Bemilon (Cream) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

ATC Code

D07BC01 (Betamethasone in combination with antiseptics)

Active Substances

Chlorhexidine (Rec.INN registered by WHO)

Betamethasone (Rec.INN registered by WHO)

Dosage Form

Bemilon

Cream for external use: tubes 15 g or 30 g

Dosage Form, Packaging, and Composition

15 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Glucocorticosteroid + antimicrobial agent

Pharmacological Action

A combined drug, the action of which is due to the components that make up its composition.

Betamethasone is a glucocorticosteroid that has local anti-inflammatory, anti-allergic, antipruritic, anti-edematous, and anti-proliferative effects. It has a stronger vasoconstrictor effect than other fluorinated glucocorticosteroids; systemic effects are insignificant due to limited absorption through the skin. When applied to the skin, it prevents the marginal accumulation of neutrophils, which leads to a reduction in exudation, cytokine production, and inhibition of macrophage migration, ultimately resulting in a reduction in infiltration and granulation processes.

Chlorhexidine is an antimicrobial drug that acts on gram-positive and gram-negative microorganisms, yeasts, and dermatophytes.

Indications

Inflammatory and allergic dermatoses complicated by secondary infection and for the prevention of secondary infection

• Psoriasis;
• Parapsoriasis;
• Lipoid necrobiosis;
• Contact dermatitis;
• Atopic dermatitis;
• Eczemas;
• Neurodermatitis;
• Seborrheic dermatitis;
• Erythroderma – annular erythema;
• Nodular erythema;
• Lymphocytoma;
• Benign lymphoplasia;
• Lichen planus – prurigo;
• Phlebotoderma;
• Exfoliative dermatitis;
• Dermatitis herpetiformis;
• Radiation dermatitis;
• Discoid lupus erythematosus;
• Skin itching of various etiologies (including itching of the anus and external genitalia, senile pruritus).

ICD codes

Dosage Regimen

Apply the cream externally in a thin layer to the affected skin areas.

Rub the cream in gently until fully absorbed.

Apply the drug two to three times daily.

For mild cases, a single daily application may be sufficient.

In difficult-to-treat cases, the use of an occlusive dressing is permissible to enhance efficacy.

Do not use occlusive dressings on children.

Limit the treatment course to a maximum of 5 days for pediatric patients.

Limit the treatment course to a maximum of 5 days when treating facial skin lesions.

Discontinue use if irritation develops or if no improvement is observed after a reasonable period.

Avoid application on or near mucous membranes, including the eyes.

Adverse Reactions

Burning, skin itching, steroid acne, striae, dry skin, folliculitis, hypertrichosis, miliaria.

With long-term use – skin atrophy, local hirsutism, telangiectasia, purpura, hypopigmentation; when applied to large surfaces, systemic manifestations characteristic of glucocorticosteroids are possible.

Contraindications

• Skin manifestations of syphilis;
• Skin tuberculosis;
• Viral skin lesions;
• Trophic leg ulcers associated with varicose veins;
• Skin neoplasms;
• Rosacea, acne vulgaris, post-vaccination skin reactions;
• In children under 1 year – rash (due to diaper rash);
• Hypersensitivity to the components of the drug.

With caution in case of long-term use or application to large surfaces – cataract, diabetes mellitus, glaucoma, tuberculosis.

Use in Pregnancy and Lactation

The safety of using topical glucocorticosteroids in pregnant women has not been established. The prescription of this group of drugs during pregnancy is justified only if the potential benefit outweighs the potential risk to the fetus.

Pediatric Use

Contraindicated for the treatment of rash (due to diaper rash) in children under 1 year.

In children, the course of treatment should not exceed 5 days.

Special Precautions

Avoid contact with eyes and mucous membranes. When using the drug on large surfaces and/or with an occlusive dressing, the possibility of developing systemic effects of betamethasone should be considered. In the case of using the drug for acne vulgaris or rosacea, an exacerbation of the disease is possible.

Overdose

Symptoms with long-term use of the drug in high doses, the development of symptoms of hypercorticism is possible.

Treatment symptomatic therapy is carried out. Gradual withdrawal of the drug is recommended. If necessary, correction of the electrolyte balance is performed.

Drug Interactions

Chlorhexidine is incompatible with detergents containing an anionic group (saponins, sodium lauryl sulfate, sodium carboxymethylcellulose) and soaps. The presence of soap can inactivate Chlorhexidine, so before using the drug, soap residues must be thoroughly washed off.

Storage Conditions

At a temperature from 12°C (53.6°F) to 15°C (59°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

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.