Belogent, cream, 40g

Composition

>

of 1 g of cream contains

Active ingredient:  

• betamethasone dipropionate-0.640 mg (0.064%) in terms of betamethasone-0.500 mg

• gentamicin sulfate in terms of gentamicin base-1,000 mg (0.1%);

Excipients: chlorocresol, sodium dihydrogen phosphate monohydrate, phosphoric acid, soft white paraffin, liquid paraffin, macrogol cetostearate, cetostearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%], sodium hydroxide, water.

Pharmacological action

Belogent® is an anti-inflammatory, anti-allergic, antipruritic, antibacterial agent.

Betamethasone dipropionate is a synthetic glucocorticosteroid (corticosteroid) that has anti-inflammatory, anti-allergic, antipruritic and vasoconstrictor effects.

When applied to the skin surface, it 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 lowers the permeability of the vascular wall.

It interacts with specific receptors in the cytoplasm of the cell, stimulates the synthesis of mRNA, which induces 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, and leukotrienes (which contribute 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 skin infections.

Active against gram – negative bacteria: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Proteus vulgaris, Klebsiella pneumonia; and gram-positive bacteria: Streptococcus spp. (sensitive strains of beta-and alpha-hemolytic streptococcus group A), Staphylococcus aureus (coagulase-positive, coagulase-negative strains and some penicillinase-producing strains).

Inactive against anaerobes, fungi and viruses.

Pharmacokinetics

When the drug is applied externally in therapeutic doses, the transdermal absorption of active substances into the blood is very insignificant. The use of occlusive dressings increases the absorption of betamethasone and gentamicin, which may lead to an increased risk of side effects.

Indications

• Dermatoses, allergic and inflammatory skin diseases that respond to topical corticosteroid therapy, the course of which is complicated by bacterial infection or there is a risk of its attachment in children from 1 year and adults:
• eczema, diffuse neurodermatitis;
• dermatitis — atopic, contact (including occupational), allergic, seborrheic;
• infected dermatitis that developed as a result of insect bites;
• impetigo;
• psoriasis;
• lichen planus;
• phlebotoderma;
• anogenital pruritus.

Infected dermatitis caused by insect bites, scabies, scratching, abrasions, thermal skin lesions, and diaper rash. Pyoderma of various localization (streptostaphyloderma, impetigo, sycosis, ectima). Belogent ® cream is mainly used for the treatment of acute and subacute stages of inflammatory skin diseases, including those accompanied by exudation.

Use during pregnancy and lactation

Topical application of 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, limited to small areas of the skin.

The drug should not be applied to the skin of the breast before feeding.

Contraindications

Hypersensitivity in patients to betamethasone, gentamicin or any of the auxiliary components of the drug; viral skin infections, skin post-vaccination reactions, open wounds, trophic ulcers, acne vulgaris, rosacea, chickenpox, skin manifestations of syphilis, skin tuberculosis.

Side effects

When using the drug in therapeutic doses, side effects are usually mild.

Rarely, as with other glucocorticosteroids, hypersensitivity reactions (itching, burning, redness), irritation, dry skin, acne-like changes, hypopigmentation, striae, skin atrophy, folliculitis, hypertrichosis, telangiectasia may develop.

With prolonged uncontrolled treatment and application to a large surface, systemic side effects characteristic of corticosteroids may develop.

If a hypersensitivity reaction or side effects occur, therapy should be discontinued and a doctor should be consulted.

Interaction

The interaction of Belogent with other medicinal products is unknown.

How to take, course of use and dosage

For external use only.

Belogent ® cream for external use is applied to the affected area in a thin layer in the amount necessary to cover the affected surface, twice a day, lightly 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 no more than 4 times a day.

The duration of a continuous course of treatment is usually no more than 4 weeks. To prevent relapses in the treatment of chronic diseases, therapy should be continued for some time after all symptoms disappear. Repeated therapy is possible throughout the year.

Overdose

With prolonged continuous use of the drug, especially in children, on extensive skin surfaces, applied to skin with impaired integrity or when used under an occlusive dressing, side effects associated with increased absorption of betamethasone or gentamicin may develop.

It should be emphasized that the probability of such phenomena is extremely low.

Treatment: it is recommended to cancel the drug and, if necessary, prescribe symptomatic therapy.

Special instructions

Long-term (more than 4 weeks) external use of Belogent®is not recommended on the skin of the face, as it is possible to develop rosacea, perioral dermatitis and acne.

Belogent® do not use 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 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 of developing striae, so continuous application of the cream for external use on these areas of the skin should be short (no more than 4 weeks).

In cases of development of fungal microflora on the skin, additional use of an antifungal agent is necessary.

Influence on the ability to drive vehicles and mechanisms

There are no data on the adverse effects of Belogent® cream for external use on the ability to drive vehicles and mechanisms.

Form of production

Cream for external use.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

4 years

Active ingredient

Betamethasone, Gentamicin

Dosage form

cream

Description

Children over 1 year of age, For adults, Nursing mothers as prescribed by a doctor, Pregnant women as prescribed by a doctor, Children as prescribed by a doctor

Indications

Dermatitis, Eczema, Diaper Rash, Dermatosis, Psoriasis, Allergies