Mycospor^® (Solution, Cream) Instructions for Use

ATC Code

D01AC10 (Bifonazole)

Active Substance

Bifonazole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

External antifungal drug

Pharmacotherapeutic Group

Antifungal agent

Pharmacological Action

Broad-spectrum antifungal agent, an imidazole derivative.

The mechanism of action is associated with the disruption of ergosterol synthesis, which is a component of the fungal cell membrane, leading to a change in its structure and properties.

It is active against dermatophytes, yeasts (including the genus Candida), molds, and other types of fungi (Malassezia furfur).

It also shows activity against Corynebacterium minutissimum.

Pharmacokinetics

It penetrates well into the affected layers of the skin.

Absorption is 0.6-0.8%, and the concentration in blood plasma is not detectable.

Six hours after application, the concentration in the skin reaches or many times exceeds the minimum effective concentration for the main fungi causing dermatomycoses.

It is detected in the skin for 36-48 hours.

Indications

Treatment of fungal diseases caused by microorganisms sensitive to bifonazole: microsporia, trichophytosis of smooth skin and scalp, favus, rubrophytosis, mycoses of feet and hands, onychomycosis, tinea cruris, pityriasis versicolor, erythrasma, superficial skin candidiasis, candidiasis of nail folds, nails, genitals; interdigital intertrigo, foot hyperhidrosis.

ICD codes

Dosage Regimen

Apply a thin layer of the cream or a few drops of the solution to the affected and surrounding skin areas once daily.

Administer the product preferably in the evening before bedtime. Gently rub it in until fully absorbed.

For skin infections, including tinea pedis, tinea cruris, and cutaneous candidiasis, the typical treatment duration is 2 to 4 weeks.

For pityriasis versicolor, continue treatment for 1 to 2 weeks.

For erythrasma, the usual treatment period is 2 to 3 weeks.

In cases of onychomycosis, apply the formulation daily under occlusive dressing until the nail regrows completely. This process may require several months.

Continue application for at least two weeks after the clinical symptoms have completely resolved to prevent relapse.

If no improvement is observed after 3 to 4 weeks of treatment, re-establish the diagnosis.

Avoid contact with the eyes, mucous membranes, and open wounds.

Wash hands thoroughly before and after each application.

Adverse Reactions

Local reactions rarely – slight redness, skin irritation, burning and tingling sensation.

When treating fungal nail diseases, reactions at the edges or on the nail bed are possible (irritation, redness, maceration, peeling, contact dermatitis).

Allergic reactions are possible in predisposed patients.

Contraindications

Hypersensitivity to bifonazole.

Use in Pregnancy and Lactation

Use in the first trimester of pregnancy is possible only for strict indications.

Pediatric Use

Use in infants should be done with caution, under medical supervision.

Special Precautions

Use in infants should be under medical supervision.

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.