No information provided.
Nystatin Topical Powder should not be used for the
treatment of systemic, oral, intravaginal or ophthalmic infections.
If irritation or sensitization develops, treatment should
be discontinued and appropriate measures taken as indicated. It is recommended
that KOH smears, cultures, or other diagnostic methods be used to confirm the
diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection
caused by other pathogens.
If there is a lack of therapeutic response, KOH smears,
cultures, or other diagnostic methods should be repeated.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No long-term animal studies have been performed to
evaluate the carcinogenic potential of nystatin. No studies have been performed
to determine the mutagenicity of nystatin or its effects on male or female fertility.
Category C. Animal reproduction studies have not been
conducted with any nystatin topical preparation. It also is not known whether
these preparations can cause fetal harm when used by a pregnant woman or can
affect reproductive capacity. Nystatin topical preparations should be
prescribed for a pregnant woman only if the potential benefit to the mother
outweighs the potential risk to the fetus.
It is not known whether nystatin is excreted in human
milk. Caution should be exercised when nystatin is prescribed for a nursing
Safety and effectiveness have been established in the
pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION).