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Nystatin Vaginal (Nystatin Vaginal) - Warnings and Precautions



General:    Discontinue treatment if sensitization or irritation is reported during use.

Information for Patients:    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.

Laboratory Tests:    If there is a lack of response to Nystatin Vaginal Tablets, USP, 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).

Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential, mutagenesis, or whether this medication effects fertility in females.

Pregnancy:    Teratogenic Effects: Pregnancy Category A. 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.

Pediatric Use:    Safety and effectiveness in pediatric patients have not been established.

Page last updated: 2006-11-07

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