Pharmaderm^® GK (Cream) Instructions for Use

Marketing Authorization Holder

Pharmasintez, JSC (Russia)

Manufactured By

Lok-Beta Pharmaceuticals (India), Private Limited (India)

Packaging and Quality Control Release

Pharmasintez, JSC (Russia)

ATC Code

D07XC01 (Betamethasone in combination with other drugs)

Active Substances

Clotrimazole (Rec.INN WHO registered)

Betamethasone (Rec.INN WHO registered)

Gentamicin (Rec.INN WHO registered)

Dosage Form

Pharmaderm® GK

Cream for external use 0.5 mg+1 mg+10 mg/1 g: tubes 15 g or 30 g

Dosage Form, Packaging, and Composition

Cream for external use white or almost white, homogeneous, soft consistency, free from foreign inclusions.

Excipients: white soft paraffin – 150 mg, propylene glycol – 100 mg, cetearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%] – 72 mg, liquid paraffin – 60 mg, cetomacrogol 1000 – 22.5 mg, benzyl alcohol – 10 mg, sodium dihydrogen phosphate dihydrate – 2.995 mg, phosphoric acid – 0.03 mg, phosphoric acid or sodium hydroxide – to adjust pH, purified water – up to 1 g.

15 g – laminated aluminum tubes (1) – cardboard boxes.
30 g – laminated aluminum tubes (1) – cardboard boxes.

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Anti-inflammatory, antibacterial, antifungal agent

Pharmacological Action

Combined medicinal product for external use with anti-inflammatory, antiallergic, antifungal (fungicidal), and antibacterial action.

Gentamicin – 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 – a glucocorticosteroid, has anti-inflammatory, antiallergic, and anti-exudative action.

Clotrimazole – an antifungal agent from the group of imidazole derivatives. 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); circumscribed 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 to the affected areas of the skin in a small amount, 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, skin post-vaccination 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

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

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.