Gusmander (Cream) Instructions for Use

Marketing Authorization Holder

Pharmregister LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

D07CC01 (Betamethasone in combination with antibiotics)

Active Substances

Betamethasone (Rec.INN registered by WHO)

Gentamicin (Rec.INN registered by WHO)

Dosage Form

Gusmander

Cream for external use 0.5 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

Cream for external use is homogeneous, white in color, free from mechanical inclusions, with a characteristic odor.

Excipients: chlorocresol – 1 mg, sodium dihydrogen phosphate monohydrate – 3 mg, phosphoric acid – 0.02 mg, white soft paraffin – 150 mg, liquid paraffin – 60 mg, macrogol cetostearyl ether – 22.5 mg, cetostearyl alcohol – 72 mg, sodium hydroxide – to adjust pH to 4.5-5.5, purified water – 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

Drug with anti-inflammatory action for external use

Pharmacotherapeutic Group

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

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 arachidonic acid metabolism, and induces the formation of lipocortin.

Gentamicin is a broad-spectrum antibiotic from the aminoglycoside group, acting 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; 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 cream to the affected skin areas twice daily, in the morning and evening.

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

For mild cases, a single daily application may be sufficient. Continue application until clinical resolution is achieved.

Limit the treatment duration to two consecutive weeks. Do not exceed this period without medical supervision.

Avoid application on large body surface areas, under occlusive dressings, or on sensitive regions like the face, groin, or axillae for prolonged periods.

If no improvement is observed within 3-5 days, re-evaluate the diagnosis and treatment strategy.

Discontinue use immediately if signs of skin irritation, sensitization, or superinfection appear.

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

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 area – 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-hypothalamic-adrenal system, Cushing’s syndrome, growth retardation, delayed weight gain, increased intracranial pressure (betamethasone) may occur.

Contraindications

Skin tuberculosis; skin manifestations of syphilis; chickenpox; herpes simplex; vaccinia (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 appropriate antibacterial therapy initiated.

It should be borne in mind that systemic absorption increases when applied to large skin areas, using high 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.