Canespor set: ointment for external use 10 g tube with applicator, 15 plasters, and 1 nail scraper

Pharmacological Properties

Pharmacodynamics. The active ingredient of Canespor and Canespor Set is bifonazole, an imidazole derivative with a broad spectrum of antifungal activity. The preparations are active against dermatophytes, yeasts, molds, and other fungi (Malassezia furfur, Corynebacterium minutissimum). Unlike other azoles and fungicidal drugs, bifonazole inhibits ergosterol biosynthesis at two different levels. Inhibition of ergosterol synthesis leads to structural and functional damage to the cytoplasmic membrane of pathogens.

The MIC for these fungi is 0.062–16 µg/ml or less. Bifonazole shows fungicidal activity against dermatophytes, including the pathogens of trichophytosis.

Bifonazole exhibits strong fungicidal activity against dermatophytes at a concentration of 5 µg/ml with an exposure time of 6 hours. Against yeasts (e.g., Candida species), bifonazole acts mainly fungistatically at 1–4 µg/ml, and fungicidally at 20 µg/ml. Additionally, it shows fungistatic action at concentrations 2–10 times lower than the MIC. A rapid inhibition of proliferating mycelium of Trichophyton mentagrophytes is observed at 3 µg/ml.

For Gram-positive cocci (except enterococci), the MIC of bifonazole is 4–16 µg/ml. For corynebacteria, MIC is 0.5–2 µg/ml. Bifonazole remains effective even in strains resistant to other antifungal agents. Primary resistance is very rare, and no secondary resistance has been observed in previously sensitive strains.

Urea in Canespor Set softens keratinized tissue and facilitates non-invasive, painless removal of the infected nail. It also enhances the penetration of bifonazole into the affected nail, increasing the antifungal effect.

Pharmacokinetics

Bifonazole penetrates well into the affected skin. Six hours after application, concentrations range from 1000 µg/cm³ in the upper epidermis to 5 µg/cm³ in the papillary layer, remaining within antifungal activity levels. The protective effect on the skin lasts for 48–72 hours, allowing for once-daily application. Systemic absorption is minimal, with plasma levels below 1 ng/ml, even during nail treatment.

Indications

Canespor Cream: Treatment of fungal skin infections caused by bifonazole-sensitive pathogens (dermatophytes, yeasts, molds, Malassezia furfur, Corynebacterium minutissimum), superficial candidiasis, tinea pedis, tinea corporis, pityriasis versicolor, erythrasma, and treatment of the nail bed after removal of the nail plate.

Canespor Set: Treatment of fungal nail infections with atraumatic removal of the affected nail and simultaneous antifungal therapy.

Application

Canespor Cream: Apply once daily (preferably at bedtime) as a thin layer and rub gently. Continue treatment for 2–4 weeks depending on the infection, even after symptoms disappear. For example: tinea pedis – 3 weeks, tinea corporis – 2–3 weeks, pityriasis versicolor – 2 weeks, superficial candidiasis – 2–4 weeks.

Canespor Set: Apply once daily to the affected nail, cover with a plaster for 24 hours, then remove, soak, and gently scrape the softened infected nail. Repeat daily for 7–14 days until the infected nail is removed. After removal, continue antifungal treatment with Canespor Cream for about 4 weeks.

Contraindications

Known hypersensitivity to bifonazole or other imidazoles, or to any excipients. Not for vaginal use or for treating scalp infections. Do not apply before removal of the infected nail part for nail treatment.

Side Effects

Possible local skin reactions such as irritation, redness, dermatitis, itching, or burning. Rarely, systemic hypersensitivity reactions may occur. All adverse effects subside after discontinuation.

Special Instructions

Avoid contact with eyes. Do not ingest. Use with caution in patients allergic to other imidazole antifungals. If symptoms persist, consult a physician. During pregnancy, use only if clearly necessary. Breastfeeding should be discontinued during treatment.

Storage Conditions

Store Canespor Cream at room temperature. Store Canespor Set at temperatures below 30°C.