Betaderm^® (Ointment) Instructions for Use

Marketing Authorization Holder

Bausch Health, LLC (Russia)

Manufactured By

Pharmaceutical Works Jelfa, S.A. (Poland)

ATC Code

D07CC01 (Betamethasone in combination with antibiotics)

Active Substances

Gentamicin (Rec.INN registered by WHO)

Betamethasone (Rec.INN registered by WHO)

Dosage Form

Betaderm®

Ointment for external use 0.5 mg+1 mg/1 g: tube 15 g

Dosage Form, Packaging, and Composition

Ointment for external use white or almost white, semi-transparent, homogeneous.

Excipients: liquid paraffin, lanolin alcohol, cetearyl alcohol, butylated hydroxytoluene, butylated hydroxyanisole, white petrolatum.

15 g – aluminum tubes with lacquered inner surface (1) – cardboard packs.

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 – a glucocorticosteroid, has local anti-inflammatory, vasoconstrictive, anti-allergic action.

It inhibits the release of cytokines and inflammatory mediators, reduces the metabolism of arachidonic acid, induces the formation of lipocortin.

Gentamicin – a broad-spectrum antibiotic from the aminoglycoside group, acts bactericidally.

It is effective against microorganisms: Streptococcus (beta-hemolytic and alpha-hemolytic), Staphylococcus aureus (coagulase-positive, coagulase-negative, and some strains producing penicillinase), 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; lichen simplex chronicus (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 Betaderm ointment to the affected skin areas twice daily, in the morning and evening.

Gently rub in the ointment until fully absorbed. Limit the application area to the smallest surface necessary for therapeutic effect.

For mild cases, a single daily application may be sufficient. Adjust the frequency based on disease severity and patient response.

The total treatment duration should not exceed two weeks without medical reevaluation. Avoid prolonged continuous use.

Do not use occlusive dressings unless specifically directed by a physician, as this increases systemic absorption.

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

Discontinue use and consult a physician if no improvement is observed within one week, or if condition worsens.

Do not apply to open wounds, severely infected lesions, or in the eye contour. Avoid contact with eyes and mucous membranes.

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 arising as a complication of smallpox vaccination); post-vaccination skin reactions; lactation period (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 the lactation period (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.