Beloderm express ref. d / bed. approx. 0.05% 50ml bottle # 1

Release form

Spray for external use

Packaging

Spray bottle 50 ml.

pharmachologic effect

Pharmacodynamics

Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS) that has anti-inflammatory, anti-allergic, anti-exudative, antipruritic and vasoconstrictor effects. When applied to the surface of the skin, it narrows 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, which induces the formation of proteins, including lipocortin, that mediate 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

With external use of the drug Beloderm Express 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.

It is metabolized mainly in the liver.

It is excreted by the kidneys and with bile.

Indications

Skin diseases 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)

- non-allergic dermatitis (including solar, radiation)

- reactions to insect bites

- itching of various etiologies

- discoid lupus erythematosus

- lichen planus

Contraindications

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

- bacterial (tuberculosis of the skin, skin manifestations of syphilis),

- fungal, viral (chickenpox, herpes simplex) skin diseases,

- post-vaccination skin 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 old.

Application during pregnancy and lactation

The use of the drug Beloderm Express, a spray for external use in pregnant women, is allowed in cases where the intended 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-lived and, if possible, limited to small areas of the skin.

If necessary, use of the drug during lactation should stop breastfeeding.

special instructions

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

Long-term external use of the Beloderm Express preparation on the face skin is not recommended, since rosacea, perioral dermatitis and acne may develop.

The course of treatment should not exceed 5 days.

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

Some areas of the body, such as the armpits, groin folds, where there is a kind of natural app

Name ENG

BELODERM EXPRESS

Clinical and pharmacological group

GCS for external use

ATX code

Betamethasone

Dosage

0.05% x 50ml

Structure

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 - qs

INN / Active ingredient

betamethasone

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 2 years

Specifications

Category

Psoriasis

Scope of the drug

Leather

Release form

Spray

Manufacturer country

Croatia

Package quantity, pcs

one

Minimum age from

2 years old

Way of introduction

On the skin

,

Locally

,

Outwardly

Vacation conditions

Without recipe

Brand name

Belupo

The amount of the dosage form in the primary package

50 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Topical glucocorticosteroid

Anatomical and therapeutic characteristics

D07AC01 Betamethasone

Dosage form

Spray for external use

Expiration date in days

730

The target audience

Children

Package weight, g

75

Mode of application

:

The drug is intended for external use only. < br> Beloderm express, spray for external use is sprayed on the affected area of ��the skin in the amount necessary to cover the affected surface, 2 times a day. < br> The duration of treatment depends on the effectiveness and tolerability of therapy and is usually no more than 4 weeks. The therapy may be repeated within a year. In children and in patients with facial skin lesions, the course of treatment should not exceed 5 days. If clinical improvement does not occur, the diagnosis must be clarified. < br> To evenly cover a skin area of ��100 cm2, apply 2 ml of spray, which corresponds to 1 mg of betamethasone (that is, 13 smooth and full pressings on the dispenser the dose of the drug with one press on the dispenser is 0.15 ml and contains 0.075 mg of betamethasone ).

Dosage (volume) of the substance in the preparation

:

1 g of solution contains: active substance: betamethasone dipropionate - 0.640 mg (0.064%), which corresponds to 0.500 mg of betamethasone

Information on technical characteristics, delivery set, country of manufacture