
Fungostatin
FORMULA:
Each 1 ml suspension contains 100.000 units nystatin.
PHARMACOLOGICAL PROPERTIES:
Nystatin interferes with the permeability of the cell membrane of sensitive fungi by binding to sterols especially ergosterol so leakage of intracellular components to extracellular space.
Nystatin is poorly absorbed from the gastrointestinal tact. At the recommended oral doses nystatin blood concentrations undetectable. Administered dose appearing in the feaces as unchanged drug.
INDICATIONS:
Fungostatin Oral Suspension is indicated for the treatment of oral Candidiasis.
CONTRAINDICATIONS:
Fungostatin Oral Suspension is contraindicated in patients with a history of hypersensitivity to any of its components.
WARNINGS / PRECAUTIONS:
Pregnancy: Pregnancy category C. There have been no reports that use of nystatin oral suspension by pregnant women increases the risk of fetal abnormalities or affects later growth, development and functional maturation of the child.
DOSAGE and ADMINISTRATION:
Dosage and administration in newborns:
The recommended dosage in newborns is 2 ml (200.000 units) four times daily. 2 ml of the preparation is equally applied each side of the buccal cavity.
In premature or poor children, recommended dosage is 1 ml four times daily.
Dosage and administration in children and adults:
The recommended dosage in children and adults is 4-6 ml (400.000 - 800.000 units) four times daily.
Dosage applies each side of the buccal cavity equally. Suspension should be kept in contact with the affected oral area for as long as possible.
Treatment should be continue until following 24 hours disappearing of oral symptoms and normal culture results.
Directions for preparing suspension:
Add the half of total amount of water for reconstitution and replace the cap. Shake the bottle vigorously rock the bottle from side to side so that water rises through the powder. After mixing, rest preparation for a period, add other half of the water until the line. After replace the cap, shake in 20-second interval for a few minutes and use it.
Replace cap securely after each opening. The reconstituted suspension should be stored in the refrigerator. DISCARD AFTER 10 DAYS.
HOW SUPPLIED:
Fungostatin Powder for Oral Suspension: It is supplied in glass bottle contains 48 doses.