Betaminol ZD Trio (Ointment) Instructions for Use

Marketing Authorization Holder

Zelenaya Dubrava, CJSC (Russia)

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Clotrimazole (Rec.INN registered by WHO)

Gentamicin (Rec.INN registered by WHO)

Betamethasone (Rec.INN registered by WHO)

Dosage Form

Betaminol ZD Trio

Ointment for external use 0.5 mg+1 mg+10 mg/1 g: tubes 15 g, 30 g, 40 g, or 50 g

Dosage Form, Packaging, and Composition

Ointment for external use from white to light yellow in color, homogeneous, semi-transparent, and free from foreign inclusions.

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

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

Clinical-Pharmacological Group

Topical corticosteroids + aminoglycoside antibiotic + antifungal agent

Pharmacotherapeutic Group

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

Pharmacological Action

A combined medicinal product for external use with anti-inflammatory, anti-allergic, antifungal (fungicidal), and antibacterial action.

Gentamicin is a broad-spectrum bactericidal antibiotic from the aminoglycoside group, highly active against gram-negative bacteria Proteus spp. (indole-positive and indole-negative strains), Escherichia coli, Klebsiella spp., Salmonella spp., Shigella spp., Campylobacter spp., Staphylococcus spp. (methicillin-resistant). Active against Serratia spp., Pseudomonas spp., Acinetobacter spp., Citrobacter spp. Resistant to gentamicin are Neisseria meningitidis, Treponema pallidum, anaerobic microorganisms (Streptococcus spp. (except Streptococcus pneumoniae), Providencia rettgeri).

Betamethasone is a glucocorticosteroid (GCS) that exerts anti-inflammatory, anti-allergic, and anti-exudative effects.

Clotrimazole is an antifungal agent from the imidazole derivatives group. It acts by disrupting the synthesis of ergosterol, which is a component of the fungal cell membrane. It has a broad spectrum of action. Active against pathogenic dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), yeast and mold fungi (Candida albicans, Turolopsis glabrata, Rhodotorula spp., Pityrosporum orbiculare).

Pharmacokinetics

When this combination is applied externally in therapeutic doses, the transdermal absorption of the active substances into the blood is very insignificant. When applied to the skin, the intensity of betamethasone absorption depends on the condition of the epidermal barrier (inflammation and skin diseases increase absorption).

The use of occlusive dressings increases the transdermal absorption of betamethasone and gentamicin, which may lead to an increased risk of systemic side effects.

Indications

Simple and allergic dermatitis (especially complicated by secondary infection); diffuse neurodermatitis (including atopic dermatitis); limited neurodermatitis (including lichen simplex chronicus); eczema; dermatomycoses (dermatophytosis, candidiasis, pityriasis versicolor), especially when localized in the groin area and large skin folds.

ICD codes

Dosage Regimen

Apply externally.

The cream or ointment is applied in a small amount to the affected areas of the skin, rubbing gently, 2 times/day. The duration of treatment is determined individually and depends on the nosological form and severity of the disease. For dermatomycosis of the feet, the average duration of treatment is 2-4 weeks.

If clinical improvement does not occur in the near future, it is necessary to clarify the diagnosis or change the treatment regimen.

Adverse Reactions

Local reactions: itching, burning sensation, irritation, dry skin, folliculitis, hypertrichosis, steroid acne, hypopigmentation, allergic reactions. When using occlusive dressings – maceration, infection, skin atrophy, striae, miliaria.

Systemic reactions with prolonged treatment or application to large skin surfaces – weight gain, osteoporosis, increased blood pressure, edema, ulceration of the gastrointestinal mucosa, exacerbation of latent foci of infection, hyperglycemia, agitation, insomnia, dysmenorrhea.

Contraindications

Hypersensitivity to the components of the combination, skin tuberculosis, skin manifestations of syphilis, chickenpox, herpes simplex, post-vaccination skin reactions, open wounds, children under 2 years of age.

With caution

Pregnancy (especially the first trimester), children and adolescents aged 2 to 18 years.

Use in Pregnancy and Lactation

During pregnancy (especially in the first trimester), use is allowed only in cases where the intended benefit to the mother outweighs the potential risk to the fetus. In such cases, the use of the drug containing this combination should be short-term and limited to small areas of the skin.

It is not known whether the components of the combination are excreted in breast milk. Therefore, if it is necessary to use during lactation, breastfeeding should be discontinued.

Pediatric Use

Contraindicated for use in children under 2 years of age.

Should be used with caution in children and adolescents aged 2 to 18 years.

Special Precautions

Avoid contact with eyes.

If persistent bacterial or fungal microflora appears, the drug containing this combination should be discontinued and appropriate therapy prescribed.

Use in pediatrics

Due to the fact that in children the skin surface area relative to body weight is larger than in adults, and the epidermis is not sufficiently developed, when applying the drug containing this combination externally, the absorption of a proportionally larger amount of active substances is possible and, consequently, there is a greater risk of systemic side reactions. Use in children should be for the shortest possible duration and with all precautions observed.

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.