Description
Release form
Spray for external use
Packing
Spray bottle 50 ml.
Pharmacological action
Pharmacodynamics
Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS), which has anti-inflammatory, anti-allergic, antiexudative, antipruritic and vasoconstrictive 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, gamma interferon (from lymphocytes and macrophages), inhibits activity and reduces the permeability of the vascular wall.
Interacts with specific receptors in the cell cytoplasm, 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 (contributing to 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 in the blood is very insignificant.
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.
Contraindications
Hypersensitivity to betamethasone or to any of the auxiliary components of the drug
bacterial (skin tuberculosis, skin manifestations of syphilis),
fungal, viral (chicken pox, herpes simplex) skin diseases,
sore skin reactions trophic ulcers of the lower leg,
rosacea,
acne vulgaris,
skin cancer,
nevus,
atheroma,
melanoma,
hemangioma,
xanthoma,
sarcoma age 2 years old, srklp age 2 years.
Use during pregnancy and lactation
Use of the drug Beloderm express, 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 doctor, should be short-lived and, if possible, be limited to small areas of the skin.
If you need to use the drug during lactation, you should stop breastfeeding.
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).
Long-term external 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 onto the mucous membrane, which can contribute to the development of cataracts, glaucoma, fungal infections of the eyes and exacerbation of herpes infection.
Some parts of the body, such as armpits, inguinal folds, where there is a kind of natural occlusion, are more at risk of striae, so continuous use of the drug in these areas of the skin should be short (no more than 4 weeks).
In cases of the development of a fungal or bacterial infection on the skin, the 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 is possible, 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 large surfaces and / or under an 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 growth hormone excretion, an increase in intracranial pressure can be observed.
Effect on the ability to drive vehicles and mechanisms
The drug does not affect the ability to drive vehicles and mechanisms.
Composition of
1 g of solution contains:
active substance:
betamethasone dipropionate – 0.640 mg (0.064%), which corresponds to 0.500 mg – 400.0 mg,
carbomer 934 – 2.50 mg,
water – 596.86 mg,
sodium hydroxide – qs
Dosage and administration
For external use only.
Beloderm Express, spray for external use is sprayed 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 therapy and is usually no more than 4 weeks. Repeated therapy is possible throughout the 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.
To uniformly cover a skin area of 100 cm2, it is necessary to apply 2 ml of spray, which corresponds to 1 mg of betamethasone (that is, 13 smooth and full presses 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).
Side effects of
When used in therapeutic doses, the drug is generally well tolerated, side effects are absent or mild. As with other corticosteroids, hypersensitivity reactions (itching, burning, redness, dry skin, acne-like changes ( steroid acne, perioral dermatitis, allergic contact dermatitis, hypopigmentation) may develop.
With prolonged use, as well as when using occlusive dressings – skin maceration, secondary infections, skin atrophy, hirsutism, hypertrichosis, telangiectasia, folliculitis, pruritus, purpura. When applied to extensive body surfaces, systemic side effects of glucocorticosteroids may occur (hyperglycemia, glucosuria, reversible inhibition of adrenal cortex function, manifestation of Itsenko-Cushing’s syndrome).
In case of a hypersensitivity reaction or side effects, therapy should be discontinued and consult a doctor.
Overdose
An acute overdose is unlikely, however, with excessive or prolonged use of the drug, especially in children, on large skin surfaces, applied to skin with impaired integrity or when applied under an occlusive dressing, a chronic overdose is possible, accompanied by signs of hypercorticism (hyperglycemia, , reversible inhibition of adrenal cortex function, manifestation of Itsenko-Cushing’s syndrome).
Treatment: gradual discontinuation of the drug and symptomatic treatment is recommended.
Storage conditions
At a temperature not exceeding 25 ° C.
Expiration
2 years.
active substance
Betamethasone
Terms leave through pharmacies
without prescription
lekarstvennaja form
spray naruzhnej Application
Prescribed
Pregnant women prescribed by a doctor, Children older than 2 years old, For adults, Children prescribed by a doctor, K for mothers as prescribed by the doctor
Indications
Indications
dermatoses, dermatitis, insect bites, psoriasis, atopic dermatitis, allergy, eczema
Bezen Helske CA, Belorussia, Belarus Belarussia , medicines and cosmetics d.d, Croatia
