Belogent^® (Ointment, Cream) Instructions for Use

ATC Code

D07CC01 (Betamethasone in combination with antibiotics)

Active Substances

Gentamicin (Rec.INN registered by WHO)

Betamethasone (Rec.INN registered by WHO)

Clinical-Pharmacological Group

A drug with antibacterial and anti-inflammatory action for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid + aminoglycoside antibiotic

Pharmacological Action

Combined medicinal product.

Betamethasone is a glucocorticosteroid that exerts local anti-inflammatory, vasoconstrictive, and anti-allergic effects. It inhibits the release of cytokines and inflammatory mediators, reduces the metabolism of arachidonic acid, and induces the formation of lipocortin.

Gentamicin is a broad-spectrum antibiotic from the aminoglycoside group that acts bactericidally. It is effective against microorganisms: Streptococcus (beta-hemolytic and alpha-hemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative, and some penicillinase-producing strains), Proteus vulgaris, Escherichia coli, Pseudomonas aeruginosa, Enterobacter aerogenes. It is not active against anaerobes, fungi, and viruses.

Indications

Simple and allergic dermatitis (especially complicated by secondary infection); eczema; atopic dermatitis; diffuse neurodermatitis; simple chronic lichen (circumscribed neurodermatitis); anogenital pruritus; senile pruritus; seborrheic dermatitis; intertrigo; solar dermatitis; exfoliative dermatitis; psoriasis; erythroderma; lichen planus; dyshidrosis.

ICD codes

Dosage Regimen

Apply a thin layer of Belogent^® ointment or cream to the affected skin areas.

Administer the product twice daily, typically in the morning and evening. For mild cases, a single daily application may be sufficient.

Select the formulation based on the nature of the skin lesion. Use the ointment for dry, scaly, or lichenified conditions such as chronic eczema or psoriasis.

Use the cream for moist, weeping, or intertriginous (skin fold) areas and for conditions affecting oily skin.

Gently rub the preparation into the skin until it is fully absorbed.

Limit the treatment duration to the shortest period necessary to achieve clinical response. Avoid continuous long-term use.

Do not apply to large body surface areas, under occlusive dressings, or on the face, groin, or axillae unless specifically directed by a physician.

Discontinue treatment if significant improvement is not observed within one week. Re-evaluate the diagnosis.

Wash hands thoroughly before and after application, unless the hands are the treated area.

Prevent contact with the eyes, mucous membranes, and open wounds.

Adverse Reactions

Skin and subcutaneous tissue disorders at the application site – burning, itching, irritation, dry skin, folliculitis, hypertrichosis, steroid acne, hypopigmentation. Transient skin irritation is possible: itching, erythematous rashes (Gentamicin).

When using occlusive dressings – skin maceration, infection, skin atrophy, striae, miliaria.

With prolonged treatment or application to a large surface – development of systemic side effects of glucocorticosteroids: weight gain, osteoporosis, increased blood pressure, edema, ulceration of the gastrointestinal mucosa, exacerbation of latent foci of infection, hyperglycemia, agitation, insomnia, menstrual cycle disorders.

Systemic reactions: in children, suppression of the pituitary-hypothalamus-adrenal system, Cushing’s syndrome, growth retardation, delayed weight gain, increased intracranial pressure (betamethasone) are possible.

Contraindications

Tuberculosis of the skin; skin manifestations of syphilis; chickenpox; herpes simplex; vaccinia (a dermatosis occurring as a complication of smallpox vaccination); post-vaccination skin reactions; lactation (breastfeeding); hypersensitivity.

With caution

First trimester of pregnancy.

Use in Pregnancy and Lactation

Use with caution during pregnancy, especially in the first trimester.

Contraindicated for use during lactation (breastfeeding).

Special Precautions

Avoid contact with eyes.

If signs of sensitization or irritation appear, treatment should be discontinued.

In case of superinfection development, the drug should be discontinued and adequate antibacterial therapy prescribed.

It should be borne in mind that systemic absorption increases when applied to large areas of the skin, when using large doses and for a long time, as well as when applied under occlusive dressings.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.