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Glucocorticosteroid for topical use + antibiotic aminoglycoside
D.07.X.C.01 Betamethasone in combination with other drugs
Белогент® - anti-inflammatory, antiallergic, antipruritic, antibacterial agent.
Betamethasone dipropionate is a synthetic glucocorticosteroid (GCS) that has anti-inflammatory, anti-allergic, antipruritic and vasoconstrictive effects. When applied to the surface of the skin narrows 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 the activity of hyaluronidase and reduces the permeability of the vascular wall. Interacts with specific receptors in the cytoplasm of the cell, stimulates the synthesis of mRNA, inducing the formation of proteins, including lipocortin, mediating cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and the biosynthesis of endoperekisy, prostaglandins, leukotrienes (contributing to the development of inflammation, allergies and other pathological processes).
Gentamicin is a broad-spectrum antibiotic of the aminoglycoside group. It has a bactericidal effect and provides highly effective local treatment of primary and secondary bacterial infections of the skin. Active against gram-negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumonia; and gram-positive bacteria: Streptococcus spp. (sensitive strains of β- and α-hemolytic streptococcus group A), Staphylococcus aureus (coagulase-positive, coagulase-negative strains and some strains producing penicillinase).
Inactive against anaerobes, fungi and viruses.
With external use of the drug in therapeutic doses, transdermal absorption of active substances into the blood is very low. The use of occlusive dressings increases the absorption of betamethasone and gentamicin, which can lead to an increased risk of side effects.
Dermatosis, allergic and inflammatory diseases of the skin with the addition of a secondary bacterial infection or the likelihood of its development: eczema, atopic dermatitis, neurodermatitis, contact dermatitis (including professional), allergic dermatitis, psoriasis, lichen planus, phletoderma, anogenital itching.
Infected dermatitis caused by insect bites, scabies, scratching, abrasions, thermal skin lesions and diaper rash.
Pyoderma of various localization (strepto-staphyloderma, impetigo, sycosis, ecthyma).
Cream Belogent® is used primarily for the treatment of acute and subacute stages of inflammatory skin diseases, including those accompanied by exudation.
1 g of cream contains:
active ingredient: betamethasone dipropionate 0.640 mg (0.064%) in terms of betamethasone - 0.500 mg and gentamicin sulfate in terms of gentamicin base 1.000 mg (0.1%);
excipients: chlorocresol 1,000 mg, sodium dihydrogen phosphate monohydrate 3.0 mg, phosphoric acid 0.020 mg, soft white paraffin - 150,000 mg, liquid paraffin 60,000 mg, macrogol cetostearate 22,500 mg, cetostearyl alcohol [cetyl alcohol 60%, stearic alcohol 40%] 72,000 mg, sodium hydroxide - qs, water - qs up to 1000.0 mg.
Betamethasone, Gentamicin is marketed under different brands and generic names, and comes in different dosage forms:
|Brand name||Manufacturer||Country||Dosage form|
|Betaderm||Elfa Pharmaceutical Plant||Poland||ointment|
|Celestoderm-B with garamycin||Bayer Pharma AG||Germany||ointment|
|Celestoderm-B with garamycin||Bayer Pharma AG||Germany||cream|
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Dosage and Administration
For external use only.
Belogent® cream for external use is applied to the affected area with a thin layer in an amount necessary to cover the affected surface twice a day, slightly rubbing. On areas with denser skin (for example, elbows, palms and feet), as well as places from which the drug is easily erased, Belogent® can be applied more often, but not more than 4 times a day. The duration of the continuous course of treatment is usually no more than 4 weeks. For the prevention of recurrence in the treatment of chronic diseases, therapy should continue for some time after the disappearance of all symptoms. During the year, repeated therapy may be repeated.
When using the drug in therapeutic doses, side effects are usually mild. Rarely, as with the use of other glucocorticosteroids, hypersensitivity reactions (itching, burning, redness), irritation, dry skin, acne-like changes, hypopigmentation, striae, skin atrophy, folliculitis, hypertrichosis, telangiectasis can develop. With prolonged uncontrolled treatment and application to a large surface, the development of systemic side effects characteristic of GCS is possible.
In the event of a hypersensitivity reaction or side effects, therapy should be canceled and consult a doctor.
Hypersensitivity in patients to betamethasone, gentamicin, or to any of the auxiliary components of the drug; viral infections of the skin, skin vaccine reactions, open wounds, trophic ulcers, acne vulgaris, rosacea, chicken pox, skin manifestations of syphilis, skin tuberculosis.
Interactions of the drug Belogent® with other medicines are unknown.
Pregnancy and Lactation
Topical use of the drug Belogent ® cream for external use in pregnant women and nursing mothers is allowed under the supervision of the attending physician. In such cases, the use of the drug should be short and, if possible, be limited to small areas of the skin. The drug should not be applied to the skin of the breast before feeding.
Long-term (more than 4 weeks) external use of Belogent® on the skin of the face is not recommended, since it is possible to develop rosacea, perioral dermatitis and acne.
Belogent® should not be used in the eye area due to the likelihood of the drug getting on the mucous membrane, which may contribute to the development of cataracts, glaucoma, fungal infections of the eye and exacerbation of herpes infection.
Some areas of the body, such as the armpits, inguinal folds, where there is a kind of natural occlusion, are more at risk for striae, therefore, continuous use of the cream for external use in these areas of the skin should be short-lived (no more than 4 weeks).
In cases of development of fungal microflora on the skin, an additional antifungal agent is needed.
Impact on the ability to drive vehicles and mechanisms
Data on the adverse effects of Belogent® cream for external use on the ability to drive vehicles and mechanisms are not available.
With prolonged continuous use of the drug, especially in children, on large surfaces of the skin, applied to the skin with impaired integrity or when used under an occlusive dressing, side effects associated with increased absorption of betamethasone or gentamicin may occur. It should be emphasized that the likelihood of such side effects is extremely small.
Symptoms: development of systemic side effects of corticosteroids.
Treatment: It is recommended to cancel the drug and, if necessary, to carry out symptomatic treatment.
- Brand name: Belogent
- Active ingredient: Betamethasone, Gentamicin
- Dosage form: cream for external use
- Manufacturer: Belupo
- Country of Origin: Croatia
Studies and clinical trials of Betamethasone, Gentamicin (Click to expand)
- Experimental Investigations on Interactions between Gentamicin and Betamethasone Dipropionate
- Ophthalmic fluorometholone-gentamicin versus ophthalmic betamethasone-gentamicin following cataract surgery
- Pulpal Responses to Direct Capping with Betamethasone/Gentamicin Cream and Mineral Trioxide Aggregate: Histologic and Micro–Computed Tomography Assessments
- A comparative trial between diclofenac-gentamicin and betamethasone-neomycin drops in patients undergoing cataract extraction
- Betamethasone dipropionate/clotrimazole/gentamicin
- Betamethasone valerate/dexamethasone/gentamicin
- Combination Dermatological Products: a Comparison of Betamethasone Dipropionate/Clotrimazole/Gentamicin Sulphate and Flumethasone Pivalate/Clioquinol Creams