Nystatin for oral administration
Nystatin is an antimycotic (anti fungal) of the polygene groupey, which was discovered in 1950. Nystatin is mainly active against Candida Albicans.; only on particularly sensitive persons all by persons with imunodeficiency it develops into a mycosis, which is a kind of local infection that may occur only on certain part of the body (skin, mouth, vagina, esophagus).
Nystatin is a product which is not absorbed by the gastrointestinal tract but its therapeutically effect is only local, also when it is taken orally the effect is only on the external part of the entertain, and has no systemic effect, only topical and genealogical. The pharmaceutical forms of Nystatin are therefore mostly for topical use (cream, ointment, lotions, chewable tabs, vaginal tabs, etc.)
Recently Nystatin has been used widely for treatment of AIDS patients, which are usually affected by all kind of “opportunistic” infections, including mycosis. Due to the very low toxicity, in comparison with other more effective anti fungal, Nystatin is a good application
It is yellow or slightly brownish crystalline powder. The product is used for preparation of suspensions
| Parameters |
Limits |
| |
|
| Loss on drying |
not more than 5% |
| Microbiological assay |
not less than 5000 IU (dried substance) |
Pharmacopoeial Quality:
USP
Ph. Eur.
BP
Regulatory information:
USA: FDA
Great Britain: MCA
Germany: BfArM
France: AFSSAPS
Italy: MOH
Ukraine: Ministry of health
India: Health Services
Packaging and Shipping:
Double polyethylene bags in zinc coated metal drum (50 and 100 Bou) or double polyethylene bags in fiber drum (100 Bou)
Shelf-life:
3 years in the original packaging
Storage conditions:
up to 25°C