CONTRAINDICATIONS
Nystatin is contraindicated in patients with a history of hypersensitivity to any of their components.
PRECAUTIONS
General
Cream, Topical Powder, and Ointment: Should a reaction of hypersensitivity occur the drug
should be immediately withdrawn and appropriate measures taken.
These preparations are not for ophthalmic use.
Oral Suspension and Oral Tablets: Usage in Pregnancy: No adverse effects or complications
have been attributed to nystatin in infants born to women treated with nystatin.
Vaginal Tablets: Discontinue treatment if sensitization or irritation is reported during use.
Pastilles: This medication is not to be used for the treatment of systemic mycoses. In order to
achieve maximum effect from the medication, pastilles must be allowed to dissolve slowly in the
mouth; therefore, patients for whom the pastille is prescribed, including children and the elderly,
must be competent to utilize the dosage form as intended.
If irritation or hypersensitivity develops with nystatin pastilles, treatment should be discontinued and
appropriate therapy instituted.
Information for the Patient
Vaginal Tablets: The patient should be informed of symptoms of sensitization or irritation and told
to report them promptly.
The patient should be warned against interruption or discontinuation of medication even during
menstruation and even though symptomatic relief may occur within a few days.
The patient should be advised that adjunctive measures such as therapeutic douches are
unnecessary and sometimes inadvisable, but cleansing douches may be used by nonpregnant
women, if desired, for esthetic purposes.
Pastilles: Patients taking this medication should receive the following information and instructions:
1. Use as directed; the medication is not for any disorder other than for which it was
prescribed.
2. Allow the pastille to dissolve slowly in the mouth; do not chew or swallow the pastille.
3. The patient should be advised regarding replacement of any missed doses.
4. There should be no interruption or discontinuation of medication until the prescribed course
of treatment is completed even though symptomatic relief may occur within a few days.
5. If symptoms of local irritation develop, the physician should be notified promptly.
6. Good oral hygiene, including proper care of dentures, is particularly important for denture
wearers.
Laboratory Tests
Vaginal Tablets: If there is a lack of response to nystatin vaginal tablets, appropriate
microbiological studies should be repeated to confirm the diagnosis and rule out other pathogens
before instituting another course of antimycotic therapy (see INDICATIONS AND USAGE).
Pastilles: If there is a lack of therapeutic response, appropriate microbiological studies (e.g., KOH
smears and/or cultures) should be repeated to confirm the diagnosis of candidiasis and rule out other
pathogens before instituting another course of therapy.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Vaginal Tablets: Long-term studies in animals have not been performed to evaluate carcinogenic
potential, mutagenesis, or whether this medication effects fertility in females.
There have been no reports that use of Nystatin vaginal tablets by pregnant women increases the
risk of fetal abnormalities or affects later growth, development and functional maturation of the
child. Nevertheless, because the possibility of harm cannot be ruled out, nystatin vaginal tablets
should be used during pregnancy only if the physician considers it essential to the welfare of the
patient.
Animal reproduction studies have not been conducted with nystatin vaginal tablets.
Pastilles: Studies have not been performed to evaluate carcinogenic or mutagenic potential, or
possible impairment of fertility in males or females.
Animal reproduction studies have not been conducted with nystatin pastilles. It is also not known
whether nystatin pastilles can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. Nystatin pastilles should be dispensed to a pregnant woman only if
clearly needed.
Pediatric Use:
Vaginal Tablets: Safety and effectiveness in children have not been established.
Pastilles: See PRECAUTIONS, General.