Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Bayer
MYCOSPOR® ONYCHO-SET SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): MYCOSPOR ® ONYCHO-SET COMPOSITION: Bifonazole 10 mg Urea 400 mg Inert ointment base to 1 g PHARMACOLOGICAL CLASSIFICATION: A.13.9.2. Fungicides PHARMACOLOGICAL ACTION: Bifonazole is a broad-spectrum antifungal. Its in vitro activity against dermatophytes (e.g. Trichophyton spp.) is primarily fungicidal whereas that against yeasts is primarily fungistatic. In this formulation the addition of urea allows for the softening of the infected nail keratin, which permits non-invasive and painless detachment of the infected nail. INDICATIONS: Treatment of nails infected with dermatophytes, Candida species, yeasts and Aspergillus species. CONTRA-INDICATIONS: Sensitivity to bifonazole and urea. WARNING: For external use only. DOSAGE AND DIRECTIONS FOR USE: Apply sufficient Mycospor Onycho-Set Ointment to cover the entire nail, once a day. Cover the treated nail for 24 hours with a waterproof plaster. Change dressing daily. Remove plaster and soak nails in warm water for about 10 minutes. Remove as much of the softened infected nail as possible. Dry nail and apply Mycospor Onycho-Set Ointment as before and cover with plaster. This treatment must be carried out carefully each day and continued until no more softened, fungally infected nail substance can be scraped off. Mycospor Onycho-set ointment acts only on fungally infected nails; healthy areas remain unaffected. The treating physician should check that the infected nail has been completely removed. After detachment of the nail, antimycotic treatment of the nail bed with Mycospor Cream or Solution should be carried out for about 4 weeks. Treatment can only be successful if the instructions for use are followed exactly: Bathe the foot or hand in warm water, Read the complete document