Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
MYCOSTATIN ORAL SUSPENSION SCHEDULING STATUS: S2 PP ZIMBABWE ONLY PROPRIETARY NAME (and dosage form) MYCOSTATIN ORAL SUSPENSION COMPOSITION MYCOSTATIN ORAL SUSPENSION contains 100 000 units nystatin per mL, preserved with methylparaben 0,1% m/v and propylparaben 0,02% m/v.Contains 0,5% v/v ethyl alcohol. PHARMACOLOGICAL CLASSIFICATION Category A 20.1.7 Antifungal antibiotics. PHARMACOLOGICAL ACTION Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. 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 dependent 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, protozoa or viruses. INDICATIONS Treatment of candidal (monilial) infections of the oral cavity. CONTRA-INDICATIONS Patients with a history of hypersensitivity to any component. Safety in pregnancy and lactation has not been established. It is not known whether nystatin is excreted in human milk. DOSAGE AND DIRECTIONS FOR USE INFANTS: The usual dose is 1 mL to 2 mL (100 000 to 200 000 units) four times daily, dropped into the mouth. CHILDREN AND ADULTS: The usual dose is 1 mL to 2 mL (100 000 to 200 000 units) four times daily, dropped into the mouth and held for some time before swallowing. This dose may be increased to 4 mL to 6 mL (400 000 to 600 000 units) four times daily for more severe infections. (On administration by dropper, the suspension readily disperses throughout the mouth, and is compatible with commo Read the complete document