Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
MYCOSTATIN CREAM MYCOSTATIN OINTMENT SCHEDULING STATUS: S1 PROPRIETARY NAME (and dosage form) MYCOSTATIN CREAM MYCOSTATIN OINTMENT COMPOSITION MYCOSTATIN CREAM and MYCOSTATIN OINTMENT for topical application each contain 100 000 units nystatin per gram. PHARMACOLOGICAL CLASSIFICATION Category A 20.1.7 Antifungal antibiotics. PHARMACOLOGICAL ACTION Nystatin is an antibiotic with antifungal activity against a wide variety of yeasts and yeast-like fungi. The antifungal activity of nystatin is at least in part dependant on its binding to a sterol moeity, primarily ergosterol, present in the membrane of sensitive fungi, which results in an increase in the permeability of the membrane and leakage of intra- cellular components. Nystatin exhibits no appreciable activity against bacteria. INDICATIONS Treatment of cutaneous mycotic infections, caused by Candida albicans (monilia). Conditions such as athlete's foot (dermatophytosis), perlèche, paronychia, intertrigo, nappy rash and other cutaneous lesions can be expected to respond. The cream is usually preferred to the ointment in moniliasis involving intertriginous areas. CONTRA-INDICATIONS Patients with a history of hypersensitivity to any component. DOSAGE AND DIRECTIONS FOR USE Apply liberally to affected areas twice daily until healing is complete. SIDE-EFFECTS AND SPECIAL PRECAUTIONS Nystatin is virtually non-toxic and non-sensitising and is well tolerated by all age groups including debilitated infants, even on prolonged administration. Large oral doses have occasionally produced diarrhoea and gastro-intestinal disturbance. Local irritation and sensitization (including rash, dermatitis, pruritis and burning) have been reported. If local sensitisation develops, treatment should be discontinued. Nystatin topical preparations should not be used for the treatm Read the complete document