Please refer to the PRECAUTIONS section.
Nystatin cream 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, And 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 the effects on male or female fertility.
Animal reproduction studies have not been conducted with
any nystatin cream. It also is not known whether this cream can cause fetal
harm when used by a pregnant woman or can affect reproductive capacity.
Nystatin cream 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.)
Clinical studies with nystatin cream did not include
sufficient numbers of subjects aged 65 years and older to determine whether
they respond differently than younger subjects. Other reported clinical experience
has not identified differences in responses between elderly and younger
patients, but greater sensitivity of some older individuals cannot be ruled