Amyclon (Cream) Instructions for Use

Marketing Authorization Holder

Nizhpharm JSC (Russia)

ATC Code

D01AC01 (Clotrimazole)

Active Substance

Clotrimazole (Rec.INN registered by WHO)

Dosage Form

Amyclon

Cream 1%: tubes 10 g, 15 g, or 20 g

Dosage Form, Packaging, and Composition

Cream 1% white or almost white in color.

Excipients: white soft paraffin, peach oil, macrogol 400, emulsifier No. 1, nipagin, nipasol, purified water.

10 g – tubes (1) – cardboard packs.
15 g – tubes (1) – cardboard packs.
20 g – tubes (1) – cardboard packs.

Clinical-Pharmacological Group

External and topical antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Antifungal drug from the group of imidazole derivatives for external and topical use. It reduces the synthesis of ergosterol, which is a component of the microbial cell membrane, leading to a change in its structure and properties, causing cell lysis.

In low concentrations, it has a fungistatic effect, and in high concentrations, it has a fungicidal effect, not only on proliferating cells.

In fungicidal concentrations, it interacts with mitochondrial enzymes and peroxidases, resulting in an increase in the concentration of hydrogen peroxide to a toxic level, which also contributes to the destruction of fungal cells.

Active against pathogenic dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), yeast and mold fungi (genus Candida, Torulopsis glabrata, genus Rhodotorula, Malassezia furfur), the causative agents of pityriasis versicolor, erythrasma, gram-positive (Staphylococcus, Streptococcus, Corinobacterium minutissimum) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), Trichomonas vaginalis.

Pharmacokinetics

The drug accumulates in the stratum corneum of the epidermis. The concentration in the deep layers of the epidermis is higher than the MIC for dermatophytes.

Amyclon is poorly absorbed through the skin and mucous membranes and has virtually no systemic effect.

Indications

• Skin and mucous membrane mycoses (including dermatomycosis, dermatophytosis, trichophytosis, epidermophytosis, microsporia, candidamycosis);
• Interdigital fungal erosion;
• Fungal paronychia;
• Candidal balanitis;
• Pityriasis versicolor;
• Erythrasma;
• Mycoses complicated by secondary pyoderma.

ICD codes

Dosage Regimen

The drug is intended for external and topical use. Amyclon cream is applied in a thin layer to the affected areas of the skin and mucous membranes 2-3 times/day and gently rubbed in.

A single dose for an area the size of a palm is a 5 mm long strip of cream.

The course of treatment averages about 4 weeks. After achieving the therapeutic effect, it is advisable to continue using the drug for another 14 days. The duration of therapy for erythrasma is 2-4 weeks, for pityriasis versicolor – 1-3 weeks.

For fungal infections of the skin of the feet, after achieving the therapeutic effect, it is recommended to continue treatment for 2-3 weeks.

Before using the drug, wash the feet with warm water and soap, dry thoroughly, especially between the toes.

Adverse Reactions

Allergic reactions: itching, urticaria.

Local reactions: burning sensation, tingling at the site of cream application, erythema, edema, irritation, peeling.

Contraindications

• First trimester of pregnancy;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The drug Amyclon is contraindicated for use in the first trimester of pregnancy.

The issue of the advisability of prescribing the drug in the second and third trimesters of pregnancy should be decided individually.

Caution should be exercised when using the drug during lactation.

Special Precautions

Use in pediatrics

Clinical data on the efficacy and safety of the drug Amyclon in children are not available.

Overdose

Data on overdose of the drug Amyclon are not provided.

Drug Interactions

With simultaneous use of amphotericin B, nystatin and natamycin with clotrimazole, a decrease in the effectiveness of the latter is noted.

Storage Conditions

The drug should be stored in a dry place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.