne vulgaris,
skin cancer,
nevus,
atheroma,
melanoma,
hemangioma,
xanthoma,
sarcoma,
lactation period,
children under 2 years of age.

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)).

With long-term use, as well as when using occlusive dressings, skin maceration, secondary infections, skin atrophy, hirsutism, hypertrichosis, telangiectasia, folliculitis, prickly heat, purpura.

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

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

Overdose

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

Treatment: gradual withdrawal of the drug and symptomatic treatment are recommended.

Storage conditions

At a temperature not exceeding 25 °C.

Shelf life

2 years.

Manufacturer

Belupo, medicines and cosmetics d.d., Croatia