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:

Active ingredient

Composition

1 g of the solution contains:

the active ingredient:

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

accompanies:

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

The duration of treatment depends on the efficiency and tolerability of the therapy and is usually not 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 there is no clinical improvement it is necessary to specify the diagnosis.

To evenly cover an area of 100 cm2 of skin 2 ml of the spray must be applied, which is equivalent to 1 mg of betamethasone (i.e. 13 smooth and full presses on the doser; one press of the doser equals 0.15 ml and contains 0.075 mg of betamethasone).

Special Instructions

Beloderm Express in spray form is preferred for use in acute dermatoses, including those accompanied by exudation (formation of oozing surfaces).

Long-term external application of Beloderm Express on the face is not recommended since 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 with mucosa which may lead to cataracts, glaucoma, fungal eye infections and worsening of herpes infections.

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

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

In children the drug is prescribed only with 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 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 symptoms of hypercorticism may occur, reduction of growth hormone excretion and increased intracranial pressure may be observed.

Influence on driving and operating ability

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

Contraindications

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.)

Long-term use and use of occlusive dressings causes skin maceration, secondary infections, skin atrophy, hirsutism, hypertrichosis, telangiectasia, folliculitis, sweats and purpura.

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

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

Overdose

Acute overdose is unlikely; however, when the drug is used excessively or prolonged, especially in children, on large skin surfaces, applied to skin with compromised integrity or when used under an occlusive dressing, chronic overdose accompanied by signs of hypercorticism (hyperglycemia, glucosuria, reversible suppression of adrenal function, the appearance of Icenko-Cushing syndrome) is possible.

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

Pregnancy use

The use of Beloderm Express, topical spray in pregnant women is allowed in cases when the expected benefits to the mother exceed the risk to the fetus.

In such cases the use of the drug should be supervised by a physician, should be of short duration and, if possible, limited to small areas of the skin.

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

Similarities