Belogent, ointment, 40g

Composition

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of 1 g of ointment contains:

Active ingredient:  

• betamethasone dipropionate-0.640 mg in terms of betamemetazone-0.500 mg

• gentamicin sulfate in terms of gentamicin base-1,000 mg;

Auxiliary substances:  

• liquid

• paraffin, soft white paraffin.

Pharmacological action

Pharmacodynamics

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).

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, the course of which is complicated by a bacterial infection or there is a risk of its attachment.
• Dermatoses with the addition of a secondary infection or the likelihood of its development: eczema, atopic dermatitis, neurodermatitis, contact dermatitis (including occupational), allergic dermatitis, psoriasis, lichen planus, phleboderma, anogenital pruritus.
• Infected dermatitis caused by insect bites, scabies, scratching, abrasions, thermal skin lesions, and diaper rash.
• Pyoderma of various localization (streptostaphyloderma, impetigo, sinosis, ectima).

Use during pregnancy and lactation

Topical application of Belogent ® ointment for external use in pregnant women 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.

During breastfeeding, the use of the drug Belogent® is possible according to strict indications, but 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

Side effects are usually mild in nature. Rarely, as with other glucocorticosteroids, hypersensitivity reactions (itching, burning or redness), acne-like changes, hypopigmentation, striae, skin atrophy, hypertrichosis, telangiectasia may develop.

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

Interaction

Interactions of Belogent with other medicinal products are unknown.

How to take, course of use and dosage

For external use only.

Belogent ® ointment 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.

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, it is theoretically possible to develop side effects associated with increased absorption of betamethasone or gentamicin. It should be emphasized that the probability of such phenomena is extremely low. Treatment:  it is recommended to cancel the drug and, if necessary, conduct symptomatic treatment.

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 striae, so the continuous application of ointment 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 the preparation Belogent® ointment for external use on the ability to drive vehicles and mechanisms.

Form of production

ointment for external use

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C.

Shelf

life is 4 years.

Active ingredient

Betamethasone, Gentamicin

Dosage form

ointment

Description

Children prescribed by a doctor, Nursing mothers prescribed by a doctor, Children over 1 year old, Pregnant women prescribed by a doctor, For adults

Indications

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