Betanecin Genta (Ointment) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

D07CC01 (Betamethasone in combination with antibiotics)

Active Substances

Gentamicin (Rec.INN registered by WHO)

Betamethasone (Rec.INN registered by WHO)

Dosage Form

Betanecin Genta

Ointment for external use 0.50 mg+1 mg/1 g: tubes 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 50 g, 60 g, 70 g, 80 g, or 100 g

Dosage Form, Packaging, and Composition

Ointment for external use white in color, homogeneous, semi-transparent.

Excipients : liquid paraffin – 50 mg, white soft paraffin – up to 1 g.

10 g – aluminum tubes (1) – cardboard packs.
15 g – aluminum tubes (1) – cardboard packs.
20 g – aluminum tubes (1) – cardboard packs.
25 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
35 g – aluminum tubes (1) – cardboard packs.
40 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
60 g – aluminum tubes (1) – cardboard packs.
70 g – aluminum tubes (1) – cardboard packs.
80 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs

Clinical-Pharmacological Group

Topical corticosteroids + aminoglycoside antibiotic

Pharmacotherapeutic Group

Corticosteroids used in dermatology; corticosteroids in combination with antibiotics; high-potency corticosteroids in combination with antibiotics

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, and 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 ointment to the affected skin areas twice daily, in the morning and evening.

Gently rub in until absorbed. Use the minimum amount necessary to cover the treatment area.

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

Limit the treatment duration to two weeks for continuous use unless directed otherwise by a physician.

Avoid application on large body surface areas, on skin with compromised integrity, or under occlusive dressings due to increased risk of systemic absorption.

Do not use on the face, groin, or axillae unless specifically prescribed.

Wash hands thoroughly before and after application, unless hands are the treatment site.

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

Monitor for potential local adverse reactions such as skin atrophy, striae, or signs of sensitization with prolonged use.

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

Skin tuberculosis; skin manifestations of syphilis; chickenpox; herpes simplex; vaccinia (a dermatosis occurring 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 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 should be 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.