No Information Provided.

General:    This medication is not to be used for the treatment of systemic mycoses.

In order to achieve maximum effect from the medication, MYCOSTATIN (nystatin lozenges, USP) PASTILLES must be allowed to dissolve slowly in the mouth; therefore, patients for whom the MYCOSTATIN PASTILLE is prescribed, including pediatric patients and the elderly, must be competent to utilize the dosage form as intended.

If irritation or hypersensitivity develops with MYCOSTATIN PASTILLES, treatment should be discontinued and appropriate therapy instituted.

Information for the Patient:   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 MYCOSTATIN 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:   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, Impairment of Fertility: Studies have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.

Pregnancy: Teratogenic Effects:   "Category C". Animal reproduction studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MYCOSTATIN PASTILLES should be dispensed to a pregnant woman only if clearly needed.

Nursing Mothers:   It is not known whether nystatin is excreted in human milk. Although gastrointestinal absorbtion is insignificant, caution should be exercised when nystatin is prescribed for a nursing woman.

Pediatric Use:   The use of MYCOSTATIN PASTILLES has not been systematically studied in pediatric patients.

Bookmark this page: