Akriderm^® GK (Cream) Instructions for Use

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Contact Information

AKRIKHIN JSC (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 Forms

	Akriderm® GK	Cream for topical application 0.05%+0.1%+1%: tubes 15 g or 30 g
		Ointment for topical application 0.05%+0.1%+1%: tubes 15 g or 30 g

Dosage Form, Packaging, and Composition

Cream for topical application white or almost white in color.

Excipients: petrolatum – 15 g, propylene glycol – 10 g, liquid paraffin – 6 g, cetearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) – 7.2 g, macrogol cetostearyl ether (macrogol-20 cetostearyl ether) – 2.3 g, disodium edetate – 500 mg, sodium dihydrogen phosphate dihydrate – 260 mg, purified water – up to 100 g.

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

Ointment for topical application white or almost white in color, semi-transparent.

* theoretical content of gentamicin sulfate, equivalent to 0.1 g of gentamicin, is 0.1667 g.

Excipients: propylparahydroxybenzoate (nipasol) – 0.05 g, liquid paraffin (mineral oil) – 5 g, isopropyl myristate – 1 g, petrolatum – up to 100 g.

15 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum 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 drug for topical application 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), exerts anti-inflammatory, anti-allergic, and anti-exudative action.

Clotrimazole is 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 the drug is applied topically 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

The drug is applied topically.

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

• Skin tuberculosis;
• Skin manifestations of syphilis;
• Chickenpox;
• Herpes simplex;
• Skin post-vaccination reactions;
• Open wounds;
• Children under 2 years of age;
• Hypersensitivity to the components of the drug.

Use with caution during pregnancy (especially in the first trimester), in children and adolescents aged 2 to 18 years.

Use in Pregnancy and Lactation

During pregnancy (especially in the first trimester), the use of the drug 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 should be short-term and limited to small areas of the skin.

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

Pediatric Use

The use of the drug is contraindicated in children under 2 years of age.

Use with caution in children and adolescents aged 2 to 18 years.

Special Precautions

Avoid contact of the drug with the eyes.

If persistent bacterial or fungal microflora appears, the drug 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, topical application of the drug may lead to the absorption of a proportionally larger amount of active substances and, consequently, there is a greater risk of systemic side effects. The drug should be used in children for the shortest possible time and with all precautions.

Overdose

Symptoms development of symptoms of hypercorticism.

Treatment gradual withdrawal of the drug, symptomatic therapy, if necessary – correction of electrolyte disturbances.

Drug Interactions

Interaction of Akriderm^® GK with other medicinal products has not been established.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed without a prescription.

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.