Bifasam (Cream) Instructions for Use

Marketing Authorization Holder

Samaramedprom, OJSC (Russia)

ATC Code

D01AC10 (Bifonazole)

Active Substance

Bifonazole (Rec.INN WHO registered)

Dosage Form

Bifasam

Cream for external use 1%: tubes or jars

Dosage Form, Packaging, and Composition

Cream for external use is homogeneous, ranging from colorless with a grayish tint to colorless with a grayish-cream tint.

Excipients: macrogol 400 34.65 g, macrogol 1500 34.65 g, propylene glycol 29.7 g.

30 g – tubes (1) – cardboard packs.
30 g – jars (1) – cardboard packs.

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 part of the fungal cell membrane, leading to a change in its structure and properties.

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

It exhibits 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 the feet and hands, onychomycosis, tinea cruris, pityriasis versicolor, erythrasma, superficial skin candidiasis, candidiasis of the nail folds, nails, genitals; interdigital intertrigo, foot hyperhidrosis.

ICD codes

Dosage Regimen

Apply the cream once daily in a thin layer to the affected skin areas and gently rub in.

Use in the evening before bedtime.

For skin mycoses and erythrasma, the typical treatment duration is 2 to 3 weeks.

For pityriasis versicolor, the typical treatment duration is 1 to 2 weeks.

For cutaneous candidiasis, the typical treatment duration is 2 to 4 weeks.

Continue application for at least 2 weeks after the clinical symptoms have completely resolved to prevent relapse.

For onychomycosis, apply the cream once daily under an occlusive dressing.

Before application, remove the affected parts of the nail using a file or other abrasive means.

The treatment duration for onychomycosis is typically several months until a new, healthy nail fully regrows.

For intertriginous areas, apply the cream once or twice daily.

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

Should be used with caution in infants, under medical supervision.

Special Precautions

Should be used in infants 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.