Mycostatin Special Precautions

General: Should not be used for the treatment of systemic mycoses.
If irritation or sensitization develops, treatment should be discontinued.
It is recommended that potassium hydroxide (KOH) smears, cultures, or other diagnostic methods be used to confirm the diagnosis of candidiasis and to rule out infection caused by other pathogens.
Information for the Patient: Patients taking Mycostatin should receive the following information and instructions: Use Mycostatin as directed. Mycostatin is not for any disorder other than that for which it was prescribed. Even if symptomatic relief occurs within the 1st few days of treatment, do not interrupt or discontinue Mycostatin until the prescribed course of treatment is completed. If symptoms of irritation develop, advise the physician promptly. Good oral hygiene is of importance, including the proper care (where applicable) of dentures.
Carcinogenicity, Mutagenicity & 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 effect on male or female fertility.
Use in pregnancy: Animal reproduction studies have not been conducted with Mycostatin oral suspension. It is also not known whether Mycostatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Mycostatin oral suspension should be prescribed to pregnant women only if the potential benefit to the mother outweighs the potential risk to the fetus.
Use in lactation: It is not known whether nystatin is excreted in human milk. Though gastrointestinal absorption is insignificant, caution should be exercised when nystatin is prescribed to nursing women.