Beloderm Express - instructions for use, dose, side effects, contraindications

Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS), which exerts anti-inflammatory, antiallergic, antiexudative, antipruritic and vasoconstrictive action. When applied to the skin surface, it narrows the 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 lowers the permeability of the vascular wall. Interacts with specific receptors in the cytoplasm of the cell, stimulates the synthesis of matrix ribonucleic acid, which induces the formation of proteins, including lipocortin, which mediates cellular effects. Lipocortin depresses phospholipase A₂, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, prostaglandins, leukotrienes (contributing to the development of inflammation, allergy and other pathological processes).

Pharmacokinetics:

With external use of the drug in therapeutic doses, transdermal absorption of the active substance into the blood is very low.The use of occlusive dressings, inflammation and skin diseases increase the transdermal absorption of betamethasone, which can lead to an increased risk of systemic side effects. Metabolized mainly in the liver. It is excreted by the kidneys and with bile.

Indications:

Diseases of the skin, amenable to glucocorticosteroid therapy:

- eczema (various forms);

- atopic dermatitis / neurodermatitis;

- erythroderma;

- psoriasis;

- bullous dermatoses;

- exudative erythema multiforme;

- photodermatosis (including sunburn);

- allergic contact dermatitis;

- contact dermatitis (including professional dermatitis);

- non-allergic dermatitis (including sunlight, radiation);

- reactions to insect bites;

- itching of various etiologies;

- discoid lupus erythematosus;

- red flat herpes.

Contraindications:

- Hypersensitivity to betamethasone or to any of the auxiliary components of the drug;

- bacterial (skin tuberculosis, cutaneous manifestations of syphilis), fungal, viral (varicella, herpes simplex) skin diseases, skin post-vaccination reactions, open wounds, trophic ulcers of the shin, rosacea, acne vulgaris, skin cancer, nevus,atheroma, melanoma, hemangioma, xanthoma, sarcoma;

- lactation period;

- Children under 2 years.

Pregnancy and lactation:

Application 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 drug should be administered under the supervision of a doctor, should be short-lived and, if possible, limited to small areas of skin.

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

Dosing and Administration:

For external use only.

Beloderm® express, spray for external use, spray on the affected area of the skin in an 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 is usually not more than 4 weeks.

During the year, a repeat of therapy is possible.

In children and patients with skin lesions, treatment should not exceed 5 days. If clinical improvement does not occur, it is necessary to clarify the diagnosis.

In order to evenly cover a skin area of 100 cm, 2 ml of spray should be applied, which corresponds to 1 mg of betamethasone (i.e., 13 smooth and full doses of the dispenser, a dose of 0.15 ml at one pressure on the dispenser and 0.075 mg of betamethasone).

Side effects:

When used in therapeutic doses, the drug is generally well tolerated, the side effects are absent or mild.

As with the use of other GCS, 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 with the use of occlusive dressings - skin maceration, secondary infections, skin atrophy, hirsutism, hypertrichosis, telangiectasia, folliculitis, sweating, purpura.

When applied to extensive body surfaces, it may cause systemic side effects of glucocorticosteroids (hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Itenko-Cushing syndrome).

In case of a hypersensitivity reaction or side effects, 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 extensive skin surfaces, application to the skin with impaired integrity or when applied under an occlusive dressing, chronic overdose is possible, accompanied by signs of hypercorticism (hyperglycemia, glucosuria, reversible oppression of function adrenal cortex, manifestation of Isenko-Cushing syndrome).

Treatment: It is recommended that the drug be phased out and that symptomatic treatment be performed.

Interaction:

Drug interactions Beloderm® Express with other drugs are unknown.

Special instructions:

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

It is not recommended long-term external use of the drug Beloderm® Express on the skin of the face, since it is possible to develop rosacea, perioral dermatitis and acne. The course of treatment should not exceed 5 days.

Beloderm® Express Do not use in the eye area due to the likelihood of the drug getting on the mucous membrane,which can contribute to the development of cataracts, glaucoma, fungal infections of the eyes and exacerbation of herpetic infection.

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

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

Children are prescribed the drug only under strict indications and under medical supervision, since 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 extensive surfaces and / or under the occlusive dressing, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercorticism, a decrease in the excretion of growth hormone,increased intracranial pressure.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Spray for external use, 0.05%.

Packaging:

For 20 ml and 50 ml of the drug in a white bottle of high-density polyethylene with a plastic sprayer and a lid.

One bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:LP-002492

Date of registration:06.06.2014

Expiration Date:06.06.2019

The owner of the registration certificate:Beluga, medicines and cosmetics.Beluga, medicines and cosmetics. Croatia

Manufacturer: & nbsp

BELUPO, Pharmaceuticals & Cosmetics, d.d. Croatia

Representation: & nbspBeluga, medicines and cosmetics. Beluga, medicines and cosmetics. Croatia

Information update date: & nbsp21.01.2017

Illustrated instructions

Instructions

Beloderm® Express (Beloderm® Express)